Medical Devices industry disappointed on not getting a separate Act

New Delhi, July 12, 2022 :

The medical devices industry has expressed its disappointment in the government not addressing its aspirations for a separate Act for the sector, while considering the new draft bill for the pharmaceutical and medical devices in the country.

The Association also raised its concerns about the schedules in Chapter VI of the new Bill, which terms a medical device as adulterated if it consists in whole or in part, of rusted or corroded, among others.

Commenting on the draft of New Drugs, Medical Devices and Cosmetics Bill, 2022, Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD), in his initial response said, “We are disappointed that the aspirations of a Separate Act for Medical Devices have not been addressed and budding entrepreneurs and startups, developers and engineers will still need to grapple with a complex joint law.”

The organisation is studying the draft of the combined Drugs, Cosmetics & Devices Bill and seeking comments from its members.

The medical devices have a huge potential of investment of over Rs. 50,000 crore to meet the market of over Rs 1,00,000 crore and it's time for the aspiring younger son to move on from the joint family house being shared with elder Pharma & Cosmetics brothers, he said.

“….the house can't be renovated to accommodate the potentially large growing family needs and we seek a separate housing in same community - the parents should realise that it doesn't mean that son loves them lesser but his aspirations and practicalities need to be addressed,” added Nath.

“Medical Devices are engineering products and not homogeneous powders , tablets or liquids that can be adulterated so treating a rusted part of a medical devices as adulterated and criminal offence is absurdity in the making - a law needs to be simple , reasonable and implementable and not become a barrier to Make in India or Innovate in India,” said Nath.

“Once we study the fine print and seek implications of interpretation of the clauses over the next few days we will be in a better position to comment on the efforts done by MoH&FW in drafting this Bill,” he added.

However, on the positive side, AiMeD said that it is pleased to find the proposal of a Separate Medical Device Technical Advisory Board - a recommendation sought since long as it's unfair for the medical devices industry to rely on pharmaceutical experts and industry representatives decide what's a good way to regulate medical devices without having medical devices experts present or part of the DTAB. At least this issue is proposed to be corrected, he averred.

The new Bill proposes a separate chapter for import, manufacture, sale, distribution and clinical investigation of medical devices, defining standards of medical devices, misbranded, adulterated and spurious medical devices, prohibition of import or manufacture and sale of medical devices which are not of standard quality, misbranded, adulterated or spurious and details the role of Medical Devices Officers and the punishment for those who import, manufacture, sell or distribute medical devices which are not of standard quality, misbranded, adulterated or spurious, with both imprisonment and penalty.

It defines that a medical devices shall be deemed to be misbranded if it is configured so as to conceal any damage or made to appear of better or greater functional value or made to appear of lesser risk that it really is, or if it is not labelled or packed in such a manner as may be prescribed or bears label, container, statement, design or device which makes any false claim or containing colours not expressly permitted in the license or permission issued under the Chapter.

A medical devices shall be deemed to be adulterated if it consists, in whole or in part, of rusted or corroded or filthy or putrid or decomposed substance; or is prepared, packed or stored under insanitary conditions where by it may have been rendered injurious to health; or contains any harmful or toxic substance or component or software or parts which may render it dangerous to use or injurious to health; or is having any substance or component or software or part mixed or added, substituted, or removed from so as to reduce its quality or performance or safety; or if it is having a pack or container composed, in whole or in part, of any deleterious substance which may render it dangerous to use or injurious to health.

A medical device shall be deemed to be spurious if it is having the label or pack or container bearing the name of an individual or firm or company purporting to be the manufacturer of the device, which individual or a firm or a company is fictitious or does not exist; or if it purports to be the product of a manufacturer who is actually not the manufacturer of the product.  Pharmabiz