The recent exposé of the poorly regulated medical device industry by the International Consortium of Investigative Journalists (ICIJ) and The Indian Express highlights a matter of grave concern. The worldwide investigations revealed flaws in the medical device market in more than 36 countries. But in my opinion, the India revelations are the most serious and, unfortunately, the most worrisome because we have seen in the past that despite evidence against offenders, hardly any action is taken against them. A similar investigation, the Panama Papers by the ICIJ, did not result in any punitive action in our country (though cases are pending before courts of law) even when in Pakistan a court case sealed the fate of a sitting prime minister in the same scandal.
The exposé has not only thrown up some disturbing facts on medical devices and their poor regulation but has also exposed the intrinsic faultlines in the Indian healthcare system. The “Implant Files” show that from the implant manufacturer to the treating physician, impunity pervades the system. The findings make us understand that the interplay between the device manufacturer (or supplier), the end-user, namely the physician, and the regulator, namely the government, is not only complex but also full of opportunities for financial gain and hence wrongdoing is becoming the norm, not the exception.
The implant market in India should thus be seen in the context of the implant manufacturer, the physician and the government. Of the three arms of this unholy trio, the device manufacturer is the one who is exceptionally brazen as we have already seen in the Johnson & Johnson hip replacement case. What more should we expect from a multi-national company? It should be clear to us that the implant manufacturers who bring their stuff in the Indian market do so only for one purpose — to earn money.
The implant industry in India is currently valued at $5.2 billion and contributes 4-5 per cent to the $96.7 billion Indian health care industry. This huge amount is up for grabs and to believe that the implant manufacturers will not be using this opportunity to earn by all means, legal or otherwise, would be naive. In the process of implant promotion, the expose has shown how gimmicks like live surgeries are arranged by multinational implant companies. These “live surgeries” are performed by both national and international experts. In this regard, the stories of Rameshbhai Dodhiya, Dinesh Pillai and Raman Singh, as revealed in this paper, are a chilling reminder of how these companies can behave if surgeries go wrong.
The culpability for this should be equally shared by the operating surgeon, the implant manufacturer and the local surgeon who organises the live surgery. But in the absence of specific regulating guidelines, implant manufacturers continue to organise such live surgeries over gullible patients in the name of “professional education programmes and continuing medical education”, as has been revealed by the Implant Files. Multinational implant giants should be made to realise that implant misuse is as grave an offence in India as it is in western countries. The arrogance of the multinational implant companies in India needs to be urgently reined in.
The second weak link in the Implant Files is the treating physician. The exposé has shown that freebies are distributed among doctors by the implant and pharma companies to promote their products. Implant Files revealed that the cardiac stent manufacturer, Medtronic, gave away Rs 50 crore worth of freebies as “product giveaways” to doctors over four years. Doctors becoming “brand ambassadors” for drugs and implants is an open secret in the Indian medical bazaar.
The poor reporting of adverse events for a drug or an implant by the treating physician is rampant in India. The expose showed that till 2014, adverse events were hardly reported by the Indian physicians or the manufacturer. Even after the formation of what is called the “Medical Device Adverse Event” (MDAE) report, the initial reporting of adverse events was minimal. Compared to this, the exposé revealed that in the UK regulators received 62,000 “adverse incident” reports linked to medical devices between 2015-18.
The inappropriate behaviour of the Indian physician has led to the erosion of trust among patients. No wonder the physician, considered to be God by a large chunk of Indian patients, is fast losing the halo. Unfortunately, the regulation of the Indian physician is also not a streamlined process. The confusion within the administration of the Medical Council of India (MCI), with multiple laws passed every other year for the governance of the apex body, has only added to the inappropriate behaviour of the Indian physician.
The MCI or any physician regulating body which replaces it in future needs to be robust in taking immediate punitive action against doctors involved in misappropriation of implants and drugs. It is worth mentioning that the General Medical Council (GMC), the physician regulating body in the United Kingdom, is a doctor administered body which has formulated strict laws for its own doctors. We need to learn from the GMC.
Finally, the onus of implant misappropriation lies with the government because it is the single agency which can regulate both the implant manufacturers and the physicians. A political will in this respect is essential. The exposé has shown that device companies in India are not regulated as per local standards but are dependent on the standards set by either the European regulators or the American FDA. This is a major loophole which is used by the implant manufacturers. The Implant Files reveal that successive governments in India have neglected the medical device sector.
The proposed Medical Device Regulation Bill is still to see the light of day. First drafted in 2006, it is interesting to note that in 2016 it was decided that the bill be converted and introduced only as medical device rules and regulations, applicable from 2018. The Implant Files revealed that this delay in bringing a law and converting it into an executive order was because the bureaucracy of the day felt that a separate bill will bring in “more control” and “curtail growth and innovation” in the medical device industry.
We can very well imagine that if there is reluctance in the highest offices of the executive, it will be nearly impossible to regulate this ever expanding market of implants in the country. In fact, the Implant Files reveal that under the new rule, despite an estimated 5,000 medical devices being sold in the country, the categories of medical devices “notified” and, therefore regulated, number only 23. This is a serious flaw in a market which is supposedly the fourth-largest in Asia after Japan, China and South Korea. The regulations in these three countries are not only robust but also more people friendly.
The Implant Files thus reveal a serious illness within the Indian medical implant and device market. This market is expected to grow to $50 billion by 2025. The onus of regulation of this ever growing market solely rests on the government of the day. For my fellow physicians, I am reminded of what Friedrich Nietzsche had once said, “I am not upset that you lied to me, I am upset that from now on I can’t believe you.”
The writer is professor, Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi, and author Man with the White Beard. Views are personal