Experts have urged the government to pass the Drugs, Medical Devices, and Cosmetics Bill, 2023, expected to be introduced during the ongoing session of Parliament.
The bill 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. Additionally, the bill focuses on overseeing clinical trials for new drugs, investigating experimental medical devices, and evaluating the clinical performance of new in-vitro medical devices. The bill covers a wide range of drug products, including Ayurveda, Unani, Siddha, Sowa-Rigpa, and homoeopathic products, in its regulatory framework and is intended to replace the 83-year-old Drugs and Cosmetics Act of 1940 and accommodate the new requirements within the regulated space and the adaptation of new technology.
“The groundbreaking initiative by the Health Ministry is positioned to enhance both the pharmaceuticals and medical devices industries, simultaneously bringing benefits to patients. The compelling nature of the bill, with its diverse provisions emphasising patient safety, highlights the need for its prompt passage,” said Dr. Rajiv Desai, Senior Technical Advisor, Quality & Regulatory, Indian Pharmaceutical Alliance.
“For the pharma industry, quality is fundamental, and this proposed bill encourages innovation and R&D, strengthens quality management systems, and propels the pharma industry to the next level,” he said.
The bill introduces a precise categorization for medical devices, covering a wide range of diagnostic tools and their associated software. This comprehensive definition includes implants, devices aiding individuals with disabilities, life support systems, disinfection tools, as well as reagents or kits.
Previously, the regulation of medical devices under the 1940 Act led to their treatment in a manner that posed significant challenges to the medical device industry and raised concerns. Notably, the establishment of the Medical Devices Technical Advisor Board (MDTAB) and the creation of a dedicated regulatory body are significant steps taken by the government. This structure involves a Controller General (Medical Devices) at both the central and state levels, explicitly stating that medical devices will no longer be treated as drugs. Moreover, the updated recruitment rules for medical device regulators now encompass relevant qualifications, such as engineering graduates, reflecting a more tailored approach to staffing in this sector.
“Quality serves as the bedrock of the pharmaceutical industry, and the Bill’s promotion of innovation and research and development (R&D) is poised to fortify the country’s quality management systems. By fostering an environment that nurtures innovation and R&D, this bill is anticipated to serve as a catalyst for elevating the industry’s standards and practices in ensuring top-notch quality across the board,” said Anubha Taneja Mukherjee, Member Secretary, Thalassemia Patients Advocacy Group.
“Despite its significance, the much-awaited Bill faced a setback during the monsoon session of Parliament, where it did not even make it to the business agenda. The delay in its passage is disheartening, and its potential impact on patient welfare remains a major concern,” said Mukherjee.
The bill puts forth comprehensive regulations for drugs, cosmetics, and medical devices, prioritising their quality, safety, and efficacy. This framework establishes a conducive environment that fosters research, development, and innovation to effectively meet the escalating needs of patients. It also outlines a structured framework for conducting clinical trials while steadfastly safeguarding the rights, safety, and well-being of participants and ensuring compensation in cases of injury or fatality.
“India’s healthcare sector relies heavily on both the pharmaceutical and medical device industries, crucial pillars in ensuring robust healthcare services. The government’s ambitious Promotion of Research and Innovation in Pharma-MedTech Sector (PRIP) scheme, with a substantial allocation of Rs 5,000 crore over five years from FY 2024 to FY 2028, holds promising prospects for both sectors,” said Mukherjee. "However, any delay in passing the bill could potentially impact these schemes, tightening their timelines and affecting their implementation,” she said.
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