Under the skin

Medical device industry needs govt action

The Indian medical devices industry is in serious need of examination. A series of reports from The Indian Express and the International Consortium of Investigative Journalists (ICIJ) has revealed multiple signs of danger in this respect. For one, the number of “medical device adverse events”, such as deaths after the installation of a stent, has gone up from 40 in 2014 to 556 so far this year. Then there is the question of devices that have been recalled elsewhere — as many as 117 devices have been recalled over the past two years by the United States Food and Drug Administration (or USFDA) because they have led to adverse events — yet half, perhaps more, of these devices are still on the market in India. Medical device manufacturers are not following up on their responsibility to track down the recipients of medical devices that have been withdrawn, such as hip implants that have turned toxic. Nor have they paid the compensation that is consequent upon such withdrawals.

These reports are deeply disquieting. The medical device industry is a unique blend of engineering and medicine — the creation of machines that are then used to support life within the human body. It needs not only careful regulation but also the highest ethical standards. Neither of these two seems to be on display in India. Reports that global withdrawals are not being followed through in India are particularly dismaying. According to the reports, there is not even a public list maintained by the regulator — the Central Drugs Standard Control Organisation (CDSCO) — of devices that have been recalled from the global or Indian markets. This is an extraordinary dereliction of duty. Even if regulators are not willing to take action, they must at least serve as information clearinghouses and broadcasters so that recipients, their relatives, or citizens concerned can take action on their own. The data maintained by the Indian Pharmacopoeia Commission, or IPC, is also worryingly incomplete. This is likely because the reporting standards are too low. In general, the incentive structure for doctors and medical centres, particularly in metropolitan cities, is not to rock the boat when it comes to a troublesome medical device. Thus problems may not be reported. The close links between medical device companies and medical professionals are a variant of those between pharmaceutical companies and doctors that have led to so much trouble in the past.

It is clear that major changes are needed in the sector. The Medical Council of India, of course, is toothless and discredited. It is up to the government to reinvigorate both the IPC and the CDSCO, and give them more resources and a clearer mandate. The deeper question, however, is whether such misuse is an inevitable consequence of a tertiary health care system that relies excessively on the private sector. A large and vibrant public sector in tertiary health care is the only way to counteract the hurtful consequences of information asymmetries and poor regulation, especially in sectors such as medical devices, pathological tests, and so on. The government should re-examine its plan for universal health care that chooses to give too much space to a health care sector that has shown itself to be insufficiently trustworthy.