Schedule M rollout may face delay as MSMEs seek more time for upgrade

Small drugmakers seek a three-month extension to submit GMP compliance plans under revised Schedule M, raising concerns about delays in national rollout

An industry body representing over 7,000 pharma companies has sought three more months for small drug makers to submit the “plan of upgradation”, a precursor to complying with the revised Schedule M standards which seek to set quality standards and good manufacturing practices.

 

Experts, however, have raised concern saying that subsequent extensions could delay the implementation of the revised guidelines. 

 

The government introduced the revised Schedule M following reports from various parts of the globe where Indian cough syrups and eye drops were found to be spurious and contaminated. Big pharma units have already implemented revised Schedule M guidelines.

 

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