AdvaMed in its submission suggested that all the regulations for medical devices are harmonized with international best practices such as the International Organization for Standardization (ISO) and International Medical Device Regulators Forum (IMDRF), so that medical device manufacturers achieve the highest standards of safety and efficacy and also become globally competitive. The suggestions also highlight adoption of risk based approach to ensure timely access to medical technology and revision of provisions related to clinical trials to maintain highest ethical standards.
The Drugs & Cosmetic (Amendment) Bill 2013 was introduced in Parliament during the last monsoon session and at present the bill is being examined by the Parliamentary Standing Committee on Health and Family Welfare. The committee is likely to table the bill along with its recommendations during the forthcoming winter session of Parliament.
In its suggestions, AdvaMed said that the industry is concerned about the lack of standardisation in line with global best practices like the Global Harmonization Task Force (GHTF) and the IMDRF. Some of the penal provisions as defined in the Bill, where even minor violations attract severe penal action often disproportionate to the nature or severity of the crime, are not in line with international practices. The bill also needs to clarify the terms ‘manufacture’ and ‘manufacturer’, as appropriate to medical devices (presently, the same definitions as applicable to drugs have been used for devices).
At a broader level, the bill recognizes the fact that medical devices are different from drugs, but the distinction needs to be carried to the last mile. In keeping with the proactive spirit of introducing the bill, the industry is hopeful that adequate consideration and deliberation will take place ahead of the passing of the bill, and that it can contribute meaningfully to the formulation of the bill.
Abby Pratt, associate vice president, Global Strategy & Analysis at AdvaMed states, “The medical device industry is encouraged by the Bill for recognizing medical devices as a separate and critical element of the Indian healthcare delivery system, and believes that the Bill will improve the industry’s ability to serve India’s growing healthcare needs in a safe, effective and timely manner. We congratulate the government for introducing the bill and thank the Parliamentary Standing Committee for soliciting our suggestions. AdvaMed and its member companies stand ready to participate as full partners in India’s effort to improve the quality of life for all its citizens.”
REFERENCE: PharmaBiz.com; Saturday, November 02, 2013