- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
India’s large population and robust healthcare market are truly turning India into a medical devices hub. Consequently, on January 31, 2017, the Ministry of Health and Family Welfare notified the Medical Devices Rules, 2017. These new regulations are set to replace the country’s longstanding Drugs and Cosmetics Act, 1940 upon implementation.
These long-awaited new medical device and in vitro diagnostic (IVD) regulations, issued by the Ministry’s Central Drugs Standard Control Organization (CDSCO), will be in effect from January 01, 2018. They have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and seek to adhere to the best international practices. Currently, only 15 categories of medical devices are regulated as drugs and to that extent, the prevalent regulatory practices in India were not fully geared to meet the requirements of medical devices sector in the country. The new Rules thus seek to remove the existing regulatory bottlenecks to Make in India and facilitate the ease of doing business while ensuring availability of better medical devices for patient care and safety.
Medical devices, under the new Rules, will be classified as per GHTF practices, based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices will be required to meet risk proportionate regulatory requirements that have been specified in the Rules.
The Prime Minister’s Office has been pushing the Department of Pharmaceuticals to fast-track formulation of the medical devices policy that will give the sector a much required boost and help magnetize FDI. According to information from the Department of Pharmaceuticals (DoP), the work on the policy has been expedited and it will be released soon. The policy assumes significance given the fact that India imports about 80% of its medical device requirements.
The Rules, it appears, will provide a propitious environment for fostering India specific innovation and improving accessibility and affordability of medical devices across the globe by leveraging the comparative cost advantage of manufacturing in India. The transparent regulatory framework will boost the assurance of investors and, consequently, the superiority and range of products and services will improve.
GDS’ expert team is presently analyzing these new rules to determine how existing and prospective medical device registrations in India will be impacted. Stay tuned for additional updates.
 U.S. Food and Drug Administration