By Rajiv Nath
Thirty years have gone by since the first medical device was regulated as a drug. A comprehensive regulatory framework is nearly in sight with the Draft Medical Devices (Safety, Effectiveness & Innovation) Bill from NITI Aayog to be shortly proposed as a separate law.
India currently imports 80-90% of medical devices, of which the vast majority is 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. The medical devices market in India is over $15 billion (`105,000 crore) and projected to grow to $50 billion by 2025, and is the fourth-largest in Asia.
Our policymakers in the health ministry were surprisingly undecided, and seemed 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 USFDA. As Ministry of Health & Family Welfare (MoH&FW) had been surprisingly very reluctant to draft a separate law, and CDSCO has a conflict of interest to empower itself, the industry watchers are waiting with anxiety the details of the draft Medical Devices Bill that NITI Aayog is reportedly working upon in consultation with other stakeholder departments and ministries to address the regulatory vacuum & the national patient safety concerns.
Devices do need to be regulated, but the two draft and two final notifications recently issued by MoH&FW on October 18, have indicated notifying all medical devices that are engineering products as ‘medicines’ under the Drugs & Cosmetics Act from December 2019, but the roadmap being defined in cover note from the under-secretary does not entail migrating these to a separate ‘Medical Devices Act’ in due course (as being drafted by NITI Aayog), and seems to be an independent parallel action. This is causing huge confusions and apprehensions amongst domestic manufacturers, especially of medical electronics, as while one notification talks about a reasonable transition period of 3-4 years, another notification to regulate ultrasound equipment gives only one year, and there’s no mention of a separate Act. At present, only 24 out of over 6,000 medical devices are regulated by being notified as drugs.
It is 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 are 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 in replicating this limitation for devices too. The recent J&J episode showed the limitations of the Drugs Act, and the Drugs Controller was initially seen to be handicapped to discipline overseas manufacturers.
Medical devices have failed to attract investors to put up factories. Why? 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 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.
Policymakers, while needing to view devices and drugs differently, must also ensure these are of high quality, and are safe, and must consider regulating devices under the ministry of health, as is done for food. Food is not regulated under the Drugs Act or by DCGI, or the CDSCO, but has FSSAI with a chairman and CEO. While many of the manufacturers of the 24 categories of already notified devices are okay with being regulated under a familiar CDSCO, but wish it to be revamped, with a medical devices specific division and appropriately needed competent staffing, a vast majority of the manufacturers of devices that are currently not regulated prefer a separate regulatory body as reportedly envisioned in the NITI Aayog draft Bill.
The government should stick to the earlier four-step assurance given to the industry by the MoH&FW in 2016—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 Bill to be reviewed stakeholders, and passed by Parliament, and the MDR to be tweaked accordingly in order for it to migrate to an eventual Medical Devices Law.
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, and continuing to attempt to regulate devices as drugs under the Drugs Act without an assurance of migrating to a separate legislation, will do more harm than good to MakeinIndia campaign.
The witer is forum coordinator of AiMeD. Views are personal
