The government’s decision to bring all medical devices and diagnostic equipment sold in India under the purview of the Drugs and Cosmetics (D&C) Act of 1940, but some with just a one-year transition period and others with three-four years, instead of implementing an exclusive regulatory mechanism has left the industry baffled. As government think tank NITI Aayog is reportedly working on a draft Act, the details of which are awaited anxiously, these notifications are “seemingly a parallel exercise and uncoordinated”, industry veterans say.
According to the draft notification reviewed by CNBC-TV18, the health ministry, in consultation with the Drugs Technical Advisory Board, has defined all medical devices “intended for use in human beings or animals as drugs’ with effect from December 1, 2019. Through a separate circular, ultra-sound machine was also added to the notified list. From November 1 next year, import, manufacture and sale of these machines will be allowed only under the legal ambit of the D&C Act.
What are the problems with the new rules?
Once a medical device is notified, manufacturers and importers will have to get the approval of the Central Drugs Standard Control Organisation, the national drug regulatory body, to sell these products in the domestic market. Earlier this year, the health ministry had decided to add all implantables, along with CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET and X-Ray machines, and bone marrow cell separator to the notified list. This rule will come into force in April 2020.
At present, India doesn’t have a comprehensive law to ensure the quality and safety of medical devices and they are regulated as ‘drugs’. A medical device regulatory bill, first drafted a decade ago, is yet to take effect and another draft has reportedly been lying with the ministry since 2016. Though an exclusive Medical Device Rules (MDR) came into effect early this year, these products are still regulated as ‘drugs’.
While, the rationality of regulating a medical device, an electro-mechanical unit, as ‘drug’, is questionable, only 23 devices are notified and monitored by the government under the D&C Act. There are more than 6,000 medical devices available in the market, leaving the majority of them completely unregulated. The country currently imports 80-90 percent of medical devices of the $15 billion market.
Instead of adhoc addition to the notified list, the domestic manufacturers had suggested a list of 38 medical device categories to be regulated on a priority basis, considering their risk proportion, followed by voluntary registration for all devices and then a phased in mandatory regulations for all devices under a separate Act. However, their suggestions remain largely ignored.
Why is the industry upset with the new rules?
Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry, said the government continues to shock the industry with its cherry-picking approach, adding that the manufacturers have been confused with informal and arbitrary choosing of products and notifying them as ‘drugs’. “We seek a predictable and comprehensive regulatory framework that allows for adequate transition. Only then will investments speed up as companies get discouraged to be regulated as drugs, especially item by item and not as a category,” he told CNBC-TV18.
Like many others in the industry, he is anxiously waiting for the NITI Aayog draft Act. Nath said such notifications are seemingly a parallel exercise and uncoordinated, given NITI Aayog’s similar effort.
In the case of ultra-sound machines, the Pre-Conception and Pre-Natal Diagnostic Techniques Act, 1994, currently regulates the sale of these machines to entities registered under the law. Now, under the MDR and the D&C Act, the government will regulate additionally the import and manufacturing of the equipment.
The Drug Controller General of India recently unveiled a roadmap to regulate all devices in a phased manner and assured an adequate transition period of nearly four years for high-risk devices. “The one-year transition period is not as per the assurance given to the industry,” Nath noted.
According to industry insiders, the one-year transition is impossible as the regulator has to define the applicable product and horizontal standards, the tests involved and their frequency, the testing equipment and which tests will be permitted to be outsourced to accredited laboratories. Another impediment is the training and competence of regulatory officers and auditors familiar with the technology and subject expertise. “Countries such as Australia, Canada, Singapore and the EU nations provide a 3-5 year transition period so that mandatory regulatory requirements won’t disrupt the supply chain,” an industry executive said.
The government decision is cheered by the Medical Technology Association of India (MTaI), a lobby group representing multinational companies such as Abbott, Boston Scientific and Medtronic. "The health ministry's proposal to regulate all medical devices will allow Indian patients the access to quality medical devices and put a check on garage manufacturing. The CDSCO under the Ministry of Health and Family Welfare has the most experience and over time have built the expertise to regulate this intricate medical device sector," said Pavan Choudary, director general and chairman of MTaI. “Bringing all medical devices under regulation has been a long-pending demand from the industry and it is encouraging to see the government taking cognisance of industry concerns.”
Regulating medical devices in accordance with their risk profile is crucial. A recent analysis by the Associated Press has shown that collectively, insulin pumps and their components are responsible for the highest overall number of malfunction, injury and death reports in the US Food and Drug Administration’s medical device database since 2008. In terms of injuries alone, insulin pumps were second only to metal hip replacements.