Enactment of the new medical device regulation, the Drugs and Cosmetics Amendment Bill 2013, which is to be introduced in Parliament soon, would translate the medical devices into an affordable and user-friendly products. This according to experts will be the outcome of right differentiation between drug and device which would further boost innovation.
This would also help in categorization of medical devices into different types - capital equipment, implants, consumables, in-vitro diagnostics which will further facilitate the process of regulating them.
Experts advocate that innovation is vital in medical devices considering it as a core segment of public health. Unlike drugs, where the shelf-life of an innovation is 10 to 15 years, industry comes up with new design improvements every six to nine months in the devices segment which leads to better efficacy and improved clinical outcomes. This directly leads to higher patient safety, reduced risk of re-hospitalization, and overall better healthcare outcomes at lower costs for patients.
As per the current provisions of the Drugs and Cosmetics Act, 14 categories of medical devices are regulated as “drugs”. Medical Devices are very different from drugs and pharmaceuticals. Bracketing devices as drugs poses unique challenges to the manufacturers, importers and distributors in India. Opines Sanjay Banerjee, MD, Zimmer India Pvt Ltd, a US based company into joint replacement technologies and musculoskeletal health care, "These challenges are not limited to registration for manufacture and import with the Central Drugs Standard Control Organization (CDSCO) and extend to other related administrative and regulatory departments dealing with reimbursements, taxation, price control, provision of services, training of healthcare practitioners etc."
Beyond that, as policy goes through a life-cycle of regulations, it is important to differentiate between Rules made for Drugs and the Rules made for Medical Devices at every stage. "It is important that the Bill and the subsequent Rules to be framed incorporate regulations that are harmonised with international best practices such as the International Organization for Standardization (ISO) and International Medical Device Regulators Forum (IMDRF). This will also allow indigenous industry to prosper and become globally competitive," Banerjee explains.
The lacunae to be addressed is that a majority of developing countries, including India, do not seem to recognize the management of medical devices as a public health priority and also lack the capacity to do so. In countries that provide a favourable ecosystem, multinational companies have already established manufacturing facilities in new destinations, such as China, Malaysia, Indonesia as a way of accessing the local market directly but also exploiting opportunities for lower production cost. Some companies have even relocated their business off-shore altogether and produce medical devices for re-export to the home country.
"In order to support innovation, there is a need for increasing fund from government, venture finance companies, more developed academia industry partnerships," concludes D L Pandya, CEO, Medical Plastics Data Service.