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India signals crackdown on dubious fixed dose drug combinations

BMJ 2013; 347 doi: (Published 17 July 2013) Cite this as: BMJ 2013;347:f4588
  1. Ganapati Mudur
  1. 1New Delhi

The Indian government, jolted into action by a stinging report from a parliamentary panel, has signalled a crackdown on dubious fixed dose combinations of drugs sold across India without mandatory approvals or evidence of their safety and effectiveness.

The Central Drugs Standard Control Organisation, India’s main drug regulatory agency, has set 30 August as the deadline for manufacturers to submit documents in support of the safety and effectiveness of fixed dose combinations being sold without the agency’s approval.

The agency has also asked manufacturers to submit protocols for clinical trials of fixed dose combinations—formulations that contain two or more active pharmaceutical compounds in a fixed ratio of doses— introduced without safety and efficacy studies.

India’s drug laws require drug combinations that have already been approved individually to be treated as new drugs and undergo evaluation, but this has been widely flouted. A parliamentary panel on health last year exposed collaboration on the issue between the drug industry, regulators, and doctors, and decried government …

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