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:
In the recently concluded Winter Session of Parliament, nine Bills were introduced. Of the Bills introduced, 4 bills have been referred to the relevant Standing Committee for examining the Bill. The Standing Committees have been given three months to scrutinize the bills, hold consultations and present a report. Details of these Bills are: 1. The Forward Contracts (Regulation) Amendment Bill, 2010 (to be examined by the Committee on Food, Consumer Affairs and Public Distribution) 2. The Multi-State Co-operative Societies (Amendment) Bill, 2010 (to be examined by the Committee on Agriculture) 3. The NIMHANS, Bangalore Bill, 2010 (to be examined by the Committee on Health and Family Welfare) 4. The National Identification Authority of India Bill, 2010 (to be examined by the Committee on Finance) The composition of the Standing Committees examining the Bills can be found here. Typically, during the process of review the parliamentary standing committees issue advertisements in newspapers inviting public feedback and comments on the Bill. As and when the advertisements appear, details can be found on the PRS website.