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:
As per news reports, the union government has filed a Presidential Reference in relation to the 2G judgment. In this judgment the Supreme Court had cancelled 122 2G licences granting access to spectrum and had ordered their re-allocation by means of an auction. It also held that use of first cum first serve policy (FCFS) to allocate natural resources was unconstitutional. It had held that natural resources should be allocated through auctions. As per the news report, the Presidential Reference seeks clarity on whether the Supreme Court could interfere with policy decisions. This issue has been discussed in a number of cases. For instance, the Supreme Court in Directorate of Film Festivals v. Gaurav Ashwin Jain[1] held that Courts cannot act as an appellate authority to examine the correctness, suitability and appropriateness of a policy. It further held that Courts cannot act as advisors to the executive on policy matters which the executive is entitled to formulate. It stated that the Court could review whether the policy violates fundamental rights, or is opposed to a Constitutional or any statutory provision, or is manifestly arbitrary. It further stated that legality of the policy, and not the wisdom or soundness of the policy, is the subject of judicial review. In Suresh Seth vs. Commissioner, Indore Municipal Corporation[2] a three judge bench of the Court observed that, “this Court cannot issue any direction to the Legislature to make any particular kind of enactment. Under our constitutional scheme Parliament and Legislative Assemblies exercise sovereign power or authority to enact laws and no outside power or authority can issue a direction to enact a particular piece of legislation.” In the present case it may be argued that whereas the Court was empowered to declare a policy such as FCFS as unconstitutional, it did not have the jurisdiction to direct auctioning of spectrum and other natural resources. The Presidential Reference may conclusively determine the Court’s jurisdiction in this regard. However, it has been urged by a few experts that this Presidential Reference amounts to an appeal against the decision of the Court. They have argued that this could be done only through a Review Petition (which has already been admitted by the Court). The advisory jurisdiction of the Court invoked through Presidential References, is governed by Article 143 of the Constitution. Under Article 143 of the Constitution of India, the President is empowered to refer to the Supreme Court any matter of law or fact. The opinion of the Court may be sought in relation to issues that have arisen or are likely to arise. A Presidential Reference may be made in matters that are of public importance and where it is expedient to obtain the opinion of the Supreme Court. The Court may refuse to answer all or any of the queries raised in the Reference. A Presidential Reference thus requires that the opinion of the Court on the issue should not have been already obtained or decided by the Court. In the Gujarat Election Case[3] the Supreme Court took note of Presidential References that were appellate in nature. Thus, a Presidential Reference cannot be adopted as a means to review or appeal the judgment of the Supreme Court. Against judgments of the Court the mechanisms of review is the only option. This position was also argued by Senior Advocate Fali S. Nariman in the Cauvery Water Case[4], where the Court refused to give an opinion. Whether the Court had the authority to determine a policy, such as FCFS, as unconstitutional is not disputed. However, there are conflicting judgments on the extent to which a Court can interfere with the executive domain. It would be interesting to see whether the Court would give its opinion on this issue. In the event it does, it may bring higher level of clarity to the relationship between the executive and the judiciary.
[1] AIR 2007 SC 1640
[2] AIR2006SC767
[3] (2002) 8 SCC 237
[4] (1993) Supp 1 SCC 96(II)
