Volume 2, No.5, July to September' 2013 - amam-ayurveda.org

From the Editor’s desk
Dear Members,
We have come up with new edition of infoAyurveda for this session
covering few interesting regulatory updates, Pharmacopeial standards
of Ashwagandhadyarishta with special mention of Ashwagandha, a
brief compilation on quality, efficacy & safety of Ashwagandha and
a brief of clinical study on Stresscom (Ashwagandha capsules) in
Chronic Fatigue Syndrome.
As the regulations for getting manufacturing license are getting
stringent day by day, the implications are imposed for the proof of
efficacy and safety for the products whether ASU or Proprietary.
Therefore, in order to apply for the license, the clinical trials now days
for the ASU medicines are coming in shape. In making the stringency,
AYUSH Department has made it mandatory to register at Clinical Trial
Registry of India all the clinical trials that are being conducted in India
on ASU medicines. This, in turn, will help us to know the number of
clinical trials initiated in the country alongwith the various indications
on ASU medicines. Recently, CDSCO has also made it mandatory for
the registration of the Ethics Committee before giving approval for
any clinical trial. As per our assumptons this implies that though ASU
medicines do not fall under perview of DCGI but, without saying,
for getting the approval from Ethics Committee, the same needs to be
registered under DCGI. Moreover, the AYUSH department has issued
guidelines for Good Clinical Practices for the clinical trials in Ayurveda,
Siddha and Unani Medicine (GCP-ASU). These guidelines are intended
to serve as a reference source for research scientists, registered medical
practitioners, manufacturers, and health authorities. These guidelines
are formulated based on CDSCO Document on GCP Guidelines (2001)
for Clinical Trials on Pharmaceutical Products. However, at present
these guidelines are a guiding tool and are for voluntary use by the
researcher, but will be superseded by regulatory provisions as and when
brought in.
In view of the current scenario, developing an ASU medicine, downthe-line
would require more scientific and methodological approach
which will have time and financial implications in the drug development
process on ASU medicines.
Though all these new regulations/guidelines are welcome steps,
however, we are of the view that AYUSH industry (especially the small
scale industries) as on date may not be well equipped to follow all the
regulations all together; Rather it would have been smooth, in case, if it
these guidelines/regulations were introduced in a stepwise manner.
Warm Regards
Editorial Board
Patron
Suresh Sharma
Pradip Burman
President
AMAM’S
Management Committee
Vaidya Devender Triguna
Tel: 011-24354141
Vice President
Mr. Ajay Sharma
Shri Baidyanath Ayurved Bhawan Ltd.,
Asad Mueed
Hamdard (WAKF) Laboratories
e-mail:amueed@hamdardindia.com
Devendra Garg
Dabur India Limited
e-mail: gargd@dabur.com
Dr. Rangesh
The Himalaya Drug Co.
e-mail: dr.rangesh@himalayahealthcare.com
Hon. Gen. Secretary
Pradeep Multani
Multani Pharmaceuticals Ltd.
e-mail: chairman@multaniayurved.org
Treasurer
Tejinder Singh
Dabur India Limited
e-mail: singht@dabur.com
Jt. Secretary
Dr. Manju Rakesh
Sanat Products Limited
e-mail: ceo@sanat.co.in
Arun Chauhan
BACFO Pharmaceuticals (India ) Ltd.
e-mail: chauhanarun@akcgroup.com
Dr. N. B. Brindavanam
Dabur India Limited
e-mail: baba@dabur.com
M.J. Saxena
Sanat Laboratories Ltd.
e-mail: mjsaxena@sanatproducts.co.in
Members
Mr. Krishan Chutani
Dabur India Limited
e-mail: chutanikk@dabur.com
Dr. Anantha Narayana D B
Ph.D., Consultant
e-mail: dba.narayana@gmail.com
Pramod Sharma
Shri Baidyanath Ayurved Bhawan Ltd.
e-mail: pramodsharma54@yahoo.com
Amit Agarwal
Natural Remedies
e-mail: amit@naturalremedies.com
Vijay Grover
Kamal Pharmacy, New Delhi
e-mail: Vijay@kamalpharmacy.com
Editorial Board
Chief Editor:
Mr. Pradeep Multani
Honorary General Secretary AMAM
Chairman Multani Pharmaceutical Limited
H-36, Connaught Place, New Delhi- 1
Editor:
Dr. J.L.N. Sastry
Dabur India Limited, Plot No. 22, Site IV,
Sahibabad - 201010, Ghaziabad (U.P.)
Mr. Asad Mueed, Director
Hamdard (WAKF) Laboratories, Asaf Ali Road, New Delhi – 2
Mr. Ajay Sharma, President
Shri Baidyanath Ayurved Bhawan, Naini,
28, Ishwar Nagar East, New Delhi – 65
A Publication of:
Association of Manufacturers of Ayurvedic Medicines
Regd. Office: 22, Site –IV, Sahibabad,
Ghaziabad - 201010 (UP), Tel: 0120 4378400, Fax: 0120 4376909
Correspondence Address: H-36, Connaught Place, New Delhi-110001,
Tel: 011-23350062, Fax: 011-23350063
e-mail : amamindia@gmail.com website: www.amam-ayurveda.org
Disclaimer: Articles in the newsletter are written by independent individuals. News Clips of Upcoming
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info Ayurveda, Volume 2, No.5, July - Sept’ 2013
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