The central government has decided to incorporate certain additional provisions in the Schedule M of the Drugs and Cosmetics Rules to give discretionary powers to state drug licensing authorities to relax or alter the provisions of Schedule M under special circumstances. The decision is likely to be helpful to drug manufacturers as they would now have a chance to convince the drug regulatory authorities of both the necessity and non necessity of some of the requirements of premises, plant and equipment as mandated by the Schedule M.
It is known that the government is in the process of inserting a note after Part II of Schedule M giving discretionary power to Licensing Authority. The relaxation / alteration of provisions would be under particular circumstances and the manufacturer would be asked to carry out necessary modifications as deemed fit by the state authority before approving the manufacture of certain categories of drugs.
The government may also extend these discretionary powers for trouble free manufacture of nutraceuticals, cosmetics, ayurvedics etc in the licensed premises. Here the additional note would extend discretionary powers to Licencing Authority to relax or alter the provisions of Schedule M in respect of non pharmaceuticals having dual purposes, which include feeds fortified with vitamins or antibiotics, certain health supplements etc.
It should be recalled that the small-scale drug sector, which is trying hard to comply with the Schedule M requirements by year-end was expecting relaxation of clauses pertaining to ancillary areas and air handling systems.
Schedule M was first introduced in 1988 requiring Good Manufacturing Practices (GMP) to be observed by drug producers with respect to premises, equipment processes etc. The revised GMP was announced within three years to update and harmonise the existing GMP requirements with international guidelines like ICH and WHO. Though the revised Schedule M was to be made applicable from 2003, the drugs pharmaceutical sector managed to get the deadline for its implementation extended up to January 1, 2005.