Unless the drugs regulator cracks down on imports of the sub-standard implants, healthcare in India will be of serious concern
With or without price caps on stents and other medical implants, the problem of proliferation of sub-standard makes continues unabated. In this background, there are, according to domain experts, a few urgent steps that need to be taken.
One of these is of immediate and stringent regulation to ensure that sub-standard implants do not flood the Indian healthcare market.
According to Dr Anant Bhan, Researcher, Bioethics and Health Policy in Bhopal, there are a number of issues with structure and regime of drug control in India.
“The structures are in place to a large extent but there is a big hole as far as implementation is concerned in India,” he said. “The whole situation is worrisome and we need to ensure that such holes in safety of medical implants should be red flagged immediately.
The Indian market is price sensitive. Patients will definitely go in for cheaper implants if they are presented with the option by the hospital or the doctor. This is where the role of the government becomes important,” he said.
This concern is echoed by AdvaMed, a global lobby for medical devices and implant manufacturers and they are urging the Indian government to resolve regulatory issues.
In an email questionnaire, AdvaMed wrote – “As a global organization, AdvaMed has consistently advocated for comprehensive regulations for medical devices and diagnostics - separate from drugs - to ensure that all medical technologies in the healthcare delivery system are safe and effective. Medical devices and pharmaceuticals are vastly different in their development, evolution, manufacture, method of delivery and impact on patients. The Medical Device Rules 2017 and the Medical Devices Road Map introduced by CDSCO is a step towards more appropriate regulations for medical devices. We applaud this work by the government to create a more distinct framework for medical devices. We support the approach laid out the Road Map but also welcome future discussions with the Health Ministry on Separate Act for medical devices.”
Dr Bhan points out that imports are “porous” and that the CDSCO (Central Drugs Standard Control Organization) should understand that the onus cannot be on the patient in such a field to research and ask for a quality medical device or implant.
“It is very difficult for the consumer to be aware. When they go into a facility, there is implicit trust and when sub-standard implants are used, that reflects on the healthcare providers. A patient can ask around or maybe Google the name of a medical device but even then, such people are very very few in number. In an emergency situation, a provider can still disarm the relative or the patient and use a sub-standard product. That is why it is imperative that we have a ratings system and a minimum quality threshold. This, only the government can do,” he said.
Dr Madan Mohan Reddy, senior consultant orthopaedic surgeon with Apollo Hospitals in Chennai says that for orthopaedic implants at least, maintenance of a proper registry would be of great use in ensuring that sub-standard products do not go to other patients.
“If you look at the Johnson and Johnson implant case, the problem was with the design – it was metal on metal and the debris it generated when the metal rubbed against metal caused tumours,” said Dr Reddy. “The USFDA only tests if the material used in the implant is bio-compatible and not the design. So it is only once we use them in patients that we find out the consequences,” he said.
Dr Reddy says that while there have been attempts by orthopaedic surgeons in India to create and maintain a registry, the nature of patients and the country makes this tough. “Documentation is poor, patient compliance is poor – when they feel okay they do not come back for reviews. Some patients come to us from say, Bangladesh, and they don’t come back for reviews. So follow up is very poor and thereby maintaining a registry is tough,” he explained.
AdvaMed continues to lobby for a rollback of the price cap, explaining that it has not made a massive difference to the number of people opting for angioplasty.
“Price-control as a policy does not represent a realistic and viable means of achieving improved access to affordable healthcare for people. In a recent study by IQVIA, it was found that there was no significant increase in patient numbers post price capping. The study revealed - amongst government hospitals surveyed, ~80% hospitals cited no significant increase in the number of angioplasty procedures performed, and even in the remaining 20%, the increase was marginal (2-5% only),” wrote the organisation in an email.
However, doctors and researchers in India are asking for more basic and immediate steps. “We should not let anyone take advantage in the field of healthcare,” said Dr Bhan. “There can be no compromise on quality and safety. This issue needs intervention from the government on an urgent basis.”