Dr. T. S. Kumarvel
Founder Chairman,
GLR Laboratories Pvt. Ltd., Chennai

Considering the necessity of a strong regulatory system for medical devices, in particular, the government is working on a war foot to upgrade our systems to become globally visible and provide quality medical devices. Hopefully, the introduction of the Medical Device Rules, 2017 may provide some relief to this burning issue.

We are evolving! and hope it’s for the sake of good. Well, that’s an optimistic way of establishing the fact that we have taken too long to roll up our sleeves, as far as medical devices are concerned. This article is a quick look at the metamorphosis of the Indian medical device regulations, the past, the present and what the future holds.

India, the fourth largest medical devices market in Asia is estimated to demonstrate a growth of a whopping $50 billion by 2025. This shows the enormous potential that this sector holds and is proficiently tapped by the international pharma giants. India is seen as a key market for the medical devices and diagnostic products. In a span of seven years, there has been a spurt of growth in the Indian medical device market with a compound annual growth rate of 15.8%. However, unlike the rest of the world, lack of stringent regulations made it easy for the big manufacturers to market their products in India. This is one reason why nearly 75% of the medical devices marketed in India are imported hands down.

Are all these imported devices safe and of good quality? Now, that’s a million-dollar question. About 4700 Indian patients received faulty hip implants supplied by one of the famous pharma giants even after it was recalled in other countries in 2010. What was reported as a massive failure, earned a huge amount of money in India. How could this even happen? Are we being treated as guinea pigs? And what happened to the moral responsibility of the manufacturer? Well, the answer clearly lies in the lack of defined regulations in India for handling medical device failures with no legal provisions for compensating patients. The rise in the number of serious adverse events related to medical devices from 40 in 2014 to 556 in 2018, shows the negligence by the ministry and the handicap of our regulations in this industry. As of now, there is no system in India for handling compensations for injured or dying patients due to a faulty medical device. However, according to a recent DTAB meeting, proposals are on the way to insist the manufacturing or importing companies that supplies the faulty product, to pay the compensation to the patient’s or their family. As per the proposal, the vindictive pharma company which supplied the faulty hip implants was insisted to pay a lump sum of ¹ 2 million to each patient as compensation.

Considering the necessity of a strong regulatory system for medical devices, in particular, the government is working on a war foot to upgrade our systems to become globally visible and provide quality medical devices. Hopefully, the introduction of the Medical Device Rules, 2017 may provide some relief to this burning issue. This critical document, which was drafted way back in 2006, was released in 2017 and was in effect from January 2018. The reason for this delay could have been the change in the government and all the political bureaucracies. Finally, there is this 241-page document which really has some meaningful rules to regulate medical devices in India. The remarkable part being that, it has been framed based on international standards (Global Harmonized Task Force standards), so it will certainly have an impact on the quality of the medical devices and their acceptance in the international forum. A critical component of this regulatory compliance is that, it monitors the adverse events and reports them. This is now being managed through the Materiovigilance Programme of India which was launched in 2015.

Will MDR 2017 can help in dealing with corporate misconducts? Well, the Indian regulations for medical devices is slowly being streamlined. Earlier only 23 of the many devices marketed in India were regulated. The Drugs Technical Advisory Board in its recent meeting, added some more devices including, all implantable medical devices, bone marrow cell separators, defibrillators, dialysis machines, CT scan equipment, MRI equipment, PET equipment, X-ray machines. The CDSCO, which is the apex body, aims to make this addition a dynamic process and all manufacturers are advised to be on the lookout if their devices are listed. If a medical device that has already been marketed in India is added to this list of regulated devices, the applicant needs to provide evidences of safety, performance and effectiveness.

According to the MDR 2017, medical devices are classified into A, B, C and D, where A and B are low risk devices, C and D are high risk devices. The state licensing authority shall be the issuing authority for the A and B class of devices, while the Central licensing authority issues license for the C and D class devices. An amendment to the MDR 2017 rules was made to accommodate this device-class specific issuance of licenses. Also, the fee (Rs. 1000/-) has been applied to each category of the medical device instead of each distinct device. This would add up to the cost for registration of devices that have multiple components falling under different categories. In contrast to the rest of the world, where, the manufacturer classifies his device according to the nature of contact and contact duration, in India, the regulatory body would classify the device based on its intended use, invasiveness, duration of contact, presence of a therapeutic component, presence of medicinal product/biological derivatives. In addition, the accessories would be classified separately from the main device. In a combination device, the rule would apply for each individual device.