Inspection Report - Southern Railway
Inspection Report - Southern Railway
Inspection Report - Southern Railway
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Proforma to be filled up by the Inspecting Team<br />
Note: <strong>Inspection</strong> is to be done by respective Zonal <strong>Railway</strong>s in whose jurisdiction<br />
the Manufacturing Unit is located. Wherever there is inadequate space please<br />
submit information in separate sheet enclosed and marked as Annexure (Also<br />
having item no. of this proforma in reference to which Annexure is prepared)<br />
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
1 Name of the firm Tablets (India) Limited,<br />
Jhaver Centre, 72<br />
Marshalls Road,<br />
Chennai 600 008<br />
2 Whether the firm is having registered<br />
office/Branch office. Give address and<br />
Telephone no in case more than one<br />
manufacturing unit - details all to be<br />
inspected<br />
In case marketing a product manufactured<br />
by other company. If 'yes' that also to be<br />
inspected<br />
3 Whether the firm is having 5 years<br />
standing marketing/manufacturing of<br />
pharmaceutical products<br />
4 Whether firm is having 3 years standing in<br />
marketing/manufacturing of each<br />
individual product to which it wishes to get<br />
Registered (in case 'No' names of such<br />
product to be given)<br />
5 Whether valid drug license for each<br />
product exists from Drug Controller (In<br />
case Names of such product to be given)<br />
6 Audited annual turn over figures for each<br />
product for the last 3 years<br />
7 Whether WHO GMP certificate for<br />
production unit/s is there<br />
8 Whether any other certificate for<br />
firm/manufacturing and manufacturing<br />
process (as desired in item 4 of terms and<br />
conditions exit)<br />
Yes<br />
Tablets (India) Limited,<br />
Jhaver Centre, 72<br />
Marshalls Road,<br />
Chennai 600 008<br />
Allianz Biosciences<br />
Private Limited, 55/1,2 &<br />
3, Thiruvandar Koil<br />
Street, Whirlpool Road,<br />
Pondicherry 605 102<br />
Yes<br />
Yes<br />
Yes<br />
2004-05 8,720,71 lakhs<br />
2005-06 10,556.27 lakhs<br />
2006-07 11,692.78 lakhs<br />
9 Company turn over figure for last 3 years 2004-05 8,720,71 lakhs<br />
10 R&D facilities with firm. Annual<br />
expenditure in R&D in last 3 years<br />
Yes<br />
yes<br />
2005-06 10,556.27 lakhs<br />
2006-07 11,692.78 lakhs<br />
2004-05 164.18 lakhs<br />
2005-06 213.61 lakhs<br />
2006-07 314.86 lakhs
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
11 Name of Original research<br />
products/formulations developed by firm<br />
enclosed as annexure I<br />
12 Names of products for which firm is<br />
original manufacturer<br />
enclosed as annexure I<br />
13 Whether any punitive action has been<br />
taken or contemplated State/Central<br />
Institution/Drug Controller. If yes give<br />
details<br />
14 Relevant information for each specific<br />
product as per ORG-MARG analysis or by<br />
any other agency<br />
15 a) Names of imported drug items supplied<br />
by firm. List of developed countries where<br />
item is approved and supplied<br />
b) The source of manufactured raw/finished<br />
products for quality report<br />
c) Authorization letter by OEM abroad for<br />
local agent<br />
16 Other conditions<br />
No<br />
enclosed as annexure J<br />
Nil<br />
a) Cleanliness of premises Clean<br />
b) Whether plan is manual or automatic<br />
and level of automation<br />
c)Quality of packaging and packaging<br />
system<br />
d) Availability of sterile room yes<br />
e) Degree of hand handling in<br />
manufacturing process<br />
f) Availability of technically qualified staff yes<br />
g) Quality control inhouse lab/outsource yes<br />
Not applicable<br />
Not applicable<br />
Automatic<br />
Excellent<br />
Minimal<br />
17 Date of inspection 03.11.2008<br />
18 i) Place of inspection Pondicherry<br />
ii) Storage facility holding time for<br />
manufactured products<br />
19 Name and designation of the company<br />
official accompanying for inspection<br />
yes<br />
Mr Senthil,<br />
Chief Production<br />
Manager,
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
20 Whether firm is recommended suitable for Yes<br />
registration. Whether the product being<br />
Available in open market<br />
applied by firms for registgration are<br />
in the same brand name<br />
available in open market with some brand<br />
in southern region<br />
name and the region<br />
21 Name and Designation of the Team<br />
Member<br />
Signature<br />
1) Dr. N.Kannan<br />
Chief Paediatrician, Rly Hospital,<br />
Perambur<br />
2) K.Satyababu,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur<br />
3)Dr. A.P.Preetham,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur
Proforma to be filled up by the Inspecting Team<br />
Note: <strong>Inspection</strong> is to be done by respective Zonal <strong>Railway</strong>s in whose jurisdiction<br />
the Manufacturing Unit is located. Wherever there is inadequate space please<br />
submit information in separate sheet enclosed and marked as Annexure (Also<br />
having item no. of this proforma in reference to which Annexure is prepared)<br />
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
1 Name of the firm Baxter (India) Pvt Ltd, 2nd<br />
Floor, Tower C, Building<br />
no.8, DLF Cyber City, DLF<br />
Phase II, Gurgaon 122 002,<br />
Haryana<br />
2 Whether the firm is having registered<br />
office/Branch office. Give address and<br />
Telephone no in case more than one<br />
manufacturing unit - details all to be<br />
inspected<br />
In case marketing a product manufactured<br />
by other company. If 'yes' that also to be<br />
inspected<br />
3 Whether the firm is having 5 years<br />
standing marketing/manufacturing of<br />
pharmaceutical products<br />
4 Whether firm is having 3 years standing in<br />
marketing/manufacturing of each<br />
individual product to which it wishes to get<br />
Registered (in case 'No' names of such<br />
product to be given)<br />
5 Whether valid drug license for each<br />
product exists from Drug Controller (In<br />
case 'No' names of such product to be<br />
given)<br />
6 Audited annual turn over figures for each<br />
product for the last 3 years<br />
7 Whether WHO GMP certificate for<br />
production unit/s is there<br />
8 Whether any other certificate for<br />
firm/manufacturing and manufacturing<br />
process (as desired in item 4 of terms and<br />
conditions exit)<br />
Yes<br />
Baxter (India) Pvt Ltd, 2nd<br />
Floor, Tower C, Building<br />
no.8, DLF Cyber City, DLF<br />
Phase II, Gurgaon 122 002,<br />
Haryana<br />
Baxter (India) Pvt Ltd, 69/72,<br />
SIDCO Pharmaceuticals<br />
Complex, Alathur, 603<br />
110<br />
Yes<br />
Yes<br />
Yes<br />
2004-05 17631.89 lakhs<br />
2005-06 20315.63 lakhs<br />
2006-07 26151.65 lakhs<br />
9 Company turn over figure for last 3 years 2004-05 17631.89 lakhs<br />
10 R&D facilities with firm. Annual<br />
expenditure in R&D in last 3 years<br />
Yes<br />
yes<br />
2005-06 20315.63 lakhs<br />
2006-07 26151.65 lakhs<br />
Not available
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
11 Name of Original research F. 150 to 182<br />
products/formulations developed by<br />
firm<br />
12 Names of products for which firm is<br />
original manufacturer<br />
F 185 to F 193<br />
13 Whether any punitive action has been<br />
taken or contemplated State/Central<br />
Institution/Drug Controller. If yes give<br />
details<br />
14 Relevant information for each specific<br />
product as per ORG-MARG analysis or<br />
by any other agency<br />
15 a) Names of imported drug items<br />
supplied by firm. List of developed<br />
countries where item is approved and<br />
supplied<br />
b) The source of manufactured<br />
raw/finished products for quality report<br />
c) Authorization letter by OEM abroad<br />
for local agent<br />
16 Other conditions<br />
No<br />
Nil<br />
a) Cleanliness of premises Clean<br />
b) Whether plan is manual or automatic<br />
and level of automation<br />
c)Quality of packaging and packaging<br />
system<br />
d) Availability of sterile room yes<br />
e) Degree of hand handling in<br />
manufacturing process<br />
f) Availability of technically qualified<br />
staff<br />
Not applicable<br />
Not applicable<br />
Automatic<br />
Excellent<br />
Minimal<br />
yes<br />
g) Quality control inhouse lab/outsource yes<br />
17 Date of inspection<br />
18 i) Place of inspection Alathur<br />
ii) Storage facility holding time for<br />
manufactured products<br />
19 Name and designation of the company<br />
official accompanying for inspection<br />
yes
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
20 Whether firm is recommended suitable for Yes<br />
registration. Whether the product being<br />
Available in open market in<br />
applied by firms for registgration are<br />
the same brand name in<br />
available in open market with some brand<br />
southern region<br />
name and the region<br />
21 Name and Designation of the Team<br />
Member<br />
Signature<br />
1) Dr. N.Kannan<br />
Chief Paediatrician, Rly Hospital,<br />
Perambur<br />
2) K.Satyababu,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur<br />
3)Dr. A.P.Preetham,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur
Proforma to be filled up by the Inspecting Team<br />
Note: <strong>Inspection</strong> is to be done by respective Zonal <strong>Railway</strong>s in whose jurisdiction<br />
the Manufacturing Unit is located. Wherever there is inadequate space please<br />
submit information in separate sheet enclosed and marked as Annexure (Also<br />
having item no. of this proforma in reference to which Annexure is prepared)<br />
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
1 Name of the firm Tablets (India) Limited,<br />
Jhaver Centre, 72<br />
Marshalls Road,<br />
Chennai 600 008<br />
2 Whether the firm is having registered<br />
office/Branch office. Give address and<br />
Telephone no in case more than one<br />
manufacturing unit - details all to be<br />
inspected<br />
In case marketing a product manufactured<br />
by other company. If 'yes' that also to be<br />
inspected<br />
3 Whether the firm is having 5 years<br />
standing marketing/manufacturing of<br />
pharmaceutical products<br />
4 Whether firm is having 3 years standing in<br />
marketing/manufacturing of each<br />
individual product to which it wishes to get<br />
Registered (in case 'No' names of such<br />
product to be given)<br />
5 Whether valid drug license for each<br />
product exists from Drug Controller (In<br />
case 'No' names of such product to be<br />
given)<br />
6 Audited annual turn over figures for each<br />
product for the last 3 years<br />
7 Whether WHO GMP certificate for<br />
production unit/s is there<br />
8 Whether any other certificate for<br />
firm/manufacturing and manufacturing<br />
process (as desired in item 4 of terms and<br />
conditions exit)<br />
Yes<br />
Tablets (India) Limited,<br />
Jhaver Centre, 72<br />
Marshalls Road,<br />
Chennai 600 008<br />
Allianz Biosciences<br />
Private Limited, 55/1,2 &<br />
3, Thiruvandar Koil<br />
Street, Whirlpool Road,<br />
Pondicherry 605 102<br />
Yes<br />
Yes<br />
Yes<br />
2004-05 8,720,71 lakhs<br />
2005-06 10,556.27 lakhs<br />
2006-07 11,692.78 lakhs<br />
9 Company turn over figure for last 3 years 2004-05 8,720,71 lakhs<br />
Yes<br />
yes<br />
2005-06 10,556.27 lakhs<br />
2006-07 11,692.78 lakhs
Sl.No. Description Remarks<br />
10 R&D facilities with firm. Annual<br />
expenditure in R&D in last 3 years<br />
2004-05 164.18 lakhs<br />
2005-06 213.61 lakhs<br />
2006-07 314.86 lakhs<br />
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
11 Name of Original research<br />
products/formulations developed by firm<br />
enclosed as annexure I<br />
12 Names of products for which firm is<br />
original manufacturer<br />
enclosed as annexure I<br />
13 Whether any punitive action has been<br />
taken or contemplated State/Central<br />
Institution/Drug Controller. If yes give<br />
details<br />
14 Relevant information for each specific<br />
