NEW DELHI: Compensation against adverse effects caused by faulty medical devices may not be part of the new draft law likely to be notified by health ministry in the next fortnight. Instead there may be a separate “quasi-judicial” system or entity developed outside the proposed legislation to look at ethical issues and compensation.

The draft Biomedical Devices Regulation Bill – prepared by the government’s think tank Niti Aayog – aims to regulate a range of products from blood pressure monitoring machine to critical devices like stents and orthopedic implants and even diagnostics equipments and tests.

Though Niti Aayog was in favour of introducing provisions for compensation in the bill, some other departments in the government have raised concerns about a possible conflict of interest if the regulator takes a call on judicial issues.

“The final draft of the bill is ready and will be discussed in an inter-ministerial meeting by next week. After that it will be notified by the health ministry seeking public comments,” a senior official told TOI.

The official indicated a separate “quasi-judicial” system can be formed later to deal with compensation related matters and it can be further linked to the Essential Commodities Act depending on the deliberations.

“For now, it is a matter of debate and further discussions are required,” he added.

In the absence of a clear cut legal provision, the regulator and the government has so far failed to impose a stringent directive on any company in cases of adverse events related to faulty medical devices. In the recent cases also where patients suffered from faulty hip implants, Johnson & Johnson had challenged the Centre’s compensation scheme for such patients.

The key provisions proposed under the draft legislation include setting up of a separate medical devices regulator – Medical Devices Administration— as well as penal provisions for violations. The Administration will primarily have four verticals looking after assessment or trials, laboratory testing, approvals and enforcement of regulation.

The draft law will also have provisions to promote innovative products.

At present, only 23 medical devices – notified as ‘drugs’ – are regulated under the Drugs and Cosmetics Act by the Central Drugs Standard Control Organisation (CDSCO) which primarily looks at medicines.

However, once the new law comes in to effect, all medical device manufacturers, importers and marketing companies will have to comply with a regulatory structure that will include provisions for clinical trials in case of new products and ascertain “substantial equivalence” if similar products are already there in the market.

“The idea is to ensure quality and efficacy of all medical devices sold in the country. The proposed law will ensure that all such products sold in the country are of standard quality and have undergone conformity assessment,” the official said.

The standards for medical devices will be framed by the Bureau of Indian Standards.

The government had notified separate rules for medical devices in January 2018 laying the fundamental design and manufacturing requirements for 594 medical devices, and classified them into four categories based on their risk factors. Despite this, the medical devices industry was unhappy about the sector being regulated by CDSCO under the drug law as it was lacking specific technical expertise to regulate medical devices.

The medical devices industry, currently pegged at around $7 billion in India, is rapidly growing and projected to touch $50 billion by 2025. While aiming to ensure quality and safety of medical devices, the draft bill also plans to facilitate ‘Make in India’, enhance ease of doing business and ensure availability of quality medical devices.

Currently, India is the fourth-largest medical devices market in Asia after Japan, China and South Korea. However, nearly 80% of the medical devices used in India are imported. The government is now trying to promote local manufacturing and even innovation. It is also evaluating measures to boost indigenous manufacturing and reduce the load on import from 80% to less than 50%.

