2023-04-21T06:32:53
Preface
The Expert Committee constituted by the Ministry of Health and Family Welfare to formulate policy, guidelines and standard operating procedures for approval of new drugs including biologicals, clinical trials and banning of drugs was announced on 6th February 2013. The members commenced their work on 14th February 2013 with their first meeting.
The vision of the Committee, based on the extensive mandate given to it, was to recommend changes and introduce measures which would result in a drug regulatory system for India which is robust, transparent and built on the foundations of science and ethics. This report contains the recommendations which the Committee feel will establish such a system. It is not easy to institute changes in a country as large as India with complexities that are inherent due to
varying levels of development in different states and different types of populations. The fact that 'Public Health' is a state subject in the Constitution also had to be kept in mind. The people of the country and their good health are our concern, and throughout our deliberations one guiding principle was paramount - to see that they were not exploited in any way. At the same time, we were also acutely aware that the
people of the country are entitled to the most advanced therapy available. In an endeavour to understand the present system better and to understand the perceptions of different
segments of society involved in drug regulation and use, the Committee met a large number of people. These included (a) representatives of civil society; (b) representatives of the pharmaceutical industryOrganization of Pharmaceutical Producers of India (OPPI), Indian Drug Manufacturers Association (lDMA) and Indian Pharmaceutical Alliance (IPA); (c) representatives of contract research organizationsAssociation of Contract Research Organizations (ACRO) and Indian Society for Clinical Research (lSCR); and (d) representatives from industry-Confederation-of Indian Industry (CII), Federation of
Indian Chambers of Commerce and Industry (FICCJ) and Associated Chambers of Commerce and Industry of India (ASSOCHAM). The Committee also met clinical investigators and heads of institutes carrying out clinical trials, regulators and government officials. In addition, the Committee met several experts and academicians at an individual level as well as heads of industry and leaders of nongovernmental agencies.
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