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Welcome to the December 2025 edition of our Life Sciences and Healthcare Newsletter, covering key regulatory, policy, and industry developments across the sector. This edition highlights recent updates in pharmaceutical, medical devices, and food regulations, including new food labelling, testing, and documentation requirements; enhancements in quality accreditation, and risk classification; and the launch of state-level and digital initiatives to strengthen the ecosystem.
In addition, we also examine a recent judicial decision impacting the life sciences and healthcare sectors. Stay informed on the evolving landscape with our comprehensive analysis and expert insights.
Medical Devices
MoHFW notifies draft amendment to the MDR Rules
The Ministry of Health and Family Welfare ("MoHFW") has released a draft amendment to the Medical Devices Rules, 2017 ("MDR Rules"). The draft proposes provision for Class A non-sterile, non-measuring ("NSNM") medical devices to display a "Registration Number" or "Reg. No." on their labels, as they do not have a licensing requirement under the extant MDR Rules. The amendment also enhances documentation requirements by requiring detailed sample information to be included in select forms. Notably, a new Form MD-44 has been introduced, enabling registered medical device testing laboratories to submit test or evaluation reports for medical devices.
To enhance regulatory oversight, the amendment mandates that license holders and registered medical device testing laboratories maintain an inspection book in Form MD-11. The amendment has omitted the provision for digital signature of the authority; thus, the form is required to be physically maintained, bearing the signature, seal, or stamp of the competent authority. The amendment further provides that certain licenses will now remain valid in perpetuity, unless suspended, cancelled, or surrendered, subject to the timely payment of the prescribed license retention fee under the MDR Rules. These changes aim to streamline procedures while reinforcing post‑market surveillance and clarity in regulatory responsibilities.
CDSCO adds new module on the Medical Devices Online Portal
The Central Drugs Standard Control Organization ("CDSCO"), through a circular dated 4 December 2025 has made functional a new Risk Classification Module on the CDSCO Online System for Medical Devices with effect from November 27, 2025, to simplify approvals and ease the process of risk classification of medical devices other than in-vitro diagnostic ("IVD") devices.
Under this new provision, applicants seeking risk classification for a medical device not included in the CDSCO's published classification list may submit application through the online portal to obtain the applicable risk classification under the MDR Rules. The initiative is intended to streamline the classification process and provide greater regulatory clarity for stakeholders.
ICMR and CDSCO publish MedTech Mitra's IVD Innovators Handbook
The Indian Council of Medical Research ("ICMR"), in collaboration with CDSCO has released the MedTech Mitra's IVD Innovators Handbook to provide structured regulatory and developmental guidance to innovators and manufacturers of IVD medical devices in India. The handbook sets out a step-by-step roadmap covering the entire IVD lifecycle, including proof of principle, product optimization, quality management systems, analytical and clinical performance evaluation, and regulatory submissions under the MDR Rules. It also includes stage-wise checklists and documentation guidance to assist founders in the industry in aligning product development with regulatory requirements.
Food Laws
FSSAI introduces standardised format for risk assessment representations
The Food Safety and Standards Authority of India ("FSSAI") has issued an office order mandating a standardised format for submissions of representation seeking risk assessment by its Science and Standards Division. The measure aims to address inconsistencies and data gaps in past representations, and to streamline scientific evaluation in line with the FSSAI (Transaction of Business and Procedure for the Scientific Committee and Scientific Panel) Regulations, 2016. With effect from January 1, 2026, all such representations are required to be submitted through the National Science Centre portal. The order also encourages voluntary data sharing by food business operators ("FBOs") and other stakeholders to support scientific assessment and standards-setting activities.
FSSAI clarifies use of the term "Tea" in labelling products
FSSAI has issued an office order clarifying the appropriate use of the term "Tea" under the Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 and the Food Safety and Standards (Labelling and Display) Regulations, 2020. The order specifies that beverages labelled as tea must be derived exclusively from the Camellia sinensis plant (including green tea, Kangra tea, and instant tea). Products marketed as "herbal tea," "rooibos tea," "flower tea," or other plant-based infusions that do not contain ingredients derived from Camellia sinensis are misleading and constitute misbranding under the Food Safety and Standards Act, 2006. FSSAI has directed all FBOs to refrain from using the term "Tea" for products that do not meet this requirement.
FSSAI Scheme of Testing of Packaged Drinking Water and Mineral Water replaces BIS certification standard
FSSAI has notified a Scheme of Testing for Packaged Drinking Water ("PDW") and Mineral Water ("MW"), following the gazette notification omitting the earlier requirement of mandatory Bureau of Indian Standards ("BIS") certification under the Food Safety and Standards (Prohibition and Restriction of Sales) Regulations, 2011. As a result of the omission, the BIS Certification Mark is no longer required for PDW and MW. The Scheme, effective from January 1, 2026, is intended to ensure the ongoing safety and regulatory compliance of PDW and MW in the Indian market, and all FBOs involved in their manufacture and sale are required to strictly comply with it.
