A comprehensive regulatory framework is nearly in sight 30 years after the first medical device was regulated as a drug but the big question being asked is, why not under a separate law? India currently imports 80-90% of medical devices of the $15 billion market, the vast majority of which are unregulated for quality and safety.
The ministry of health and family welfare is surprisingly unsure about ushering in a ‘Patient Safety Medical Devices Law’ to protect patients, even after the recent publication of implant files by the International Consortium of Investigative Journalists or the Johnson & Johnson (J&J) incident, or the recent ban on pelvic mesh by the US Food and Drug Administration. Industry watchers are anxiously awaiting the details of a draft biomedical devices bill that the Niti Aayog is reportedly working on to address the regulatory vacuum and the national concerns.
The four draft notifications issued by the health ministry on 18 October has notified all medical devices as ‘medicines’ under the Drugs Act from December 2019 but the roadmap being defined in the cover note by the under secretary does not entail migrating these to a separate ‘Medical Devices Act’ in due course. This is causing huge confusion and apprehension among domestic manufacturers. At present only 24 out of over 6,000 devices are regulated. We need to understand that devices are not drugs. 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.
The Medical Device Rules in 2018 have risk proportionate controls correlating to the risk classification of devices. The law and penal provisions need to be similarly 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. The recent J&J episode showed the limitations of the Drugs Act and the Drugs Controller was seen to be handicapped to discipline overseas manufacturers.
Presently, investors shy away from an unpredictable, incomplete and incorrect regulatory environment. In the absence of norms, domestic manufacturing suffers as a surgeon is unsure of trying an unregulated device from a startup on a patient.
A road map needs to lead for a robust Medical Devices Law. Policymakers need to consider regulating devices under the ministry of health as done for food under the Healthcare Products Regulatory Authority as a revamped Central Drugs Standard Control Organization (CDSCO) with separate divisions for drugs, devices and cosmetics. Food is not regulated under the Drugs Act or under the CDSCO, but has a Food Safety and Standards Authority of India (FSSAI) chairman and CEO.
The government should stick to earlier assurance given to the industry by the health ministry 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 six 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.
Continued attempts to regulate medical devices under Drugs Act without an assurance of migrating to separate legislation will do more harm than good to the Make in India campaign.
Rajiv Nath is forum coordinator at the Association of Indian Medical Devices Industry, or AiMeD.