FACING a backlash after faulty medical devices risked lives, the government plans to bring “all medical devices” and diagnostics in the country under the purview of its existing laws for medicine. If implemented, the country’s drug regulator will enforce standards to ensure safety and effectiveness of these products while its pricing regulator will monitor the prices, said experts.
According to a draft notification shared Friday, the Health Ministry proposes to notify all devices under a section of the Drugs and Cosmetics Act, 1940, that would define them as “drugs” starting December 1.
This would include “all devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function.”
This, according to the draft, will apply to devices used for diagnosis, prevention, monitoring, treatment or alleviation or assistance for any disease, disorder, injury or disability. It will also apply to products, including implants, used for the “investigation, replacement or modification or support” of the anatomy or of a physiological process.
Read our coverage on Implant Files here
Clears space for regulation
If implemented, all devices and diagnostics will need to meet specific standards. But in the absence of a law, the government will have to ensure it can effectively prevent issues like those seen with Johnson and Johnson’s faulty hip implants — which risked lives and were already notified as ‘drugs’.
Devices used to support or sustain life, medical device disinfectants as well as contraceptive devices will also be regulated under this notification. The Ministry has sought comments on the proposal before November 17.
Manufacturers and importers of most of these devices will have at least 1.5 years to voluntarily register with the Central drug regulator’s licencing authority, according to another draft notification released Friday. The draft, which would amend the country’s existing Medical Device Rules (2017), would apply to all devices in a phased manner, starting with 23 devices, including disposable syringes, cardiac stents, intra ocular lenses, knee and hip implants and heart valves, that are already regulated as “drugs” under the country’s drug laws.
By Jan 1, 2020, nebulizers, blood pressure monitoring devices, glucometers, digital thermometers, will have to start registering with the Central Licencing Authority, while around nine devices, including all implantable medical devices and equipment, CT scan equipment, defibrillators, X-ray and dialysis machines will face this requirement from April 1, 2020.
In April, the Drugs Technical Advisory Board (DTAB) recommended notifying all medical devices in a phased manner. This came almost five months after 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 US laws to obtain approval for and marketing hip implants in India, that had to be globally recalled in 2010.
“The (draft notification) means that CDSCO (Central Drugs Standard Control Organisation) can apply provisions of the Drugs and Cosmetics Act as well as the Medial Devices Rules 2017 on all medical devices...It can also punish them for violations as per the Act. Once devices are defined as ‘drugs’, NPPA (the National Pharmaceutical Pricing Authority) can also monitor their prices and ensure that they don’t raise it more than 10 per cent every year,” said Archana Sahadeva, an independent lawyer representing pharma companies.
“There are apprehensions that this is a knee jerk reaction to subvert the framing of a new medical devices act that will institute a separate devices regulatory agency, independent of CDSCO,” said a stakeholder who did not wish to be identified. “Merely expanding the scope of regulation to all devices is not enough in a moment of growing number of safety disasters involving devices and the CDSCO’s pathetic track record in responding to them. We have been asking for strengthening and comprehensive reforms of regulation for patient safety,” said Malini Aisola of patient activist group All India Drug Action Network (AIDAN).
“Continuing attempts to incorrectly regulate devices as ‘drugs’ may not help fully address patient needs to access affordable safe devices that are indigenously available,” said Rajiv Nath, forum coordinator of Indian medical devices lobby group, Association of Indian Medical Devices Industry (AIMED).
“Devices need a risk proportional penal system and decriminalisation of most offences. Regulator needs to have administrative powers to...protect public or ensure field safety actions or product recalls and not feel inept or handicapped to do so as was seen last year in the J&J case. Every minor issue need not be referred to an over burdened judiciary with limited technical knowledge,” he added.