A recent case before the Supreme Court has once again highlighted the issue of judicial decisions potentially replacing/ amending legislation enacted by Parliament. The case importantly pertains to the judiciary’s interpretation of existing law concerning itself. The eventual outcome of the case would presumably have important implications for the way the higher judiciary interprets laws, which according to some amounts to the judiciary “legislating” rather than interpreting laws. This assertion has often been substantiated by citing cases such as Vishaka v. State of Rajasthan (1997) where the Supreme Court actually laid down the law pertaining to sexual discrimination at workplaces in the absence of a law governing the same. In numerous other cases, courts have laid down policy guidelines, or have issued administrative directions to governmental departments. In the recent case of Suraz India Trust v. Union of India, a petition has been filed asking the court to reconsider its own judgements regarding the manner of appointment and transfer of judges. It has been contended that through its judgements in 1994 and 1998 (Advocate on Record Association v. Union of India and Special Reference No. 1 of 1998) the Supreme Court has virtually amended Constitutional provisions, even though amendments to the Constitution can only be done by Parliament. This question arises since the Constitution provides for the appointment and transfer of judges by the government in consultation with the Chief Justice of India. The two Supreme Court judgements however gave the primary power of appointment and transfer of judges to the judiciary itself. Importantly, one specific question which has been raised is whether the judgements referred to above really amount to amending the relevant provisions of the Constitution. Another question raised which is relevant to this discussion is whether the interpretation by courts can actually make provisions in the Constitution redundant. In its judgement on the 4th of April, the Supreme Court referred this case to the Chief Justice of India for further directions. The outcome of this judgement could potentially require the Supreme Court to define the circumstances when it interprets law, and when it “legislates”. An indication of the Supreme Court's attitude concerning this issue may be gleaned from the recent speech of the Chief Justice of India, Justice S.H. Kapadia at the M.C. Setalvad lecture. The CJI unambiguously stated that: "...In many PILs, the courts freely decree rules of conduct for government and public authorities which are akin to legislation. Such exercises have little judicial function in them. Its justification is that the other branches of government have failed or are indifferent to the solution of the problem. In such matters, I am of the opinion that the courts should be circumspect in understanding the thin line between law and governance..."
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:
