Health Ministry Unlikely to Extend Schedule M GMP Deadline for Small Drug Manufacturers
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Health Ministry Unlikely to Extend Schedule M GMP Deadline for Small Drug Manufacturers

The Union health ministry is reportedly unlikely to extend the deadline for small drug manufacturers to comply with revised Good Manufacturing Practices (GMP) under Schedule M. The ministry, along with CDSCO, is consulting state governments on implementation, emphasizing that drug safety will not be compromised. Revised norms require tighter quality controls, including PQS, QRM, and product recall mechanisms, with no flexibility for manufacturers unwilling to upgrade.

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