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 recent 2G-controversy and the related debate over the role of the PAC as opposed to the JPC also raises a broader Issue regarding the general scrutiny of government finances by Parliament. Oversight of the government’s finances involves the scrutiny of the government’s financial proposals and policies. The Indian Constitution vests this power with the Parliament by providing that (a) taxes cannot be imposed or collected without the authority of law, and (b) expenditure cannot be incurred without the authorisation of the legislature. The Indian Parliament exercises financial oversight over the government budget in two stages: (1) at the time of presentation of the annual budget, and (2) reviewing the government’s budget implementation efforts through the year. The Parliament scrutinises the annual budget (a) on the floor of the House, and (b) by the departmentally related standing committees. Scrutiny on the floor of the House The main scrutiny of the budget in the Lok Sabha takes place through: (a) General discussion and voting: The general discussion on the Budget is held on a day subsequent to the presentation of the Budget by the Finance Minister. Discussion at this stage is confined to the general examination of the Budget and policies of taxation expressed during the budget speech. (b) Discussion on Demand for Grants: The general discussion is followed by a discussion on the Demand for Grants of different ministries. A certain number of days or hours are allocated for the discussion of all the demands. However, not all the demands are discussed within the allotted number of days. The remaining undiscussed demands are disposed of by the Speaker after the agreement of the House. This process is known as the ‘Guillotine’. Figure 1 shows the number of Demands discussed and guillotined over the last five years. It shows that nearly 90% of the Demands are not discussed every year. 
Some Important Budget Documents Annual Financial Statement – Statement of the estimated receipts and expenditure of the government. Demand for Grants –Expenditure required to be voted by the Lok Sabha. A separate Demand is required to be presented for each department of the government. Supplementary Demand for Grants – Presented when (a) authorized amounts are insufficient, or (b) need for additional expenditure has arisen. Finance Bill – Details the imposition of taxes, the rates of taxation, and its regulation. Detailed Demand for Grants – Prepared on the basis of the Demand for Grants. These show further break-up of objects by expenditure, and also actual expenditure in the previous year. For more details see detailed note on Financial Oversight by Parliament here.
