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Medical device law tweak call

New Delhi, Nov. 28: A consortium of international manufacturers of medical devices has asked the Centre to eliminate the need for clinical trials in India for medical devices already used in other countries for several years.

The Advanced Medical Technology Association (AdvaMed) has asked the government to tweak proposed changes in the law governing drugs and medical devices and classify devices according to the risks they pose.

The proposed amendments to India’s Drugs and Cosmetics Act are intended to cover an array of medical devices, from pacemakers to stents to intraocular lenses, which sections of the industry estimate make up an annual $3 billion market in India.

However, device industry officials are unhappy at what they say are inappropriate penal provisions in the amendments and a lack of clarity on risk categorisation of devices.

“A syringe or a stethoscope should not be treated in the same way as a cardiac stent,” said Gautam Khanna, the chair of AdvaMed India who also chairs business chamber Ficci’s panel on medical devices.

AdvaMed has asked the government to classify devices under different categories such as low risk, low moderate risk, high moderate risk, and high risk.

“Some devices in the low-risk category may not require clinical trials,” a device industry official said.

The consortium has also asked the government to reconsider the penalty provisions in the proposed amendments, which have set a fine of Rs 3 lakh and a jail term of three years for even minor violations of the law.

“There are penal provisions for mislabelling, but under the proposed amendments even a smudge on the expiry date of a device could make the CEO of a device company liable for a jail term of three years,” Khanna said. “The penalties should be progressive, linked to the severity of the violation.”

AdvaMed has also asked the government to adopt “international best practices” to ensure that the highest standards of safety and efficacy are implemented.

“We’re questioning the need for clinical trials for medical devices that have already been approved by regulators elsewhere and have been used in patients in foreign countries for four or five years,” said Vibhav Garg, vice-chair of AdvaMed.

While Indian drug laws require clinical trials to assess the efficacy of medicines on Indian patients even when the medicines have been approved in other countries, device industry officials say certain devices need to be treated differently.

“Medical devices are electrical and mechanical instruments. A product that has already proven itself for several years in another country need not be subject to clinical trials all over again on Indian patients,” Garg said.