The poorly regulated medical implant sector is a scandal waiting to become tragedy. Policymakers need to act
Arecent investigation spearheaded by the International Consortium of Investigative Journalists — an umbrella body that includes international news organisations in 36 countries, including The Indian Express in India — has exposed the chilling lack of accountability of the medical devices industry. In the Indian context, the findings expose the nexus between implant makers, health finance players and doctors, as they chase targets at the expense of vulnerable, unsuspecting patients. Quality lapses are not readily accounted for (be it knee implants, hip implants, pacemakers or intra-uterine devices) because for patients, there is no clear agency to deal with such situations. With surgeries being performed, as the Express reported, in “basement operating theatres of DDA flats”, it is clear that the regulatory system has failed. For an industry that is valued in India at $5.2 billion and is growing at 16 per cent annually, with imports accounting for 80 per cent of all sales, this is a grim state of affairs. The regulatory failure is evident at various levels: in the testing of the implants; in informing the patient of the consequences and making her aware of her rights; and in the compensation mechanism. In the case of J&J, India’s drugs regulator was slow to react to the global recall and establish the extent of damage. The wrangling over compensation continues because there are no clear norms laid down under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017 for such eventualities. Hence, while 8,000 US patients have been awarded $2.5 billion for hip implants gone awry, which works out to about ₹2 crore per patient, in India the compensation levels are set to vary from ₹30 lakh to ₹1.2 crore. However, it appears that as a response to the public outcry over faulty hip implants on 4,700 patients in India, some regulatory changes are in the offing.
The Medical Devices Rules, 2017 may be modified to include compensation aspects, with a committee looking into the issue. So far, compensation sums have been arrived at on the basis of damages laid down in clinical trial regulations. This is inappropriate, as a patient or individual who submits herself to clinical trials cannot be equated with one who actually needs an implant and opts for a trusted product. The rules rightly categorise devices into various categories of risk and spell out regulatory requirements for each. However, over-reliance on certification from the US, EU or Japan for imported products may require to be reviewed.
There can be no getting away from double standards in compensation for Indian lives lost in medical tragedies. From the Bhopal gas tragedy of 1984 to J&J implants 35 years later, it’s a tale of deja vu. This cannot carry on.