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:
Most legislative assemblies make Parliament look like a paragon of virtue A COUPLE of days ago, an MLA from Orissa made news for climbing on to the speaker's table in the assembly. Not so long ago, television screens beamed images of Karnataka MLAs snacking and sleeping all night in the assembly. But these are only indicative of the incidents of the raucous behaviour of several MLAs in the recent past across the country. And the poor behaviour of some MLAs is only one aspect of the pitiable state of several of our state legislatures. The other aspect of our state legislatures that goes largely unnoticed is how poorly the secretariats of legislatures are equipped and how several systems that are seen as essential in Parliament are nonexistent in states. Even to know the complete picture of how our legislatures function, you need data. And several state assemblies are notoriously poor at putting out data on the functioning of the institution or the MLAs. After one gets used to the quality of Parliament websites and the regularity of their updates, it would be shocking to see that there are some state legislatures that do not even have functional websites. It has been observed that some state legislatures are lagging behind by a couple of years in compiling the "resume of work" which summarises the work done in a session of the legislature. So the first bottleneck in several instances is the inability to access data of the assembly. From the data we have managed to access, it is obvious that state assemblies meet for very few days a year. A case in point is the Punjab assembly which has met for an average of 19 days per year for a 10-year period between 1997 and 2007. Delhi was only marginally better averaging 21 days per year during the same period. Kerala has averaged some 50 days a year for several years now. Some states like Karnataka have legislated that they should meet for at least 60 days a year, but since passing that legislation in 2005, they have not managed to do so for even one year. I am not even accounting for the time lost due to disruptions. Bills are passed with little or no discussion in many state legislatures. While in Parliament, referring bills to the standing committees is the norm, most state legislatures do not have standing committees. The only examination of a bill, if any, happens on the floor of the House. And if data from the Delhi assembly is anything to go by, the average debate on a bill before is passed is a little over half hour. There are any number of instances where bills are introduced and passed in state assemblies on the same day -so there is not even a pretence of the need for MLAs to read, understand and deliberate on the provisions of legislation they are supposedly passing. MLAs are often far more narrowly constituency-focused than MPs are. On average, MLAs have lower education levels than members of Parliament. There is no formal definition of a role of an MLA, and they mostly have no exposure to ideas such as the separation of powers between the executive and the legislature. In one particularly revealing conversation with an MLA, he said, "At the time of elections, each of the contestants represents his party. But after the elections, the chiefministerbecomestheleader of all MLAs in the House. If an MLAneedssomeadditionalprojects/ favours for his constituency he needs to be in the good books of the chief minister and his cabinet ministers. So where is the question of taking on the chief minister on the floor of the House on any issue?" There are many aspects of state legislatures that point to a steady and visible decline of these important institutions. But beyond the frequent highlighting of theatrics by some MLAs, there is almost no public discourse on this issue. It is necessary to ensure that the legislatures run smoothly, and the speaker, as first among equals, has the biggest responsibility to ensure this. If there are rules and everyone knows that those rules will never be used to enforce discipline, then the rules will be broken, and repeatedly so. This practice needs to be urgently reviewed. The larger question is whether our legislatures are the highest deliberating and policymaking bodies or whether they are being reduced to platforms for political theatrics. Policy can almost never be devoid of politics and public posturing. But if this means poor deliberation of critical policy issues and the woefully inadequate functioning of our legislatures, then we may need to come up with creative ways in which this problem can be addressed. This article appeared in the Indian Express on December 20, 2010.
