In most Asian countries including South Korea, Indonesia, Thailand, Malaysia, Philippines, Singapore and Vietnam medical devices are regulated separately from drugs. However, in India currently medical devices, drugs, IVD’s and cosmetics are all regulated under the same Drugs and Cosmetics Act. The new government under Modi is keen on delinking the medical device industry from the pharmaceutical sector to encourage R&D, manufacturing, exports, FDI into the country.
The Ministry is expected to shortly seek public opinion and comments through the website of CDSCO, the national regulatory body for the domestic pharma and medical devices. It will then issue a notification for change in the drug rules through the Law Ministry to carry out the delinking.
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“Ambiguity in the regulations had for a long time allowed medical inspectors to harass device makers, making it very difficult to run business. Every inspector would interpret the rules with his or her own yardstick and we had no other option but to comply. The new standard would eliminate this and would help the industry to grow,” said Rajiv Nath, an enthused Forum Coordinator for AIMED.