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 presentation of the Annual Budget before the parliament is one of the mechanisms available to any legislature to scrutinise and authorise revenues and expenditures of the country. In this post I quote and summarise from two sources (Rick Stapenhurst, "The legislature and the Budget", in Legislative Oversight and Budgeting, World Bank Institute Development Studies, and The evolution of parliament’s power of the purse) which describe briefly how oversight by the legislature over the state's finances evolved historically. "The evolution of legislative "power of the purse" dates back to medieval times, when knights and burgesses in England were summoned to confirm the assent of local communities to the raising of additional taxes." By the 1300s the English parliament had begun to use its power to vote on funds depending on the acceptance of petitions presented by parliament to the monarch. In 1341, the monarch agreed that citizens should not be taxed ("charged or grieved to make common aid or sustain charge") without the assent of Parliament. "In parallel, the English Parliament began to take an interest in how money was collected, as well as how it was spent." In the 1300's itself, it started appointing commissioners to audit the accounts of tax collectors. This power of oversight however evolved gradually, and particularly over the 16th century, when the "monarchs needed parliamentary support and voting of funds for their various political and religious battles. King Henry VIII for example, gave Parliament enhanced status in policy making, in return for support during his battles with Rome." The 1689 Bill of Rights firmly established "the principle that only Parliament could authorize taxation. Still, at this stage there was still no such thing as an annual budget, and there was no comprehensive control of expenditures." The British Parliament also passed a resolution in 1713 to limit Parliament's power to "not vote sums in excess of the Government’s estimates. Consequently, the only amendments that are in order are those which aim to reduce the sums requested." "Since that time, the "power of the purse" function has been performed by legislatures around the world as a means to expand their democratic leverage on behalf of citizens."
