Successive governments in India have neglected the medical devices sector. For over 12 years, a proposed legislation, the Medical Device Regulation Bill, has awaited enactment.
The Bill was first drafted in 2006 when the UPA was in power. It was never legislated.
Under the NDA, a Group of Ministers (GoM) was constituted under Finance Minister Arun Jaitley but in 2016, a decision was taken to postpone its legislation and introduce instead the Medical Device Rules and Regulations.
For the government, this seemed adequate for the sector. As recently as July this year, at a NITI Aayog Committee of Secretaries (CoS) meeting chaired by CEO Amitabh Kant, it was noted how views have been expressed by some Secretaries who felt there was no need to bring in an exclusive piece of legislation to govern medical devices. Their logic: having a separate legislation will bring in “more control” and “curtail growth and innovation” in the fast-expanding medical devices industry.
The new Rules were circulated in 2017 and notified on January 1, 2018. The 241-page guidelines laid down the fundamental design and manufacturing requirements for 594 medical devices, and classified them into four categories (A,B,C and D) depending on their being high-risk or low-risk. A statement from the Health Ministry stated that the new Rules brought medical devices in conformity with the framework of the Global Harmonization Task Force (GHTF) and did away with the system of periodic renewal of licences for medical device manufacturers or importers.
While the new Rules might be a step in the right direction, experts and medical device bodies see this as an easy way out for politicians of the day. They remain critical of the single factor which has remained the bane for the medical device industry in India — the fact that despite India emerging as the fourth-largest medical device market in Asia, its regulation and management is done under the 1940 Drugs and Cosmetics Act. Medical Devices, thus, ride piggyback on the drug and pharma industry and have never got their share of sectoral importance.
The other pitfall of the existing market situation is that despite an estimated 5,000 medical devices being sold in the country — ranging from bone caps, metallic prosthesis, fallopian rings to catheter guide wires — the categories of medical devices “notified” and, therefore, regulated number only 23.
The first batch of devices notified in 1980 were syringes, needles and perfusion sets, and later in 2005, another batch of devices including coronary stents, catheters, orthopaedic implants and heart valves were added to the regulated list. It took five years more for another batch of 10 devices like surgical dressings, intra uterine devices (IUDs) and umbilical tapes to be added, taking the number to 23.
On June 22 this year, the CDSCO put out a public notice for comments on a proposed notification for including another batch of eight devices including “all implantable medical devices”, defibrillators, dialysis machines and X-ray scans.
A majority of these devices figured in the list of 32 categories which the Association for Indian Medical Device Industry (AIMED) had written about to the government in August 2017.
Rajiv Nath, Forum Coordinator for AIMED, said that despite the proposed notification for additional devices being on the cards, questions remain. For instance, which implantable devices are to be put under regulation? What of the rest? As he put it, “Historically incomplete and incorrect framework that have been attempting to regulate medical devices like medicines has been confusing investors and discouraging investments as they need a predictable regulatory environment. How can, for instance, an X-ray machine or an ultrasound machine be regulated as a drug? We have been seeking regulations, not the inspector raj pharma kind but on the lines of international best practices of voluntary compliance…’’
“There have been at least three attempts over a decade to amend the 1940 Drugs Act to regulate devices. In April 2016, the last draft Bill was rejected by a Group of Ministers who decided correctly to initiate a separate law specific to medical devices. This too was drafted and was to be presented to Parliament in December 2016 when the Joint Secretary concerned in the Ministry of Health & Family Welfare was transferred. This draft too has been buried and not even discussed with stakeholders like us,” he said.
That the government is still dithering on the subject of delinking medical devices from the Drugs Act is evident from the minutes of the NITI Aayog meeting held on the subject of “incentivising manufacturing of medical devices in India’’.
