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:
In a recent judgement, the Karnataka High Court upheld the disqualification of five independent MLAs from the Assembly. These MLAs, who had previously served as Ministers in the Yeddyurappa government, were disqualified along with 11 others after they withdrew their support to the government. The disqualifications raise some important questions on the working of the anti-defection law. While the law was framed in 1985 with the specific intent of 'combating the evil of political defections', over the years several unanticipated consequences have come to the fore. The primary among these is the erosion of independence of the average legislator. The need for an anti-defection law was first felt in the late 1960s. Of the 16 States that went to polls in 1967, Congress lost majority in eight and failed to form the government in seven. Thus began the era of common minimum programmes and coalition governments. This was accompanied with another development - the phenomenon of large scale political migrations. Within a brief span of 4 years (1967-71), there were 142 defections in Parliament and 1969 defections in State Assemblies across the country. Thirty-two governments collapsed and 212 defectors were rewarded with ministerial positions. Haryana was the first State where a Congress ministry was toppled. The Bhagwat Dayal ministry was defeated in the Assembly when its nominee for speakership lost out to another candidate. Congress dissidents defected to form a new party called the Haryana Congress, entered into an alliance with the opposition and formed a new government under the Chief Ministership of Rao Birender Singh (also a Congress defector). Haryana thus became the first State to reward a defector with Chief Ministership. Another Haryana legislator, Gaya Lal, defected thrice within a fortnight. The now well know terms 'Aya Ram' and 'Gaya Ram' that are often used to describe political turncoats owe inspiration to him. It was to address this issue that the anti-defection law was passed in 1985. This law amended the Constitution and added the Tenth Schedule to the same. The Supreme Court, in Kihota Hollohon vs. Zachilhu (1992), while upholding the validity of the law held that decisions of disqualification shall be open to judicial review. It also made some observations on Section 2(1) (b) of the Tenth schedule. Section 2(1) (b) reads that a member shall be disqualified if he votes or abstains from voting contrary to any direction issued by the political party. The judgement highlighted the need to limit disqualifications to votes crucial to the existence of the government and to matters integral to the electoral programme of the party, so as not to 'unduly impinge' on the freedom of speech of members. This anti-defection law has regulated parliamentary behaviour for over 25 years now. Though it has the advantage of providing stability to governments and ensuring loyalty to party manifestos, it reduces the accountability of the government to Parliament and curbs dissent against party policies. In this context, Manish Tewari's private member bill merits mention: he suggests that anti-defection law be restricted to votes of confidence and money bills. Such a move will retain the objective of maintaining the stability of the government while allowing MPs to vote freely (subject to the discipline of the party whip) on other issues. This brings us to the question - Is the anti-defection law indispensable? Is defection peculiar to India? If not, how do other countries handle similar situations? It is interesting to note that many advanced democracies face similar problems but haven't enacted any such laws to regulate legislators. Prominent cases in UK politics include the defection of Ramsay Macdonald, the first Labour Prime Minister, in 1931. He defected from his party following disagreements on policy responses to the economic crisis. Neither Macdonald nor any of his three cabinet colleagues who defected with him resigned their seats in the House of Commons to seek a fresh mandate. Australian Parliament too has had its share of defections. Legislators have often shifted loyalties and governments have been formed and toppled in quick succession. In the US too, Congressmen often vote against the party programme on important issues without actually defecting from the party. India might have its peculiar circumstances that merit different policies. But, the very fact that some other democracies can function without such a law should get us thinking. Sources/ Notes: [1] PRS Conference note: The Anti-Defection Law – Intent and Impact [2] Column by CV Madhukar (Director, PRS) titled 'Post-independents' in the Indian Express
