The recent amendments of Schedule Y of the Drugs & Cosmetics Act will help India tap about US$ 1 billion opportunity in the field of clinical research by 2010, opined experts at a seminar on Schedule Y organised by the Indian Drugs Manufacturers Association (IDMA) in Mumbai, last week.
They pointed out the amended Schedule Y incorporates definitions for phases 1-4 provided, the phase lag requirements have given way to acceptance of concurrent phase 2-3 as a part of global clinical trials. Further, a new classification of fixed dose combinations for new clinical trials is included and appendices specifying a checklist for informed consent documents and the format for informed consent form are some of the salient features of the amended Schedule Y. To comply with the regulations of International Conference on Harmonization, the Schedule Y of Drugs and Cosmetics Act was amended on 20th January 2005.
Since, the amended Schedule Y has changed the focus of clinical departments of pharma companies, the thrust of CRO’s, has enlightened the clinicians and overall has been beneficial to the image of the country – both drug industry and medical fraternity, the speakers noted.
The chief guest for the function was M Ramesh Kumar, Commissioner, Maharashtra FDA. The chairman of Apothecaries, Brijesh Regal spoke on the Amended schedule Y- how is it different and an overview on schedule Y was discussed by Dr. Venkateshahwarlu, Deputy Drugs controller, West zone; Pharma industry and Schedule Y was covered by Dr. V V Joshi, head of clinical research, USV.
Dr. Purnima Sharma, Gen. Manager, Biotech Consortium India Ltd. discussed the regulatory aspects for Biotech Pharmaceuticals. Dr. Ashok Vaidya, Director, SPARC spoke on Natural Drugs, Appendix 1(B) for Schedule Y, Challenges in selection of investigator sites were discussed by Dr. Arun Bhatt, President, ClinInvent and Monitoring of clinical trials was covered by Sanjay Sane, Head of Clinical development and Drug safety, Novartis. The other subjects of discussion were, Ethical considerations in clinical trials by Dr. Urmila Thatte, Industry and PSUR by Dr. Arvind Jha and PSUR- data capturing and its significance by Dr. Sanath Hegde.