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 trust vote drama in Karnataka has hit the national headlines. The incumbent chief minister, B.S. Yeddyurappa appears to have won the first round. It remains to be seen how the BJP responds to the governor’s direction that a second trust vote be held by the 14th of this month. In the 225-member Karnataka assembly, the ruling BJP had a wafer-thin majority since the 2008 assembly elections. And it was not surprising to find that some political forces in the state felt that there was an opportunity to unseat the government. But what has transpired over the past few days has once again reminded citizens of the ugly side of politics. Leading up to the trust vote, the governor of Karnataka wrote a letter to the speaker of the Karnataka assembly asking that no MLAs be disqualified before the trust vote was conducted on the floor of the assembly. Subsequently, there have been a number of allegations about the conduct of the trust vote itself. The governor openly called the trust vote “farcical”, and wrote to the Centre asking that President’s Rule be imposed in the state, before he directed the government to prove its majority again. This phenomenon of trust votes is not uncommon in our dynamic political culture. Just before the 2009 general elections, the BJD and the BJP had differences over seat-sharing in Orissa. The BJP decided to withdraw support to the Naveen Patnaik government. The BJD passed the floor test by a voice vote. While the opposition claims that the process was not fair, the BJD leadership has maintained that there was no request for a division, which would have required recorded voting. The relatively small Goa assembly has seen a number of similar occurrences in the recent past, with governments changing as a result. But there are some critical issues that merit examination. In some recent trust votes, there have been allegations that large amounts of money have been exchanged. Of course, following the 2008 trust vote in the Lok Sabha on the India-US nuclear agreement, the infamous cash-for-votes scam broke out, with wads of cash being shown on the floor of the House. In the Karnataka trust vote, too, there have been allegations that large amounts of money have changed hands. The second issue is how some of these trust votes are managed on the floor of the House. Both the recent Orissa episode and the ongoing Karnataka one have been very contentious about the procedure that has been used to prove the majority. In both cases, the opposition alleged that they asked for a division, which would require a physical count of votes rather than just a voice vote, and in both cases a division was not held. A parallel issue which needs to be kept in mind is the governor’s power to ensure compliance with procedure in the state legislatures. The third issue that needs some discussion is whether the decision on defections should be judged by the speaker, usually a member of the ruling party or coalition, or by a neutral external body, such as the Election Commission. In the latest episode in Karnataka, the speaker has disqualified MLAs on the ground that they have voluntarily exited the party under which they were elected. In a 1994 case (Ravi S. Naik v. Union of India), the Supreme Court ruled that the words “voluntarily giving up membership” have a wider meaning. An inference can also be drawn from the conduct of the member that he has voluntarily given up the membership of his party. There is a huge paradox in the anti-defection law that was passed 25 years ago. While MLAs and MPs vote along party lines on ordinary legislation, they do not appear to be daunted by the consequences in the case of trust votes. So, in effect, the anti-defection law appears to be effective in controlling members of all parties on policy-making — which could in fact benefit from more open input from across party lines — but ineffective in several cases with regard to trust votes. Clearly, there is much more at stake for all concerned in trust votes, and therefore the scope for greater negotiation. Politics in our large and complex democracy is fiercely competitive. Dissidence is to be expected because there are too many people vying for too few of the top positions. While there are no perfect solutions, the only sustainable and meaningful approach is to encourage inner-party democracy so as to enable a selection process for positions of responsibility that is accepted as free and fair by all concerned. While the political uncertainty continues, the only certainty for India’s citizens is a very unhealthy politics for some time to come. - CV Madhukar This article was published in Indian Express on October 13, 2010
