While the Health Ministry charts out its five-year vision for the Narendra Modi-led government’s second term, finally bringing a vast majority of the medical devices sector under regulation is expected to be a “priority”, The Indian Express has learnt. The Ministry is now planning stakeholder consultations to understand how to implement an expert advisory body’s recommendations to make sure medical device companies are accountable for the safety and quality of their products here.
At the same time, some industry bodies feel the plan would be ineffective in the long run in the absence of a separate medical device law, which has been in the works for over a decade.
In May, Prime Minister Narendra Modi tasked all ministers with drawing up five-year vision plans for their ministries after taking office for a second term.
“Smoothing (issues with) medical devices is high on our agenda,” said a senior Health Ministry official close to the development on condition of anonymity.
The official told The Indian Express there is a sense of “urgency” to address concerns related to this industry, under scrutiny over the last year after major health concerns and adverse reactions were highlighted with some high-risk devices.
“Because medical devices are largely unregulated today, we believe we need to set something like a goal for ourselves early on,” the official said.
However, with the Ministry still discussing its five-year vision, a timeline has not been worked out for this, according to the official cited above. The Ministry plans inter-ministerial consultations to implement a “detailed roadmap” for devices outlined by the country’s top drug advisory body, the Drugs Technical Advisory Board (DTAB), earlier this year, the official said.
This includes working out how to notify all medical devices under India’s Drugs and Cosmetics Act in a phased manner, which DTAB had recommended in April. While the government currently regulates only 24 notified medical devices under its existing regulations, notifying all medical devices in a phased manner as recommended by DTAB would be India’s first significant step towards holistic regulation.
“There is more or less a consensus (on the recommendations), but some minute procedures may have to be ironed out,” said another senior Health Ministry official, requesting anonymity.
DTAB’s recommendations came almost five months after The Indian Express published the ‘Implant Files’, a series of investigative reports highlighting lapses in regulation on India’s medical devices industry and the impact it has had on patients. This includes multinational firm Johnson & Johnson’s use of loopholes in US laws to obtain approval for and market hip implants in India, that later had to be globally recalled in 2010.
However, with the government currently using its 1940 drug laws to regulate the devices notified so far, it may not be able to effectively address issues unique to the industry, according to Association of Indian Medical Device Industry (AiMeD) forum coordinator Rajiv Nath.
“This roadmap would be incomplete if it doesn’t address patient safety under a separate medical devices law and revamp CDSCO (India’s top drug regulatory body) to include a separate division for medical devices,” he said.
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According to Nath, current regulations are a “misfit” for medical devices, which have different risk profiles that require different types of regulatory action.
“The Act needs to recognise that penalties for high risk device need to be higher than penalties for low-risk devices,” he said. “The idea has to be to discipline companies instead of allowing loopholes for negligent firms to skirt penalties or scaring off investment by treating every case as a criminal offence.”
Over 90 per cent of the country’s estimated $15 billion medical devices industry is unregulated, according to AiMeD. This includes over 6,000 devices like pacemakers, MRI machines and even tubes that collect blood samples.
While the UPA government had drafted a separate Medical Device Regulation Bill in 2006, it was never notified into an act. The NDA government had also postponed the legislation, instead notifying rules to regulate medical devices under existing regulations. While the Health Ministry had been reworking the bill around 2016, the work has since passed on to government think tank NITI Aayog. – The Indian Express