The introductory part of the minutes state that “so far’’ medical devices have either been unregulated or regulated under the Drugs and Cosmetics Act 1940 and by being notified as “drugs”. Also, that similar to the practice in other countries, where medical devices are treated as a distinct segment/vertical, the medical device industry in India has expressed a need to have a separate medical device Act and a medical device policy.
The target set at the CoS meeting: the government should aim to “reduce the current import dependence of medical devices from over 70% to less than 50% by the year 2030.’’
Indicating the government’s prevarication, this was noted following the meeting: “On this recommendation of the industry (of having a separate legislation), no consensus could be reached among the Secretaries. The views expressed during the meeting were both in favour and in opposition of regulating medical devices.’’ And this was recorded about why medical devices do not need further regulation: “The other view suggested that the Medical Device Rules 2017 have already been notified for regulatory requirement for commercialization of medical devices. Having a separate legislation for the devices will bring in more control and thus, would curtail the growth and innovation in the sector…”
Little focus on adverse events
The lack of political will to give the medical devices industry an exclusive status and a sound regulatory framework has resulted in laxity for safety and reporting norms as well. The country’s main regulator, the CDSCO (Central Drug Standard Control Organization), has failed to make public the global device recalls, even when the US FDA (Food & Drug Administration) has posted information about 57 of them being imported and marketed in India between 2016 and 2018.
In contrast to the thousands of FDA recalls for key devices like defibrillators, infusion pumps and ventilators, the CDSCO has put out just about a dozen recall alerts on its website for a period covering over five years, a majority from the global FDA recalls.
The reason, CDSCO officials admitted, is that they have a “weak system of recalls”, and that more and more voluntary, assessment-based recalls were the need of the hour.
Another critique of the existing system comes from Dr Arun Agarwal, former Dean of New Delhi’s Maulana Azad Medical College and chairman of the expert committee which inquired into the Johnson & Johnson hip implant recall mess in India. He says in the J&J case, it was the victims that came forward to press for compensation but now it is time for the medical fraternity to pay the role of referee. “The problem is that doctors are themselves scared of reporting adverse events and faulty devices. They think: could it be my mistake,” he said.
According to Dr Agarwal, there is no registry to track usage of medical devices in the country. This was, in fact, one of the major “general recommendations” the committee headed by him had made. Along with this, the committee had wanted a mechanism to be created through which online information could be made available about any withdrawal by regulatory agencies/voluntary withdrawal by the company of devices/safety issue of devices.
A fresh initiative was taken by the government in 2015 when the Health Ministry launched the “Materiovigilance Programme of India (MvPI)’’ and nominated the Indian Pharmacopeia Commission (IPC), Ghaziabad as the National Coordination Centre. A complex system of adverse event reporting has now been put in place, and, to begin with, 10 dedicated MDAE (Medical Device Adverse Event) monitoring centres set up in premier hospitals across the country. The proposal is for the monitoring centres to dispatch adverse event reports to the IPC, which will then pass them through a committee and “if required”, refer them to the CDSCO.
There is no proposal yet to either make the adverse event reports on medical devices public or put an analysis of the data received in the public domain. Officials at the IPC told The Indian Express that the flow of adverse event reports had increased from 40 reports in 2014 to 556 already for 2018 and that they were now waiting for the nod from the Health Ministry to formally “launch” a new, detailed reporting form, patterned on forms used in other countries.
Dr Vivekanandan Kalaiselvan, IPC’s Chief Scientific Officer, said this was needed since they found several of the adverse events were being reported by hospitals in an incomplete manner, with crucial details missing.
CDSCO chief,Dr S Eswara Reddy told The Indian Express that as far as medical devices and reports of adverse events go, their approach has been to go one step at a time.
“There is no medical device that is 100% safe but yes, we want all stakeholders, including the doctors and patients to come forward and join the system of reporting possible faults. Plus, manufacturers also have to come forward and announce voluntary recalls as most of the FDA recalls are. But what we do not want to do is create panic among the public and make patients suspect the medical devices they are using or implanted inside them,” he said.