Medical device industry has asked for Medical Devices Technical Advisory Group (MDTAG) representation in Centre’s committee for framing of new drugs, cosmetics and medical devices act.
The Drugs and Cosmetics (D&C) Act, 1940 regulates the import, manufacture, distribution and sale of drugs and cosmetics. Recently, it was amended to add medical devices with the notification of New Medical Device (MD) Rules, 2017.
Industry experts have advocated that there is also a need to take the NITI Aayog bill forward to regulate devices separately from drugs.
The Union Health Ministry had in 2019 constituted a special committee under the name Medical Devices Technical Advisory Group (MDTAG) to advice the apex drug regulator, Central Drugs Standard Control Organisation (CDSCO) on matters related to the regulation and implementation of medical devices.
“If Food can have Food Safety and Standards Authority of India (FSSAI), we need something similar for devices which are engineering goods undergoing constant innovation. Medical Devices have outgrown the joint family home shared too long with Pharma , the separate MD rules were a good step to allow us to have our own home but CDSCO is not letting go,” stated Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD).
The Union Health Ministry has formed a committee to frame the New Drugs, Cosmetics And Medical Devices Bill for the enactment of New Drugs, Cosmetics and Medical Devices Act.
As per the terms of reference of the order titled ‘Constitution of Committee for Framing of New Drugs, Cosmetics and Medical Devices Act’, the committee shall undertake pre-legislative consultations and examine the present Act, previously framed drugs and cosmetics bills and submit a draft document for a de-novo drugs, cosmetics and medical devices bill by November 30, 2021.
Representations were made in the past that there is a need for New Drugs, Cosmetics and Medical Devices as the current act is completely obsolete dating as back as 1940.
Drug and cosmetic Act was enacted in 1940 and subsequently three Medical devices were added in this Act in 1991 as stop gap arrangement since no medical devices were regulated till such time.
According to Kishore Khanna, Managing Director from Noida based Romsons Group Private Limited, a company which manufactures nebulizers, pulse oximeters and blood pressure monitors indigenously,
“In 2017, more medical devices were added in the notified list but most important is that the CDSCO is not interested in let go of its power and opposing the new bill drafted by NITI Ayog which is the right bill for Medical devices. Most of the manufacturers favour the new drafted bill.”
He further added, “Drug is a chemical product whereas medical device is an engineering product therefore it is most inappropriate to regulate medical devices by the pharmaceutical authorities.”
Last year, the union health ministry had brought medical devices within the regulatory ambit, treating them as a category of ‘drugs’ for the purpose of regulation.
The newly formed eight-member panel is headed by the Drugs Controller General of India (DCGI) VG Somani.
The other members of the panel include Rajiv Wadhawan, Director, Union Health Ministry, Dr Eswara Reddy, Joint Drug Controller, AK Pradhan, Joint Drug Controller, NL Meena and Drug Controllers of Haryana, Gujarat and Maharashtra.
New MD Rules 2017 were notified last year and have come into effect from January 1, 2018 onwards in the country. Following the notification, issues related to post grant compliance, data protection, product recalls and product liabilities among others will be implemented effectively towards device or product safety.