Our 30th Year of Publication
Page  1 of 2

Aimed & Regulatory Update

Medical devices industry asks govt to define and bring clarity on online sale of devices in New Drugs Bill, 2022

The medical devices industry in the country has sought the Centre to define online and offline mode of sale, provide more clarity on the regulations that are binding the online sales and suggested inclusion of online medical devices players under the Uniform Code for Medical Devices Marketing Practices (UCMDMP).

The Association of Indian Medical Device Industry (AiMeD), in its feedback to the government on the draft New Drugs, Medical Devices and Cosmetics (NDMDC) Bill, 2022, has said that there needs more clarity to some of the sections which points on regulations related to online sales of medical devices.

For instance, in the Section 130 (4) of the draft, where it discusses prohibition of import or manufacture and sale of medical devices, the government intends to make regulations that no person shall himself or by any other person on his behalf sale, distribute or offer for sale the medical devices by online method, as may be prescribed, for which a license or permission is required to be obtained from the licensing authority, except under and in accordance with such license or permission subject to such exemptions and conditions and in such form and manner as may be prescribed.

“We would suggest defining what is Online and Offline Mode for greater clarity and understanding of all stakeholders from a policy maker/regulatory perspective,” said the Association.

“Both Methods of Sale are totally different and communities' health and well being is compromised with sale/delivery formats which have no clarity,” it added.

Under the Section 158 (z) of the draft, where it discusses the powers of the Central Government to make rules for the Chapter VI related to medical devices after consultation with or on recommendation of the Medical Devices Technical Advisory Board and subject to previous publication, the government has powers to prescribe the manner of regulating online sale or distribution or offer for sale of the medical device.

“We would like that better clarity is provided on the following: Whether online players in medical devices are also covered under Consumer Protection (Ecommerce Rules), 2020 under Consumer Protection Act 2019? Whether they are also subject to Medical Device Regulation?,” said the Association.

The online players are also covered under IT Act and this means the online businesses will be subject to multiple regulations and all acts have to be cross referenced for better clarity to protect consumer safety.

Communities, consumers are often under the impression that online businesses are strictly regulated and all regulatory, licensing aspects are already addressed. Food Safety Standards and Regulations Authority can be referred to as FSSAI has brought all Online FBOs under strict regulatory mechanism with well defined Regulatory specification, it added.

Besides, the Association also suggested that the online players should also be brought under the marketing code of conduct.

“Marketing Code of Conduct (UCMDMP) should include the Marketing Code of Conduct for Online players based on the Consumers Protection (ecommerce rules) 2020, released by the ministry of consumer affairs under the Consumer Protection Act 2019. Basic Marketing Code of Conduct is defined for online players under the said rules,” it added.

As reported earlier, the Association also sought the Centre to include software or an accessory to the definition of In-vitro diagnostics device which is referred to in the Section 3 (zd)(b) of the draft Bill.

http://www.pharmabiz.com/NewsDetails.aspx?aid=153165&sid=1 September 12, 2022

DoC approves setting up of separate Export Promotion Council for Medical Devices

The Department of Commerce (DoC) has approved setting up a separate Export Promotion Council (EPC) for the medical devices sector under the administrative control of the Department of Pharmaceuticals to help exporters in promoting their products in international markets. The medical devices industry welcomed the move and the strategic step will go a long way in accelerating the exports of medical devices from India.

The creation of the EPC for medical devices is approved by the DoC with one time waiver of the condition in guidelines on the subject, stipulating creation of an Export Promotion Forum initially, before its upgradation as EPC.

The Council will be headquartered in YEIDA, Greater Noida, Uttar Pradesh with regional offices in Andhra Pradesh (in AMTZ, Visakhapatnam) and Telangana (in Hyderabad). The headquarters will be set up with initial funding of Rs. 3 crore, in free office space of around 5,000 swift area at the upcoming Medical Devices Park Common Facility Centre in Greater Noida, and required secretarial staff to run the Council.

The Regional Office at Visakhapatnam is expected to be set up in a period of one year, by the end of 2023, and the regional office at Hyderabad will be set up in a period of three years, by 2025. The office space, manpower and other requirements for the regional offices has to be fulfilled by the respective State Governments, said an Office Memorandum from the DoC.

The Council’s administration and management will be through the Committee of Administration with elected and nominated members. The nominated members shall be from Department of Pharmaceuticals, Department of Commerce, Department for Promotion of Industry and Internal Trade (DPIIT), ministry of health and family welfare, Central Drugs Standard Control Organisation (CDSCO), chief executive officers or managing directors of major medical device clusters or parks especially, including the MD of Andhra Pradesh MedTech Zone and chief executive officer of Hyderabad Pharma City etc.

Commenting on the initiative, Rajiv Nath, forum coordinator of Association of Indian Medical Device Industry (AiMeD) said, “It's a great news, a big boost to Indian Medical Devices Manufacturing. The long sought and requested Medical Devices Exports Promotion Council is finally sanctioned to be created under the aegis of DoP, Government of India. This strategic step will go a long way in accelerating the exports and manufacturing growth of the medical devices sector.”

India currently exports Rs. 23,766 crore (2021-22) of medical devices up from previous year Rs. 19,736 crore. However, with almost 80 per cent of the medical devices demand in the country is met through imports, the government and the industry are looking at various methods to improve domestic manufacturing and increase the exports from the country.

The Office Memorandum further states that the chairman and vice chairman of the Council shall be elected from members who are manufacturers or processors of medical devices and other members, including from merchant exporters, shall not be eligible for the post. While the final decision on the jurisdiction will be taken by the CoA, the office in Visakhapatnam is expected to have jurisdiction over Andhra Pradesh, Orissa, Tamil Nadu and Chhattisgarh, the office in Hyderabad will have jurisdiction over the States of Telangana, Karnataka, Kerala and Maharashtra. The headquarters will serve the requirements of the member exports pan India till the regional facilities come up.

The entire range of medical devices goods and services could be broadly qualified into sub-groups named as panels, such as disposables, consumables, orthopaedic implants, IVD equipment and reagents and surgical instruments. There would also be panels for policy advocacy, technology upgradation and transfer and start-ups.

“The proposed council shall, inter alia, help exporters in promoting their products in international markets, through various promotional activities including organising/participating in international trade fairs, buyer-seller meets, RBSM in India, etc., in line with the Foreign Trade Policy (FTP) of India,” said the Office Memorandum. The Council may also organise awareness programmes for dissemination of information regarding assistance available for the MSME exporters under various government schemes. EEPC India will provide assistance and guidance to the new Council in discharge of its function for a period of five years.

Nath said, “The Exports Promotion Council for Medical Devices will help bring in coordinated inter-ministerial policy measures for unleashing the huge export potential and investment potential of over Rs. 80,000 crore for manufacturing medical devices for the global market in India’s quest to be one of top 5 preferred supplier base of medical devices worldwide and we are thankful to the minister of commerce and industry in taking this initiative to help realise our Prime Minister’s vision.”

http://www.pharmabiz.com/NewsDetails.aspx?aid=153404&sid=1 September 23, 2022

Back | Back to Top  | Previous | Next