Centre Moves to Let Regulators Halt Sale and Order Destruction of Unsafe Medical Devices

The news

New Delhi. The government is considering amending the Medical Devices Rules, 2017 to make it easier for regulators to stop the manufacture and sale or distribution, and to order the destruction, of medical devices found to be unsafe, defective, substandard or spurious, The Economic Times reports in a story by Teena Thacker based on an official document it has seen. Under the current rules, licensing authorities can only suspend or cancel a licence if a licensee contravenes the Drugs and Cosmetics Act, 1940 or the Medical Devices Rules, 2017; there are no provisions for stronger steps. The proposal to amend Rule 30(1) has been placed before the Drugs Consultative Committee, a body of experts, for deliberation and recommendation. It seeks to explicitly empower State licensing authorities and the Central Drugs Standard Control Organisation (CDSCO), the national regulator, to direct a licensee to stop production and sale or distribution of the device concerned. State and central authorities may also be empowered to direct destruction of devices and stocks wherever considered necessary, in the manner specified by the regulator; according to the report, destruction would take place under the supervision of a medical device officer. The document says there may be cases where devices contravene statutory requirements and their continued manufacture, sale or distribution may be prejudicial to “public health”, and that “effective enforcement requires not only regulatory action against the licence (holder) but also an explicit provision enabling the licensing authority to direct cessation of manufacture, sale or distribution”. It adds that without such a provision the existing Rule 30(1) “may lead to ambiguity in the exercise of regulatory powers and difficulties in taking uniform action”. A person aware of the matter told ET that devices “ranging from implants and surgical instruments to diagnostic equipment and consumables” are routinely used in critical care settings where defective products pose significant risks, and that supervised destruction would reduce the chance of unsafe products remaining in circulation. In plain words, a regulator today can punish the company but cannot clearly order that the faulty product itself be pulled out of use. The syllabus link is health regulation, patient safety and the design of regulatory institutions.

Static syllabus linkage

1. Devices are regulated under a drug law, through a notification route. The Drugs and Cosmetics Act, 1940 defines “drug” to include devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease that the Central Government notifies. Using this power, the Centre framed the Medical Devices Rules, 2017, which came into force on 1 January 2018, and later brought all medical devices within the regulatory net in phases. India still has no separate statute for devices, which is why rules made under a 1940 drug law must stretch to cover implants, software-driven equipment and diagnostic kits.
2. The 2017 Rules classify devices by risk and split licensing between Centre and States. The Medical Devices Rules, 2017 classify devices into four classes on the basis of risk: Class A (low risk), Class B (low-moderate), Class C (moderate-high) and Class D (high risk). Manufacturing licences for Class A and B devices are granted by the State Licensing Authority, while those for Class C and D devices, and all imports, are granted by the Central Licensing Authority, the Drugs Controller General of India who heads CDSCO. The Rules also provide for notified bodies to audit manufacturers, for clinical investigation of new devices and for medical device officers to inspect and sample.
3. The Drugs Consultative Committee exists to secure uniformity across States. Section 5 of the Drugs and Cosmetics Act, 1940 constitutes the Drugs Technical Advisory Board to advise on technical matters, and Section 7 constitutes the Drugs Consultative Committee, with representatives of the Centre and every State, to advise on securing uniformity in the administration of the Act throughout India. Uniformity matters because drug control is administered largely by State drug controllers, while the Centre regulates new drugs, imports and high-risk devices. Rules under the Act are made by the Central Government after consulting the Board.
4. A recall power acts on the product; a licence power acts on the firm. Regulatory law distinguishes between sanctions on a licensee — suspension, cancellation, prosecution — and measures on a product already in the market, such as a stop-sale order, a recall and supervised destruction. International practice treats the second set as essential for devices, because implants and equipment remain in hospitals long after a licence is cancelled. Supervised destruction with documentation prevents a withdrawn product from being quietly resold, which is a known risk in fragmented supply chains.

Why UPSC loves this

1. Regulatory capacity in health is a GS2 staple. The GS2 syllabus covers statutory, regulatory and quasi-judicial bodies and issues relating to health. Mains has asked about the quality of drug regulation, and the faulty hip-implant controversy of the last decade and cough-syrup deaths linked to Indian exports are standard examples. This amendment is a concrete instance of closing a statutory gap.
2. Prelims likes the classification and the licensing authority. Questions on which authority licenses which class of device, on the parent Act of CDSCO and on the difference between the Drugs Technical Advisory Board and the Drugs Consultative Committee are fair game. The four risk classes and the Centre–State split should be memorised.

Analysis

1. The amendment fixes a gap that should never have existed. A regulator that can cancel a licence but cannot order the product off the shelf protects the licence register more than the patient. The gap is a legacy of regulating devices through a drug law, where the typical remedy was to stop a manufacturer and let existing stock be sold down. For an implant or a diagnostic kit, the stock in hospitals is the risk. The proposal is therefore less a tightening than a correction of a design error.
2. Uniformity across States is the more important half of the proposal. The document’s complaint about “difficulties in taking uniform action” is revealing: when a defective device is found in one State, action elsewhere depends on the energy of each State drug controller. An explicit power held by both State authorities and CDSCO, with a specified procedure, allows a nationwide stop-sale to be issued and followed. The risk is the opposite problem — two authorities issuing inconsistent orders — so the amendment should state which authority leads when a device crosses State lines.
3. Stronger powers need due process to survive court challenge. An order to destroy stock is a serious interference with property and trade, protected by Article 19(1)(g) and Article 300A, and manufacturers will challenge orders made without reasons or hearing. The amendment is more likely to hold if it provides for a written reasoned order, an opportunity to be heard except in urgent cases, testing by a notified laboratory and an appeal. Due process is not a concession to industry; it is what makes the power usable.
4. A power to recall is only as good as the ability to trace. Stopping sale is easy to write and hard to execute if nobody knows which hospitals received a particular batch. Effective recall requires unique device identification, distributor records and hospital implant registries that link a patient to the device inside her body. Without such traceability, the new power will remove what is in warehouses but not what is already in patients. The counter-view is that traceability costs small manufacturers money, which is why it should be phased by risk class.
5. Rule-making under a 1940 Act is reaching its limits. Each new problem with devices is being solved by amending subordinate rules, which can be done quickly but rests on a statute written before modern devices existed. A separate law on medical devices, with its own definitions, recall and compensation provisions, has been discussed for years. The present amendment is a sensible interim step, but it also shows why a dedicated statute would give regulators clearer authority and patients clearer rights.

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