Gandhi Nagar/New Delhi : The shrill call of recall of The New Drugs, Medical Devices & Cosmetics Bill is in-your- face in the midst of Indian MedTech Expo under the aegis of high sounding G20 Presidency here. The body of domestic medical device makers AiMeD has said without mincing words that the Make in India is headed to unmitigated disaster, thanks to the bill. It has demanded immediate recall of the bill if PM’s chant is in earnest. AiMed has made a fervent appeal to PM Modi to intervene to save the face of his own Make in India slogan
‘Make in India’ enthusiasts in the domain of domestic medical device are in for rude shock due to this bill. They say PM Modi’s Make in India chant seems to be reduced to a cant. It rings hollow vis a vis new bill. In one fell swoop, the bill will ensure that the powerful import lobby will have the last laugh.
The joke is on three day India MedTech Expo held in Gandhi Nagar alongside G20 health Ministers meeting. It has been organized to highlight the capabilities of Indian Medical Devices Sector under the G-20 Indian Presidency. It is the first ever expo being spearheaded by the Government in association with Indian medical devices industry 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. The voice of despair emanating from the expo seems to make a mockery of Make in India slogan.
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) here today.
He further 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.
“From being AtmaNirbhar 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.
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?”
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 legalize 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.