International Consortium of Investigative Journalists has exposed lack of accountability of the medical devices laws in India.
- Medical device industry is valued in India at $5.2 billion and is growing at 16 per cent annually, with imports accounting for 80 per cent of all sales, this is a grim state of affairs
- Report expose the nexus between implant makers, health finance players and doctors, as they chase targets at the expense of vulnerable, unsuspecting patients.
Major Issues with Medical device industry
- The regulatory failure at various levels such as in the testing of the implants in informing the patient of the consequences and making her aware of her rights.
- While the Drugs and Cosmetics Act does contain certain provisions specifically for medical devices, it applied exclusively to the notified devices, thereby hindering the development of the industry.
- In the compensation mechanism – In the case of J&J, India’s drugs regulator was slow to react to the global recall and establish the extent of damage. The wrangling over compensation continues because there are no clear norms laid down under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017 for such eventualities.
- Quality lapses are not readily accounted for (be it knee implants, hip implants, pacemakers or intra-uterine devices) because for patients, there is no clear agency to deal with such situations.
- There is no medical devices-specific legislation presently in force, specifying inter alia standards of safety and quality for most of the medical devices.
- Only a handful of devices such as cardiac stents, disposable hypodermic needles/ syringes, catheters, etc. make the cut of being classified as a “drug” and thus being regulated under the Drugs and Cosmetics Act, 1940 (“Act”).
- Other medical devices presently have no legal provisions governing the aspects of manufacture, product standards, sale or distribution.
The Medical Devices Rules, 2017
The New device rule is propitious for achieving the main goals of the National Health Policy 2017 that calls for addressing the changing priorities in Indian healthcare, mainly bridging the accessibility and affordability gap.
Challenges to the new rules:
- Creating the right ecosystem: The primary concern in implementation is the establishment of an ecosystem for the notified bodies, which will be responsible for taking the burden of evaluating regulatory compliance.
- Infrastructure issues: The “Make in India” program has proposed Medtech parks However, the relatively slow pace of infrastructure development of these parks is delaying the domestic industry from setting shop.
- Industry awareness – Industry is dominated by large players and multinational corporations however in India the domestic medical tech landscape comprises small and medium players who manufacture low risk and precision equipment and lack awareness about the rules and regulations governing the manufacturing of medium to high risk devices.
- Overcome policy uncertainty: While the policy has the right intent for addressing multiple aspects of this paradigm shift – encouraging domestic manufacturers, boosting innovation and R&D (research and development) will be a big game changer.
- Another aspect is to streamline the licensing process to ensure that manufacturers who already possess reputed international certifications can obtain the Indian mark easily.
- Revamping Make in India: Medical electronics is considered as a critical aspect in the new manufacturing policy for electronics. Both the industry and the government should work together to clear implementation bottlenecks to ensure they reap the benefits of the policy.
- Promoting startups: In the interest of promoting domestic manufacturing and bridging the accessibility-affordability gap, the state governments should set-up schemes to fund the medtech startups.
The need for a separate legislation governing medical devices has long been felt by all the stakeholders of the industry.
- A robust legal framework would lead to a boost in the position of the Indian medical devices industry in the global market, as the devices produced in India are often not in compliance with the international standards for medical devices.
- Regulations would provide a more conducive environment for local manufacturers to set up industries in India.
- It would increase the interest in India as an investment hub for foreign investors,
- Finally, it would lead to a higher level of satisfaction among the consumers of these devices, who in the absence of regulations may be wary of the quality of products produced by Indian manufacturers.