New Medical Device Bill, 2023 will prove catastrophic for domestic players: Rajiv Nath
The New Drugs, Medical Devices and Cosmetics Bill, 2023 is fraught with loopholes and repercussions for domestic medical device industry and must be recalled for further deliberations and corrections failing which Prime Minister Narendra Modi’s ambitious ‘Make in India’ campaign will be derailed, said Rajiv Nath, Forum Coordinator, Association of Indian Medical Industry (AiMeD).
He said the Bill is totally divorced from the ground realities, concerns and interests of patients, their safety and survival of local players who have invested so hugely over the years. “The Bill is heavily tilted in favour of MNCs. The New Bill will prove catastrophic for domestic players. Nothing could be more prudent than recalling the Bill by the Union Ministry of Health and Family Welfare and referring it to a new committee of Medical Devices regulatory experts under the Chairmanship of ICMR or DST or DBT as Devices are engineering products and not Drugs,” added Nath.
To highlight the capabilities of Indian medical devices sector under the G-20 Indian Presidency, the first ever expo being spearheaded by the Government in association with Indian medical devices industry, the three-day India MedTech Expo (IMTE)-2023 is being held at Gandhi Nagar, alongside the G-20 Health Ministers meeting, for showcasing the capabilities of Indian medical devices industry and to create opportunities to network and explore collaborations both for the sector’s growth in India and its potential contribution globally.
“From being Atma Nirbhar in terms of medical devices, effective management of e-waste, affordability and quality, creating of direct and indirect job opportunities to completely reduce our dependence on imports – the adoption of Bill will leave behind an array of multifaceted repercussions, ultimately ensuring that Make in India campaign derails much to the delight of entrenched overseas MNCs and their aficionados in the country, only those who are seriously committed to make in India are equally concerned as us domestic manufacturers,” said Nath.
Flawed bill by a flawed process
Instead of providing progressive modern regulations benchmarked to latest best international regulations, the Bill has been drafted by a committee of regulators seemingly misled by MNC lobby to suit themselves, without following due democratic pre-legislative processes and that continues to seek to regulate devices alongside drugs under the garb of a separate chapter for some provisions, he said.
Nath said, “The need of the hour is a progressive modern separate law for addressing patient safety concerns. NITI Aayog had drafted an excellent Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 but in vain. Even the impactful legislations in countries like Canada, UK, EU, Brazil, Japan, and Saudi Arabia were not studied. Who blocked that progressive visionary Bill?”
“An inclusive process will help shape an appropriate Regulatory Policy that needs to impact the Medical Devices sector positively,” said Nath, adding that collective voices of the entire industry and stakeholders may be heard, especially of the domestic manufacturers and consumer and patient safety groups, who should also be allowed to participate in formulating the regulations, which will help in making India a global manufacturing hub of medical devices.
One step forward two steps back
According to Nath, the New Drugs, Medical Devices and Cosmetics Bill, 2023 has even revised the definition of manufacturer that will now allow a marketing company to get a manufacturing licence and inadvertently proposes to legalise pseudo manufacturing of low-quality cheaper imports that may affect patient safety.
“Unfortunately, it discourages investments to manufacture these in India by treating domestic manufacturers as potential criminals while overseas manufacturers are not needing to go through the same rigours to demonstrate conformity,” he said, adding that all the efforts put in by the PMO, MoH&WF, industry and other stakeholders will be a big waste if this Bill is not recalled and reviewed to fructify the dream of Make in India in medical devices sector.
Patients gain if there’s healthy competition
Nath said that patients gain if there’s healthy competition between multiple domestic manufacturers. For this, investment and entrepreneurship in medical device manufacturing needs to be encouraged. Those engineers and scientists who step forward to design and develop products need to do so fearlessly following defined simple regulatory pathways, he said.
He added, “Manufacturers similarly need to be disciplined and compliant to regulatory conformity requirements and prove conformity by third party certification or testing to accredited certification bodies and laboratories.”
No more inspector raj
The AiMeD Forum Coordinator further said that India needs to move away from Inspector Raj where inspectors are empowered for search and seizure for even licensed manufacturers and treat them as criminals with threats of imprisonment for even minor offences.
He said that a good law needs to be simple, reasonable and implementable and give direction of intent for a progressive aspiring nation with superior effective compliance systems. Medical electronic devices which are an engineering product like cars can’t be manufactured or regulated like drugs and need to be stored, transported, installed, and maintained and regularly calibrated to ensure patient safety for the lifecycle of the product, said Nath.
MNC lobby’s unmake in India drive misusing FICCI platform
Nath said that nothing could have been worse than the MNCs lobby misleading and misusing FICCI Medical Devices Division. Much to our dismay and disappointment, FICCI Medical Devices Division is working against the interest of domestic medical devices manufacturers and needs to be aligned to the rest of FICCI’s Make in India agenda. The current lobbying of the ‘Un-make in India’ campaign amounts to bulldozing the Make in India dream of PM Modi, he said.
“The decision to permit the import of pre-owned medical devices was in contravention to India’s recently launched National Medical Device Policy-2023 that seeks to make our country not only Atma Nirbhar in medical devices but also the global leader. The OM was a regressive step that has confused the investors who have been putting up manufacturing capacity in the last few years in response to the PM’s call for self-reliance and we hope this will be recalled and corrected.”
Vibrancy of domestic players being ignored
Nath revealed that 90 to 95 per cent high end medical devices are now beginning to be manufactured in India. Why import used medical devices when we are capable of delivering our own quality machines? Why kill the spirit of National Medical Devices Policy-2023, which aspires to make India a global leader in manufacturing and innovation of medical devices by increasing our share in the global market from the current 1.5 per cent to 10-12 per cent in the next 25 years,” asked Nath.
The AiMeD Forum Coordinator cautioned that as the GTRI report explained, we must understand the motives of MNCs who want to dump their obsolete and old equipment in India, as this used equipment has no market in their own countries. They are replacing them with new products and new technology. We should also understand why these preowned products are not allowed in 22 countries like China., Vietnam, Indonesia, Egypt, Peru, etc., that constitute over 58 per cent of the world’s population.
India is not a dumping ground for obsolete technologies and Indians are not guinea pigs. If MNCs are so confident of the quality of refurbished products, why do they not use them in their own countries?” said Nath.
Wise parliamentarians
Nath said the wise Parliamentarians in the Health & Family Welfare Committee have responded to the government’s action taken report that instead of drafting a combined legislation for Drugs, Medical Devices and Cosmetics, the Ministry should appreciate the huge potential of the Medical Device industry and formulate a separate legislation for medical devices.
The Department related Parliamentary Standing Committee on Health and Family Welfare in its 146th report, which was laid on the table of the Lok Sabha on August 4, 2023, says that “to bring a world class regulatory framework, give boost to the medical device industry and minimize the dependence on imports, a separate Department and separate legislation is required.”
Nath said that a Parliamentary panel has recommended multiple positive measures including a separate department and legislation for domestic medical devices players, which are wise and in alignment with the spirit of Atma Nirbhar Bharat as envisioned by Prime Minister Modi.
While thanking the Minister for delaying the tabling of Bill to Parliament subject to a review exercise and Parliament Committee recommendations for a Separate Act and Regulatory Framework, Rajiv Nath hoped that the government will place the Bill to a new Committee that will have experts on medical devices regulations and representatives of manufacturers, hospitals, Medical Professionals and Patient Safety advocacy organisations in addition to other stakeholder ministries and departments like – DST, DBT, MeITY, BiS , QCI, etc.