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 last few months saw a number of allegations of corruption in issues such as contracts for the Commonwealth Games, allocation of 2G Spectrum, and the building of the Adarsh housing society. Professor Kaushik Basu, the Chief Economic Adviser to the Ministry of Finance, has proposed a modification in order to make the anti-corruption law in the country more effective. The Prevention of Corruption Act, 1988 penalizes both bribe giving and taking. Bribe giving is punishable under the Act with imprisonment ranging between six months to five years. He argues that bribe giving should be legalized. Professor Basu distinguishes “harassment bribes”, which he defines as “bribes that people often have to give to get what they are legally entitled to” from the remaining, “Non-Harassment Bribes” which would involve illegal benefits accruing to the bribe giver at a potential cost to the public interest. He argues that legalization of harassment bribes would reduce the nexus between the giver (victim) and the taker of a bribe. Giving complete immunity to the bribe-giver would ensure higher reporting and co-operation of the giver in bringing to justice the bribe taker. The present law acts as a deterrent to reporting of bribery. Courts have also highlighted this issue. The High Court of Delhi in the Bharadwaaj Media Case (2007) observed that a “bribe giver is normally on the mercy of the officials and babus who compel him to pay bribe even for lawful work.” The Court further observed that “Instead of expressing gratefulness to the persons who expose corruption, if the institutions start taking action against those who expose corruption, corruption is bound to progress day and night.” It can be inferred from the judgement that steps ought to be taken to provide protection to those exposing bribery. The proposed legalization of bribe-giving may result in increased reporting of bribery and co-operation of the victim during prosecution. The fear that a bribe giver may report the public official could reduce corruption, at least in terms of harassment bribes. However, this proposal may reduce the stigma attached to bribe-giving and result in corrosion of morality. Much of the recent debate around corruption and the Lok Pal Bill revolve around effective prosecution. This paper looks at the incentive structure for reporting bribe-giving, and merits public debate.
