Regulation of all medical devices: DoP, AiMeD, Biotech Consortium to create comprehensive roadmap

New Delhi: At a recent conference, jointly organized by Department of Pharmaceuticals (DoP), Association of Indian Medical Device Industry (AiMeD) and Biotech Consortium India Limited (BCIL), the Government ensured to create a comprehensive road map for the regulation of medical devices.

The conference was attended by Minister of Science & Technology, Minister of Health and Family Welfare and Minister of Earth Sciences, Government of India Dr Harsh Vardhan, Minister of State, Ministry of Shipping and Ministry of Chemicals & Fertilizers, Government of India, Shri Mansukh Mandaviya and Dr Vinod Paul, Member, NITI Aayog.

Besides, Dr Balram Bhargava, DG, ICMR, Dr P D Vaghela, Secretary – DOP and Dr V G Somani, DCGI, CDSCO have also confirmed to participate and share their remarks, vision and direction for spearheading the medical device sector in the country.

The key highlight of the conference was the urgent need for the Government to expedite steps to end the 80-90 per cent import dependence forced upon us 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 accessible and affordable and ethical indigenous manufacturing viable.

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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.

The panel discussion during the first technical session ‘Opportunities and Challenges for Patient Safety and Incentivising Quality Assurance Standards’ raised the issues of patient safety, quality concerns and compensation mechanism.

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Rajiv Nath, Forum Coordinator, AiMeD and Dr Purnima Sharma, MD, BCI lauded all the guests from Government, Industry, Academia and Indian Medical Device Industry Associations and apprised the members about the key challenges being faced by the Indian medical device industry for suitable policy interventions by the Govt to uplift the sector.

Dr Vinod Paul, Member, NITI Aayog emphasised on the need for integrated efforts to promote innovations and development of indigenous medical devices for having a vibrant domestic medical devices industry for the society. He assured full support of NITI Aayog to ensure that the intent of domestic industry to provide access to a safe, effective and quality medical device to the patients are kept in all Govt policies.

Dr VG Somani, Drugs Controller General of India (DCGI), CDSCO, 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.”

According to a media report by Express Healthcare, a pro-active policy formulation to regulate medical devices differently than drugs should permit free market dynamics to succeed and keep regulations simple, protecting consumers and incentivising Make in India.