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

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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 However, at present these guidelines are a guiding tool and are for voluntary use by the researcher, but will be superseded by regulatory provisions as and when brought in.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 Events, Govt. Notifications, Schemes have been taken from different sources. Their opinions do not necessarily reflect those of infoAyurveda. They are put here for interest and reference only. None of the contributors, sponsors, administrators, or anyone else connected with infoAyurveda in any way whatsoever shall be responsible for the appearance of any inaccurate information or for your use of the information contained in the newsletter. info Ayurveda, Volume 2, No.5, July - Sept’ 2013 2
Regulatory Update REGISTRATION OF CLINICAL TRIALS ON ASU MEDICINES AT CLINICAL TRIALS REGISTRY-INDIA (CTRI) K. 11022/10/2007-DCC (AYUSH) Government of India Ministry of Health and Family Welfare Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy (AYUSH) IRCS Building, New Delhi Date: 22nd August, 2012 ORDER Department of AYUSH takes cognizance of the fact that a large number of clinical trials are conducted in India on AYUSH remedies and therapies. These trials involve human participants for proving the efficacy of drugs and therapies used in the AYUSH systems. The intention of these trials is to promote evidence based clinical practice for the benefit of patients. Unfortunately, the data and other relevant details of clinical trials conducted by the different institutions are difficult to find or many of the trials are abandoned or not published due to negative or equivocal results. The practice of evidence- based medicine requires access to all information generated through clinical trials. Clinical Trial Registry - India (CTRI) has been hosted at the National Institute of Medical Statistics under Indian Council of Medical Research. It is a free and online public record system for registration of clinical trials conducted in India. The researchers involved in clinical trials including those conducted in AYUSH systems are expected to register the clinical trials in CTRI before enrolment of the first patient for the study. The guidelines in this regard are given in the CTRI website (www.ctri.nic.in) or can be sought from - Administrator, Clinical Trials Registry -India (CTRI) National Institute of Medical Statistics, (Indian Council of Medical Research). Ansari Nagar, New Delhi - 110 029 -India Telephone: 91-11 - 26588725, 91-11-26588803 Fax: 91-11-26589635 e-mai1: ctr.nims@gmail.com All Institutions including Research Councils and National Institutes of AYUSH are hereby directed to ensure registration of all AYUSH clinical trials in the clinical trial registry. It is also desired that the registration of clinical trials in the registry be informed to the Department of AYUSH annually. Anil Kumar Ganeriwala Joint Secretary to Govt. of India info Ayurveda, Volume 2, No.5, July - Sept’ 2013 3
Page 1: Volume 2, No.5, July to September
Page 5 and 6: GOOD CLINICAL PRACTICE GUIDELINES F
Page 7 and 8: STORAGE Store in a cool place in ti
Page 9 and 10: BRIEF REVIEW ON ASHWAGANDHA (Withan
Page 11 and 12: urinary stones and hemorrhagic dise
Page 13 and 14: Double Blind Randomized Placebo Con
Page 15 and 16: 3.6. TOLERANCE The drug was well to

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

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