By Rajiv Nath
Thirty years have gone by since the 1st medical device was regulated as a drug but a comprehensive regulatory framework still remains elusive. India imports 70-90% of its medical devices of which the vast majority are unregulated for quality and safety. While many of these products may have regulatory certifications in other countries, the reality is that a considerable number of them are being exported from countries that do not regulate their exports.
Our policymakers are surprisingly undecided and seem to be in no urgency to usher in a “Patient Safety Medical Devices Law” to protect patients, even after the recent ICIJ implant files or J&J incident, or the most recent ban on Trans-vaginal Pelvic Mesh by US FDA.
Devices do need to be regulated but, once again, the DTAB (Drugs Technical Advisory Board) has suggested forcibly notifying all medical devices that are engineering products as ‘medicines’ under the Drugs & Cosmetics Act and the road-map being defined by it does not entail migrating these to a separate ‘Medical Devices Act’ in due course.At present, only 23 out of over 5,000 medical devices are regulated by being notified as ‘drugs’. Additionally, the health ministry has recently cherrypicked and notified 12 other products as ‘drugs’. The medical devices market in India is over $10 billion (`70,000 crore) and projected to grow to $50 billion by 2025 and is the fourth-largest in Asia.
Devices, not drugs
It’s imperative to have a separate law as devices are engineering items and not medicines—an X-ray machine by no stretch of the imagination can be called a drug, and, so, continued attempts to regulate devices as drugs is illogical and incorrect unless assured that it is a temporary measure. A beginning was made to correct the anomalous situation with the introduction of the Medical Device Rules in 2018. These Rules have risk-proportionate controls correlating to the risk classification of devices. Similarly, the law and penal provisions need to be risk-proportional as you can’t have the same penalty for a manufacturing failure of a pair of spectacles as for a contact lens or for an intra-ocular lens. Patient safety is more complex with devices where the same are ‘a shared responsibility of the manufacturer, medical practitioners, product user and the regulator’. The Drugs Act itself needs reforms as it does not uniformly and equitably regulate quality from state-to-state in the absence of a national singular regulatory authority and there is no point of replicating this limitation for devices too.
Can a competent builder from Mumbai, experienced enough to make a 90-storey building, risk starting the construction of a 70-storey one in Gurgaon if the building by-laws there don’t permit construction of over 36 floors only under hearsay that said by-laws are under amendment or will he wait?
Similarly, medical devices manufacturers need to know the legal requirements, penalties, rules and roles that every stakeholder in the system needs to follow, in a predictable manner. This will attract overseas and Indian investments. Presently, investors shy away from an unpredictable, incomplete and incorrect regulatory environment. In the absence of regulations, domestic manufacturing suffers as a surgeon is unsure of trying an unregulated device from a start-up on a live patient.
Road-map for a robust Medical Devices Law
Policymakers need to view devices and drugs differently in order to make them safe and consider regulating devices under the ministry of health as done for food. Food is not regulated under the Drugs Act or under DCGI, or the CDSCO, but has a FSSAI with a chairman and CEO.
The government should stick to its earlier assurance given to the industry by the MOH&FW in 2016 of four steps—starting with the Medical Devices Rules (MDR), initially experimenting with a few electronic devices under the MDR, the MDR to be amended as per experience gained after 6 months of introduction and the simultaneous drafting of a Medical Device Patient Safety Bill to be reviewed and passed by Parliament and the MDR to accordingly be tweaked in order for it to migrate to an eventual Medical Devices Law.
The National Accreditation Board of Certification Bodies is already accrediting certification bodies for voluntary quality assurance (the Indian Certification for Medical Devices (ICMED) scheme) under the QCI (Quality Council of India). Incentivizing ICMED certification by the QCI will help manufacturers in capacity building for voluntary compliance to quality standards, thereby ensuring global competitiveness and enabling the smooth transition to mandatory compliance under a Patient Safety Medical Devices Law. A strong and fair regulatory environment will help the Make in India campaign by encouraging the growth of this industry.
If we are serious about placing India as a top global medical devices manufacturing hub, then one needs to understand that piecemeal reforms will not work. Right from trade margin rationalisation to ensuring a separate set of legislations and regulatory frameworks to govern the medical device sector and everything in between needs to be looked at afresh to galvanise domestic manufacturing.
