India has begun to bounce back in clinical trials with new regulations issued at frequent intervals. The latest guidance issued by the Ministry of Health & Family Welfare early this month, permitting clinical trials at hospitals with less than 50 beds and with no restriction on the number of clinical trials, has added to the momentum built in the last nine months.

With sponsors making a comeback, India, which was considered a promising hub until 2012, is back in the reckoning once again. Stepping up pace of approvals at the regulatory enforcement front and requisite clearances in a time-bound manner will need to be in place.

After extreme scrutiny in the global market, CDSCO has begun to align India's regulations with international standards. Previously, drugs and medical devices in India were both regulated under the Drugs and Cosmetics Act of 1940. After failing to amend the Act in 2013, CDSCO decided to draft two legislations instead - one for drugs and one for devices. The new laws distinguish medical devices from drugs, outline various types of medical devices, make improvements to the clinical trial process, and extend the registration process to many medical devices that were previously not required to be registered.

The Medical Devices Bill 2016 shall bring about comprehensive changes in the way medical devices in the country are approved and monitored. This notified amendment to the Drugs and Cosmetics Rules 1945 (Schedule MIII) stipulates the infrastructure and quality system requirements for all 22 types of medical devices that are notified as drugs. An earlier version of this rule covered only three types of medical devices. Further, the revised Schedule MIII is aligned to the ISO/IS 13485.

The first draft released recently by the ministry has been withdrawn. The second revised draft shall be released shortly.

The Indian medical devices industry is currently growing at a healthy CAGR of around 12 percent, significantly higher than global industry growth of 4-6 percent. With the right measures in place, the industry has the potential to grow to a Rs. 65,000-crore industry by 2022.


From the Editor's Desk

Anju Arora

Anju Arora is the founder and managing director of ADI Media Private Limited, a business-to-business (B2B) information provider. ADI Media’s B2B products include Medical Buyer, Communications Today, Broadcast & CableSat, and TV Veopar Journal

She is an Economics Honors graduate from Lady Shri Ram College, New Delhi and PGDP from Indian Institute of Foreign Trade. She has also participated in the OPM Key Executives Program at Harvard Business School.

Anju Arora is also the co-founder and executive director on the Board of ADI BPO Services Limited, the majority shareholder in MPS Limited, listed on all the major India stock exchanges and a Macmillan company till 2011.

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