Medical technology industry is of the view that the Union government should on top priority enforce a dedicated medical device regulation. It should now take immediate steps to amend the Drugs & Cosmetics Act Schedule M 111 Rule 76 move away from the current regulation separating medical devices from drugs considering patient safety and efficacy.
According to Anjan Bose, Secretary General, NATHEALTH (Healthcare Federation of India), there is a major distinction between drugs and devices. There is a need for an exclusive regulation considering many relevant factors like difference in life cycles. Going by the new Government’s approach to engage in positive dialogues with the industry, we are optimistic that separate guidelines for medical devices will be considered.
“The guidelines should be a regulatory framework for medical devices that is dedicated, predictable, transparent, globally harmonized and appropriate for medical devices. It could preferably be based on a separate medical device regulatory act and governed by an independent regulatory body with specialized regulators. If that is not achievable in the short term, at the very least, we request the Government to include industry inputs and pass the Drugs & Cosmetics Amendment Bill, which can then provide a starting point to separate medical devices from drugs and pharmaceuticals. Since this is a sensitive and complex issue, NATHEALTH will like to take a balanced approach on the subject and will be happy to provide any possible support to the Government, pointed out Bose.
“The key challenges which hampers growth of the sector which is valued at around Rs. 30,000 crore but account for 80 per cent of imports are the inverse customs duty structure, excise duty and VAT (value added tax) anomalies, import favourable policies and lack of trust even within India on ‘Made in India’ label,” said Dr GSK Velu, founder and managing director, Trivitron Group of companies.
Medical devices are lot different from drugs and hence require different classification and regulations. It is necessary to have norms which are in sync globally but also ensure cost effective availability of medical devices with vibrant domestic manufacturing industry without compromising quality, said Dr Srinivasan.
It is very unfortunate that the medical devices are regulated by the D&C Act and also regulated by the DCGI. Drugs and the devices are totally different entities and being a small sector, it is handled by the drugs control department who are mostly pharmacy graduates and post graduates personnel, with limited exposure to diagnostic products. We need a separate regulatory department armed with knowledgeable staff on the industry. The in-vitro diagnostics (IVD) are totally different from drugs and all the regulations for drugs are not applicable to it, said Dr Shama Bhat, CMD, Bhat Biotech.