product as per ORG-MARG analysis or by<br />
any other agency<br />
15 a) Names of imported drug items supplied<br />
by firm. List of developed countries where<br />
item is approved and supplied<br />
b) The source of manufactured raw/finished<br />
products for quality report<br />
c) Authorization letter by OEM abroad for<br />
local agent<br />
16 Other conditions<br />
No<br />
enclosed as annexure J<br />
Nil<br />
a) Cleanliness of premises Clean<br />
b) Whether plan is manual or automatic<br />
and level of automation<br />
c)Quality of packaging and packaging<br />
system<br />
d) Availability of sterile room yes<br />
e) Degree of hand handling in<br />
manufacturing process<br />
f) Availability of technically qualified staff yes<br />
g) Quality control inhouse lab/outsource yes<br />
Not applicable<br />
Not applicable<br />
Automatic<br />
Excellent<br />
Minimal<br />
17 Date of inspection 03.11.2008<br />
18 i) Place of inspection Pondicherry<br />
ii) Storage facility holding time for<br />
manufactured products<br />
yes
Sl.No. Description Remarks<br />
19 Name and designation of the company<br />
official accompanying for inspection<br />
Mr Senthil,<br />
Chief Production<br />
Manager,<br />
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
20 Whether firm is recommended suitable for Yes<br />
registration. Whether the product being<br />
Available in open market<br />
applied by firms for registgration are<br />
in the same brand name<br />
available in open market with some brand<br />
in southern region<br />
name and the region<br />
21 Name and Designation of the Team<br />
Member<br />
Signature<br />
1) Dr. N.Kannan<br />
Chief Paediatrician, Rly Hospital,<br />
Perambur<br />
2) K.Satyababu,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur<br />
3)Dr. A.P.Preetham,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur
Proforma to be filled up by the Inspecting Team<br />
Note: <strong>Inspection</strong> is to be done by respective Zonal <strong>Railway</strong>s in whose jurisdiction<br />
the Manufacturing Unit is located. Wherever there is inadequate space please<br />
submit information in separate sheet enclosed and marked as Annexure (Also<br />
having item no. of this proforma in reference to which Annexure is prepared)<br />
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
1 Name of the firm Glaxosmithkline<br />
Pharmaceuticals Limited,<br />
262, Golden Towers (II floor),<br />
Royapettah, Chennai 600 014<br />
2 Whether the firm is having registered<br />
office/Branch office. Give address and<br />
Telephone no in case more than one<br />
manufacturing unit - details all to be<br />
inspected<br />
In case marketing a product manufactured<br />
by other company. If 'yes' that also to be<br />
inspected<br />
3 Whether the firm is having 5 years<br />
standing marketing/manufacturing of<br />
pharmaceutical products<br />
4 Whether firm is having 3 years standing in<br />
marketing/manufacturing of each<br />
individual product to which it wishes to get<br />
Registered (in case 'No' names of such<br />
product to be given)<br />
5 Whether valid drug license for each<br />
product exists from Drug Controller (In<br />
case 'No' names of such product to be<br />
given)<br />
6 Audited annual turn over figures for each<br />
product for the last 3 years<br />
7 Whether WHO GMP certificate for<br />
production unit/s is there<br />
8 Whether any other certificate for<br />
firm/manufacturing and manufacturing<br />
process (as desired in item 4 of terms and<br />
conditions exit)<br />
Yes<br />
Glaxosmithkline<br />
Pharmaceuticals Limited,<br />
262, Golden Towers (II floor),<br />
Royapettah, Chennai 600 014<br />
Orchid Healthcare (A<br />
division of Orchid Chemicals<br />
and Pharmaceuticals<br />
Limited) B 77, SIDCO<br />
Industrial Estate, Alathur<br />
Yes<br />
Yes<br />
Yes<br />
2004-05 1575.89 crores<br />
2005-06 1677.57 crores<br />
2006-07 1712.87 crores<br />
9 Company turn over figure for last 3 years 2004-05 1575.89 crores<br />
10 R&D faciRAVIKUMAR.M [ MRK ]lities<br />
with firm. Annual expenditure in R&D in<br />
last 3 years<br />
Yes<br />
yes<br />
2005-06 1677.57 crores<br />
2006-07 1712.87 crores<br />
Not available
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
11 Name of Original research F 2 to 38<br />
products/formulations developed by<br />
firm<br />
12 Names of products for which firm is<br />
original manufacturer<br />
F 452<br />
13 Whether any punitive action has been<br />
taken or contemplated State/Central<br />
Institution/Drug Controller. If yes give<br />
details<br />
14 Relevant information for each specific<br />
product as per ORG-MARG analysis or<br />
by any other agency<br />
15 a) Names of imported drug items<br />
supplied by firm. List of developed<br />
countries where item is approved and<br />
supplied<br />
b) The source of manufactured<br />
raw/finished products for quality report<br />
c) Authorization letter by OEM abroad<br />
for local agent<br />
16 Other conditions<br />
No<br />
F 423-437<br />
Available<br />
Available<br />
a) Cleanliness of premises Clean<br />
b) Whether plan is manual or automatic<br />
and level of automation<br />
c)Quality of packaging and packaging<br />
system<br />
d) Availability of sterile room yes<br />
e) Degree of hand handling in<br />
manufacturing process<br />
f) Availability of technically qualified<br />
staff<br />
Automatic<br />
Excellent<br />
Minimal<br />
yes<br />
g) Quality control inhouse lab/outsource yes<br />
17 Date of inspection<br />
18 i) Place of inspection Alathur<br />
ii) Storage facility holding time for<br />
manufactured products<br />
19 Name and designatioRAVIKUMAR.M [<br />
MRK ]n of the company official<br />
accompanying for inspection<br />
yes
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
20 Whether firm is recommended suitable for Yes<br />
registration. Whether the product being<br />
Available in open market in<br />
applied by firms for registgration are<br />
the same brand name in<br />
available in open market with some brand<br />
southern region<br />
name and the region<br />
21 Name and Designation of the Team<br />
Member<br />
Signature<br />
1) Dr. N.Kannan<br />
Chief Paediatrician, Rly Hospital,<br />
Perambur<br />
2) K.Satyababu,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur<br />
3)Dr. A.P.Preetham,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur
Proforma to be filled up by the Inspecting Team<br />
Note: <strong>Inspection</strong> is to be done by respective Zonal <strong>Railway</strong>s in whose jurisdiction<br />
the Manufacturing Unit is located. Wherever there is inadequate space please<br />
submit information in separate sheet enclosed and marked as Annexure (Also<br />
having item no. of this proforma in reference to which Annexure is prepared)<br />
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
1 Name of the firm Micro Labs Limited<br />
27, Race Course,<br />
bangalore 560 001<br />
2 Whether the firm is having registered<br />
office/Branch office. Give address and<br />
Telephone no in case more than one<br />
manufacturing unit - details all to be<br />
inspected<br />
Yes<br />
# 92, Sipcot Industrial<br />
Complex, Hosur 635 126<br />
In case marketing a product manufactured<br />
by other company. If 'yes' that also to be<br />
inspected<br />
3 Whether the firm is having 5 years<br />
standing marketing/manufacturing of<br />
pharmaceutical products<br />
4 Whether firm is having 3 years standing in<br />
marketing/manufacturing of each<br />
individual product to which it wishes to get<br />
Registered (in case 'No' names of such<br />
product to be given)<br />
5 Whether valid drug license for each<br />
product exists from Drug Controller (In<br />
case 'No' names of such product to be<br />
given)<br />
6 Audited annual turn over figures for each<br />
product for the last 3 years<br />
7 Whether WHO GMP certificate for<br />
production unit/s is there<br />
8 Whether any other certificate for<br />
firm/manufacturing and manufacturing<br />
process (as desired in item 4 of terms and<br />
conditions exit)<br />
Yes<br />
Yes<br />
Yes<br />
2004-05 533.74 crores<br />
2005-06 707.21 crores<br />
2006-07 970.10 crores<br />
9 Company turn over figure for last 3 years 2004-05 533.74 crores<br />
10 R&D facilities with firm. Annual<br />
expenditure in R&D in last 3 years<br />
Yes<br />
yes<br />
2005-06 707.21 crores<br />
2006-07 970.10 crores<br />
Not available
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
11 Name of Original research F 7 to F 11<br />
products/formulations developed by<br />
firm<br />
12 Names of products for which firm is<br />
original manufacturer<br />
F 12 to F 15<br />
13 Whether any punitive action has been<br />
taken or contemplated State/Central<br />
Institution/Drug Controller. If yes give<br />
details<br />
14 Relevant information for each specific<br />
product as per ORG-MARG analysis or<br />
by any other agency<br />
15 a) Names of imported drug items<br />
supplied by firm. List of developed<br />
countries where item is approved and<br />
supplied<br />
b) The source of manufactured<br />
raw/finished products for quality report<br />
c) Authorization letter by OEM abroad<br />
for local agent<br />
16 Other conditions<br />
No<br />
F 423-437<br />
Available<br />
Available<br />
a) Cleanliness of premises Clean<br />
b) Whether plan is manual or automatic<br />
and level of automation<br />
c)Quality of packaging and packaging<br />
system<br />
d) Availability of sterile room yes<br />
e) Degree of hand handling in<br />
manufacturing process<br />
f) Availability of technically qualified<br />
staff<br />
Automatic<br />
Excellent<br />
Minimal<br />
yes<br />
g) Quality control inhouse lab/outsource yes<br />
17 Date of inspection<br />
18 i) Place of inspection Bangalore<br />
ii) Storage facility holding time for<br />
manufactured products<br />
19 Name and designation of the company<br />
official accompanying for inspection<br />
yes<br />
ANANDAKUMAR.S [ SAK ]
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
20 Whether firm is recommended suitable for Yes<br />
registration. Whether the product being<br />
Available in open market in<br />
applied by firms for registgration are<br />
the same brand name in<br />
available in open market with some brand<br />
southern region<br />
name and the region<br />
21 Name and Designation of the Team<br />
Member<br />
Signature<br />
1) Dr N.Kannan<br />
Chief Paediatrician, Rly Hospital,<br />
Perambur<br />
2) Dr K.Satyababu,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur<br />
3)Dr A.P.Preetham,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur
Proforma to be filled up by the Inspecting Team<br />
Note: <strong>Inspection</strong> is to be done by respective Zonal <strong>Railway</strong>s in whose jurisdiction<br />
the Manufacturing Unit is located. Wherever there is inadequate space please<br />
submit information in separate sheet enclosed and marked as Annexure (Also<br />
having item no. of this proforma in reference to which Annexure is prepared)<br />
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
1 Name of the firm Arvind Remedies Limited<br />
190 Poonamalee High<br />
Road Chennai 600 084<br />
2 Whether the firm is having registered<br />
office/Branch office. Give address and<br />
Telephone no in case more than one<br />
manufacturing unit - details all to be<br />
inspected<br />
In case marketing a product manufactured<br />
by other company. If 'yes' that also to be<br />
inspected<br />
3 Whether the firm is having 5 years<br />
standing marketing/manufacturing of<br />
pharmaceutical products<br />
4 Whether firm is having 3 years standing in<br />
marketing/manufacturing of each<br />
individual product to which it wishes to get<br />
Registered (in case 'No' names of such<br />
product to be given)<br />
5 Whether valid drug license for each<br />
product exists from Drug Controller (In<br />
case 'No' names of such product to be<br />
given)<br />
6 Audited annual turn over figures for each<br />
