Substandard Subcontinent

  • by: |
  • 05/25/2012

Compulsory what?

Drug regulation in India-the time is ripe for change

The Lancet

To say that India's drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO)-whose remit includes new drug approval, licensing of manufacturing facilities, and regulation of drug trials-is not fit for purpose seems a gross understatement.

A damning 118-page report from the Indian Parliamentary Standing Committee on Health and Family Welfare documents its successive failings. It describes a vast, geographically disseminated organisation that is dangerously understaffed: nine officers at headquarters deal with 20 000 applications, more than 200 meetings, 700 parliamentary questions, and 150 court cases per year. There is also a dearth of medically qualified staff, poor support infrastructure, a seeming lack of coordination between departments, and a scarcity of decent computer systems.

It is therefore not surprising that, of 42 approved drugs randomly chosen for investigation by the Committee, some had not passed through the correct regulatory channels. But the fact that 11 had no phase 3 studies done, 13 "did not have permission for sale in any of the major developed countries", and there was "no scientific evidence to show that...33 drugs are really effective and safe in Indian patients" points to problems at the very foundations of CDSCO. Its mission of meeting the aspirations ... demands and requirements of the pharmaceutical industry", rather than the protection of patients, is a very shaky foundation indeed.

The Committee's report has several suggestions for improvement. However, rather than trying to overhaul an organisation that is failing so catastrophically, India should seize this opportunity to wipe the slate clean and form a new drug regulatory body.

A smoothly running, professional drug regulatory body is essential to ensure, first, that high-quality, adequately assessed drugs are available to India's population and, second, that India's drug industry is regulated well enough to contribute successfully to India's domestic and export sectors. It should go without saying that whatever action India takes, the philosophy of the drug regulatory body should be the protection of patients, wherever they are.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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