Indian Government Soon to Delink Medical Devices from Pharma Industry

Published Date : Dec 18, 2015

The Modi government in India is planning to delink the medical device industry from the pharmaceutical sector. The strategy is aimed at giving impetus to the ‘Make in India’ plan in the medical sector as well, as revealed by the people privy to the development. 

The Central Drugs Standard Control Organization and the Ministry of Health & Family Welfare took the decision of creating separate rules for the device manufacturers, which will be in line with the global standard. Industry representatives from the Association of Indian Medical Device Industry, were also among the officials present at the meeting. 

According to reports, currently almost 70% of the medical devices used in the healthcare sector of India is imported. The size of the medical device market in India, in terms of retail level sales, is over US$10 bn. Hence, any decision taken with regards to the pharmaceutical and medical device sector, is also likely to have an impact on the country’s annual GDP. 

While, nothing has been put down on pen and paper as of yet, the Ministry is likely to seek public opinion and comments through the CDSCO (Central Drugs Standard Control Organization) website shortly. It is only after evaluating the public opinion, will the Ministry issue a notification suggesting change in the existing drug rules through the Law Ministry. 

Speaking about the latest developments in the pharma and medical devices sector in India, Rajiv Nath, Forum Coordinator at AIMED said in a recent interview that for long ambiguity in exisiting pharma regulation has enabled medical inspectors to unethically harass the device manufacturers, making it really difficult for the latter to run business. Most of the inspectors interpreted the rule to his benefit, with individual yardstick, while the medical device makers were left with no options but to follow it. The new standards, however, Mr. Nath said, will eliminate such instances and will help the industry to grow in the forthcoming years. 

Issuing ‘Make in India’ directives for medical devices will make the industry viable for government investments, and will simultaneously address the adverse duty structure prevalent at present, he further added.