Momentum is building to introduce the new medical device bill in the Parliament. Reports indicate that the Health Ministry has sent a note proposing the new bill to the Cabinet Secretary for approval of the Union Cabinet.

The bill that would replace the earlier Drugs and Cosmetic Act is expected to lay down separate provisions for Medical Devices including a separate definition of them, their riskbased classification for regulatory control, Clinical Trials on Medical Devices, Conformity Assessment Procedures, Penal provisions, etc. This is in stark opposition to the scenario today wherein medical devices are treated as drugs. The situation is unlike in the US and EU which have separate pathways for medical devices and pharmaceuticals.

In a final draft of the guidelines on medical devices, the Drug Technical Advisory Board (DTAB) recommended strict implementation of Indian Conformity Assessment Certificate (ICAC) for the medical devices manufactured, imported and marketed on Indian market under Schedule M III of Drugs & Cosmetics Rules 1945 while classifying them into Class A, B, C & D as per their level and intended use. All such devices sold in India (except for custom made devices, meant for a particular patient use) should, as a general rule, bear the Indian Conformity Assessment Certificate mark (ICAC) to indicate their conformity with the provisions of this schedule.

The new Bill is expected to bring all medical devices sold in India under the purview of the government agency charged with regulating medical devices: the Central Licensing Approval Authority (CLAA) under the Central Drugs Standard Control Organization (CDSCO). For the moment, however, the CLAA only requires certain categories of devices that have been the subject of notifications in the Official Gazette of India (21 device categories in total) to  register with the Central Drugs Standard Control Organization (CDSCO).

Apart from the notification issued in 2005, in March last year, the Government upon the recommendation of the DCGI and examination by the Expert Committee, has further confirmed 11 devices such as Spinal needle, Insulin syringes, three way stop cock as an accessory of I. V. Cannula / Catheter / Perfusion Set, Introducer sheath, Cochlear implant, Close wound drainage set, AV fistula needle, Extension line as an accessory of Infusion set, ANGO kit / PTCA / Cath Lab kit, Measure volume set and Flow regulator as an accessory of Infusion set as drugs.

FICCI recommends a single regulatory authority with sufficient resources allocated to it for effective implementation and monitoring of the regulatory framework alongwith a thorough and careful interlinking of various Govt Ministries / Departments ( like CDSCO, MoH&FW, DEITY - MCIT, DoT - MCIT, BIS, DGFT, AERB and more ) presently involved in Governance of Medical devices.

Medical Devices Bill

Elucidating the role of CDSCO and the future ahead, Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED) says, “After the bill on Regulation of Medical Devices and Patient Safety is passed by a National Regulatory Authority under the Ministry of Health, the current CDSCO’s role could be enlarged with more autonomy and renamed as the Indian Healthcare Regulatory Authority with decentralized Divisions for Drugs, Cosmetics, Medical Devices and Diagnostics.”

He also advocates sharing of regulatory controls given the vast diversity of technologies and varying risk profile of Medical Devices with a National Regulator for Policy, Licensing & Registration of Manufacturers / Importers / Exporters for enabling a single window and harmonized controls; Utilization of CAB’s (Conformity Assessment Bodies) for delegating the task of factory audits of Indian and Overseas Manufacturers for Compliance to Good Manufacturing
Practices/ Quality Management Systems and the State Regulatory Authority for Licensing and Registration of Traders Distributors / Dealers / Warehousing Sub Contractors / Retailers etc for regulating Logistics and Sales. This would require minimal increase in employment by the Government and is the Regulatory Model being used in Europe, Canada, Australia, New Zealand with even the US and Japan reviewing the same, he adds.

As per Mr. Ajay Pitre, Managing Director, Sushrut-Adler Group, Extensive recruitment and internal training are no doubt necessary by the regulatory authorities to create an organisation that can suitably regulate the industry in an appropriate manner with the objective of creating a vibrant domestic industry that can hold its head high on the world stage.”

Dr. A. Didar Singh , Secretary General, FICCI is of the opinion that “Post marketing surveillance and adverse event reporting could be a more optimum solution for monitoring safe and effective performance than doing clinical trials on products well established for usage and safety in other countries.”

V. Sashi Kumar, Managing Director, Phoenix Medical Systems, believes ,” “With other countries, including Brazil, Russia, China and Turkey, having established regulatory systems, this bill has come none too early in India. The importance of the bill resides in the need to safeguard the welfare of India’s large population while reducing malpractices.”