The Union health ministry is contemplating 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.
The issue of compliance of Schedule M by the manufacturers of medical devices has been raised many times in the past. The Schedule M relating to the Good Manufacturing Practices for pharmaceutical products provides in the Note appended to the Schedule that in the case of certain categories of drugs including medical devices, the licensing authority have the discretion to modify the requirements of the Schedule, if he is the opinion that having regard to the nature of the products and extent of manufacturing operations and 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.
As per these provisions, it is not mandatory that all the provisions of Schedule M are required to be complied by the manufacturers of medical devices. These could be modified and approved on case to case basis. The definition of the term ‘drug’ under Section 3 of the Drugs and Cosmetics Act, 1940, under clause (iv) includes such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government.
So far the government has notified 14 categories of medical devices. They are disposable hypodermic syringes; disposable hypodermic needles; disposable perfusion sets; in vitro diagnostic devices for HIV, HBsAg and HCV; cardiac stents; drug eluting stents; catheters; intra ocular lenses; I.V. cannulae; bone cements; heart valves; scalp vein set; orthopaedic implants; and internal prosthetic replacements.