product for the last 3 years<br />
7 Whether WHO GMP certificate for<br />
production unit/s is there<br />
8 Whether any other certificate for<br />
firm/manufacturing and manufacturing<br />
process (as desired in item 4 of terms and<br />
conditions exit)<br />
Yes<br />
Shed no. 38, 39 & 40 ,<br />
SIDCO Industrial Estate,<br />
Kakkalur, Thiruvallur<br />
District<br />
Pincode 602 003<br />
Yes<br />
Yes<br />
Yes<br />
2005-06 165.08 crores<br />
2006-06 179.73 crores<br />
2007-08 201.51 crores<br />
9 Company turn over figure for last 3 years 2005-06 165.08 crores<br />
10 R&D facilities with firm. Annual<br />
expenditure in R&D in last 3 years<br />
Yes<br />
yes<br />
2006-06 179.73 crores<br />
2007-08 201.51 crores<br />
Not available
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
11 Name of Original research F 4 to F 43<br />
products/formulations developed by<br />
firm<br />
12 Names of products for which firm is<br />
original manufacturer<br />
13 Whether any punitive action has been<br />
taken or contemplated State/Central<br />
Institution/Drug Controller. If yes give<br />
details<br />
14 Relevant information for each specific<br />
product as per ORG-MARG analysis or<br />
by any other agency<br />
15 a) Names of imported drug items<br />
supplied by firm. List of developed<br />
countries where item is approved and<br />
supplied<br />
b) The source of manufactured<br />
raw/finished products for quality report<br />
c) Authorization letter by OEM abroad<br />
for local agent<br />
16 Other conditions<br />
No<br />
F 423-437<br />
a) Cleanliness of premises Clean<br />
b) Whether plan is manual or automatic<br />
and level of automation<br />
c)Quality of packaging and packaging<br />
system<br />
d) Availability of sterile room yes<br />
e) Degree of hand handling in<br />
manufacturing process<br />
f) Availability of technically qualified<br />
staff<br />
Not applicable<br />
Not applicable<br />
Automatic<br />
Excellent<br />
Minimal<br />
yes<br />
g) Quality control inhouse lab/outsource yes<br />
17 Date of inspection 26.02.2010<br />
18 i) Place of inspection Kakkalur, Thiruvallur Dis<br />
ii) Storage facility holding time for<br />
manufactured products<br />
19 Name and designation of the company<br />
official accompanying for inspection<br />
yes
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
20 Whether firm is recommended suitable for Yes<br />
registration. Whether the product being<br />
Available in open market in<br />
applied by firms for registgration are<br />
the same brand name in<br />
available in open market with some brand<br />
southern region<br />
name and the region<br />
21 Name and Designation of the Team<br />
Member<br />
Signature<br />
1) Dr N.Kannan<br />
Chief Paediatrician, Rly Hospital,<br />
Perambur<br />
2) Dr K.Satyababu,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur<br />
3)Dr A.P.Preetham,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur
Proforma to be filled up by the Inspecting Team<br />
Note: <strong>Inspection</strong> is to be done by respective Zonal <strong>Railway</strong>s in whose jurisdiction<br />
the Manufacturing Unit is located. Wherever there is inadequate space please<br />
submit information in separate sheet enclosed and marked as Annexure (Also<br />
having item no. of this proforma in reference to which Annexure is prepared)<br />
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
1 Name of the firm <strong>Southern</strong> Petrochemical<br />
Industries Corpn Ltd<br />
2 Whether the firm is having registered<br />
office/Branch office. Give address and<br />
Telephone no in case more than one<br />
manufacturing unit - details all to be<br />
inspected<br />
Yes<br />
SPIC House, No.88,<br />
Mount Road, Guindy,<br />
Chennai 600 032<br />
In case marketing a product manufactured<br />
by other company. If 'yes' that also to be<br />
inspected<br />
3 Whether the firm is having 5 years<br />
standing marketing/manufacturing of<br />
pharmaceutical products<br />
4 Whether firm is having 3 years standing in<br />
marketing/manufacturing of each<br />
individual product to which it wishes to get<br />
Registered (in case 'No' names of such<br />
product to be given)<br />
5 Whether valid drug license for each<br />
product exists from Drug Controller (In<br />
case 'No' names of such product to be<br />
given)<br />
6 Audited annual turn over figures for each<br />
product for the last 3 years<br />
7 Whether WHO GMP certificate for<br />
production unit/s is there<br />
8 Whether any other certificate for<br />
firm/manufacturing and manufacturing<br />
process (as desired in item 4 of terms and<br />
conditions exit)<br />
SPIC Ltd, Pharmaceuticals<br />
Division, Plot no.5, NH-7,<br />
Maraimalainagar 603209<br />
Kancheepuram District<br />
Yes<br />
Yes<br />
Yes<br />
2005-06 7926.35 lakhs<br />
2006-06 11199.46 lakhs<br />
2007-08 11145.27 lakhs<br />
9 Company turn over figure for last 3 years 2005-06 7926.35 lakhs<br />
10 R&D facilities with firm. Annual<br />
expenditure in R&D in last 3 years<br />
Yes<br />
yes<br />
2006-06 11199.46 lakhs<br />
2007-08 11145.27 lakhs<br />
Not available
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
11 Name of Original research F 4 to F 43<br />
products/formulations developed by<br />
firm<br />
12 Names of products for which firm is<br />
original manufacturer<br />
13 Whether any punitive action has been<br />
taken or contemplated State/Central<br />
Institution/Drug Controller. If yes give<br />
details<br />
14 Relevant information for each specific<br />
product as per ORG-MARG analysis or<br />
by any other agency<br />
15 a) Names of imported drug items<br />
supplied by firm. List of developed<br />
countries where item is approved and<br />
supplied<br />
b) The source of manufactured<br />
raw/finished products for quality report<br />
c) Authorization letter by OEM abroad<br />
for local agent<br />
1632- Other conditions<br />
No<br />
a) Cleanliness of premises Clean<br />
b) Whether plan is manual or automatic<br />
and level of automation<br />
c)Quality of packaging and packaging<br />
system<br />
d) Availability of sterile room yes<br />
e) Degree of hand handling in<br />
manufacturing process<br />
f) Availability of technically qualified<br />
staff<br />
Not applicable<br />
Not applicable<br />
Automatic<br />
Excellent<br />
Minimal<br />
yes<br />
g) Quality control inhouse lab/outsource yes<br />
17 Date of inspection 18.06.2010<br />
18 i) Place of inspection Maraimalainagar,<br />
Kancheepuram District<br />
ii) Storage facility holding time for<br />
manufactured products<br />
19 Name and designation of the company<br />
official accompanying for inspection<br />
yes
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
20 Whether firm is recommended suitable for Yes<br />
registration. Whether the product being<br />
Available in open market in<br />
applied by firms for registgration are<br />
the same brand name in<br />
available in open market with some brand<br />
southern region<br />
name and the region<br />
21 Name and Designation of the Team<br />
Member<br />
Signature<br />
1) Dr N.Kannan<br />
Chief Paediatrician, Rly Hospital,<br />
Perambur<br />
2) Dr Prasannakumar<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur<br />
3)Dr A.P.Preetham,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur
REPORT ON APPLICATION SUBMITTED BY <strong>Southern</strong> Petrochemical<br />
Industries Corporation Ltd (Pharmaceutical Division) FOR<br />
REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : <strong>Southern</strong> Petrochemical Industries<br />
Corporation Ltd (Pharmaceutical<br />
Division)<br />
2 Postal address of Head<br />
Office / Registered Office<br />
3 Name and address of<br />
manufacturer whose<br />
products are likely to be<br />
marketed by this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: SPIC House, No.88, Mount Road,<br />
Guindy, Chennai 600 032<br />
: SPIC Limited – Pharmaceutical Divisionl<br />
Plot no.5, NH 7, Maraimalainagar-<br />
603209 – Kancheepuram District,<br />
Tamilnadu<br />
“ F 10 to 86<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
MANDATORY CONDITIONS<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each<br />
product<br />
Yes –<br />
available<br />
Yes –<br />
available<br />
3 WHO GMP certificate Yes –<br />
available<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should<br />
be Rs. 50 crores for previous three<br />
years)<br />
5 Firm's Declaration with regard to<br />
non conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Yes –<br />
available<br />
Yes –<br />
available<br />
Yes –<br />
available<br />
F 94<br />
F 1 to 5<br />
F 7 to 7D<br />
F 9<br />
F 92<br />
F 95<br />
Desirable conditions<br />
1 ISO 9000 certification Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available
3 Details of supply orders received<br />
from Institutions in the previous<br />
three years<br />
Yes -<br />
available<br />
F 89 to 91e<br />
4 Cases of high value orders covering<br />
yearly requirements for the <strong>Railway</strong>/<br />
Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Yes –<br />
available<br />
Registered in<br />
Central<br />
<strong>Railway</strong><br />
F 89 to 91e<br />
F 87-88<br />
a<br />
b<br />
c<br />
d<br />
II. For drugs manufactured abroad and prolposed for suply by the firm,<br />
the following informations are MANDATORILY REQUIRED: NOT<br />
APPLICABLE<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being<br />
sold in USA Europe and other<br />
developed countries equi to Europeal<br />
countries<br />
Authorisation letter by OEM abroad<br />
for local agent<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected<br />
b. Does the firm qualify for registration<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team
Proforma to be filled up by the Inspecting Team<br />
Note: <strong>Inspection</strong> is to be done by respective Zonal <strong>Railway</strong>s in whose jurisdiction<br />
the Manufacturing Unit is located. Wherever there is inadequate space please<br />
submit information in separate sheet enclosed and marked as Annexure (Also<br />
having item no. of this proforma in reference to which Annexure is prepared)<br />
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
1 Name of the firm M/s Orchid Health Care<br />
(A division of Orchid<br />
Chemicals and<br />
Pharmaceuticals Ltd)<br />
2 Whether the firm is having registered<br />
office/Branch office. Give address and<br />
Telephone no in case more than one<br />
manufacturing unit - details all to be<br />
inspected<br />
Yes<br />
Orchid Towers, No. 313,<br />
Valluvarkottam High<br />
Road, Nungambakkam,<br />
Chennai 600 034<br />
In case marketing a product manufactured<br />
by other company. If 'yes' that also to be<br />
inspected<br />
3 Whether the firm is having 5 years<br />
standing marketing/manufacturing of<br />
pharmaceutical products<br />
4 Whether firm is having 3 years standing in<br />
marketing/manufacturing of each<br />
individual product to which it wishes to get<br />
Registered (in case 'No' names of such<br />
product to be given)<br />
5 Whether valid drug license for each<br />
product exists from Drug Controller (In<br />
case 'No' names of such product to be<br />
given)<br />
6 Audited annual turn over figures for each<br />
product for the last 3 years<br />
7 Whether WHO GMP certificate for<br />
production unit/s is there<br />
8 Whether any other certificate for<br />
firm/manufacturing and manufacturing<br />
process (as desired in item 4 of terms and<br />
conditions exit)<br />
M/s Orchid Health Care<br />
B 77, SIDCO Industrial<br />
Estate, Alathur 603110,<br />
Kancheepuram District<br />
Yes<br />
Yes<br />
Yes<br />
2007-08 120287.72 lakhs<br />
2008-09 116835.64 lakhs<br />
2009-10 121385.21 lakhs<br />
9 Company turn over figure for last 3 years 2005-06 7926.35 lakhs<br />
10 R&D facilities with firm. Annual<br />
expenditure in R&D in last 3 years<br />
Yes<br />
yes<br />
2006-06 11199.46 lakhs<br />
2007-08 11145.27 lakhs
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
