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 percent of medical devices of the USD 15 billion market of which the vast majority are unregulated for quality and safety.
The health ministry is surprisingly unsure 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 recent ban on the pelvic mesh by USFDA. Industry watchers are awaiting with anxiety the details of a draft Biomedical Devices Bill that Niti Aayog is reportedly working upon to address the regulatory vacuum and the national concerns.
The four draft notifications recently issued by MoH&FW on October 18, have 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 apprehensions amongst domestic manufacturers. At present, only 24 out of over 6000 devices are regulated.
Devices are not drugs
Devices are engineering items and not medicines – an X-ray machine by no stretch of 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 cannot 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 practitioner, 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 regulations, domestic manufacturing suffers as a surgeon is unsure of trying an unregulated device from a start-up on a live patient.
Roadmap needs to lead to robust medical devices law
Policymakers need to consider regulating devices under the Ministry of Health as done for food under a Healthcare Products Regulatory Authority as a revamped CDSCO with separate divisions for drugs, devices, and cosmetics. Food is not regulated under the Drugs Act or under the CDSCO, but has a FSSAI with a chairman and CEO.
The government should stick to 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 Devices Patient Safety Bill to be reviewed and passed by the Parliament and the MDR to accordingly be tweaked in order for it to migrate to an eventual medical devices law.
Continued attempts to regulate devices under Drugs Act, without an assurance of migrating to a separate legislation, will do more harm than good to the Make in India campaign.