Govt assures regulation of all medical devices in a stipulated time frame

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Government assured regulation of all medical devices in a stipulated time frame during a conference hosted by Association of Indian Medical Device Industry (AiMeD) and Biotech Consortium India Limited (BCIL) with support from Department of Pharmaceuticals (DoP).

It reiterated its mandate to end confusion prevalent in the medical device industry by putting a robust regulatory mechanism in place.

The first of its kind government and industry co-hosted conference on comprehensive regulation of medical devices also called for a separate medical device patient safety law separate from drugs.

Among the key highlights discussed, it was stressed to expedite steps to end 80-90 per cent import dependence forced upon the industry and an ever increasing import bill of over Rs.38,837 crore, expedite steps for patients’ protection, stronger quality and safety regulations, price controls to make medical devices and quality treatment affordable and ethical indigenous manufacturing viable.

MSME dominated medical domestic manufacturing took a hit post GST as imports become 11 per cent cheaper and shot up 24 per cent.

Dr Vinod Paul, member, NITI Aayog and Dr VG Somani, Drugs Controller General of India (DCGI) allayed apprehensions of the medical device industry and assured to regulate all medical devices in a phased manner rather than item by item in a stipulated time frame.

This according to them will start with voluntary registration of manufacturers and importers for voluntary compliance to Medical Devices (MD) rules along with infrastructure supported by an adequate team of competent officers.

Rajiv Nath, forum coordinator, AiMeD and Dr Purnima Sharma, MD, BCIL apprised the members about the key challenges being faced by the Indian medical device industry for suitable policy interventions.

Dr Paul during his inaugural address emphasised on the need for integrated efforts to promote innovations and development of indigenous medical devices. He assured full support of NITI Aayog to ensure that the intent of domestic industry to provide access to safe, effective and quality medical device to the patients is incentivised through government policies.

Dr Somani said, “Regulations need to encourage – Make in India and Made in India. To improve Brand value, credibility and acceptance of made in India medical devices, all medical devices need to be regulated at one go and not item by item.”

The opening session threw light on the need for comprehensive regulation of medical devices in India. Nath pointed out the need to regulate all medical devices under a patients’ safety medical devices law to protect patients and aid responsible manufacturing.

“Manufacturers have been confused with informally choosing of products and notifying them as drugs. They seek a predictable and comprehensive regulatory framework that allows for adequate transition and is predictable. Only then will investments speed up as they get discouraged to be regulated as drugs,” said Gurmit Chugh, joint coordinator, AiMeD.

Voicing the concerns of domestic medical devices industry, Nath said “Medical devices are not drugs though both are medical products but differ in approach in terms of marketing. We have been specifically seeking trade margin caps on devices notified as drugs but from first point of sale in supply chain. This will maintain parity between Indian and overseas manufacturers.”

“GoI needs to take policy decisions to give at least a level playing field, if not a strategic advantage to domestic manufacturers while safeguarding consumers”, he explained.

The panel discussion during the first session “Opportunities and Challenges for Patient Safety and Incentivizing Quality Assurance Standards” raised the issues of patient safety, quality concerns and compensation mechanism.

Nath during his presentation suggested Price controls can be done in a calibrated manner through 1% GST cess on MRP as a tax based disincentive on all devices, capping trade markups to a rational level on some devices and price caps on a few priority devices.

Priority issues raised during the conference were need to incentivize quality in healthcare products in public healthcare procurements by preferential pricing for Q1 e.g. ICMED (QCI’s Indian Certification for Medical Devices) instead of L1 (lowest price) to ensure patients access acceptable quality. Besides this, government must ensure importers of medical devices are not kept out of the move to cap trade margins.

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