The government of India is planning to develop an in-depth regulatory framework for medical devices. The current system lacks distinctive regulatory system and medical devices are either regulated as drugs or are unregulated. Medical devices that are regulated are under the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO); part of the Ministry of Health and Family Welfare,
The regulatory framework for medical devices is based on drug regulations under the Drugs and Cosmetic Act of 1940, and Drugs and Cosmetic Rules of 1945. Currently, 22 medical devices are “notified” under the Drugs & Cosmetics Act. Devices notified (regulated) by the Indian government must register with the CDSCO. Non-notified (unregulated) devices do not require CDSCO registration, and may be imported into India according to formal customs rules.
The Ministry of Health plans to issue a set of new guidelines to define and regulate medical devices as a separate category. These guidelines will be finalized in consultation with Association of Indian Medical Device Industry (AIMED) and will be issued by the Ministry. The new guidelines will make medical device regulations stringent for both the manufacture and importation of medical devices. The National Pharmaceutical Pricing Authority (NPPA) Department of Pharmaceuticals, responsible for current medical device regulation in India, has issued the Draft National Medical Device Policy recommending formation of an autonomous National Medical Device Authority (NDMA). The NDMA will be authorized for promoting the local device sector, enforcing stricter safety standards, and installing price controls for devices, including surgical instruments, implants, and diagnostic equipment.
– In January 2016, CDSCO implemented an online portal “SUGAM” to file applications for various services including application for registration certificate and import license application for notified medical devices. From 15th February 2016, it is required that all the applicants submit the applications online along with the hard copies.
– In June 2015, the Health Ministry approved the ‘Materio Vigilance Programme of India’ (MvPI) which would monitor Medical Device associated Adverse Events (MDAE) and can be coordinated by the Indian Pharmacopoeia commission in collaboration with CDSCO.
– The new regulations aim to bring India’s regulatory requirements in compliance with International environment. CDSCO recently issued changes to the country’s good manufacturing practices. The new standards are drafted to align to ISO 13485, which may streamline the approval of devices.
– The medical device registration and import license approval timeline will be affected, as new medical device regulations will be implemented by CDSCO. However, it is anticipated that it will take at least two years to develop and implement a proper medical device regulatory structure in India.
Yashesh Rawal is a Regulatory Affairs Specialist at MAE Consulting Group. Contact Yashesh at Yasheshr@maeconsultinggroup.com