In a recent case, the Supreme Court directed the appropriate government to enact a law by June 2011. The case, Gainda Ram & Ors. V. MCD and Ors.[1], concerned the legal framework for regulating hawking in Delhi. The judgement lays out the background to this case by stating that the regulation of hawking in Delhi had been proceeding under directions issued by the Supreme Court in previous cases, and was being implemented by municipal authorities such as the New Delhi Municipal Corporation (NDMC). The NDMC and the MCD have also framed schemes to regulate hawkers as per a policy of the government framed in 2004. However, since these schemes were not laid before Parliament, the Court held that these schemes cannot be called ‘law’ or drafted under the authority of any law. The Court also stated that there is an urgent need to enact a legislation to regulate hawking, and the rights of street vendors. It referred to a Bill which had been framed by the government, and stated that since the government has already taken the first step in the legislative process by drafting a Bill, the legislative process should be completed. On the basis of this, and other reasons, it directed the government to enact a law by June 2011. This judgement raises three issues:
[1] Decided on October 8, 2010
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:
