A series of reports in the Indian Express, in collaboration with the International Consortium of Investigative Journalists, on medical devices and implants, and nexuses between pharma giants and doctors and hospitals, has revealed that this sector, at the cutting edge of medicine, operates in a regulatory black hole. Many nations do not have their own frameworks, and depend on regulators in the country of manufacture, like the US Food and Drug Administration (FDA). India took baby steps towards regulation in 2015 by launching the Materiovigilance Programme of India under the Indian Pharmacopeia Commission, which examines reports of adverse events and passes them on to the Central Drug Standard Control Organisation (CDSCO) for action, such as recall. In 2017, the Medical Devices Rules were issued. But despite three attempts in a decade, the need to recognise implants as a separate vertical with its own regulatory framework has been ignored. On the contrary, it appears that the government hesitates to dampen the animal spirits of the Indian implant business, which is the fourth largest in Asia. So, the base legislation remains the Drugs and Cosmetics Act of 1940, which dates from the penicillin era and does not have the scope to cover most modern devices.
Within this skeletal framework, the investigation reveals huge information gaps. To begin with, there is no national registry of implanted devices, which alone defeats the statistical analysis of risk. In addition, adverse events are poorly communicated up the chain, and information submitted by hospitals is frequently incomplete. Worse, the CDSCO has failed to publicise recalls by the FDA, an elementary precaution for public safety. Within this shockingly lax system, clinics, hospitals and pharma majors have a fairly free run. Disputes over tax breaks for events for the medical profession have revealed that while the dreadful system of medical representatives directly gratifying doctors has been addressed, gratification through seminars and conferences continues. And the case of faulty orthopaedic implants, in which the government has just okayed a limit of Rs 1.2 lakh in compensation, made it clear that the state’s lack of appetite for regulation implies that costly legal action is the only recourse for patients who suffer harm.
A separate law for implants, which has been thwarted three times over, must be urgently enacted. And its framers must be aware that poor information flows constitute part of the problem. It is impossible to countenance patchy upstream reporting of adverse events, and non-existent downstream communication of recalls and warnings. We are on the brink of a biotechnology revolution which will create micromachines that work within organ systems, possibly nanomachines embedded in cells, and devices which interface directly with the nervous system. To imagine that they can be regulated by mere rules propped up by an archaic law is pure folly.
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