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Regulatory vacuum in medical devices sector endangers patient safety; experts call for incentivising ICMED certification
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Arun Sreenivasan, New Delhi
November 29 , 2018
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While the Indian medical devices sector is hitting the headlines for all the wrong reasons, industry stakeholders and policymakers make a pitch for immediately incentivising a voluntary quality certification scheme and invoking Bureau of Indian Standards (BIS) Act to regulate medical devices as a group to eliminate sub-standard products of dubious origin. The recent incidents of faulty implants supplied by a subsidiary of global pharmaceuticals major Johnson and Johnson (J&J) and investigations by a global media consortium have underscored the regulatory vacuum in the medical devices sector and the inadequacy of the Drugs and Cosmetics (D&C) Act to ensure patient safety, they say.
At present, India doesn’t have a comprehensive law to regulate the medical devices industry. A medical devices regulatory bill, first drafted a decade ago, is yet to take effect and the draft has been lying with the health ministry since 2016. Though an exclusive Medical Device Rules came into effect early this year, the products are still regulated as “drugs” under the D&C Act. Moreover, only 23 devices are regulated by the health ministry through its licensing authorities.
“It is a fact that a considerable number of medical devices are not covered by domestic regulation. The existing rules are applicable only on the 23 devices notified as drugs under the D&C Act. The regulators are fully aware of this issue and the ministry has been discussing it internally,” Niti Aayog’s advisor on health Alok Kumar told Pharmabiz.
In an effort to fill the regulatory vacuum, the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) had rolled out a voluntary quality certification scheme for medical devices. However, in the absence of an incentive mechanism, the Indian Certification for Medical Devices (ICMED) scheme, aimed at enhancing patient safety, is failing to yield results.
“As ICMED is voluntary, it needs to be incentivised by giving preference in public healthcare procurement instead of seeking US FDA and CE approvals. Giving weightage for ICMED/ISO certified products will help ensure quality and promote indigenous development. It will also help Indian firms slash the substantial time and expenses to obtain globally accepted quality certification and eliminate malpractices of obtaining fraudulent certification. And the BIS Act could be used to regulate devices as a group using horizontal standards,” Anil Jauhri, chief executive officer of NABCB, pointed out.
Industry observers bat for regulating all devices and not item by item, a major constraint under D&C Act. In the absence of sector-specific technical regulations, the BIS Act can be used to regulate all devices at one go. However, a separate law for medical devices is imperative to address quality concerns and fix accountability. According to them, it’s currently challenging for a start up to get its medical device used by a surgeon in India, as surgeons unsure of quality in the absence of a quality certification, won’t even try it.
“The government needs to regulate all kinds of devices at one go with a defined transition period; if the government is reluctant that it’s going to harm the industry, especially MSMEs, a calibrated approach of initially incentivising voluntary ICMED certification to enable capacity building of MSMEs should be considered. Then in next phase pass quality control order under BIS Act to make certain provisions in the Medical Devices Rules mandatory for all manufacturers and imports,” Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry, opined.
“As an association that encourages responsible manufactures we have consistently lobbied and requested the government for medical device regulations, caps on trade markups and a strong ethical marketing watchdog, with initial supportive response and then a confused stalemate. The government listens to us and is supportive initially but consults importers who don’t want loss of their share and end up confusing government into an inaction stalemate,” Nath added.
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