The Central Drugs Standard Control Organisation plans to conduct surprise checks at manufacturing sites, following the practice adopted by the US Food and Drug Administration (FDA).

The decision has been taken in the light of criticism of Indian pharmaceutical manufacturing facilities by US and European regulators, and to prevent substandard medicines from entering the Indian market.

The surprise checks regime could start within a month. Those units which are found flouting norms or producing sub-standard medicines which could compromise patient health will face stringent punishment, including suspension or cancellation of licenses and legal action.

Major pharmaceutical companies like Sun Pharma, Cadila Healthcare and Dr Reddy’s are among those which have received warning letters from the FDA in respect of their manufacturing units in India. “It is not a secret that some Indian companies follow two sets of standards – one for local-level consumption or supplies to markets that have a lower bar for regulatory acceptance and the other for developed markets like the US and EU,” said an international GMP consultant.


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