The draft New Drugs, Medical Devices and Cosmetics Bill, 2022 seeks to regulate e-pharmacies and medical devices for the first time, while introducing penalties for non-compliance during clinical trials
The government has proposed a new bill that aims to regulate e-pharmacies and medical devices for the first time. The draft New Drugs, Medical Devices and Cosmetics Bill, 2022 seeks to replace the existing Drugs and Cosmetics Act of 1940, bringing in new regulations and penalties for the healthcare industry.
Comprehensive Legislation to Regulate E-Pharmacies and Medical Devices
Under the proposed bill, e-pharmacies and medical devices will come under regulatory scrutiny. The existing rules for conducting clinical trials for new drugs and medical devices will also be revised, along with provisions for compensation for injury or death during clinical trials.
Enhanced Monitoring and Penalties for Compliance
The draft bill emphasizes the need for enhanced monitoring and penalties for non-compliance. It introduces a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB) to advise the central government on technical matters. Penalties for offenses related to the import of drugs and cosmetics have been enhanced, including imprisonment for failure to provide compensation to clinical trial participants.
Focus on AYUSH Drugs and Medical Devices
The draft bill also addresses the regulation of AYUSH drugs, including Sowa Rigpa and Homeopathy, for the first time. It proposes a separate chapter for AYUSH drugs, expanding the scope of regulation to include these traditional medicinal practices.
Public Feedback and Suggestions Invited
The draft bill has been made available on the Union health ministry’s website for public review and feedback. Stakeholders and the public have been given a 45-day period to provide their suggestions, comments, and objections.
In a significant move, the government has put forth a new bill that seeks to regulate e-pharmacies and medical devices, addressing key areas of concern within the healthcare industry. The draft New Drugs, Medical Devices and Cosmetics Bill, 2022 aims to replace the existing Drugs and Cosmetics Act of 1940, incorporating crucial updates to adapt to the evolving landscape of healthcare.
One of the key provisions of the proposed bill is the regulation of e-pharmacies, which have witnessed significant growth in recent years. With the increasing reliance on online platforms for purchasing medications, the bill aims to ensure the safety, authenticity, and quality of drugs sold through e-pharmacies. It mandates that no drug can be sold, stocked, exhibited, or distributed through online modes (e-pharmacies) without a valid license or permission issued in accordance with the prescribed guidelines.
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