The union health ministry has decided to bring in quality standards in the manufacture of items like chemicals and pharmaceutical aids, gauzes and bandages, medicinal gases, empty gelatin capsules, non-chemical / mechanical contraceptives, diagnostic kits and reagents etc.

The recent amendment to the Schedule M of the Drugs and Cosmetic Rules has taken note of all items that are not currently covered under the Schedule M and has given the concerned licensing authority discretionary powers to modify the requirements of the Schedule M so as to suit the nature of such products.

The note 1 added after Part II of the Schedule M states, "the licensing authority or Central Licensing Approving Authority, as the case may be, in respect of such categories of drugs, have the discretion to modify the requirements of this Schedule, if he is of the opinion that having regard to the nature of the products and the extent of manufacturing operations and for reasons to be recorded, in writing, it is necessary to relax or alter them in the circumstances of a particular case and direct the manufacturer to carry out necessary modifications in them and the modifications having been made, approve the manufacture of such categories of drugs."

Mentioning that the schedule gives general and specific requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for certain categories of drugs only, the note specified other categories of drugs like chemical and pharmaceutical aids, gauzes and bandages, medicinal gases, empty gelatin capsules, non-chemical / mechanical contraceptives, diagnostic kits and reagents, medical devices, new dosage forms, and their delivery systems, disinfectant fluids, antacids, raw materials manufactured from sea bittern, veterinary biologicals including poultry vaccines, re-packing of drugs etc.

By mentioning these categories of drugs under the amended Schedule M, the health ministry has now broadened the scope of the schedule. The schedule is to apply for all manufacturers from January 1, 2005.