11 Name of Original research F 21<br />
products/formulations developed by<br />
firm<br />
12 Names of products for which firm is<br />
original manufacturer<br />
13 Whether any punitive action has been<br />
taken or contemplated State/Central<br />
Institution/Drug Controller. If yes give<br />
details<br />
14 Relevant information for each specific<br />
product as per ORG-MARG analysis or<br />
by any other agency<br />
15 a) Names of imported drug items<br />
supplied by firm. List of developed<br />
countries where item is approved and<br />
supplied<br />
b) The source of manufactured<br />
raw/finished products for quality report<br />
c) Authorization letter by OEM abroad<br />
for local agent<br />
1632- Other conditions<br />
No<br />
Nil<br />
a) Cleanliness of premises Clean<br />
b) Whether plan is manual or automatic<br />
and level of automation<br />
c)Quality of packaging and packaging<br />
system<br />
d) Availability of sterile room yes<br />
e) Degree of hand handling in<br />
manufacturing process<br />
f) Availability of technically qualified<br />
staff<br />
Not applicable<br />
Not applicable<br />
Automatic<br />
Excellent<br />
Minimal<br />
yes<br />
g) Quality control inhouse lab/outsource yes<br />
17 Date of inspection<br />
18 i) Place of inspection Valluvarkottam,<br />
Nungambakkam, Chennai 600<br />
034<br />
ii) Storage facility holding time for<br />
manufactured products<br />
19 Name and designation of the company<br />
official accompanying for inspection<br />
yes
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
20 Whether firm is recommended suitable for Yes<br />
registration. Whether the product being<br />
Available in open market in<br />
applied by firms for registgration are<br />
the same brand name in<br />
available in open market with some brand<br />
southern region<br />
name and the region<br />
21 Name and Designation of the Team<br />
Member<br />
Signature<br />
1) Dr N.Kannan<br />
Chief Paediatrician, Rly Hospital,<br />
Perambur<br />
2) Dr Prasannakumar<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur<br />
3)Dr A.P.Preetham,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur
REPORT ON APPLICATION SUBMITTED BY M/s Orchid Chemicals and<br />
Pharmaceuticals Ltd FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Orchid Healthcare<br />
(A division of Orchid Chemicals and<br />
Pharmaceuticals Ltd)<br />
2 Postal address of Head<br />
Office / Registered Office<br />
3 Name and address of<br />
manufacturer whose<br />
products are likely to be<br />
marketed by this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: Orchid Towers, # 313, Valluvarkottam<br />
High Road, Nungambakkam, Chennai<br />
600 034<br />
: M/s Orchid Healthc (A division of<br />
Orchid Chemicals and Pharmaceuticals<br />
Ltd), B 77, SIDCO Industrial Estate,<br />
Alathur 603110, Kancheepuram<br />
District, Tamilnadu<br />
“ F 26-27<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
MANDATORY CONDITIONS<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each<br />
product<br />
Yes –<br />
available for<br />
3 yrs<br />
Yes –<br />
available<br />
3 WHO GMP certificate Yes –<br />
available<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should<br />
be Rs. 50 crores for previous three<br />
years)<br />
5 Firm's Declaration with regard to<br />
non conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Yes –<br />
available<br />
Yes –<br />
available<br />
Yes –<br />
available<br />
F 24<br />
F 33-34, 2A-6A<br />
F 11 – 12<br />
Rs. 1,21,385.21.28<br />
< 50 crores<br />
F 4<br />
F 3<br />
Desirable conditions<br />
1 ISO 9000 certification F 6-7<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Nil
-2 -<br />
3 Details of supply orders received<br />
from Institutions in the previous<br />
three years<br />
Yes -<br />
available<br />
F 29-32<br />
4 Cases of high value orders covering<br />
yearly requirements for the <strong>Railway</strong>/<br />
Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Yes –<br />
available<br />
Registered in<br />
Central<br />
<strong>Railway</strong><br />
F 89 to 91<br />
F 5<br />
a<br />
III. For drugs manufactured abroad and prolposed for suply by the firm,<br />
the following informations are MANDATORILY REQUIRED: NOT<br />
APPLICABLE<br />
The source of manufactured<br />
Not applicable<br />
raw/finished products and quality<br />
report<br />
b<br />
c<br />
d<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being<br />
sold in USA Europe and other<br />
developed countries equi to Europeal<br />
countries<br />
Authorisation letter by OEM abroad<br />
for local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected 11.10.2010<br />
b. Does the firm qualify for registration yes<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team
REPORT ON APPLICATION SUBMITTED BY M/s Galpha Laboratories<br />
Limited FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Galpha Laboratories Limited<br />
2 Postal address of Head<br />
Office / Registered Office<br />
3 Name and address of<br />
manufacturer whose<br />
products are likely to be<br />
marketed by this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: Jagdish Bhawan, Exhibition Road,<br />
Patna 800 001<br />
: M/s Galpha Laboratories Limited,<br />
Village-Thana Baddi, Dist.Solan (H>P)<br />
“ F 1-7<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each<br />
product<br />
Yes –<br />
available<br />
Yes –<br />
available<br />
3 WHO GMP certificate Yes –<br />
available<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should<br />
be Rs. 50 crores for previous three<br />
years)<br />
F 28-11<br />
F 73-91<br />
F 92-99<br />
2009-10 Rs.1,45,42,87,000<br />
2008-09 Rs.1,33,36,39,000<br />
2007-08 Rs.1,00,47,16,000<br />
5 Firm's Declaration with regard to<br />
non conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Yes –<br />
available<br />
Yes –<br />
available<br />
F 72 and 136<br />
F 137<br />
Desirable conditions<br />
1 ISO 9000 certification F 138<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
139-144
-2 -<br />
3 Details of supply orders received<br />
from Institutions in the previous<br />
three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the <strong>Railway</strong>/<br />
Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Yes -<br />
available<br />
Yes –<br />
available<br />
Registered in<br />
Central<br />
<strong>Railway</strong><br />
F 145-184<br />
F 202-219<br />
F 185-189<br />
IV. For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being<br />
sold in USA Europe and other<br />
developed countries equi to Europeal<br />
countries<br />
Authorisation letter by OEM abroad<br />
for local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
No<br />
a. If yes, has the firm been inspected Not applicable<br />
b. Does the firm qualify for registration yes<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s Galpha Laboratories<br />
Limited FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Fourrts (India)Laboratories Pvt Ltd<br />
2 Postal address of Head<br />
Office / Registered Office<br />
3 Name and address of<br />
manufacturer whose<br />
products are likely to be<br />
marketed by this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: No.1, Fourrts Avenue, Annai Indira<br />
Nagar,Okkiyum Thoraipakkam,<br />
Chennai 600 097<br />
: M/s Fourrts (India) Laboratories Pvt<br />
Ltd, Vandalur Road, Kelambakkam<br />
603 103<br />
“ Product list at 1a and 1b<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each<br />
product<br />
Yes –<br />
available<br />
Yes –<br />
available<br />
3 WHO GMP certificate Yes –<br />
available<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should<br />
be Rs. 50 crores for previous three<br />
years)<br />
5 Firm's Declaration with regard to<br />
non conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Desirable conditions<br />
F 48<br />
Yes - F-34<br />
available<br />
Yes –<br />
available<br />
Yes –<br />
available<br />
F 11 to 16<br />
F 4 to 10<br />
F 49<br />
F 49<br />
1 ISO 9000 certification F 17<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
F-3
-2 -<br />
3 Details of supply orders received<br />
from Institutions in the previous<br />
three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the <strong>Railway</strong>/<br />
Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Yes -<br />
available<br />
Yes –<br />
available<br />
Not available<br />
F 18 to 32<br />
F 18 to 32<br />
V. For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being<br />
sold in USA Europe and other<br />
developed countries equi to Europeal<br />
countries<br />
Authorisation letter by OEM abroad<br />
for local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
No<br />
a. If yes, has the firm been inspected Not applicable<br />
b. Does the firm qualify for registration yes<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s Indian Immunologisticals<br />
Limited FOR REGISTRATION<br />
IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Indian Immunologicals Ltd<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
: Road No. 44, Jubilee Hills,<br />
Hyderabad 500 033<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: M/s Human Biologicals Institute (A<br />
division of India Immunologicals Ltd,<br />
Kozhipannai, Pudumund Post,<br />
Uddhagamandalam 643 007<br />
“ Rabies vaccine – Human (Cell Culture) –<br />
I.P<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
3 WHO GMP certificate Folios 12 - 14<br />
Market standing o three years vide<br />
Folio 22<br />
License for the period from 2007-<br />
2011 issued by the Director of<br />
Drugs Control (I/c) and Licensing<br />
Authority, Tamilnadu and<br />
countersigned by the Central<br />
License Approving Authority and<br />
Drug Controller General (India),<br />
New Delhi – Folio 30<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Desirable conditions<br />
1 ISO 9000 certification<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Rs.272.89 crores for 2009-10 at<br />
Folio 11<br />
Folio 16 and 17<br />
Folio 10
-2 -<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
-<br />
-<br />
-<br />
VI. For drugs manufactured abroad and proposed for supply by the firm, the<br />
following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
Yes<br />
Kozhipannai, Pudumund Post<br />
Udhamandalam 643 007<br />
a. If yes, has the firm been inspected<br />
b. Does the firm qualify for registration<br />
The firm does not qualify on the market standing certificate is only<br />
available for three years (Item no.1 mandatory conditions)<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s Centaur Pharmaceuticals<br />
Pvt Ltd FOR REGISTRATION<br />
IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Centaur Pharmaceuticals Pvt Ltd<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
: Centaur House, Near Grand Hyatt, Vakola,<br />
Santacruz (E), Mumbai 400 055<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: M/s Centaur Pharmaceuticals Pvt Ltd<br />
Plot No.3, Tivim Industrial Estate,<br />
Karaswada, Mapusa, Goa 403 526<br />
“ F. 7 to 10<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Yes - Available<br />
F.78-156<br />
Yes - Available F.14 to 76<br />
3 WHO GMP certificate Yes - Available F.116 to 170<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Desirable conditions<br />
Yes - Available F. 283<br />
Yes - Available F.216 & 217<br />
Yes- available<br />
1 ISO 9000 certification No – Not<br />
available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
No – Not<br />
available
-2 -<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Yes –<br />
available<br />
Yes –<br />
available<br />
No – not<br />
available<br />
F.182 to 213-<br />
F.172 to 180<br />
-<br />
VII.For drugs manufactured abroad and proposed for supply by the firm, the<br />
following informations are MANDATORILY REQUIRED:NOT APPLICABLE<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
Not available<br />
a. If yes, has the firm been inspected No<br />
b. Does the firm qualify for registration Yes/No<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s BOEHRINGER INGELHEIM<br />
