New Schedule M rules: Most drug companies not yet ready for upgrade

Only a small number of pharmaceutical companies have submitted plans for upgradation of facilities even as a revised deadline for implementation of revised Schedule M ends on Monday. Health ministry officials said out of about 10,000 medium and small manufacturing enterprises, just about 100 have submitted applications.

Health secretary Punya Salila Srivastava has now written to state health secretaries, asking them to issue necessary directions to state drug regulators to discuss the matter with drugmakers in their own areas.

Schedule M of the Drugs and Cosmetics Act outlines quality standards for pharmaceutical products.


This February, the ministry issued a notification extending the deadline for implementing revised Schedule M, whereby manufacturers with revenues of less than ₹250 crore were required to submit applications to the Central License Approving Authority within three months, along with their upgradation plans.

"However, as per the data available, very few firms have submitted their application requesting extension of timelines for implementation of revised Schedule M," said the health secretary in her letter to states.