The Central Drugs Standard Control Organization (CDSCO) has issued the draft Schedule M III-Good Manufacturing Practices and requirements of premises, plant and equipment for medical devices and in-vitro diagnostic kits & reagents.
The draft Schedule M III, issued by the health ministry only for feedback purpose, is part of its effort is to revise the Schedule M-III for medical devices under the Drugs and Cosmetics Rules, 1945 replacing the present limited Schedule M-III to address the problems of medical device industry and to make the requirements for medical devices harmonious to the international standards.
The medical devices industry in the country has been airing the difficulties faced by the industry in respect of implementation of the provisions of the Drugs and Cosmetics Act, 1940 and Rules made thereunder regarding the implementation of Good Manufacturing Practices for medical devices. The industry has been demanding that the requirement of GMP compliance for medical devices should be as per IS: 15579: (ISO 13485) standards.
To achieve the objectives listed in the draft, each licensee shall evolve a quality system in line with BIS 15579/ISO 13485 as amended. In the case of combination devices, the process of manufacture of the drug/biologics will be as per schedule M. However the process of loading of drug/biologics on to the device and thereafter will be governed by this schedule. No part of the Schedule M shall be applicable for medical device and in-vitro diagnostic kits and reagents manufacture.
As per the 57-page draft document, the factory building(s) for manufacture of devices shall be so situated and shall have such measures as to avoid risk of contamination from external environment including open sewage, drain, public lavatory or any factory which produce disagreeable or obnoxious odour or fumes, excessive soot, dust, smoke, chemical or biological emissions.
The premises used for manufacturing, assembling, packaging, labelling, warehousing shall be adequately provided with working space to allow orderly and logical placement of equipment, materials and movement of personnel so as to avoid the possibilities of mix ups by providing suitable mechanism; and designed / constructed / maintained to prevent entry of insects, pests, birds, vermins and rodents. Interior surface (walls, floors and ceilings) shall be smooth and free from cracks, and permit easy cleaning, painting and disinfection.
The CDSCO has invited comments and suggestions on this document from the stakeholders within 15 days.