FOR REGISTRATION<br />
IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s BOEHRINGER INGELHEIM<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
: 11 th FLOOR,<br />
HALLMARK BUSINESS PLAZA<br />
NR.GURU NANAK HOSPITAL<br />
BANDRA (E)<br />
MUMBAI – 400 051.<br />
: M/S BOEHRINGER INGELHAIM PHARMA<br />
I&CO.<br />
KG, BIRKENDORFER STR64, 88397<br />
BIBERACH AN DER RIASS, GERMANY.<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
“ : AVAILABLE AT FOLIO 2.<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
: Available at Folio 13 & Folio 4A<br />
: Available at Folio 6-12<br />
3 WHO GMP certificate : Available Folio 1A<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
: Available Folio. 51<br />
: Available at Folio .58<br />
: Available at Folio 2<br />
Desirable conditions<br />
1 ISO 9000 certification : Not available
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
: Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
4 Cases of high value orders covering yearly<br />
requirements for the <strong>Railway</strong>/Unit<br />
: Available<br />
at<br />
Folio 48-50<br />
: Available Folio 44-47<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
: Not<br />
available<br />
-<br />
a<br />
VIII.For drugs manufactured abroad and proposed for supply by the firm, the<br />
following informations are MANDATORILY REQUIRED:<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
: M/s BOEHRINGER<br />
INGELHAIM PHARMA I&CO .<br />
KG, BIRKENDORFER STR 64,<br />
88397 BIBERACH AN DER<br />
RIASS, GERMANY.<br />
b<br />
c<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
: A WHOLLY OWNED<br />
SUBSIDIARY OF<br />
BOEHRINGER INGELHEIM<br />
INTERNATIONAL GmbH,<br />
GERMANY.<br />
: AVAILABLE IN GERMANY.<br />
d<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
: AT FOLIOS 4 & 5<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected : NOT APPLICABLE<br />
b. Does the firm qualify for registration : YES<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s HEXAGON NUTRITION PVT.<br />
LTD. FOR REGISTRATION<br />
IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s HEXAGON NUTRITION PVT. LTD.<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
: 404/a, GLOBAL CHAMBERS, ADARSH<br />
NAGAR, OFF. LINK ROAD, ANDHERI<br />
(W)MUMBAI – 422 202.<br />
: M/S HEXAGON NUTRITION PVT. LTD..<br />
PLOT NO.92, UNANDA NAGAR,<br />
LAKHMAPUR, TAL. DINDORI, DIST.<br />
NASHIK-422 202.<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
“ : AVAILABLE AT FOLIO 2.<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
: Available at Folio 7<br />
: Available at Folio 6<br />
3 WHO GMP certificate : Available at folio 5<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
: * Please see comments below<br />
: Available at Folio 3<br />
: Available at Folio 2<br />
Desirable conditions<br />
1 ISO 9000 certification : Available at<br />
folio 1<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
: Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
: Not<br />
Available
4 Cases of high value orders covering yearly<br />
requirements for the <strong>Railway</strong>/Unit<br />
: NOT<br />
AVAILABLE<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
: Not<br />
available<br />
-<br />
a<br />
IX. For drugs manufactured abroad and proposed for supply by the firm, the<br />
following informations are MANDATORILY REQUIRED:<br />
The source of manufactured<br />
: NOT APPLICABLE<br />
raw/finished products and quality<br />
report<br />
b<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
: NOT APLICABLE.<br />
c<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
: NOT APLICABLE..<br />
d<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
: NOT APLICABLE.<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected : NOT APPLICABLE<br />
b. Does the firm qualify for registration : -<br />
* Even though the annual turnover is less than Rs. 50 crores(Folio 4), the firm is<br />
manufacturing and marketing exclusively speciality food & nutrition products. It<br />
Casuais recommended for registratiion, subject to approval by competent<br />
authority.<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s Themis Medicare Limited<br />
FOR REGISTRATION<br />
IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Themis Medicare Limited<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
: Sector 6A, Plot No. 16,17,18,<br />
I.I.E.SIDCUL, Haridwar,Uttarakhand<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: Themis Medicare Limited<br />
Sector 6A, Plot No. 16,17,18,<br />
I.I.E.SIDCUL, Haridwar,Uttarakhand<br />
“ Available at folios 20 – 63<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Market standing three years vide<br />
Folio 67<br />
Available at folio 65<br />
3 WHO GMP certificate Available at folio 15<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Available at folio 14<br />
Available at folio 7<br />
Available at folio 6<br />
Desirable conditions<br />
1 ISO 9000 certification Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
-<br />
Not available -<br />
Available at folios 1-5
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Not available<br />
II. For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected Not applicable<br />
b. Does the firm qualify for registration No<br />
The firm does not qualify as the market standing certificate is only<br />
available for three years (Item no.1 mandatory conditions)<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s Sandoz Private Limited<br />
FOR REGISTRATION<br />
IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Sandoz Private Limited<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: Dr.Annie Besant Road, Worli,<br />
Mumbai 400 042<br />
: M/s Sandoz Private Limited,<br />
Plot No.8-A/2 and 8-B, TTC Industrial<br />
Area, Kalwe Block, Village Dighe, Navi<br />
Mumbai 400 078<br />
“ Available at folios 52 and 53<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available at folio 72<br />
Available at folio 71<br />
3 WHO GMP certificate Available at folio 68<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Available at folio 65<br />
Available at folio 54 and 55<br />
Available at folio 3<br />
Desirable conditions<br />
1 ISO 9000 certification Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
Available at folio 2<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
-<br />
Available at folios 1 and 2A
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Not available<br />
II. For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected No<br />
b. Does the firm qualify for registration No<br />
The firm was registered on 06.04.2009 under the New Regulations for<br />
Registration of Firms. The firm had submitted Market Standing Certificate for 5<br />
yeaqrs then. The firm qualified for registration as they have now submitted a<br />
Market Standing Certificate for 3 years.<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s Tablets India Limited<br />
FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Tablets India Limited<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: Jhaver Centre, Marshalls Road, Chennai<br />
600 008<br />
: No. 179, TH Road, Chennai 600 081<br />
“ Available at Annexure F and G<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available at Annexure H<br />
Available at Annexure A<br />
3 WHO GMP certificate Available at Annexure B<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
Available at Annexure D<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
Available at Annexure E<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Available at Page 7 of Annexure F<br />
Desirable conditions<br />
1 ISO 9000 certification Available at Annexure I<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
Nil<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
-<br />
Nil<br />
Available at Annexure J
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected No<br />
b. Does the firm qualify for registration Yes<br />
The firm was registered on 06.02.2009 under the New Regulations for<br />
Registration of Firms. The firm had submitted Market Standing Certificate for 5<br />
yeaqrs then. The firm now qualified for registration as they have submitted a<br />
Market Standing Certificate for 3 years. Thus the total market styanding will be<br />
or more than 5 years and hence the firm qualiies for registration.<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s NIRMA LIMITED<br />
FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Nirma Limited<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
: Nirma House Ashram Road Ahmedabad,<br />
Gujarat, India<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
: M/s Nirma Limited (Healthcare Limited)<br />
Village: Sachana, Taluka:Viramgam, Dist.<br />
Ahmedabad 382 150<br />
4 Products for which “ Available at Folio 15<br />
registration is sought<br />
strength wise<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
MANDATORY CONDITIONS<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
Available only for three years (Folio 5)<br />
(should be atleast 5 years)<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available at Folio 3 and 4<br />
3 WHO GMP certificate Available at Folio 7<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
Available at Folio 6<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
Available at Folio 10<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retail sale in the<br />
same brand name<br />
Available at Folio 12<br />
Doies not specifically mentioned that<br />
products submitted for registgration are<br />
available in market for retain sale in the<br />
same brand name<br />
Desirable conditions<br />
1 ISO 9000 certificate Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Not available<br />
Not available<br />
Not available
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected No<br />
b. Does the firm qualify for registration No<br />
The firm does not qualify for the regisgtratin since the firm submitted a<br />
Market Standing Certificate is only for 3 years (Item No. 1 of Mandatory<br />
conditions)<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s TORRENT<br />
PHARMACEUTICALS<br />
FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Torrent Pharmaceuticals<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
: Torrent House, Off. Ashram Road,<br />
Ahmedabad 380 009<br />
: M/s Torrent Pharmaceuticals Limied,<br />
Villege Bhud and Makhumajra, Baddi<br />
173205, the. Nalagarh, Dist Solan<br />
(H.P)India<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
“ Available at Folio 1 to 22<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available for three years only<br />
Available at Folio 3 and 4<br />
3 WHO GMP certificate Available at Folio 7<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
Available at Folio 6<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
Available at Folio 10<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Available at Folio 12<br />
Desirable conditions<br />
1 ISO 9000 certificate Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
Not available
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
-<br />
Not available<br />
Available at folio 12 and 13<br />
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected No<br />
b. Does the firm qualify for registration Yes<br />
The firm does not qualify for the regisgtratin since the firm submitted a<br />
Market Standing Certificate is only for 3 years.<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s AUROBINDO PHARMA LTD<br />
FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Aurobindo Pharma Ltd<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: 'Auro House', 313 Bachupally,<br />
Quthuballapur (Mandal ), RR District,<br />
Hyderabad 500 072<br />
: Plot No. 2, Matrivihar, Amerpet,<br />
Hyderabad 500 072<br />
“ Available at Folio 2<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available for three years only<br />
Available at Folio 6<br />
Available at Folio 11 and 12<br />
3 WHO GMP certificate Available at Folio 13 to 21<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
