Expert Committee on new drugs, trials, ECs expected to complete report in few months

The Expert Committee set up by Government of India in February 2013, with Professor Ranjit Roy Chaudhury, National Professor of Pharmacology and Adviser to Department of Health, Government of National Capital Territory of Delhi as the Chairman, is expected to complete the report in a few months. The Committee has already had four meetings and is planning to hold separate meetings with representatives of drug industry, the Contract Research Organizations, the civil society and clinical investigators of clinical trials.

The Expert Committee was formed to formulate policies, guidelines and Standard Operating Procedures for approval of new drugs, clinical trials, ethics committee and for banning of drugs already on the market. The Committee will also provide guidelines on requirements of post marketing trials and on functioning of the New Drug Advisory Committees.

It is hoped that the report of this high powered Committee will lay down the framework of a transparent and equitable drug regulatory system based on ethics and accountability as has been suggested by the Parliamentary Committee on Health and the Supreme Court.

Other members of the Committee are Dr VP Kamboj, Former Director of the Central Drugs Research Institute, Lucknow; Dr BT Kaul, Professor of Law, Delhi University, Dr Mira Shiva, Coordinator, Initiative for Health Equity and Society, Dr Vasantha Muthuswamy, Former Senior Director General of the Indian Council of Medical Research and Dr Uma Tekur, Professor of Pharmacology, Maulana Azad Medical College, Delhi.

EP News Bureau – Mumbai