MedTech stakeholders seek recall of New Drugs & Cosmetics & Medical Devices Bill 2023

New Delhi: The multiple stakeholders have joined hands and want the New Drugs, Cosmetics & Medical Devices Bill, 2023 to be recalled. They say it will have devastating impact on the domestic players and India’s preparedness to deal with any pandemic like situation.

In a joint plea made by the Indian medical device manufacturers, patient interest groups, users and hospitals to Union Health Minister Dr Mansukh L Mandaviya, they have articulated their concerns and have sought the recall of the Bill in the larger interests of the nation and budding indigenous manufacturers of medical equipment, who are playing a pivotal role in bringing resilience in the country’s MSME sector.

The letter has been signed by Rajiv Nath, Forum Coordinator, Association of Indian Medical Devices (AiMeD); Jatin Mahajan, Secretary, Admi; Dr Giridhar Gyani, Secretary General, Association of Healthcare Providers India; Manish Sabharwal, Secretary, SDMAI; Vivek Mangalwedhkar, Coordinator, IMA; Sanjiv Rehlan, Chairman, PWMAI; Harvinder Singh, General Secretary, SIDS; Vimal Khemka, Secretary, AISNMA; Hitesh Ostwal, ORAMAI; and Prof Bejon Misra, Founder Director, Patient Safety And Access Initiative of Foundation India.

In the joint letter, they have called for a consultation meeting with a fresh committee under the Chairmanship of ICMR/DST/DBT and key stakeholders for discussing feedback from them and careful consideration of their suggestions before finalizing the draft of the Bill and submitting it to the Parliament.

“An inclusive process will help shape an appropriate Regulatory Policy that needs to impact the Medical Devices sector positively,” said Rajiv Nath, Forum Coordinator, AiMeD, and one of the signatories in the letter dated August 2, 2023, while appreciating the tremendous efforts being made to regulate the drugs and cosmetics sector.

In view of the enormous role of domestic players in ensuring India’s self-reliance in the field of medical devices manufacturing, they have stated that the “Bill may kindly be recalled and collective voices of the entire industry and stakeholders may be heard, especially of the domestic manufacturers and consumer and patient safety groups, who should also be allowed to participate in formulating the regulations which will deeply impact us all, before the Bill is presented to the Honorable Members of the Parliament.”

Talking about the Bill, Dr Girdhar Gyani, Director General, Association of Healthcare Providers India, said that “if the bill is implemented, the Medical Devices Manufacturing sector may face supply chain crisis and effectively lose its ability to meet domestic demand, hence in a wider interest the draft bill needs to be reviewed for its effective implementation.

In the letter, they have reiterated the collective plea of the industry “for the need of a separate Medical Devices Act, different from the one meant for regulation of drugs and the need to treat Regulations and Regulatory Framework of Medical Devices as a separate legislative book from Drugs, as is scientifically the case.”

“To buttress their point further, Prof Bejon Misra, Founder Director, Patient Safety and Access Initiative of Foundation India, pointed to legislations adopted in other progressive countries like Canada, EU, UK, Japan, Brazil, Saudi Arabia, etc., and the visionary NITI Aayog Draft Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019, which could act as impactful works of reference to discipline Manufacturers”.

Seeking the decriminalization of transgressions without mens rea to avoid discouraging investments in manufacturing of the medical devices, they have further stated that for medical devices the penalties/punishment for manufacturing, import and sale or marketing of unsafe medical devices may kindly be rationalized. The penalty/punishment may be staggered, keeping in view the gravity of the offense, and in proportion to the offence.

Reflecting on the issue, Harvinder Singh, General Secretary, (Surgical Instrument Development Society), said: “Leaders of our country have given repeated assurances for decriminalization of offences and proposed proportionate punitive action. Legislators should avoid replicating the penalties meant for Drugs Act on to the medical devices sector, which are essentially engineering Products. Instead, effective compliance mechanisms in progressive countries may be deployed to discipline manufacturers.”