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In India, one of the common threads that run through many of the corruption scandals is the issue of conflict of interest i.e. public officials taking policy decisions based on their personal interest. For example, Shashi Tharoor in the IPL controversy or Ashok Chavan in the Adarsh Housing Society scam. Many countries take measures to minimize conflict of interest of its MPs by regulating membership of parliamentarians in Committees, making it mandatory for them to declare pecuniary interest, and restricting employment both during and after completion of tenure. For example, the US Senate has a detailed Code of Official Conduct that provides guidelines on conflict of interest. India also has some measures in place to minimize conflict of interest. These are codified in the Code of Conduct for Ministers, Code of Conduct for Members of the Rajya Sabha, Rules of Procedure and Conduct of Business in the Lok Sabha and Rajya Sabha and Handbook for Members of Lok Sabha and Rajya Sabha. Every Rajya Sabha MP has to declare his or her interest (along with assets and liabilities). He has to declare five pecuniary interests: remunerative directorship, remunerated activity, majority shareholding, paid consultancy and professional engagement. Lok Sabha MPs can object to another MP joining a parliamentary committee on grounds that he has personal, pecuniary or direct interest. (For more details, see PRS note on Conflict of Interest Issues in Parliament). On December 1, 2010, PRS held its annual Conference on Effective Legislatures. One of the topics discussed was MPs and Conflict of Interest: Issues and Resolution. Panelists included D Raja, Prakash Javdekar and Supriya Sule. Issues such as requirement for transparency, expertise of legislators, election of honest legislators, and ethical media were discussed. The issues that were raised during the discussion are summarised in the PRS Summary of Proceedings from the Conference.
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: