Medical devices sector still waits for regulation
13 years have gone but a comprehensive regulatory framework is elusive
Thirteen years. That’s how long it has been since a direction was given to the Indian health authorities to have a comprehensive framework for medical devices.
In a case involving drug-eluting stents being heard at the Bombay High Court in September 2005, then Chief Justice did not just express shock that medical devices like a heart valve or pacemaker, for instance, were not covered by domestic, safety-related regulations. He also directed the Central and State regulatory machinery to regulate these products.
The issue has been simmering since, flaring up occasionally. In 2010, Johnson and Johnson’s (J&J) DePuy Orthopaedics voluntarily recalled its faulty ASR Hip System, globally. And acting on a local patient complaint, the Maharashtra Food and Drug Administration looked into the recall and the subsequent J&J payment to settle patient litigation in the US (2013).
Eight years since the recall, as of this week, Indian patients are still seeking redress and compensation for their faulty hip implants, as they live with debilitating pain and disability.
Such concerns recently got amplified on a global scale following an investigation into medical devices by media entities. The reportage revealed the opaqueness around this industry.
Back in India, failed promises and industry data narrate the medical device evolution story. Just 23 of 5,000 product categories are presently covered by any regulation. And industry estimates peg the entire market at $10 billion or an estimated ₹70,000 crore. On its part, the Centre did implement the Medical Device Rules, from January 1, 2018. But this falls short of a 2015 promise to have a separate ministry for pharmaceuticals and medical devices — an assurance given by late Ananth Kumar, then Minister of Chemicals and Fertilisers, the ministry overseeing medicines and devices.
Industry representatives also point to the shift from initial discussions, where policymakers had agreed on treating medical devices as different from drugs. Medical devices continue to be under the Drugs and Cosmetics Act 1940 and industry representatives are pushing for a comprehensive regulation that views medical devices separately, through the entire life-cycle of the product, from design to tests on patients, incorporating doctor feedback, and surveillance of patients in whom the implants are used, etc.
This becomes critical in a product recall, for example. Several global product recalls see little or no follow-throughs in India. Instead of being proactive, companies shield themselves behind inadequate regulations and by keeping the drug regulatory authorities “informed”.
Devices, not drugs
“Devices are not medicines made from a homogeneous chemical batch with very long lifecycles but usually an assembly of precisionengineered components with an ever-evolving, innovative, shortterm product lifecycle,” explains Rajiv Nath, with the Association for Indian Medical Device Industry (AiMED). Besides, patient safety is more complex with devices, he says, where it is “a shared responsibility of the manufacturer, medical practitioners, product user and the regulator.”
Stressing the need to de-link medical devices from pharmaceuticals, AdvaMed’s Abby Pratt says, “there is no need to reinvent the wheel here”, as there are global benchmarks and a task force to help harmonise rules.
Pratt represents foreign device makers and replying to the global investigation, she says it gave the industry an opportunity to explain the nature of their products and challenges. For instance, reporting adverse events on a product was not a negative feature. Such feedback is used by the manufacturer to innovate further and bring out a better, safer product, she explains. Products with global certifications leave a trail in terms of registrations, etc, she says, cautioning on local companies who sold products without having even registrations.
Former Maharashtra FDA Commissioner Mahesh Zagade says medical devices are not stringently regulated because of the “lack of willingness,” at administrative/political levels. “Money”, he alleges, prevents the system from acting in patient interest and holding companies accountable. Zagade had proceeded against J&J on the faulty hip implants (2013).
The Centre ‘s recent committee for patient compensation could have been done when the issue first surfaced years ago, he says. The laws are adequate and Central regulators could have done much more, if they wanted to, he adds. His prescription for greater operational transparency is for patients and civil society to pressure their elected representatives to ask questions of the administration and get them to work in the interest of patients.