DMDC Bill will align India regulatory system with global best regulatory practices

New Delhi: The Drugs, Medical Devices, and Cosmetics Bill, 2023, which is expected to be introduced during the ongoing session of Parliament, aims to regulate and supervise the import, production, distribution, and sale of drugs, medical devices, and cosmetics, and ensure standards in quality, safety, efficacy, and performance. If made into a law, is expected to benefit patients in terms of expeditious access to new, safe, and quality therapies, informed Dr Anil Matai, Director General, Organisation of Pharmaceutical Producers of India (OPPI)

 

Speaking to ETHealthworld, Dr Matai said, "OPPI is firmly committed to supporting the government's vision behind the introduction of the Drugs, Medical Devices, and Cosmetics Bill, 2023. The Bill underscores our commitment to advancing clinical research in the country. The Bill strives to align India's regulatory system with that of global best regulatory practices. It highlights the Government's dedication to creating a clear, streamlined regulatory framework for easier compliance that aims to ensure the quality, safety, and efficacy of drugs, medical devices, cosmetics & AUSSH products. The Bill, if made into a law, is expected to benefit patients in terms of expeditious access to new, safe, and quality therapies.

 

Adding that as an integral part of the pharmaceutical industry, OPPI has provided its comments to the 2022 draft Bill along with the rationale thereto, Matai further shared the key recommendations included are the need for simplification of the regulatory processes, alignment with global regulatory standards, clarity in provisions to rule out subjective interpretations, adherence to the New Drugs Clinical Trial Rules, 2019 (NDCT 2019), which were established following extensive stakeholder consultations and reviewing redundant provisions that exist in the Drugs and Cosmetics Act, 1940 and the Rules made thereunder.

 

Additionally, OPPI emphasizes the importance of statutory recognition for guidelines issued by the Central Drugs Standard Control Organization (CDSCO) regarding similar biologics.

 

"While OPPI acknowledges the need for stringent measures to uphold patient safety and health, concerns have been raised regarding the seemingly disproportionate penalties outlined in the Bill. It is imperative to strike a balance between ensuring patient safety and fostering a conducive environment for business operations which can be achieved by decriminalizing minor contraventions and by levying compounding fines for offences in cases of minor contraventions," he added.

 

He further informed that OPPI remains optimistic about the Bill's potential and sincerely hopes that the final regulation will reshape India's healthcare & pharma regulatory landscape.

 

"The aim is to achieve global harmonization, aligned with WHO standards, and the establishment of a transparent and streamlined regulatory regime for the benefit of patients while simultaneously facilitating ease of doing business," Dr Matai concluded.

 

Source: Healthworld