The Scheme prescribes detailed testing and quality parameters, including microbiological, chemical, pesticide residue, and packaging-related controls, and it specifies testing frequencies and levels of control FBOs must follow. Testing must be conducted through FSSAI-notified laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories, using approved methods. FBOs are required to maintain test records and ensure appropriate corrective actions in cases of non-compliance. The Scheme also provides for increased testing frequency and potential risk-based inspections if non-compliances are detected.
Pharmaceuticals
NPPA fixes retail prices for 37 pharmaceutical formulations
The National Pharmaceutical Pricing Authority ("NPPA") has issued an order fixing the retail prices of 37 pharmaceutical formulations under paragraphs 5, 11, and 15 of the Drugs (Prices Control) Order, 2013 ("DPCO 2013"). The formulations span multiple therapeutic categories, including analgesics, antibiotics, cardiovascular drugs, anti-diabetics, respiratory medicines, vitamins, syrups, injections and combination therapies. The prices fixed by NPPA are exclusive of Goods and Services Tax ("GST") and apply only to the specific manufacturers or marketers who applied for price fixation as 'new drugs' under the DPCO 2013. NPPA has directed these entities to issue updated price lists in Form V through the Integrated Pharmaceutical Database Management System and to comply with applicable display and reporting requirements. Any overcharging may result in recovery of the excess amount along with interest, in accordance with provisions of the DPCO 2013 and the Essential Commodities Act, 1955.
Liberia accepts Indian Pharmacopoeia standards
The Indian Pharmacopoeia Commission ("IPC") has released an update highlighting the expanded acceptance and formal recognition of the Indian Pharmacopoeia ("IP") as an official reference for drug quality standards in multiple foreign countries, reflecting the growing global adoption of IP standards. The list of countries recognizing the IP has most recently expanded with the addition of Liberia, where a Memorandum of Understanding has been signed enabling Liberia to adopt the IP for medicine quality standards.
Education
NMC directs Medical Colleges to make legible handwriting as curriculum requirement
The National Medical Commission ("NMC") has directed all medical colleges and institutions across India to constitute a Sub-Committee under the Drugs and Therapeutics Committee ("DTC") to monitor prescription practices and ensure compliance with applicable statutory, regulatory, and ethical standards. This direction has been issued pursuant to a public notice of the Post-Graduate Medical Education Board of the NMC, following an order of the Punjab and Haryana High Court in Yogesh v. State of Haryana (CRM-M-30305-2024), wherein the Court recognized that the writing of clear and legible medical prescriptions forms an integral component of the right to health under Article 21 of the Constitution of India.
Under the NMC's directions, the DTC Sub-Committee is required to periodically review prescriptions, identify deviations from prescribed norms, recommend corrective measures, and maintain records of such reviews for inspection by the NMC. Medical institutions have also been instructed to reinforce, including through their academic curricula and training programmes, the importance of issuing clear and legible prescriptions, preferably written in capital letters and of prescribing medicines by their generic names.
Government Initiatives
QCI launches the Quality Setu Portal
The Quality Council of India ("QCI") has introduced the Quality Setu portal, a secure, ticket-based digital platform designed to enable time-bound grievance redressal and streamlined stakeholder engagement. Launched under the National Board for Quality Promotion, the portal offers a centralized and personalized interface for users to submit, track and resolve requests across QCI's boards, divisions, and cells. As part of QCI's broader quality reforms, the initiative is complemented by the proposed rollout of a single, paperless, modular one-stop accreditation platform aimed at replacing multiple existing accreditation portals and simplifying accreditation processes.
Government of Odisha releases Pharmaceutical and Medical Devices Policy, 2025
The Industries Department, Government of Odisha has introduced the Pharmaceutical and Medical Devices Policy, 2025, with the objective of strengthening the State's life sciences ecosystem through targeted incentives and integrated infrastructure development. A central feature of the policy is the establishment of the Odisha Pharma Park and the Odisha Medical Device Park as a mega pharma cluster, featuring Good Manufacturing Practices-compliant facilities supported by shared infrastructure such as effluent treatment plants, zero liquid discharge systems, skill development centres, and pre-approved industrial layouts equipped with cleanroom infrastructure, sterilization units, and assembly lines. The policy also promotes the development of private industrial parks and emphasizes skill development, institutional convergence, and academic collaboration.
To enhance investment attractiveness, it provides a comprehensive mix of financial and non-financial incentives such as land-related benefits, capital investment subsidies, power infrastructure support, State GST reimbursement, employee-linked incentives, and support for innovation and research and development. Pharmaceutical, bulk drug, biotechnology-based pharmaceutical, and medical device units eligible under Odisha's Industrial Policy Resolution, 2022 are also eligible to avail benefits under this policy.
