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:
The union government is reportedly considering a legislation to create anti-corruption units both at the centre and the states. Such institutions were first conceptualized by the Administrative Reforms Commission (ARC) headed by Morarji Desai in its report published in 1966. It recommended the creation of two independent authorities - the Lokpal at the centre and the Lokayuktas in the states. The first Lokpal Bill was introduced in Parliament in 1968 but it lapsed with the dissolution of Lok Sabha. Later Bills also met a similar fate. Though the Lokpal could not be created as a national institution, the interest generated led to the enactment of various state legislations. Maharashtra became the first state to create a Lokayukta in 1972. Presently more than 50% of the states have Lokayuktas, though their powers, and consequently their functioning varies significantly across states. Existing institutional framework The Central Vigilance Commission (CVC) and the Central Bureau of Investigation (CBI) are the two cornerstones of the existing institutional framework. However, the efficacy of the current system has been questioned. [1] Though the CVC (set up in 1964) is an independent agency directly responsible to the Parliament, its role is advisory in nature. It relies on the CBI for investigation and only oversees the bureaucracy; Ministers and Members of Parliament are out of its purview. Thus, presently there is no authority (other than Parliament itself) with the mandate to oversee actions of political functionaries. At the state level, similar vigilance and anti-corruption organisations exist, although the nature of these organisations varies across states. Karnataka Lokayukta Act The Karnataka Lokayukta is widely considered as the most active among the state anti-corruption units. [1] It was first set up in 1986 under the Karnataka Lokayukta Act, 1984. The Act was recently amended by the state government following the resignation of the Lokayukta, Justice Santosh Hegde. Justice Hegde had been demanding additional powers for the Lokayukta - especially the power to investigate suo-motu. Following the amendment, the Lokayukta has been given the suo motu powers to investigate all public servants except the CM, Ministers, Legislators and those nominated by the government. Following are the main provisions of the Karnataka Lokayukta Act:
The forthcoming Ordinance/ Bill Given that a Lokpal Bill is on the anvil, it might be useful at this point to enumerate some metrics/ questions against which the legislation should be tested:
What do you think? Write in with your comments. Notes: [1] Report of the Second Administrative Reforms Commission (ARC), 'Ethics in Governance' (2007) [2] Additional reading: An interview with the Karnataka Lokayukta
