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 today's Opinion piece, in the Indian Express, we discuss how enacting hasty new legislation in response to public events may not be the answer. The recent spot fixing controversy in the Indian Premier League has brought the issue of betting in sports back into the limelight. As a result, public debate around betting, and steps that need to be taken to prevent the recurrence of such events, is gaining traction. The government's response to this incident has been somewhat predictable. The minister of state for sports has reportedly stated that his ministry is committed to putting in place new legislation to deal with the menace of fixing in sports. This approach to law making points towards a growing trend of initiating policy and legislative decisions as a reaction to public events. This is not something new. The Mumbai terror attack in 2008 was the catalyst for the enactment of the National Investigation Agency Act, and the brutal rape and murder of a young girl in Delhi led to the overhaul of India's penal code to ensure stricter penalties for crimes against women. Both these bills were passed without effective scrutiny, as they were not referred to a parliamentary standing committee for examination. Events in the country may, on occasion, highlight gaps in our policy and legislative framework. However, they often point out the ineffectiveness of existing laws and the lack of proper implementation. And that is not always a result of not having enough laws in the country. There are more than a 1,000 Central laws and over 15,000 state laws. The problem lies with our law-making process, which is ad hoc in nature. It is geared towards churning out legislation that is not entirely evidence based and does not take the feedback of different stakeholders into account. In its reports, the National Commission to review the working of the Constitution had observed that "our legislative enactments betray clear marks of hasty drafting and absence of Parliament scrutiny from the point of view of both the implementers and the affected persons and groups". Take, for example, the Gram Nyayalaya Act, which establishes village courts to provide people with easy access to justice and reduce the case law burden on the court system. Structured feedback from villagers, whom this act is trying to empower, prior to introducing the bill in Parliament would have given valuable insights about implementation challenges. A comprehensive study to examine the impact that village courts would have in reducing pendency in the judicial system would have provided hard numbers to substantiate what types of cases should be adjudicated by the village courts. A detailed financial analysis of the cost implications for the Central and the state governments for implementing the law would have helped policymakers decide on the scale and effectiveness of implementation. In the absence of these studies, there is no way to measure whether the law has been effective in giving villagers easy access to justice and in reducing the burden on the judicial system. The importance of stakeholder consultation was recently stressed by the parliamentary committee examining the land acquisition bill. In its report on the bill, the committee recommended that, "before bringing in any bill in future, the government should ensure wider, effective and timely consultations with all relevant and stakeholders so that all related issues are addressed adequately." Rajya Sabha MP N.K. Singh, while testifying before the parliamentary standing committee on the National Food Security Bill, had drawn the attention of the committee towards the need for an accurate financial memorandum accompanying the bill, to "avoid serious consequences in the implementation of the bill." The National Advisory Council has also suggested a process of pre-legislative scrutiny of bills and delegated legislation. In its approach paper, the Financial Sector Legislative Reforms Commission had suggested that delegated legislation should also be published in draft form to elicit feedback and that a cost benefit analysis of the delegated legislation should be appended to the draft. New laws can have a significant impact on the lives of people, so it is important that our law-makers enact "effective laws". For this to happen our law-making process needs to evolve. While there will always be public pressure for new laws, the solution lies in ensuring that the law-making process is robust, consultative and deliberative. The solution to addressing policy opportunities does not always lie in making new laws but in ensuring that whatever law is enacted is well thought out and designed to be effective.
