Regulatory Focus™ > News Articles > New Proposal Could Allow Third-party Drug Quality Audits in India

New Proposal Could Allow Third-party Drug Quality Audits in India

Posted 12 April 2012 | By Alexander Gaffney, RAC 

A new proposal being advanced by India's Planning Commission would allow private, third-party auditors from specially trained companies to inspect pharmaceutical manufacturers and issue certificates of compliance, reports Wall Street Journal subsidiary Live Mint.

The proposal would likely be phased in, with traditional medicines being audited for some time before modern pharmaceutical manufacturers would be allowed to participate, said a source interviewed by Live Mint.

The proposal could ease pressures on the Central Drugs Standard Control Organization (CDSCO), which has been experiencing regulatory capacity issues as a result of a shortage of funding.

CDSCO and other regulatory bodies will still retain the right to inspect all manufacturing facilities for any valid reason, reports Live Mint.


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