After the Johnson & Johnson (J&J) faulty artificial hip implant controversy, the government is plugging loopholes in the Medical Devices Rules (MDR) 2017 to ensure action against the players who violate regulations.
In its meeting on Thursday, the Drug Technical Advisory Board (DTAB) passed a proposal to include a provision in the MDR for cancellation and suspension of import licence of the medical devices in case of noncompliance with the regulatory provisions.
India imports around 80 per cent of its medical devices and a fourth of that comes from the US. The overall medical devices market in India is estimated to be ~640 billion.
The DTAB also passed a proposal to include provisions for compensation in case of injury or death due to any medical device found malfunctioning, unsafe or not in compliance with the conditions of the licence.
The DTAB is the apex drug advisory body in the country that advises the government on matters related to public health.
A senior government official confirmed the same. The proposals, now approved by the DTAB, would move to the ministry of health (MoH) and take a while before these are implemented.
The Central Drugs Standard Control Organisation (CDSCO) regulates the medical devices industry under the Drugs and Cosmetics Act, which was meant for pharmaceutical products.
The government eventually brought in MDR 2017 that comes under the existing Act.
"There was no provision under the MDR 2017 for suspension and cancellation of import licence of medical devices in case of noncompliance with regulatory provisions. Therefore, it was proposed to add a provision related to the same," said a source.
The Central Licensing Authority would give an opportunity to the licensee to show cause as to why a cancellation or suspension order should not be passed when any licensee is found to contravene any provision of the Act and MDR 2017.
The proposal also says the orders of suspension issued or revoked, or cancellation of license shall be duly published on the websites concerned of the Central Licensing Authority.
As for the proposal to amend the rules to include provision to provide compensation to those affected patients in case the medical device is found to be unsafe or malfunctioning, the DTAB recommended that the manufacturer or importer shall provide medical management or compensation or both to such person.
It also said the amount of compensation shall be determined in accordance with the formula as prescribed in the New Drugs and Clinical Trials Rules 2018.
Rajiv Nath, forum coordinator of Association of Indian Medical Device Industry (AIMED), said the government was trying to plug the loopholes in the medical devices rules after the recent spate of controversies around J&J. He, however, felt the need of the hour was to have an entirely separate Act to regulate medical devices, and not make amendments to the existing one.
The hip implants manufactured by J&J's wholly-owned subsidiary DePuy International were found to be faulty and several instances of revision surgeries were reported in India and across the globe. There has been a five year revision rate of 12-13 per cent for ASR hip-implants globally, which is higher than the expected rate.The artificial hip implants were recalled worldwide by the company in 2010. Around 93,000 patients were had received ASR implants globally and around 4,700 patients had received these implants in India between 2004-2010.
While J&J has agreed to initiate an India-specific reimbursement programme and cooperate with the government agencies in the process of identifying the patients, there was no provision in the existing Drugs and Cosmetics Act to compel J&J to do so. This was a case when compensation to affected patients depended on whether the device maker or importer voluntarily chose to cooperate.
J&J row prompts DTAB to tweak rules to ensure action against violators
DTAB passes a proposal to include provision to pay compensation for faulty devices
It also clears a plan to cancel or suspend licence of importers in case they violate regulations
Amendments to be made to Indian Medical Devices Rules ‘17
Medical Devices Rules 2017 come under the Drugs and Cosmetics Act
Proposal to be sent to MoH for deliberation and approval
Industry feels a separate Act to regulate medical devices is required