Available at Folio 114 to 120<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
Available at Folio 58 to 60<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Available at Folio 121<br />
Desirable conditions<br />
1 ISO 9000 certificate Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
Available at Folio 82 to 113<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
-<br />
Available at Folio 79 to 81<br />
Available at folio 75 to 78<br />
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected No<br />
b. Does the firm qualify for registration No<br />
The firm does not qualify for the regisgtratin since the firm submitted a<br />
Market Standing Certificate is only for 3 years.<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s Biological Limited<br />
FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Biological Limited<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
4 Products fo<br />
r which registration is sought<br />
strength wise<br />
: 18/1 and 3, Azamabad, Hyderabad<br />
500 020, AP<br />
: 18/1 and 3, Azamabad, Hyderabad<br />
500 020, AP<br />
“ Available at Folio 1 to 10<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available for three years only<br />
(Folio 61 to 74)<br />
Available at Folio 11 to 12<br />
3 WHO GMP certificate Not available<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
Available at Folio 43<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
Available at Folio 46<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Available at Folio 3<br />
Desirable conditions<br />
1 ISO 9000 certificate Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
Not available<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
-<br />
Not available<br />
Available at folio 12 and 13
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected Not Available<br />
b. Does the firm qualify for registration Yes/No<br />
The firm was registered on 09.04.2009 under the New Regulations for<br />
Registration of Firms. The firm had submitted Market Standing Certificate for 5<br />
yeaqrs then. The firm qualified for registration as they have now submitted a<br />
Market Standing Certificate for 3 years.<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s Albert David Limited<br />
FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Albert David Limited<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: 15, Chittaranjan Avenue, Kolkata 700 072<br />
: B-12/13, Meerut Road, Industrial Area,<br />
Ghjaziabad, UP<br />
“ Available at Folio 6 to 15<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available for three years only<br />
(Folio 16 to 20)<br />
Available at Folio 1 to 5<br />
3 WHO GMP certificate Available at Folio 22 to 24<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
Available at Folio 21<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
Index Page<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Index Page<br />
Desirable conditions<br />
1 ISO 9000 certificate Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
Not available<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
-<br />
Not available<br />
Not available
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected Not applicable<br />
b. Does the firm qualify for registration Not applicable<br />
The firm was registered on 30.03.2009 under the New Regulations for<br />
Registration of Firms. The firm had submitted Market Standing Certificate for 5<br />
yeaqrs then. The firm qualified for registration as they have now submitted a<br />
Market Standing Certificate for 3 years.<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s Albert David Limited<br />
FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Zee Laboratories<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: Zee Laboratories, Uchani, G.T.Road,<br />
Karnal 132 001, India<br />
: Zee Laboratories<br />
47, Industrial Area, Paonta-Sahib District,<br />
Sirmour, H.P. India<br />
“ Available in Annexures<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available at Folio 30<br />
Available at Folio 35-37<br />
3 WHO GMP certificate Available at Folio 34<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Available at Folio 19<br />
Available at Folio 38<br />
Available at Folio 1<br />
Desirable conditions<br />
1 ISO 9000 certificate Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Folios 2-11<br />
Folios 12-18<br />
Not available
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected Not applicable<br />
b. Does the firm qualify for registration Yes<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s Albert David Limited<br />
FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s CIPLA Ltd<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: 106 A, Alapakkam Main Road,<br />
Alapakkam, Chennai 600 116<br />
: CPO Ltd<br />
Vill. Malpur, Baddi District, Solan (H>P)<br />
“ Available between Folios 397 and 414<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available between Folios 462 and<br />
513<br />
Available between Folios 1 and 322<br />
3 WHO GMP certificate Available between Folios 323 and<br />
376<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Available at Folio 395<br />
Available between Folios 377 and<br />
392 and Index Page<br />
Covering Letter<br />
Desirable conditions<br />
1 ISO 9000 certificate Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Not available<br />
Not available<br />
Not available
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected Not applicable<br />
b. Does the firm qualify for registration Yes<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s Albert David Limited<br />
FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Ranbaxy Laboratories Limited<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: Sahiubzada Ajit Singh Nagar 160 055 ,<br />
Dist Ropar (Punjab)<br />
: Sahiubzada Ajit Singh Nagar 160 055 ,<br />
Dist Ropar (Punjab)<br />
“ Available between Folios 39-18<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available atFolio 17<br />
Available at Folio 321<br />
3 WHO GMP certificate Available at folio 153<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Available at Folio 58<br />
Available at folio 57<br />
Available at folio 1<br />
Desirable conditions<br />
1 ISO 9000 certificate Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Not available<br />
Not available<br />
Not available
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected Not applicable<br />
b. Does the firm qualify for registration Yes/No<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s SHREE KRISHNA KESHAV<br />
LABORATORIES LIMITED FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Shree Krishna Keshav Laboratories<br />
Limited<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose products<br />
are likely to be marketed by<br />
this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: Devashish 3 rd floor, Near Hotel Klasic<br />
Gold, Off C.G.Road, Ahmedabad 380 006<br />
: Shree Krishna Keshav Laboratories<br />
Limited, Old No. 69, New 141, Linghi<br />
Chetty Street, Chennai 600 001<br />
“ Available between Folios 32 to 35<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available at Folio 26 & 26A for<br />
Three years only<br />
However the item manufactured by<br />
this firm has been procured on a<br />
regular basis for the past 5 years<br />
Available at Folio 1 & 2<br />
Licence under the process of<br />
renewal<br />
3 WHO GMP certificate Available at folio 23<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Available at Folio 36, Less than 50<br />
Crores for the past 3 years *<br />
Available at folio 25<br />
Available at folio 27<br />
Desirable conditions<br />
1 ISO 9000 certificate Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Not available<br />
Not available<br />
Not available
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being sold<br />
in USA Europe and other developed<br />
countries equi to Europeal countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected Not applicable<br />
b. Does the firm qualify for registration Yes/No *<br />
* We have been experiencing difficulties in procuring the following<br />
medicines from sources other than M/s Krishna Keshav Laboratories.<br />
Sl.No. Item No. Description<br />
1 90005 Normal Saline-Glass Bottle<br />
2 90033 Dextrose 100 ml<br />
3 90034 Dextrose plus Half Normal Saline<br />
4 90038 Glycine irrigation 1.5%<br />
5 90040 Isolyte E<br />
6 90120 3% Sodium Chloride 100 ml<br />
For the above items, the only source of supply for us has been (Shree<br />
Krishna Keshav Laboratories Limited). The above items come under the Vital<br />
Group and are life saving in nature. Hence, even though the annual turn over the<br />
said firm is less than 50 Crores, for the previous 3 years, the undersigned<br />
recommend the inclusion of the firm in the Suppliers List subject to extant rules<br />
and procedures, for selected vital medicines like IV fluid preparations.<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s FRESNIUS KABI ONCOLOGY<br />
LIMITED FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Fresnius Kabi Oncology Limited<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose<br />
products are likely to be<br />
marketed by this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: Echelon Institutional Area, Plot No. 11,<br />
Sector No. 32, Gurgon 122 001<br />
: Plot No. 19, HPSIDC, Industrial Area,<br />
Baddi, Dist Solan, H.P<br />
“ Available at Folios 1 - 3<br />
MANDATORY CONDITIONS<br />
1 Firm's standing In<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available at Folios 91-97 * (Three<br />
years certificate now enclosed. This<br />
firm was registered in 16.04.2009,<br />
duly verifying the<br />
manufacturing/market standing for<br />
three years then)<br />
Available at Folio 4 to 66<br />
3 WHO GMP certificate Available at Folios 67 to 82<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Desirable conditions<br />
Available at Folio 88<br />
Available at Folios 89, 90A<br />
Available at Folio 115<br />
1 ISO 9000 certificate Available at Folio 98<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
Available at Folios 107 to 110<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Registered in North Central<br />
<strong>Railway</strong>, PO of Western Central<br />
<strong>Railway</strong> at Folio 105 to 106<br />
Available at Folio 100 to 102
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being<br />
sold in USA Europe and other<br />
developed countries equi to Europeal<br />
countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
IV . If yes, has the firm been inspected<br />
Not applicable<br />
V. Does the firm qualify for registration Yes/No *<br />
* Note: The firm was registered on 16.04.2009 under the new Regulations<br />
for Registration of Firms, duly obtaining a Market Standing Certificate then. The<br />
firm now qualifies for registraton as they have submitted a Market Standing<br />
Certificate for three years, EXCEPT for the products under Folio 95 and 96,<br />
wherein the Market Standing is less than Five years.<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s M/s MEDOPHARM FOR<br />
REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Medopharm<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose<br />
products are likely to be<br />
marketed by this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: P.B.No. 2353, No. 25, Puliyur 2 nd Main<br />
Road, Trustpuram, Kodambakkam,<br />
Chennai 600 0243<br />
: Medopharm<br />
50 Kayarambedu Village, Guduvanchery<br />
603 203<br />
“ Available at Folio 31<br />
MANDATORY CONDITIONS<br />
1 Firm's standing In<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available at Folios 51-54<br />
Available at Folios 32-40 and<br />
Folios 57-58<br />
3 WHO GMP certificate Available at Folios 55-56<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Available at Folio 5<br />
Available at Folios 28<br />
Available at Folio 30<br />
Desirable conditions<br />
1 ISO 9000 certificate Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Available at Folios 69-88<br />
Not available<br />
