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:
Yesterday the Rajya Sabha and Lok Sabha engaged in a debate on the President's speech, known as the Motion of Thanks. The President's speech is a statement of the legislative and policy achievements of the government during the preceding year and gives a broad indication of the agenda for the year ahead. Close to the end of the UPA government’s term, it would be useful to evaluate the status of the commitments made in the President’s addresses. (To know more about the significance of the President’s speech refer to this Indian Express article. To understand the broad policy and legislative agenda outlined in this year's address see this PRS Blog.) The President's speeches since the beginning of the 15th Lok Sabha in 2009, have addressed reforms to the financial and social sectors, improving accountability of public officials, and making the delivery of public services more efficient. We analyse the status of each of these commitments. Accountability in governance processes In an effort to increase accountability and transparency in governance processes, the government introduced a number of Bills.
These bills have been passed by the Lok Sabha and are pending in the Rajya Sabha. The government has recently approved amendments to the Lokpal Bill, which may be considered by the Rajya Sabha in the Budget session. Public service delivery In order to make public service delivery more efficient, the government introduced the Electronic Services Delivery Bill and the Citizen’s Charter Bill.
Social sector reforms: land, food security and education Broad sectoral reforms have been undertaken in land acquisition, food security and education to aid development and economic growth.
Financial sector reforms In order to aid growth and encourage investments, the President had mapped out necessary financial sector reforms.
In the backdrop of these legislations, it will be interesting to see the direction the recommendations of the Financial Sector Legislative Reforms Commission, responsible for redrafting all financial sector regulation, takes. Internal security The government is taking measures to deal with internal security concerns such as terrorism and naxalism. In 2009, the President mentioned that the government has proposed the setting up of a National Counter Terrorism Centre. However, this has been on hold since March 2011. At the beginning of the 15th Lok Sabha in June 2009, the President presented the 100 day agenda of the UPA II government, in his address. Of the eight bills listed for passing within 100 days, none have been passed. In addition, the President’s address in 2009 mentioned five other Bills, from which, only the RTE Act has been passed. In the final year of its tenure, it needs to be seen what are the different legislative items and economic measures, on which the government would be able to build consensus across the political spectrum.