From UPSC perspective, the following things are important :
Prelims level : Nothing Much
Mains level : Regulation of medical devices
- Last year, a series of reports revealed the traumatic experiences of Indian patients who had received faulty hip implants manufactured by the pharma major, Johnson and Johnson
- Another investigation has revealed that Johnson and Johnson paid hefty compensations to US patients who had received the defective implants.
- In India, however, the company has challenged government orders to compensate 4,700 patients who had undergone hip replacement surgeries.
- The reports also highlight that the story is more than that of corporate negligence.
- That Johnson and Johnson continue to brazen it out in India has much to do with the regulatory deficit in the country.
- The investigations pertain to implants manufactured under two brand names, ASR and Pinnacle.
- Both products are not in the market currently.
- Johnson and Johnson recalled ASR from the global market in 2010, while Pinnacle was withdrawn in 2013.
Recalling of medical Device
- But recalling a medical device is not like recalling a consumer product.
- Defective implants can cause crippling pain — even death.
- Patients who receive such implants need regular monitoring. In several countries, registries track the health of such patients.
- In fact, Johnson and Johnson’s recalling of ASR owes to the more than 15 warnings, between 2007 and 2009, issued to it by the Australian Joint Registry (though the company describes its decision as “voluntary”).
- Pinnacle was pulled out of the market after a flurry of lawsuits in the US alerted the country’s Food and Drug Administration (FDA) about the device’s defects.
The slow reaction by India
- In India, in contrast, regulators were slow to react.
- Maharashtra’s FDA red-flagged ASR a few months after Johnson and Johnson withdrew the product from the global market.
- But it took another year for the Central Drugs Standard Control Organisation to ban the import of ASR.
- Another year went by before the drug regulator issued an advisory to orthopaedic surgeons asking them to not implant ASR.
Defence by corporate
- These delays are significant because last year, Johnson and Johnson told a Union Ministry of Health and Family Welfare (MoHFW) expert committee that it cannot trace as many as 3,600 patients who underwent surgeries involving the faulty implant.
- That India did not have a joint registry when these surgeries happened has compounded the problem.
- The want of a registry has also come in the way of ascertaining the damage caused by Pinnacle. Johnson and Johnson claims that it has no adverse reports of the device in the country.
- However, reports in this paper have highlighted the trauma of at least seven patients with Pinnacle implants.
- In 2017, the MoHFW issued the Medical Devices Rules. However, the country’s base legislation on implants continues to be the Drugs and Cosmetics Act, 1940, which does not have the scope to cover most modern devices, including hip implants.
- The Indian orthopaedic device market is valued at over 450 million dollars and is expected to grow by 30 per cent per year till 2025.
- The investigations into faulty hip implants bring out the urgent need for a law to regulate medical devices.