Ten organisations including medical devices industry demand recall of New Drugs, Medical Devices & Cosmetics Bill
Ten collective stakeholders of Indian healthcare industry, including the industry associations of medical devices manufacturers, patient interest group, and healthcare providers, have jointly demanded to the Union health minister Dr Mansukh Mandaviya to recall the New Drugs, Medical Devices & Cosmetics Bill, 2023 that is listed to be tabled in Parliament during the ongoing session.
The implementation of the Bill will have a devastating impact on the domestic players and India’s preparedness to deal with any pandemic-like situation, they said. The demand is not only to safeguard the spirit of Prime Minister Narendra Modi’s ‘Make in India’ call but also to keep India’s preparedness intact to deal with any pandemic-like situation in the future.
The recall of the Bill would be 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, they added.
In the joint letter, they called for a consultation meeting with a fresh committee under the chairmanship of Indian Council of Medical Research/Department of Science and Technology/Department of Biotechnology and key stakeholders for discussing feedback from them and careful consideration of their suggestions before finalising the draft of the Bill and submitting it to 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 to the letter sent on August 2, 2023.
In view of the enormous role of domestic players in ensuring India’s self-reliance in the field of medical devices manufacturing, they stated, “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.”
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 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.”
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.
They have sought the decriminalisation of transgressions that are without intention or knowledge of wrongdoing, to avoid discouraging investments in manufacturing of the medical devices. For the medical devices sector, the penalties/punishment for manufacturing, import and sale or marketing of unsafe medical devices may be rationalised.
The penalty/punishment may be staggered, keeping in view the gravity of the offense, and in proportion to the offence, they added.
Harvinder Singh, general secretary, Surgical Instrument Development Society, said, “Leaders of our country have given repeated assurances for decriminalisation 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.”
The letter has been signed by Rajiv Nath, forum coordinator, Association of Indian Medical Devices (AiMeD); Jatin Mahajan, secretary, Association of Diagnostics Manufacturers of India (ADMI); Dr Giridhar Gyani, secretary general, Association of Healthcare Providers India (AHPI); Manish Sabharwal, secretary, Surgical Dressing Manufacturers Association (SDMA); Vivek Mangalwedhkar, coordinator, Orthopaedic Implant Manufacturers Association (OIMA); Sanjiv Rehlan, chairman, Preventive Wear Manufacturers Association of India (PWMAI); Harvinder Singh, general secretary, Surgical Instrument Development Society (SIDS); Vimal Khemka, Secretary, All India Syringe & Needle Manufacturers Association (AISNMA); Hitesh Ostwal, president, Orthopedic Rehabilitation Aid Manufacturers Association (ORAMAI); and Prof Bejon Misra, founder director, Patient Safety And Access Initiative of Foundation India.
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