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:
According to news reports, the Supreme Court stayed a Calcutta High Court judgement on the Singur Land Rehabilitation and Development Act, 2011 [Singur Act] on August 24, 2012. The apex court also issued a notice to Tata Motors seeking its response within four weeks, on the West Bengal government's petition challenging the High Court order. In 2008, the Left Front government acquired land in Singur under the Land Acquisition Act, 1894, for Tata Motors to build a Nano car factory. In its first year of coming to power in West Bengal, the Trinamool Congress (TMC) led government notified the Singur Act through which it sought to reclaim this land to return a portion of it to farmers. On June 22, 2012, a Division bench of the Calcutta High Court struck down the Singur Act terming it unconstitutional and void. In its judgment, the Court found some sections of the Singur Act to be in conflict with the central Land Acquisition Act, 1894. As land acquisition is a Concurrent List subject under the Constitution, both Parliament and state legislatures have the power to make laws on it. However, if provisions in the state law conflict with provisions in the central law, then the state law cannot prevail unless it receives Presidential assent. The Calcutta High Court held the Singur Act to be unconstitutional because: (a) it was in conflict with the central Land Acquisition Act, 1894, and (b) Presidential assent was not obtained for the Act to prevail in West Bengal. The central Act mentions that for the government to acquire land, it has to demonstrate: (1) that land is being acquired for a public purpose,[i] and (2) that the government will provide compensation to persons from whom land is being acquired. Provisions in the Singur Act that relate to public purpose and compensation were found to be in conflict with the corresponding provisions in the central Act. The Court was of the opinion that transfer of land to the farmers does not constitute ‘public purpose’ as defined in the central Act. As argued by the Tata Motors’ counsel, return of land to unwilling owners is a ‘private purpose’ or in ‘particular interest of individuals’ rather than in the ‘general interest of the community’. Second, clauses pertaining to compensation to Tata Motors for their investment in the Nano project were found to be vague. The Singur Act only provides for the refund of the amount paid by Tata Motors and the vendors to the state government for leasing the land. It does not provide for the payment of any other amount of money for acquiring the Tata Motors’ land nor the principles for the determination of such an amount. The High Court ordered that these provisions tantamount to ‘no compensation’ and struck down the related provisions. The matter will come up for consideration in the Supreme Court next on October 15, 2012.
[i] According to Section 3 of the Land Acquisition Act, 1894, acquisition of land for ‘public purpose’ includes, among others: provision or planned development of village sites; provision of land for town or rural planning; the provision of land for planned development of land from public funds in pursuance of a scheme or policy of the Government; and the provision of land for a corporation owned or controlled by the State.
