Drug Information Bulletin - Indian Pharmaceutical Association

Drug Information Bulletin
(Electronic)
Drug Information Centre (DIC)
Indian Pharmaceutical Association, Bengal Branch
Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com
Web Site: http://www.ipabengal.org
Contact: 09830136291
5 th
Year
Volume: 05 Number: 10 18 th June 2011
Content
• Notification GSR 418(E): Prohibition to Manufacture, Sale and distribute the Drug
Human Placenta Extract and its formulation, 30-May-2011
• CDSCO Letter F. No. 12-01/11-DC (Pt.27): Clarification regarding continued
availability of Gatifloxacin Ophthalmic formulations - 03-Jun-2011
• Office Order DCG (I)/Misc/2011/: Transfer of certain functions & delegation of
powers to Zonal Offices of CDSCO under Rule 22 of Drugs & Cosmetics Rules, 01-
Jun-2011
• Implementation of bar code date extended to 1 st October 2011
• Vaccinating girls will cut rates of cervical cancer
• Scientists come up with new molecule that may lead to better drug for TB
• House cuts FDA's budget
• ASEAN members sign new action plan to fight Dengue
• Forthcoming Event
Notification GSR 418(E): Prohibition to Manufacture, Sale and distribute the Drug
Human Placenta Extract and its formulation, 30-May-2011
This notification amends item No. (4) of the third paragraph of notification GSR 82(E)
(120484) as under: "4 Human Placental Extract and its formulations for human use except its
(i) Topical application for wound healing, and (ii) Injection for pelvic inflammatory disease
subject to the condition that the manufacturers of Human Placental Extract and its
formulations for human use shall maintain meticulous details and traceability of the donors of
the Placenta so as to ensure that the Placenta is collected from the donors who are free from
HIV, HBsAg, HCV and other viruses." For details www.cdsco.nic.in
CDSCO Letter F. No. 12-01/11-DC (Pt.27): Clarification regarding continued
availability of Gatifloxacin Ophthalmic formulations - 03-Jun-2011
With this Letter, the Central Drugs Standard Control Organization, Office of Drugs Controller
General clarified that Gatifloxacin ophthalmic formulations, like eye drops and ointments
which are topical formulations and are not for systemic use, are not covered under the
Gazette notification no. GSR 218(E) dated 16-Mar-201.
Office Order DCG (I)/Misc/2011/: Transfer of certain functions & delegation of
powers to Zonal Offices of CDSCO under Rule 22 of Drugs & Cosmetics Rules, 01-
Jun-2011
This office order informs that it has been decided to delegate the powers listed below to the
zonal officers: 1. No Objection certificates for grant of license to manufacture drugs for the

2
purpose of examination, test or analysis and provided under Rule 89 of the Drugs &
Cosmetics Rules (65251). 2. No objection certificate for grant of permissions for manufacture
for export only of unapproved/approved new drugs and drugs banned under sanction 26-A of
the Drugs &.Cosmetics Act (91230). 3: Permit for import of small quantities of drugs for
personal use under Form-12B of the Drugs & Cosmetics Rules. 4. No objection certificates for
grant of permissions for import of dual use items, not for medicinal use. Following officers of
the respective zone will exercise the powers within the jurisdiction with effective from 20-
Jun-2011 till further order.

Implementation of bar code date extended to 1 st October 2011
3

4
Vaccinating girls will cut rates of
cervical cancer
The first evidence has emerged that
Australia’s nationwide vaccination program
for young women against HPV, the virus
that triggers cervical cancer, are likely to
cut the numbers who get the disease. A
study in Australia, one of the first countries
to introduce the vaccination, has shown a
drop in high-grade cervical abnormalities -
changes to the cells in the neck of the
womb that can be the precursor to cancer.
Source:
http://pharmalive.com/news/index.cfm?arti
cleID=788786&categoryid=9&newsletter=
1
Scientists come up with new molecule
that may lead to better drug for TB
Scientists at the Tuberculosis Research
Centre (TRC) here have hit upon a new
molecule with anti-bacterial and anti-viral
properties that could potentially lead to a
better drug for the treatment of TB and
common HIV sub-types.
The team at TRC extracted the molecule,
Transitmycin, from the marine
microorganism Streptomyces sp. isolated
from a soil sample off the Rameswaram
coral reef.
The brominated and pigmented (yellow)
antibiotic was found effective during in
vitro tests against dormant and active
forms of Mycobacterium tuberculosis — the
pathogen that triggers one of the leading
infectious diseases worldwide. For details
https://conferences.niaid.nih.gov/TBIndia/
Presentations/Posters/12_Poster_Vanaja_K
umar.pdf
House cuts FDA's budget
The Washington Post reports that on
Thursday "House Republicans cut millions
of dollars...from the Food and Drug
Administration's budget, denying the
agency money to implement landmark
food safety laws approved by the last
Congress." The lawmakers said the cuts
"were needed to lower the national deficit"
and argued that "the US food supply is 99
percent safe" as is. The House also
reduced funding for the USDA's food safety
inspection service. Additionally, they
barred the FDA from "approving the sale of
genetically engineered salmon." The Post
states that the "White House opposed
many of the cuts, saying they would force
the USDA to furlough inspectors at meat
and poultry processing plants and leave
the FDA unable to meet the requirements
of a food safety law passed in December."
ASEAN members sign new action plan
to fight Dengue
Members of the Association of Southeast
Asian Nations (ASEAN) on Wednesday as
part of an event marking ASEAN Dengue
Day signed a new action plan aimed at
fighting dengue in the region, the Jakarta
Post reports. The Jakarta Call for Action on
the Control and Prevention of Dengue
"calls upon stakeholders in the region to
strengthen regional cooperation on dengue
prevention, to combat the disease in
sustainable ways, and promote intersectoral
collaboration," the newspaper
writes (6/15).
Forthcoming Event:
Annual General Meeting of
IPA, Bengal Branch
26 th June, 2011
IPA Auditorium
22 B Panchanontola Road
Kolkata-700029
at 5.00 pm