Health

Medical Device Regulation: Health Ministry Takes One Step Forward, Two Steps Back

The process was neither consultative nor scientific, and the outcome wasn’t comprehensive.

In 2017, we witnessed the cardiac stent price being capped, thanks to one intrepid patient and a Delhi high court order. In 2018, we saw patients taking Johnson and Johnson’s (J&J) to court due to faulty hip implants, which resulted in metal ion poisoning. And 2018 was rounded off with the big International Centre of Investigative Journalists’ (ICIJ) exposé, #ImplantFiles. A total 250 journalists from 36 countries, working for some of the most credible media platforms, came together to expose malpractice in the medical implants sector, the sheer harm caused to patients thanks to low/no safeguards and the abysmal regulation.

The Indian Express led the investigation in India and revealed a complete lack of regulation. India had reposed too much faith in American and EU regulatory standards, and any manufacturer with those licenses was free to set shop in India. The collusion of some leading implant manufacturers and some doctors has been causing bodily harm to patients, including death. That apex institutions like the All India Institute of Medical Sciences (AIIMS) had to set up a new department dedicated to revision surgery is an indicator of how deep the rot had set in.

Circa 2019: the Ministry of Health and Family Welfare issued a gazette notification on February 8, bringing all implants that go into the human body within regulation, under the Drugs and Cosmetics Act 1940. The gazette states that this latest order is in response to the Drugs Technical Advisory Board (DTAB) of the Central Drugs Standards Controlling Organisation (CDSCO). However, the impact of #ImplantFiles expose’ deserves equal credit. Other than the 24 notified implants, devices like CT Scanners, MRI scanners, defibrillators, dialysis machines, PET equipment, X-ray machines and bone marrow cell separators have all come under regulation. The regulation kicks in on April 1, 2020.

Some groups working on patients’ rights like the People’s Health Movement (PHM) and the All India Drug Action Network (AIDAN), manufacturers’ fora like the Association of Indian Medical Device Industry (AIMED) and institutions like the Andhra Med Tech Zone (AMTZ) have been demanding comprehensive regulation for all medical devices and implants. So why are they not happy with the latest gazette?

Malini Aisola of AIDAN puts it succinctly: “This notification came without any consultation. Demands for regulation has been there and the DTAB was working on a draft but no civil society members, bio-ethicists, patients’ rights advocates have been consulted. We welcome this regulation but we don’t know if this is interim or forever. If the most important stakeholders – the patients – do not get consulted, what kind of regulation are we envisaging?”

Also read: US Government Finds ‘Make in India’ for Medical Devices Discriminatory

Rajiv Nath, coordinator of AIMED and one of the sharpest voices for comprehensive regulation, explains, “We want the ministry of health to take the lead and bring all medical devices under regulation. But this needs to be through a consultation process, where products are not cherry-picked for regulation but are selected based on scientific rationality. We also want a comprehensive and phased regulation where all medical devices are covered. The latest notification is technically flawed. For example, it states ‘dialysis machine’ but doesn’t state ‘dialysers’. And the 2020 deadline is not realistic either. There aren’t enough testing labs either to support this flawed and fragmented approach. What purpose does it serve to bring in regulation but with a completely unrealistic deadline?”

To complicate the matter further, Nath explains, regulation is too scattered and spread across multiple ministries. Regulation is spread across CDSCO, the National Pharmaceutical Pricing Authority (NPPA), the Bureau of Indian Standards (BIS), the Quality Council of India (QCI) and othersThere is little coordination across these bodies and, thus, less regulation.

Dr Jitendar Sharma, managing director and CEO of the Andhra Pradesh Medtech Zone Limited (AMTZ), says that the CDSCO process was both flawed and fragmented. Neither consultative nor scientific, it cherry-picked products based on perverse factors, hinting at irrational lobbying by those who do not wish India to grow in the segment of medical device manufacturing.

Sharma elaborates: “It leaves hundreds of common devices that could have actually been regulated. The notification brings into regulation a defibrillator but not an ECG. Whereas what we have in market is a defibrillator with an inbuilt ECG. Again, it regulates MRI. But there isn’t a single lab in India to test the same. By bringing in X-ray machines and CT Scans, it is subjecting X-ray and CT Scan equipment to double regulation since X-ray machines & CT Scans are already regulated by the Atomic Energy Regulatory Board (AERB). These are all high-end equipment and by bringing them under regulation with such an early deadline of 2020, the manufacturing capacity of Indian manufacturers of medical devices will be stymied and India will be dependent on imports for such equipment.”

Why is self-dependency important in medical device manufacturing in India? Because it is already a sector with a 70-80% import dependency. The current notification brings into regulation those products that are majorly imported and the makers of these already have an EU regulation certificate (CE) and/or an American regulation certificate (US-FDA), which are valid in India for regulatory purposes. Therefore, the current notification will not impact them at all and such a technically-flawed approach, with 2020 as the kick-in time, will kill the emerging domestic industry.

Also read: Government’s Cap on the Absurdly High Prices of Stents is a Good First Step

While CDSCO claims that DTAB cleared this selection, the fact is that there is not a single medical technology expert on DTAB. Both Ms Aisola and Dr Sharma stress on the lack of bio-engineers and medical technology experts in DTAB.

An important concern is expressed by lawyer Anand Grover, co-founder of Lawyers’ Collective and former special rapporteur of right to health at the United Nations Human Rights Council (2008-2014). “Regulation is not just about price-capping. It is also about safety standards and the quality of devices. It is about the human right to health. Everything in the space of health should be regulated. And the regulator should have the skills to regulate and the expansive and progressive remit to protect health and safety. It should also be above all conflicts of interest and the power to bark and bite. Hence, it is imperative that every regulation has the widest public consultation, including patients’ rights groups, journalists and lawyers, when such regulation is drafted.”

Regulation, at heart, is about law. However, the lawyers should not just be lawyers representing medical device manufacturers and large pharmaceutical firms – intent on rigging the system, drafting loopholes and escaping clauses. Lawyers sitting at the drafting table need to be patients’ rights lawyers, too.

Biraj Swain is a Senior Fellow with the Kalam Institute of Health Technology. She works on international development and human rights in South Asia, East Africa and the UN. She can be reached at biraj_swain@hotmail.com

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