Need for a single authority to regulate Medical Devices sector:FIC

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New Delhi, Dec 31 (UNI) There should be a single authority dedicated to addressing the regulatory issues relating to medical devices, as suggested by the revision of the ''Drugs, Cosmetics and Medical Devices (Amendment) Act, 2007, suggested industry chamber Ficci.

In a note to the government, the chamber said the act aims to provide new separate provision for establishing regulatory controls, specific to Medical Devices.

The note also higlights the concerns of the Medical Devices Industry on the proposed Drugs and Cosmetic Amendment Bill. Among other measures, the chamber said that the term 'Clinical Investigation' (Trial) for Medical devices need to be defined separately and specifically for medical devices.

The eight-point recommendation made by the act includes, Changing the title of the Act to ''Drugs, Cosmetics&Medical Devices (Amendment) Act, 2007''.

It further suggests, the term Medical Device needs to be defined separately from drugs as these are a different class of products in line with GHTF definitions.

Apart from that there is need to provide adequate medical device industry bodies representation in the proposed Drug Consultative Committee and representation from industry in various expert committees responsible for the framing of medical device specific regulations and guidelines.

The Bill should also provide new and separate provisions in the Act for regulatory controls specific to medical devices.

Such separate provisions would be analogous to those already existing in the Act for Ayurvedic, Siddha, Unani, or homeopathic drugs.

It also recommends single authority specifically dedicated to regulatory affairs on Medical Devices.

''Address the Industry concern on functions and responsibilities of CDA vs MDRA. There is a preference for a single regulatory body,'' said a statement.

Ficci stated that the Medical devices should be regulated on the basis of comprehensive harmonised regulatory guidance developed by GHTF including international standards standards like (ISO and IEC).

GHTF guidance represents a consensus model of medical device regulatory practices and requirements, it said.

It is intended to accommodate the needs and public health priorities of established as well as developing regulatory systems in developed and developing economies, according to the act.

Ficci suggected that regulations on Medical Devices, be implemented in stages (as per WHO guidelines) over a sufficient period of time, by giving adequate preparation time to the industry to comply with the requirement and regulations recommends.

The industry sees value in international regulatory harmonisation based on guidance of the Global Harmonisation Task Force (GHTF) and the World Health Organization (WHO). Adoption of GHTF guidance will help prepare India's domestic medical device industry to meet the regulatory requirements of major export markets, says the act.

UNI

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