Parliament passes an average of 60 Bills a year. Each state legislature also passes a similar volume of legislation addressing an array of complex issues. Bills cover subjects ranging from microfinance, land acquisition, and honour killings to the impact of pesticides on health. Legislative matters have become increasingly more technical and require specialist inputs to be framed as effective public policy. Unlike other large democracies, legislators in India do not have access to institutional research support. Access to formal information channels is normally available only to the Minister drafting the bill or to the select committee if the bill is referred to it. This deprives MLAs from participating in a more informed debate. Towards this end, PRS and the Indian School of Business (ISB) have initiated the first policy workshop of its kind for MLAs in India. There is an emerging breed of proactive MLAs who are willing to seek out information to help them perform their role better. There are over 4000 MLAs in India, and a small group of MLAs in many states are showing this initiative. They use the internet, consult specialists, and use resources like PRS to get updated or further information on issues affecting their state. About the Workshop The India Leadership workshop is for MLAs who want to be more effective legislators and assume positions of greater influence in state and national policymaking. This unique workshop is for rising stars who want to imbibe new approaches to policymaking and build professional networks with MLAs from different states. The programme is led by distinguished faculty from internally reputed institutions including Harvard, IITs and IIMs. The three day workshop for progressive MLAs will be held at the campus of ISB in Hyderabad. Four such sessions will be held during the year, with the maiden edition being launched in January 2011. Over the last five years, PRS has worked with MPs across all political parties to brief them on relevant issues for their work in Parliament. MPs have recommended that MLAs also would benefit from similar research services. Ajit Rangnekar, Dean, Indian School of Business (ISB) says, “The ISB is committed to working with the Industry and the Government to help achieve national goals. We already have had a long track of engaging with public sector enterprises, and more recently with various government departments, in both executive education and research. We are now delighted to partner with the PRS Legislative Research to develop this programme targeted at capacity building among Indian Legislators. We believe that this ongoing interaction between the government and academia will strengthen our collective understanding of national priorities and spur collaboration for greater impact.”
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:
