Need for Relook on Indian Medical Devices Industry
iasparliament
November 30, 2018
What is the issue?
The International Consortium of International Journalists (ICIJ) recently published the 'Implants Files investigation' on medical devices. Click here to know more.
In this backdrop, the Indian medical devices industry is in serious need of examination.
What are the concerns highlighted?
The investigation has revealed multiple signs of danger in regards with the medical devices industry.
The number of “medical device adverse events” has gone up from 40 in 2014 to more than 550 in 2018.
One instance would be the deaths after the installation of a stent.
Then there is the question of devices that have been recalled elsewhere.
E.g. 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.
But 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are not following up on their responsibility to track down the recipients of medical devices that have been withdrawn.
They also do not pay the compensation that is consequent upon such withdrawals.
What are the drawbacks in India?
The global withdrawals are not being followed through in India.
There is not even a public list maintained by the regulator of devices that have been recalled from the global or Indian markets.
In this case, the Central Drugs Standard Control Organisation (CDSCO) has the responsibility.
Even if regulators are not willing to take action, they must at least serve as information clearinghouses and broadcasters.
By this, at least, the 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, are not supportive.
So they do not react appropriately to a troublesome medical device and thus problems may not be reported.
The close links between medical device companies and medical professionals are widespread, a variant of those between pharmaceutical companies and doctors.
What does it call for?
The medical device industry is a unique blend of engineering and medicine.
It involves the creation of machines that are then used to support life within the human body.
Given this, it needs not only careful regulation but also the highest ethical standards.
Certainly, major changes are needed in the sector.
It is up to the government to reinvigorate both the IPC and the CDSCO, and to give them more resources and a clearer mandate.
The issue of the trustworthiness of the private sector to be relied for the tertiary health care system also needs attention.
A large and vibrant public sector in tertiary health care is essential.
This is possibly the way to counteract the hurtful consequences of information asymmetries and poor regulation.
The government should re-examine its plan for universal health care, at this juncture.
