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.


  1. The central government is responsible for approving drugs for circulation in the country; granting permissions to conduct clinical trials; examining the quality of imported drugs; passing laws for regulating drugs; and prescribing standards for drugs and cosmetics.

  2. The problems in the drug regulatory system in India are primarily due to the inadequate drug control infrastructure at the central and state levels, insufficient drug testing facilities, a shortage of drug inspectors and a lack of trained officials for specific drug regulatory activities.

  3. The states with more than 75 per cent of India’s drug manufacturing licenses are Andhra Pradesh, Goa, Gujarat, Karnataka, Maharashtra, Tamil Nadu and West Bengal. Bihar, Delhi, Haryana, Kerala, Madhya Pradesh, Orissa, Punjab, Rajasthan and Uttar Pradesh accounted for roughly 20 per cent of drug manufacturing licenses in India. The remaining states and union territories recorded registering about five per cent of the country’s licenses.

  4. The Drugs and Cosmetics Act, 1940, is the primary legislation regulating the import, manufacture, distribution and sale of drugs in India. Its enforcement, the report states, has been inadequate in many states. A reason for this is that the law’s provisions have not been uniformly interpreted across the country.

  5. The New Delhi-based Central Drugs Standard Control Organisation (CDSCO) oversees the central government’s drug regulatory activities. The CDSCO falls under the Directorate General of Health Services, Ministry of Health and Family Welfare, government of India. The Committee suggests that the CDSCO be made the Central Drug Administration, an independent body under the Ministry of Health and Family Welfare.

  6. The Committee recommends that State Drug Control Organisations be strengthened with funds as well as competent and trained personnel for the effective regulation of drugs.

  7. The pharmaceutical industry, pharmaceutical trade associations and consumer, medical and paramedical associations, should coordinate to tackle the problem of spurious and sub-standard drugs.

  8. The penalty for the sale and manufacture of spurious drugs that cause grievous hurt or death, states the Committee, should be increased from life imprisonment to death. Offences related to the manufacture and sale of spurious drugs should be made non-bailable.

  9. The report also contains recommendations on health foods, dietary supplements and therapeutic foods, medical devices, over-the-counter medication, drugs from Indian systems of medicine, clinical trials and drug distribution systems.

    Focus and Factoids by Abizar Shaikh.


Expert Committee on a Comprehensive Examination of Drug Regulatory Issues, Including the Problem of Spurious Drugs (Chair: Dr. R. A. Mashelkar)


Ministry of Health and Family Welfare, Government of India, New Delhi


Nov, 2003