Not available
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being<br />
sold in USA Europe and other<br />
developed countries equi to Europeal<br />
countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
IV . If yes, has the firm been inspected<br />
To be inspected<br />
V. Does the firm qualify for registration Yes/No<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s FOURRTS (INDIA)<br />
LABORATIRES LTD FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Fourrts (India)Laboratories Pvt Ltd<br />
2 Postal address of Head<br />
Office / Registered Office<br />
3 Name and address of<br />
manufacturer whose<br />
products are likely to be<br />
marketed by this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: No.1, Fourrts Avenue, Annai Indira<br />
Nagar,Okkiyum Thoraipakkam,<br />
Chennai 600 097<br />
: M/s Fourrts (India) Laboratories Pvt<br />
Ltd, Vandalur Road, Kelambakkam<br />
603 103<br />
“ Product list at 1a and 1b<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each<br />
product<br />
Yes –<br />
available<br />
Yes –<br />
available<br />
3 WHO GMP certificate Yes –<br />
available<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should<br />
be Rs. 50 crores for previous three<br />
years)<br />
5 Firm's Declaration with regard to<br />
non conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Desirable conditions<br />
F 48<br />
Yes - F-34<br />
available<br />
Yes –<br />
available<br />
Yes –<br />
available<br />
(Available for 3<br />
years)<br />
F 11 to 16<br />
F 4 to 10<br />
F 49<br />
F 49<br />
1 ISO 9000 certification F 17<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
F-3
-2 -<br />
3 Details of supply orders received<br />
from Institutions in the previous<br />
three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the <strong>Railway</strong>/<br />
Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Yes -<br />
available<br />
Yes –<br />
available<br />
Not available<br />
F 18 to 32<br />
F 18 to 32<br />
X. For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being<br />
sold in USA Europe and other<br />
developed countries equi to Europeal<br />
countries<br />
Authorisation letter by OEM abroad<br />
for local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
No<br />
a. If yes, has the firm been inspected Not applicable<br />
b. Does the firm qualify for registration Yes/No<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s FOURRTS (INDIA)<br />
LABORATIRES LTD FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Fourrts (India)Laboratories Pvt Ltd<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose<br />
products are likely to be<br />
marketed by this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: No.1, Fourrts Avenue, Annai Indira<br />
Nagar,Okkiyum Thoraipakkam,<br />
Chennai 600 097<br />
: M/s Fourrts (India) Laboratories Pvt<br />
Ltd, Vandalur Road, Kelambakkam<br />
603 103<br />
“ Product list at 1a & 1b<br />
MANDATORY CONDITIONS<br />
1 Firm's standing In<br />
manufacturing/marketing<br />
pharmaceutical products<br />
2<br />
7<br />
(should be atleast 5 years)<br />
Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available at Folios 51-54<br />
Available at Folios 32-40 and<br />
Folios 57-58<br />
3 WHO GMP certificate Available at Folios 55-56<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Available at Folio 5<br />
Available at Folios 28<br />
Available at Folio 30<br />
Desirable conditions<br />
1 ISO 9000 certificate Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Available at Folios 69-88<br />
Not available<br />
Not available
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being<br />
sold in USA Europe and other<br />
developed countries equi to Europeal<br />
countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
IV . If yes, has the firm been inspected<br />
To be inspected<br />
V. Does the firm qualify for registration Yes/No<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Sr Divl Medical Officer Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
Proforma to be filled up by the Inspecting Team<br />
Note: <strong>Inspection</strong> is to be done by respective Zonal <strong>Railway</strong>s in whose jurisdiction<br />
the Manufacturing Unit is located. Wherever there is inadequate space please<br />
submit information in separate sheet enclosed and marked as Annexure (Also<br />
having item no. of this proforma in reference to which Annexure is prepared)<br />
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
1 Name of the firm M/s Medopharm<br />
2 Whether the firm is having registered<br />
office/Branch office. Give address and<br />
Telephone no in case more than one<br />
manufacturing unit - details all to be<br />
inspected<br />
In case marketing a product manufactured<br />
by other company. If 'yes' that also to be<br />
inspected<br />
3 Whether the firm is having 5 years<br />
standing marketing/manufacturing of<br />
pharmaceutical products<br />
4 Whether firm is having 3 years standing in<br />
marketing/manufacturing of each<br />
individual product to which it wishes to get<br />
Registered (in case 'No' names of such<br />
product to be given)<br />
5 Whether valid drug license for each<br />
product exists from Drug Controller (In<br />
case 'No' names of such product to be<br />
given)<br />
6 Audited annual turn over figures for each<br />
product for the last 3 years<br />
7 Whether WHO GMP certificate for<br />
production unit/s is there<br />
8 Whether any other certificate for<br />
firm/manufacturing and manufacturing<br />
process (as desired in item 4 of terms and<br />
conditions exit)<br />
P.B.No. 2353, No. 25, Puliyur<br />
2 nd Main Road, Trustpuram,<br />
Kodambakkam,<br />
Chennai 600 024<br />
Yes<br />
50, Kayarambedu Village,<br />
Guduvancherry 603 203<br />
Yes<br />
Yes<br />
Yes<br />
2008-09 12980.60 lakhs<br />
2009-10 12748.00 lakhs<br />
2010-11 13307.52 lakhs<br />
9 Company turn over figure for last 3 years 2008-09 12980.60 lakhs<br />
10 R&D facilities with firm. Annual<br />
expenditure in R&D in last 3 years<br />
Yes<br />
yes<br />
2009-10 12748.00 lakhs<br />
2010-11 13307.52 lakhs<br />
Not available
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
11 Name of Original research Available at Folio 30<br />
products/formulations developed by<br />
firm<br />
12 Names of products for which firm is<br />
original manufacturer<br />
Nil<br />
13 Whether any punitive action has been<br />
taken or contemplated State/Central<br />
Institution/Drug Controller. If yes give<br />
details<br />
14 Relevant information for each specific<br />
product as per ORG-MARG analysis or<br />
by any other agency<br />
15 a) Names of imported drug items<br />
supplied by firm. List of developed<br />
countries where item is approved and<br />
supplied<br />
b) The source of manufactured<br />
raw/finished products for quality report<br />
c) Authorization letter by OEM abroad<br />
for local agent<br />
16 Other conditions<br />
No<br />
a) Cleanliness of premises Clean<br />
b) Whether plan is manual or automatic<br />
and level of automation<br />
c)Quality of packaging and packaging<br />
system<br />
d) Availability of sterile room yes<br />
e) Degree of hand handling in<br />
manufacturing process<br />
f) Availability of technically qualified<br />
staff<br />
-<br />
Not Applicable<br />
Not Applicable<br />
Not Applicable<br />
Automatic<br />
Excellent<br />
Minimal<br />
yes<br />
g) Quality control inhouse lab/outsource yes<br />
17 Date of inspection 25 th June 2012<br />
18 i) Place of inspection Guduvancherry, Chennai<br />
ii) Storage facility holding time for<br />
manufactured products<br />
19 Name and designation of the company<br />
official accompanying for inspection<br />
Yes<br />
Mr. Abdul Hameed, Technical<br />
Director, No. 50, Kayarambedu<br />
Village, Guduvancherry, 603<br />
202, Kancheepuram District
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
20 Whether firm is recommended suitable for Yes<br />
registration. Whether the product being<br />
Available in open market in<br />
applied by firms for registgration are<br />
the same brand name in<br />
available in open market with some brand<br />
southern region<br />
name and the region<br />
21 Name and Designation of the Team<br />
Member<br />
Signature<br />
1) Dr N.Kannan<br />
Medical Director and Chief Paediatrician,<br />
Rly Hospital,<br />
Perambur<br />
2) Dr Prasanna Kumar,<br />
Additional Chief Health Director,<br />
Rly Hospital, Perambur<br />
3)Dr A.P.Preetham,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur
REPORT ON APPLICATION SUBMITTED BY M/s FOURRTS (INDIA)<br />
LABORATIRES LTD FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Parenteral Drugs (India) Ltd<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose<br />
products are likely to be<br />
marketed by this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: Shree Ganesh Chambers, A.B.Road,<br />
Navlakha Crossing, Indore 452 001<br />
: M/s Parenteral Drugs (India) Ltd<br />
Village Asrawad, Post Dudhia,<br />
Nemawar Road, Dist. Indore, M.P<br />
“ Available at folio 4<br />
MANDATORY CONDITIONS<br />
1 Firm's standing In<br />
manufacturing/marketing<br />
pharmaceutical products<br />
2<br />
7<br />
(should be atleast 5 years)<br />
Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available at Folios 1<br />
(Three years certificate now<br />
enclosed. This firm was registered<br />
in 2009, duly verifying the<br />
marketing standing for three years<br />
then)<br />
Available at Folio 2<br />
3 WHO GMP certificate Available at Folio 7<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Available at Folio 3<br />
Available at Folios 5<br />
Available at Folio 4<br />
Desirable conditions<br />
1 ISO 9000 certificate Not available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not available<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Not available<br />
Not available<br />
Not available
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being<br />
sold in USA Europe and other<br />
developed countries equi to Europeal<br />
countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
IV . If yes, has the firm been inspected<br />
Not Applicable<br />
V. Does the firm qualify for registration No<br />
The following products of the firm supplied to other <strong>Railway</strong>s were found<br />
to be substandard.<br />
1. Multiple Electrolyte and Dextrose 21.05.2012<br />
2. Dextrose IP 100 ml 12.02.2011<br />
3. Inj.Ondansetron 30.08.2011<br />
4. Tab.Hotril 2.5 mg 12.08.2011<br />
5. Inj.Artesunate 08.05.2011<br />
6. iv Dextrose 10% 22.06.2011<br />
7. Inj.iv Sodium Chloride 04.11.2011<br />
In view of the above it is recommended that the application from M/s<br />
Parenteral Drugs (India) Ltd should not be considered for renewal.<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director CSS/ Lab and Admn Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
No. HQ/MD/Regn. of Firms Dt: 14.08.2012.<br />
CMD/MAS<br />
Sub: Registration of firms – New Procurement Policy<br />
Ref: Your letter no. MD.69/Registration dt. 05.07.2012<br />
On perusal of the file it is seen that M/s Sanjivani<br />
Parenteral Limited have been registered with Central <strong>Railway</strong> and<br />
Western <strong>Railway</strong> during 2007 for a initial period of one year, to be<br />
reviewed subject to the performance of the Company.<br />
It may be ascertained from both Central and Western<br />
<strong>Railway</strong> regarding the performance of the firm before deciding on<br />
the issue.<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director CSS/ Lab and Admn Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team
REPORT ON APPLICATION SUBMITTED BY M/s FOURRTS (INDIA)<br />
LABORATIRES LTD FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Fourrts (India)Laboratories Pvt Ltd<br />
2 Postal address of Head Office<br />
/ Registered Office<br />
3 Name and address of<br />
manufacturer whose<br />
products are likely to be<br />
marketed by this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: No.1, Fourrts Avenue, Annai Indira<br />
