Recently the government released draft rules under the Right to Information Act for consultation before it finalised them. This process of public consultation on draft rules is a welcome step which is not often followed. Many Acts passed by Parliament 'delegate' the power to make rules and regulations to the executive (government and regulatory bodies such as RBI and TRAI). The reason is that these rules may need to be changed at frequent intervals (such as, say specifications on food labels), and may not need the time and expense required for amendment to the Act by Parliament. However, Parliament retains for itself the power to examine these rules. Most Acts passed by Parliament provide that rules framed under them will be laid before the Parliament. Any Member of Parliament may demand a discussion on the rules and a vote to modify or nullify them. In practice, a large number of rules are laid before Parliament, making it very difficult for Parliamentarians to examine them effectively. In the last session of Parliament, more than 1500 documents were laid before Parliament. No discussion on specific rules has taken place in Parliament in the 14th and 15th Lok Sabha (2004-10). Both the Lok Sabha and Rajya Sabha also have Committees on Subordinate Legislation to examine these rules. Out of 1515 rules, regulations, circulars and schemes laid before Lok Sabha between 2008 and 2010, the Committee has examined 44 documents. This amounts to only 3% of the afore-mentioned documents laid before the Lok Sabha. It is important that Parliament oversee the power to make rules that it has delegated to the government. For that, it needs to invest in strengthening the research staff of the committee on subordinate legislation as well as provide research stafff to MPs.
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:
