ON TUESDAY, the Ministry of Health and Family Welfare on Tuesday notified changes in the Medical Devices Rules, 2017 to regulate medical devices on the same lines as drugs under the Drugs and Cosmetics Act, 1940.
A look at what the changes are, what necessitated them and how they will affect the quality of medical devices in the country.
What are the changes in the rules that were notified?
Called the Medical Devices (Amendment) Rules, 2020, these are applicable to devices “intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals” (as notified by the ministry) and require online registration of these devices “with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation for this purpose”.
Among the information that the manufacturer has to upload are “name & address of the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site of medical device (and) certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device”.
This would mean that every medical device, either manufactured in India or imported, will have to have quality assurance before they can be sold anywhere in the country. “After furnishing of the above information on the ‘Online System for Medical Devices’ established by Central Drugs Standard Control Organisation for this purpose by the applicant’s, registration number will be generated. Manufacturer shall mention the registration number on the label of the medical device,” reads the gazette notification.
The notification calls for a voluntary registration within a period of 18 months from April 2020 and obtaining manufacturing/import licence under the Medical Device Rules within 36 months for some devices and 42 months for others.
What are the items covered under the Medical Device Rules?
A large number of commonly used items including hypodermic syringes and needles, cardiac stents, perfusion sets, catheters, orthopaedic implants, bone cements, lenses, sutures, internal prosthetic replacements etc are covered under the new rules and will have to comply starting April.
For some items such as sphygmomanometers (used to monitor blood pressure), glucometers (to check blood sugar), thermometers, CT scan and MRI equipment, dialysis and X-ray machines, implants etc, different deadlines for compliance have been set. For example for the first three, it is January 2021, for the others it is April next year. For ultrasound equipment, it is November 2020.
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Is this a sudden move?
No. This has been in the offing for some time now. In October last year, the ministry had circulated copies of the then proposed notification for public comments following recommendations of the Drugs Technical Advisory Board (DTAB), which is the highest technical body for these decisions and has experts among its members. In April last year, the DTAB had recommended that all medical devices should be notified as “drugs” under the drug regulation law to ensure they maintain safety and quality standards. The notification makes it clear that the government has issued it in consultation with the DTAB.
Why was the move required?
For much of the last one year, the health sector has been at the centre of attention following revelations about faulty hip implants marketed by pharma major Johnson & Johnson. This has caused major embarrassment to the government, too, as it exposed the lack of regulatory teeth when it came to medical devices. The matter dragged on, exposing the regulatory loopholes until finally the company agreed in court to pay Rs 25 lakh each to the 67 people who had had to undergo revision surgeries because the implants were defective.
In fact, even after Johnson & Johnson agreed in a Texas court to shell out $1 billion to settle about 6,000 lawsuits filed by patients in the US who used its “defective” pinnacle hip implants for 10 years from 2003 to 2013 before the product was withdrawn, in India it had for a very long time maintained that it had not received any adverse events report in the product.
That is really where the discussion started about regulation of medical devices.
The Indian Express published the ‘Implant Files’, a series of investigative reports highlighting lapses in regulation in India’s medical devices industry and the impact it had on patients. This included Johnson & Johnson’s use of loopholes in United States laws to obtain approval for and marketing hip implants in India, that had to be globally recalled in 2010.
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What are the penal provisions under Indian law?
There are various penal provisions under the Drugs and Cosmetics Act, 1940 for various kinds of offences. Manufacture or sale of substandard items is punishable with imprisonment of at least 10 years, which may extend to imprisonment for life. There is also a provision for fine that will “not be less than Rs 10 lakh rupees or three times value of the confiscated items”.
How has the industry reacted to the government move?
The industry has so far reacted positively, though doubts remain about the ability of the Central Drugs and Standards Control Organisation (CDSCO) to effectively regulate both drugs and medical devices.
Himanshu Baid, Chairman, CII Medical Technology Division and Managing Director, Polymedicure, said, “CII Medical Technology Division welcomes this move, as this will ensure that all medical devices available will be safe and effective. The temporary registration application for devices that are currently unregulated will require basic administrative documents and basic product information. The registration process carries no government processing fees and does not expire till the manufacturer/importer obtain the import/manufacturing licence within a period of 36 and 42 months for class A, B and C, D devices respectively, the temporary registration may be cancelled or suspended by the CDSCO for product safety concerns, or when superseded by an Import/ Manufacturing License. Once registered the local registration holder will be required to notify the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SEA) occurring in India.”
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