The Parliamentary Standing Committee on Health and Family Welfare tabled a Report in Parliament on May 8, 2012, on the functioning of the Central Drugs Standard Control Organization (CDSCO). CDSCO is the agency mandated with the regulation of drugs and cosmetics in India. The Report covers various aspects of drug regulation including organizational structure and strength of CDSCO, approval of new drugs, and banning of drugs, among others. Following the Report, the Minister of Health and Family Welfare has constituted a Committee to look into the procedure for drug regulation. The Committee is expected to make its submissions within a period of two months. This post focuses on irregularities in the approval of new drugs by CDSCO. It discusses the regulations relating to drug approval and the Standing Committee's observations on the working of CDSCO. Approval of new drugs Drugs are regulated by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945 [Rules]. The CDSCO, under the Ministry of Health and Family Welfare, is the authority that approves new drugs for manufacture and import. State Drug Authorities are the licensing authorities for marketing drugs. New Drugs are defined as:
The Rules require an applicant for a new drug to conduct clinical trials in India to determine the drug’s safety and efficacy. These trials are necessary for both domestically manufactured and imported drugs. However, the authority can exempt a drug from the requirement of local and clinical trials in the public interest based on data available in other countries. Observations and recommendations of the Committee The Committee found that a total of 31 new drugs were approved between January 2008 and October 2010 without conducting clinical trials on Indian patients. The Report mentioned that drug manufacturers, CDSCO officials and medical experts colluded to approve drugs in violation of laws. Following are some of the Report’s findings:
We need your ideas and inputs. Ideas on how we can inform many more people who are interested in policy about what they can access on the PRS website. The mission of PRS is to strengthen the legislative process by making it better informed, more transparent and participatory. The statement has three important components: (a) Better informed: This implies that legislators and citizens need to be better informed about the implications of legislation. For us in PRS, this implies producing easy-to-understand non-partisan analysis that can be made available to MPs and citizens. This also includes our continual efforts to personally brief MPs and political parties on the details and implications of each Bill. (b) Transparent: We mean that all proceedings of Parliament and the work of MPs in Parliament should be easily accessible to citizens. In an operational sense, this includes the effort we put into creating the Bill Track section on our website where every Bill that is pending in Parliament can be accessed, and the current status of the Bill can be tracked. It also includes the MP Track section in which we have up-to-date information about the engagement levels of MPs in Parliament. We also have a twitter page www.twitter.com/prslegislative and a Facebook presence. (c) Participatory: Which simply means that once citizens know the information, and would like to articulate a point of view, they should reach out to policy makers and get their point of view across to them. To promote this, we have had a number of workshops with NGOs and have produced a primer on "Engaging with Policy Makers". These are just some examples of what we are doing in each of these three areas. Our website has much more information. But we are increasingly of the view that we need to reach out many more people who are interested in policy -- even if it is sector specific. We would be grateful for any ideas that you might have, which you can post as responses to this post. If you also have specific ideas on what you like on our website and what can be better, do let us know. Thanks, in advance.
