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India’s parliamentary panel sees nexus between drug regulators, manufacturers, and doctors

BMJ 2012; 344 doi: http://dx.doi.org/10.1136/bmj.e3451 (Published 17 May 2012) Cite this as: BMJ 2012;344:e3451
  1. Ganapati Mudur
  1. 1 New Delhi

An Indian parliamentary panel has said a “collusive nexus” between India’s drug regulators, manufacturers, and doctors has facilitated the irregular approvals of drugs and threatens to compromise the interests of patients.

A standing committee of members of parliament who monitor the workings of the health ministry has said that India’s Central Drugs Standards Control Organisation, the top regulatory agency, has allowed dozens of drugs from domestic or foreign manufacturers to be marketed without the requirement for clinical trials.

The panel, which examined hundreds of documents from the offices of the regulatory agency, has also cited examples of letters sent by medical practitioners to drug regulators, articulating words of support for specific drugs with remarkable similarities between them in text.

The panel’s report, released last week, contains several sets of such letters, including three sets in which doctors argued that the requirement for clinical trials should be waived (http://164.100.47.5/newcommittee/reports/EnglishCommittees/Committee%20on%20Health%20and%20Family%20Welfare/59.pdf).

Under India’s drug laws, clinical trials are mandatory for all new drugs, including those that have been approved by regulators in other countries. The rules require that, while applicants for new drugs should submit available pharmacological, toxicological, and overseas clinical trials data, they should also conduct Phase III clinical trials to demonstrate efficacy and safety of the new drug in populations living in …

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