Nagar,Okkiyum Thoraipakkam,<br />
Chennai 600 097<br />
: M/s Fourrts (India) Laboratories Pvt<br />
Ltd, Vandalur Road, Kelambakkam<br />
603 103<br />
“ Product list at 1a & 1b<br />
MANDATORY CONDITIONS<br />
1 Firm's standing In<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each product<br />
Available at Folio 48<br />
Available at Folios 11 to 16<br />
3 WHO GMP certificate Available at Folios 4 to 10<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should be<br />
Rs. 50 crores for previous three years)<br />
5 Firm's Declaration with regard to non<br />
conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
2005-2006 100.64 crores<br />
2006-2007 107.33 crores<br />
2007-2008 138.22 crores<br />
Available at Folio 49<br />
Available at Folio 49<br />
Desirable conditions<br />
1 ISO 9000 certificate Available at Folio 17<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Available at Folio 3<br />
3 Details of supply orders received from<br />
Institutions in the previous three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the<br />
<strong>Railway</strong>/Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Available at Folio 18 to 32<br />
Folio 18 to 32<br />
Not available
II.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being<br />
sold in USA Europe and other<br />
developed countries equi to Europeal<br />
countries<br />
Authorisation letter by OEM abroad for<br />
local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
IV . If yes, has the firm been inspected<br />
To be inspected<br />
V. Does the firm qualify for registration Yes/No<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director Chief Staff Surgeon/Admn Sr Divl Medical Officer<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
REPORT ON APPLICATION SUBMITTED BY M/s Galpha Laboratories<br />
Limited FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Fourrts (India)Laboratories Pvt Ltd<br />
2 Postal address of Head<br />
Office / Registered Office<br />
3 Name and address of<br />
manufacturer whose<br />
products are likely to be<br />
marketed by this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: No.1, Fourrts Avenue, Annai Indira<br />
Nagar,Okkiyum Thoraipakkam,<br />
Chennai 600 097<br />
: M/s Fourrts (India) Laboratories Pvt<br />
Ltd, Vandalur Road, Kelambakkam<br />
603 103<br />
“ Product list at 1a and 1b<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each<br />
product<br />
Yes –<br />
available<br />
Yes –<br />
available<br />
3 WHO GMP certificate Yes –<br />
available<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should<br />
be Rs. 50 crores for previous three<br />
years)<br />
5 Firm's Declaration with regard to<br />
non conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Desirable conditions<br />
F 48<br />
Yes - F-34<br />
available<br />
Yes –<br />
available<br />
Yes –<br />
available<br />
F 11 to 16<br />
F 4 to 10<br />
F 49<br />
F 49<br />
1 ISO 9000 certification F 17<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
F-3
-2 -<br />
3 Details of supply orders received<br />
from Institutions in the previous<br />
three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the <strong>Railway</strong>/<br />
Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Yes -<br />
available<br />
Yes –<br />
available<br />
Not available<br />
F 18 to 32<br />
F 18 to 32<br />
XI. For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being<br />
sold in USA Europe and other<br />
developed countries equi to Europeal<br />
countries<br />
Authorisation letter by OEM abroad<br />
for local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
Yes<br />
a. If yes, has the firm been inspected Yes. <strong>Inspection</strong> report<br />
enclosed<br />
b. Does the firm qualify for registration yes<br />
(Dr.N.Kannan) (Dr.Prasannakumar) (Dr.A.P.Preetham)<br />
Medical Director & Sr Divl Medical Officer Sr Divl Medical Officer<br />
Chief Paediatrician<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
Proforma to be filled up by the Inspecting Team<br />
Note: <strong>Inspection</strong> is to be done by respective Zonal <strong>Railway</strong>s in whose jurisdiction<br />
the Manufacturing Unit is located. Wherever there is inadequate space please<br />
submit information in separate sheet enclosed and marked as Annexure (Also<br />
having item no. of this proforma in reference to which Annexure is prepared)<br />
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
1 Name of the firm M/s Fourrts (India)<br />
Laboratories Pvt Ltd<br />
2 Whether the firm is having registered<br />
office/Branch office. Give address and<br />
Telephone no in case more than one<br />
manufacturing unit - details all to be<br />
inspected<br />
In case marketing a product manufactured<br />
by other company. If 'yes' that also to be<br />
inspected<br />
3 Whether the firm is having 5 years<br />
standing marketing/manufacturing of<br />
pharmaceutical products<br />
4 Whether firm is having 3 years standing in<br />
marketing/manufacturing of each<br />
individual product to which it wishes to get<br />
Registered (in case 'No' names of such<br />
product to be given)<br />
5 Whether valid drug license for each<br />
product exists from Drug Controller (In<br />
case 'No' names of such product to be<br />
given)<br />
6 Audited annual turn over figures for each<br />
product for the last 3 years<br />
7 Whether WHO GMP certificate for<br />
production unit/s is there<br />
8 Whether any other certificate for<br />
firm/manufacturing and manufacturing<br />
process (as desired in item 4 of terms and<br />
conditions exit)<br />
Yes<br />
No.1, Fourrts Avenue,<br />
Annai Indira<br />
Nagar,Okkiyum<br />
Thoraipakkam, Chennai<br />
600 097<br />
M/s Fourrts (India)<br />
Laboratories Pvt Ltd,<br />
Vandalur Road,<br />
Kelambakkam 603 103<br />
Yes<br />
Yes<br />
Yes<br />
2008-09 145.05 crores<br />
2009-10 154.90 crores<br />
2010-11 207.79 crores<br />
9 Company turn over figure for last 3 years 2008-09 145.05 crores<br />
10 R&D facilities with firm. Annual<br />
expenditure in R&D in last 3 years<br />
Yes<br />
yes<br />
2009-10 154.90 crores<br />
2010-11 207.79 crores
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
11 Name of Original research F 4 – 10<br />
products/formulations developed by<br />
firm<br />
12 Names of products for which firm is<br />
original manufacturer<br />
Not Applicable<br />
13 Whether any punitive action has been<br />
taken or contemplated State/Central<br />
Institution/Drug Controller. If yes give<br />
details<br />
14 Relevant information for each specific<br />
product as per ORG-MARG analysis or<br />
by any other agency<br />
15 a) Names of imported drug items<br />
supplied by firm. List of developed<br />
countries where item is approved and<br />
supplied<br />
b) The source of manufactured<br />
raw/finished products for quality report<br />
c) Authorization letter by OEM abroad<br />
for local agent<br />
16 Other conditions<br />
No<br />
Nil<br />
a) Cleanliness of premises Clean<br />
b) Whether plan is manual or automatic<br />
and level of automation<br />
c)Quality of packaging and packaging<br />
system<br />
d) Availability of sterile room yes<br />
e) Degree of hand handling in<br />
manufacturing process<br />
f) Availability of technically qualified<br />
staff<br />
Not Applicable<br />
Not applicable<br />
Not applicable<br />
Automatic<br />
Excellent<br />
Minimal<br />
yes<br />
g) Quality control inhouse lab/outsource yes<br />
17 Date of inspection 02.07.2012<br />
18 i) Place of inspection Kelambakkam<br />
ii) Storage facility holding time for<br />
manufactured products<br />
yes
Sl.No. Description Remarks<br />
19 Name and designation of the company<br />
official accompanying for inspection<br />
Mr. Vanjinathan<br />
Vice President, Technical<br />
Sl.No. Description Remarks<br />
(S.No. in alphabetical list)<br />
20 Whether firm is recommended suitable for Yes<br />
registration. Whether the product being<br />
Available in open market in<br />
applied by firms for registgration are<br />
the same brand name in<br />
available in open market with some brand<br />
southern region<br />
name and the region<br />
21 Name and Designation of the Team<br />
Member<br />
Signature<br />
1.Dr.N.Kannan<br />
Medical Director and Chief Paediatrician<br />
<strong>Railway</strong> Hospital, Perambur<br />
2. Dr Prasannakumar<br />
Chief Staff Surgeon, Lab and Admn,<br />
Rly Hospital, Perambur<br />
3.Dr A.P.Preetham,<br />
Sr Divl Medical Officer, Rly Hospital,<br />
Perambur
REPORT ON APPLICATION SUBMITTED BY M/s Aventis Pharma Limited<br />
FOR REGISTRATION IN SOUTHERN RAILWAY<br />
1 Name of the firm : M/s Aventis Pharma Limited<br />
2 Postal address of Head<br />
Office / Registered Office<br />
3 Name and address of<br />
manufacturer whose<br />
products are likely to be<br />
marketed by this firm<br />
4 Products for which<br />
registration is sought<br />
strength wise<br />
: Aventis House, 54/A, Sir Mathurdas<br />
Vasanji Road, Andheri (East), Mumbai<br />
: M/s Aventis Pharma Limited, GIDC,<br />
Plot No. L 121, Phase III, Verna<br />
Industrial Estate, Verna, Nagoa, Goa<br />
403722<br />
“ Available at folio 4<br />
Amount tobe paid as Registration Fee for three years : Rs. 5,000/-<br />
1 Firm's standing in<br />
manufacturing/marketing<br />
pharmaceutical products<br />
(should be atleast 5 years)<br />
MANDATORY CONDITIONS<br />
2 Valid drug license for manufacture<br />
from Drug Controller for each<br />
product<br />
Available at folio 2A (Three years<br />
certificate now enclosed. The firm<br />
was registered in 2009, duly<br />
verifying the market standing for<br />
three years then)<br />
Available at folio 2<br />
3 WHO GMP certificate Available at folio 7<br />
4 Annual turnover of the firm from<br />
domestic market (minimum should<br />
be Rs. 50 crores for previous three<br />
years)<br />
5 Firm's Declaration with regard to<br />
non conviction of their firm<br />
6 Firm's declaration that products<br />
submitted for registratiion are<br />
available in market for retain sale in<br />
the same brand name<br />
Desirable conditions<br />
Available at folio 3<br />
Available at folio 6<br />
Available at folio 5<br />
1 ISO 9000 certification Not Available<br />
2 Market share of items as per latest<br />
ORG-MARG NIELSEN analysis or<br />
National/central Health Agencies<br />
Not Available
-2 -<br />
3 Details of supply orders received<br />
from Institutions in the previous<br />
three years<br />
4 Cases of high value orders covering<br />
yearly requirements for the <strong>Railway</strong>/<br />
Unit<br />
5 Performance <strong>Report</strong> issued by other<br />
Government Organisations<br />
Not Available<br />
Not Available<br />
Not Available<br />
XII.For drugs manufactured abroad and proposed for supply by the firm,<br />
the following informations are MANDATORILY REQUIRED:<br />
a<br />
b<br />
c<br />
d<br />
The source of manufactured<br />
raw/finished products and quality<br />
report<br />
Relation of Indian agent with the<br />
foreign company in past 3 years<br />
Whether the same product is being<br />
sold in USA Europe and other<br />
developed countries equi to Europeal<br />
countries<br />
Authorisation letter by OEM abroad<br />
for local agent<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
Not applicable<br />
III. Does the firm has manufacturing facilities<br />
situated in <strong>Southern</strong> <strong>Railway</strong><br />
a. If yes, has the firm been inspected Not applicable<br />
b. Does the firm qualify for registration yes<br />
(Dr.Prasannakumar) (Dr.R.Saravanan) (Dr.A.P.Preetham)<br />
Chief Staff Surgeon Sr Divl Medical Officer Sr Divl Medical Officer<br />
Lab & Administration (Ophthalmology) (ENT)<br />
Rly Hospital, Perambur Rly Hospital, Perambur Rly Hospital, Perambur<br />
Head of <strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team Member/<strong>Inspection</strong> Team<br />
Chief Medical Director<br />
Chief Health Director
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