Last Updated on December 30, 2023 by The Health Master
New Drugs, Cosmetics & Medical Devices Bill
Multiple stakeholders, including Indian medical device manufacturers, patient interest groups, users, and hospitals, have come together with a joint plea to Union Health Minister Dr. Mansukh Mandaviya.
They are voicing concerns and seeking the recall of the New Drugs, Cosmetics & Medical Devices Bill.
Their goal is to safeguard the spirit of Prime Minister Narendra Modi’s ‘Make in India‘ initiative and ensure India’s preparedness to handle future pandemic-like situations.
The stakeholders are emphasizing the crucial role played by indigenous medical equipment manufacturers in bolstering the country’s MSME sector.
The Joint Plea:
In a letter dated August 2, 2023, signed by various representatives, the stakeholders call for a consultation meeting with a fresh committee chaired by ICMR, DST, and DBT and key stakeholders.
They urge careful consideration of their feedback and suggestions before finalizing the draft of the Bill and presenting it to Parliament.
The stakeholders believe that an inclusive process will lead to an appropriate Regulatory Policy that positively impacts the Medical Devices sector.
Concerns and Calls for Review:
The stakeholders stress the significant role played by domestic players in achieving self-reliance in medical device manufacturing.
They contend that the implementation of the Bill may lead to a supply chain crisis and hamper the sector’s ability to meet domestic demand. Thus, they request a review of the draft Bill for effective implementation.
Separate Medical Devices Act:
In the joint letter, the stakeholders reiterate their plea for a separate Medical Devices Act distinct from the one regulating drugs.
They advocate treating the regulations and Regulatory Framework of Medical Devices as a separate legislative entity, reflecting the scientific nature of medical devices.
Reference to Global Best Practices:
The stakeholders draw attention to progressive countries like Canada, the EU, the UK, Japan, Brazil, Saudi Arabia, and India’s NITI Aayog Draft Medical Devices (Safety, Effectiveness, and Innovation) Bill, 2019, suggesting considering these legislations as impactful works of reference for discipline manufacturers.
Decriminalization and Rationalization of Penalties:
Seeking to avoid discouraging investments in medical device manufacturing, the stakeholders call for the decriminalization of transgressions without mens rea (without criminal intent).
They propose rationalizing penalties and punishments for the manufacturing, import, sale, or marketing of unsafe medical devices.
The penalties should be staggered, taking into account the gravity of the offense and being proportionate to the severity of the breach.
Conclusion:
The joint plea by multiple stakeholders highlights the need for thorough consultation and consideration before finalizing the New Drugs, Cosmetics & Medical Devices Bill.
By collaborating with key players and domestic manufacturers, the goal is to shape a Regulatory Policy that supports the Medical Devices sector and ensures patient safety while promoting ‘Make in India‘.
Disclaimer: This article contains information derived from Express Pharma. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
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