Report of the Expert Committee on a Comprehensive Examination of Drug Regulatory Issues, Including the Problem of Spurious Drugs

In January 2003, the government of India’s Ministry of Health and Family Welfare constituted the Expert Committee on a Comprehensive Examination of Drug Regulatory Issues, Including the Problem of Spurious Drugs. Dr. R. A. Mashelkar – director general of the government’s Council of Scientific and Industrial Research at the time – was appointed as its chairperson. The Committee published its report in November 2003. The Committee was to discuss the circulation and consumption of spurious drugs in India; suggest a structure for a national drug regulatory system; and recommend measures to strengthen the drug regulatory infrastructure at the central and state levels, steps to be taken by the pharmaceutical industry to reduce the manufacture of spurious drugs, as well as changes in the Drugs and Cosmetics Act, 1940. The 157-page report has two parts: Part A covers issues related to drug regulation in India; Part B examines the extent to which spurious and substandard drugs are distributed and consumed in the country, and includes measures to deal with the problem.