19 May 2025
In this update:
Partner: Kirti Balasubramanian, Associates: Yashaswini Hareesh and Rimjhim Mishra
The Central Drugs Standard Control Organisation (CDSCO) announced that the mandatory registration of clinical research organisations (CRO), introduced by the New Drugs and Clinical Trials (Amendment) Rules, 2024, is effective from 1 April 2025. This regulatory shift is a crucial step towards ensuring the integrity of patient information and the safety of clinical trial participants. The amendment rules also establish a more structured approval process, specify a five-year registration validity period, and provide for appeals in case of registration rejection. These measures aim to enhance transparency and maintain accountability within the clinical research sector. (To read our earlier update on these amendment rules, click here.)
Moving forward, CROs must adhere to strict standards of documentation, staffing, and quality control. This is intended to align India’s clinical trials with global standards. Consequently, pharmaceutical and healthcare stakeholders must ensure proactive and timely compliance. Failure to comply with these new requirements could result in penalties, rejection of trial results, or even cancellation of registration.
Schedule M of the Drugs Rules, 1945, which contains the Goods Manufacturing Practices (GMP), was amended in 2023. On 11 February 2025, the Ministry of Health and Family Welfare notified the Drugs Amendment Rules, 2025, which grant small and medium pharmaceutical manufacturers time until 31 December 2025 to meet the compliance requirements of the revised GMP under Schedule M.
This move addresses the concerns of smaller industry players regarding the financial and infrastructural challenges associated with a short compliance timeline for upgrading manufacturing facilities. Consequently, small and medium manufacturers with an annual turnover of INR 250 crore or less have been provided this extended window to become fully compliant. However, this extension will only be approved if they submit Form A to the amendment rules, actively seeking the extension. Additionally, they must provide a detailed upgradation plan and an undertaking to comply with the requirements of the revised Schedule M. The updated Schedule M introduces stricter protocols for quality management systems, facility design, documentation procedures and other key aspects of drug manufacturing to elevate manufacturing standards to global benchmarks.
In a significant move to bolster India’s healthcare innovation framework, the Indian Council of Medical Research (ICMR) has introduced the Medical Innovations Patent Mitra – a platform to provide end-to-end support for patent filings and technology transfer of medical innovations. Launched by the Union Health Ministry during the International Symposium on Health Technology Assessment (ISHTA), this initiative aims to promote and protect biomedical research by offering complete assistance, from assessments of patents to prosecution and maintenance. Developed under the guidance of NITI Aayog in collaboration with the Department of Pharmaceuticals, this initiative is seen as a crucial step towards bridging the innovation-to-market gap in the healthcare sector.
For stakeholders such as medical research institutions, this initiative presents a strategic opportunity to align with India’s vision for a self-reliant and innovation-driven MedTech ecosystem. Participation in technology transfer platforms like the MedTech “Mela” is encouraged. This move by the central government aims to accelerate transnational research and scale cutting-edge innovations across the country’s healthcare landscape.
The National Pharmaceutical Pricing Authority (NPPA) issued an office memorandum on 7 February 2025, mandating all retailers, dealers, and online pharmacies to ‘conspicuously display’ the current price list of medicines. This directive clarifies the somewhat ambiguous requirements of Paragraphs 24 and 25 of the Drugs (Prices Control) Order (DPCO), 2013 regarding how such price lists must be displayed. The office memorandum specifies that this display must be “on a conspicuous part of the premises where he carries on business”, explicitly extending this requirement to the online and electronic platforms of retailers, dealers and pharmacies, in addition to physical locations. Failure to comply with this office memorandum can result in penalties under Section 7 of the Essential Commodities Act, 1955, which includes imprisonment ranging from a minimum of three months to a maximum of seven years, along with imposition of a fine.
However, the office memorandum does not provide guidance on how these price lists may be maintained over time, especially when product prices vary. It only stipulates that the lists must contain ‘current prices’. This lack of clarity on the practical aspects of maintaining a consistent up-to-date display poses difficulties for retailers, dealers and pharmacists. The industry may need to develop a uniform approach to meet this requirement or seek further clarity from the NPPA to ensure effective implementation.
The Supreme Court has reaffirmed that medical professionals are liable under the Consumer Protection Act, 2019 for negligence and deficiencies in services by dismissing a review petition1 against its 1995 ruling in Indian Medical Association v V.P. Shantha. This ruling reinforces the legal recourse available to patients seeking redressal of medical negligence, strengthening patient rights. It also mandates higher standards of accountability in healthcare services. The Supreme Court’s continued support for consumer rights in the healthcare industry necessitates that medical professionals implement more robust risk management and compliance measures to mitigate potential legal liabilities.
The Supreme Court set aside2 the orders of the Allahabad High Court, which had restricted the sale of certain herbal medicinal products offered by Bhagwati Medical Hall, the appellant in this case. The case arose after a local drug inspector and the District Magistrate directed the appellant to cease selling ‘aromatic tincture of cardamom’, a licensed non-prescription medicine under the Drugs and Cosmetics Act, 1940 (Drugs Act), due to the high alcohol content in the tincture. The High Court had upheld these orders.
On appeal, the Supreme Court clarified that Section 26A of the Drugs Act empowers only the central government to restrict or prohibit the sale of a drug on account of public interest. The powers of drug inspectors under Section 22 of the Drugs Act are merely procedural, including sampling, inspecting, and seizing non-compliant drugs. The Supreme Court held that such powers do not confer authority on the inspectors to impose prohibitions or to classify a duly licensed drug as contraband. This ruling reinforces the principle that local authorities cannot overstep their statutory mandate and take arbitrary action impacting legitimate and licensed business operations.
[1] Medico Legal Society of India v Bar of Indian Lawyers & Ors., DIARY NO(S). 57132/2024 IN C.A. NO. 2646/2009
[2] M/s Bhagwati Medical Hall & Anr. v Central Drugs Standard Control Organization & Ors., Civil Appeal Nos.14735-14736 of 2024
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