Regulatory framework for medical devices

Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED) opines that there should be a separate law book and separate regulatory authority or a revamped CDSCO as Indian Healthcare Products Regulatory Authority

In traditional mode of regulations worldwide earlier, government was the regulator. It prescribed requirements for manufacturing, directly checked compliance through inspectors and directly punished errant manufacturers thereby creating conflict of interest and a breeding ground for corruption. As regulators worldwide are getting increasingly stretched for resources and the required technical expertise, various components of a regulatory framework are getting unbundled. India needs to imbibe similar best practices and bring in regulatory reforms

Regulations in India need to be layered to separate the role of legislature from that of a regulator, and those of a supervising accreditation body to assist the regulator from those of third party conformity assessment bodies who will audit the manufacturer in lines with principle of subsidiarity, our key policy principle (3.2):  Minimum Government – Maximum Governance

Minimum Government – Maximum Governance

In India there has been no onus on manufacturers to demonstrate compliance. There is a need to provide this layer whereby manufacturers voluntarily use accredited, third party conformity assessment bodies to verify and certify their compliance level to regulations. This will also create higher international acceptance for Indian products. Systems need to be created to do market surveillance and monitor adverse events as well as enable needful systemic action to prevent reoccurrence of such incidences for ensuring greater patient safety.

While we have been assured that this will be taken care of in rules, ideally the law should give sense of direction of framework for rules, which is missing.

• In the proposed Bill, government policies will strangely now legitimise pseudo manufacturing whereby marketing and trading companies declare themselves as manufacturers! We are already over 70 per cent import dependent. The manufacturing sector is already weakened and challenged to create Indian brands for Indian consumers.
  Users and consumers will endorse Indian products made by actual manufacturers. However, the government should not confuse consumers by giving them access to products from pseudo manufacturers which may be imported from China and just packed or sterilised in India. Even the Consumer Protection Act does not allow traders to label themselves as manufacturers so why does the Bill propose this? World over, regulations are used strategically as a non tariff barrier to protect domestic industry, in addition to protecting the interest of the consumers and patients. We should reconsider the decision permitting the definition of manufacturer to include sub contracting of a complete product to a third party. It is against Make in India vision of our Prime Minister
• Adulteration: – This definition may be deleted from proposed Bill as it relate to drugs, food and chemicals, not to devices.
• Considering the diversity of medical devices as engineering and consumer goods it is imperative to encourage existing manufacturers of engineering goods to diversify into medical devices with a similar technology base e.g. Hospital beds by furniture producers, under pads and clinical diapers by baby diaper producers etc. It is imperative to have a separate law book and a separate rule book (other than pharmaceutical based D&C Act) and not only a separate chapter without cross referencing, as is being proposed, to encourage this. The steps taken in the past to regulate medical devices as pharmaceuticals have made India increasingly import dependent and a decreasing desire for investment in manufacturing is evident. Such small Industries may not afford to hire a pharmacist or even a professionally qualified regulatory expert. Do we need an MNC, large industry dependent supply chain environment by creating an entry barrier?