Accreditation
BIS unveils new Hospital Bill Standard
The BIS has introduced Indian Standard (IS) 19493:2025, a uniform hospital billing standard aimed at improving transparency, consistency, and clarity in healthcare charges across India. Under the standard, bills are required to include clear, itemized details such as total charges, discounts or concessions, payment modes, and receipt numbers, enabling patients to better understand and verify costs of their care. The standard is currently voluntary in nature.
NABH revises Annual Accreditation Fee for NABH Ayush Accreditation Program
The National Accreditation Board for Hospitals & Healthcare Providers ("NABH") has issued a notification revising the annual accreditation fee for the NABH Ayush Hospital Accreditation Program. The revised fee slabs apply to Ayush healthcare facilities offering Ayurveda, Homeopathy, Unani, Siddha, Yoga and Naturopathy services, as well as Panchakarma Clinics and Day Care Centres, and are exclusive of GST.
The revised fee structure, which will come into effect from January 1, 2026, aligns the annual accreditation fee with the sanctioned bed strength of the facility, while the application fee remains unchanged. Ayush healthcare organizations whose accreditation fee due date falls on or after January 1, 2026, are required to comply with the revised fee structure.
Key Judgment
Kousik Pal v. B.M. Birla Heart Research Centre and Others 2025 SCC OnLine SC 2900
Background and Procedural History
The petitioner filed a complaint before the West Bengal Clinical Establishment Regulatory Commission ("Commission") under the West Bengal Clinical Establishments (Registration, Regulation and Transparency) Act, 2017 ("WBCE Act") following the death of his mother, alleging deficiency in service in detection, diagnosis, and treatment. The Commission awarded compensation of INR 20,00,000 (Indian Rupees Twenty Lakhs only). The respondent hospital's appeal was dismissed by a Single Judge of the Calcutta High Court. However, the Division Bench reversed the decision, holding that the Commission lacked jurisdiction as the issues involved medical negligence and deficiency in professional practice, which lay within the domain of specialized medical bodies. Aggrieved, the petitioner approached the Supreme Court.
Petitioners' Submissions
The petitioner alleged deficiency in service by the treating doctors, including mis recording the patient's condition as 'stable', delay in effecting transfer, and misguidance. The Commission accepted these submissions and further found that critical diagnostic procedures such as ECG and echocardiography were performed by personnel whose qualifications were not recognized by the State Medical Council ("State Council"). It held that, in a case of Acute Coronary Syndrome, performance of such procedures by unqualified personnel constituted a lapse attributable to the hospital. The Single Judge upheld these findings, observing that the Commission examined deficiency in service and not medical negligence, which falls within the jurisdiction of the West Bengal Medical Council ("WBMC").
Respondents' Submissions
The respondents contended that the Commission lacked jurisdiction to award compensation or examine professional qualifications. While this contention was rejected by the Single Judge, the Division Bench held that false claims of specialization amounted to professional misconduct under the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, falling within the exclusive jurisdiction of the WBMC. It further held that where professional competence of a medical practitioner is under scrutiny, as opposed to a hospitals' deficiency in service, the matter must be decided by the State Council. Applying the 'reasonable standard' test, the Division Bench concluded that the concerned personnel met the minimum qualifications prescribed by the Medical Council of India ("MCI") for conducting ECGs.
Court's Findings and Directions
The Supreme Court held that the Commission acted within its jurisdiction under Section 38(1)(x) of the WBCE Act in examining the qualifications of service providers. Under Section 2(v), a service provider is required to be appropriately trained and qualified, a requirement not satisfied in the present case. Relying on the MCI's letter, the Court held that clinical interpretation of echocardiograms requires an MD (Medicine), which qualification was not possessed by the concerned practitioner.
The Court clarified that the Commission confined its inquiry to deficiency in patient care services and examination of service providers credentials and did not adjudicate medical negligence. It further held that the power of the Commission to award compensation under the WBCE Act is distinct from the disciplinary jurisdiction of the State Council. By adopting an unduly expansive view of the State Council's role, the Division Bench had effectively denuded the Commission of its statutory function, contrary to legislative intent. Accordingly, the Single Judge's order was restored, and the respondents were directed to pay awarded compensation with 6% interest within eight weeks.
Legal Determinations
The Court held that the Commission's power to award compensation for deficiency in patient care service under the WBCE Act is separate and independent from the State Council's jurisdiction to adjudicate medical negligence and professional misconduct.
The Editor's Note:
The regulatory framework governing the life sciences and healthcare sector continued to expand and strengthen in December 2025, with the regulators emphasizing quality, transparency, and accountability. Key developments span proposed changes to the Medical Devices Rules and new digital module for risk classification to clarity on food labelling and new testing standards, updated pricing controls, improved hospital bill standards, and state-level policy initiative to develop life sciences ecosystem. Alongside these regulatory advances, a recent Supreme Court ruling underscores the heightened judicial scrutiny when it comes to defining jurisdictional boundaries in patient care oversight.
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