The Drugs, Medical Devices and Cosmetics Bill 2023, represents a pivotal shift in overseeing and regulating the import, production, distribution, and sale of drugs, medical devices, and cosmetics. Its core objectives revolve around ensuring stringent standards of quality, safety, effectiveness, and performance across the three domains.
Aimed at replacing the outdated Drugs and Cosmetics Act of 1940, this proposed legislation reflects a forward-thinking stance, adapting to contemporary needs and evolving technological advancements. The Health Ministry’s pioneering initiative is poised to not only streamline regulations but also stimulate growth within the pharmaceuticals and medical devices industry.
The new comprehensive legislation places significant emphasis on regulating various aspects such as clinical trials for new drugs, investigations into experimental medical devices, and evaluating the clinical performance of in-vitro medical devices.
Crucially, this Bill also places a paramount focus on safeguarding patient safety through a range of provisions. Therefore its urgency in passing is underscored by the compelling need to ensure the welfare of patients while fostering industry innovation.
Focus on quality
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.
In addition, the new Bill encompasses several noteworthy features, including the centralised regulation of drug, cosmetics, and medical device imports, alongside oversight of clinical trials for new drugs and investigations into innovative medical devices. Meanwhile, the responsibility for the sales and distribution regulation falls under the purview of individual states.
Notably, it introduces provisions for regulating or restricting drug imports in the public interest and enables emergency use and accelerated approval for new drugs and investigational medical devices. Additionally, the Bill outlines the establishment of quasi-judicial authorities to address certain procedural and minor offences, with separate regulatory verticals for the pharmaceuticals and medical devices industries.
It also marks a crucial leap in modernising India’s drug and cosmetics regulatory system, previously slow to adapt to technological progress. Its primary goal is to meet the evolving needs of contemporary healthcare by establishing a comprehensive framework that accommodates these advancements. Notably, the Bill prioritises specialised, segmented regulation, empowering dedicated governing bodies with focused expertise. This strategic approach stands to offer significant advantages to the healthcare industry at large.
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.
Boosting healthcare
The government’s commitment to modernising regulations in this vital sector is praiseworthy. The Bill introduces a clear-cut classification for medical devices, encompassing an extensive array of diagnostic tools and their related software. This expanded definition includes implants, devices assisting individuals with disabilities, life support systems, disinfection tools, as well as reagents or kits.
Previously, the regulation of medical devices under the 1940 Act meant that they were treated which posed significant challenges to the medical devices industry and was a bone of contention for it. Additionally, the creation of the Medical Devices Technical Advisory Board (MDTAB) and the establishment of a dedicated regulatory arm are significant measures undertaken by the government.
This setup includes a Controller General (Medical Devices) at both central and state levels, explicitly indicating that medical devices will no longer be regulated as drugs. Furthermore, the revised Recruitment Rules for medical devices regulators now encompass relevant qualifications, such as engineering graduates, reflecting a more tailored approach to staffing in this sector.
India’s healthcare sector relies heavily on both the pharmaceutical and medical devices 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 ₹5,000 crore over five years from FY 2024 to FY 2028, holds promising prospects for both sectors. However, any delay in passing the Bill could potentially impact these schemes, tightening their timelines and affecting their implementation.
Patients — the primary concern
The immediate passage of the Bill is imperative, given that patient interests stand as the primary concern. It sets forth comprehensive regulations for drugs, cosmetics, and medical devices, prioritising their quality, safety, and efficacy. This framework establishes a conducive environment fostering research, development, and innovation to effectively meet the escalating needs of patients.
Moreover, the Bill encompasses stringent regulations for Good Manufacturing Practices and Good Distribution Practices, aimed at elevating the quality of medical products within the supply chain. It outlines a structured framework for conducting clinical trials, while steadfastly safeguarding the rights, safety, and well-being of participants, ensuring compensation in cases of injury or fatality.
An innovative aspect of this legislation is the promotion of global clinical trials and facilitating early access to cutting-edge drugs for public use, equally crucial are its provisions for recalling drugs from the market under specific conditions to uphold patient safety. Additionally, the Bill seeks to regulate the online sale of medicines streamlining these transactions to ensure patient safety and rationalise the process effectively. Considering the numerous patient-centric proposals in the Bill, it is crucial for the Parliament to expedite its passage.
—The author, Anubha Taneja Mukherjee, is Member Secretary, Thalassemia Patients Advocacy Group. The views expressed are personal.
(Edited by : C H Unnikrishnan)
First Published: Dec 17, 2023 10:06 AM IST
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