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India's life sciences and healthcare regulatory landscape continued to evolve in February 2026, with developments spanning drug pricing, clinical trial governance, medical device regulation and digital health policy. Courts have also continued to play an important role in defining the regulatory boundaries of emerging medical treatments.
This update highlights key regulatory and policy developments relevant to pharmaceutical, biotechnology, medical device and healthcare sector stakeholders operating in India.
Key Takeaways
- CDSCO has directed manufacturers to update prescribing information for Carbimazole and Doxycycline formulations.
- NPPA has directed manufacturers to revise MRPs of certain life-saving drugs following customs duty exemptions, requiring that the benefit be passed on to consumers.
- Draft amendments to the NDCT Rules propose a structured framework for post-approval quality changes, introducing categorization of changes into major, moderate and minor levels.
- MoHFW has proposed changes to the ethics committee registration process, including removal of provisional registration.
- CDSCO has issued draft guidance on the import of IVD medical devices, clarifying regulatory expectations and documentation requirements.
- The Supreme Court has clarified that stem cell therapy for Autism Spectrum Disorder cannot be offered as a routine clinical service outside an approved research or clinical trial framework, reinforcing the requirement for evidence-based medical interventions
Pharmaceuticals
CDSCO Mandates Prescribing Information Updates for Carbimazole and Doxycycline
The Central Drugs Standard Control Organization (CDSCO), through letters dated February 17, 2026, has directed all State and Union Territory Licensing Authorities to instruct manufacturers to update the Prescribing Information Leaflets (PIL) and package inserts for Carbimazole and Doxycycline formulations.
For Carbimazole, manufacturers must include “agranulocytosis” as an adverse drug reaction (ADR) in the PIL and promotional materials. For Doxycycline, manufacturers are required to incorporate central nervous system effects (Restlessness, Anxiety, Irritability, Nervousness, and Dizziness) as ADR in the caution section of the package insert and PIL.
State Drugs Controllers have been directed to ensure implementation of the revised safety disclosures and report compliance to CDSCO. Manufacturers should review product labelling and promotional materials to ensure alignment with the updated prescribing information requirements.
Drugs (Amendment) Rules, 2026 - Endotoxin testing and supervision requirements
The Drugs (Amendment) Rules, 2026 amend provisions of the Drugs Rules, 1945 to introduce changes relating to endotoxin testing and supervision of drug sales.
Key changes include:
- Endotoxin testing requirement - Amendments to Rule 121A require solutions for parenteral administration, including accompanying aqueous solvents, must comply with bacterial endotoxin or pyrogen testing standards specified in the current edition of the Indian Pharmacopoeia.
- Supervision by competent person - Amendments to Forms 20B, 20G and 21B in Schedule A require that the sale of drugs be conducted under the personal supervision of a competent person, and any change in such person must be reported to the licensing authority within one month.
- Clarification regarding Schedule H - A clarification has been inserted specifying that drugs falling under serial number 15 of Schedule K are excluded from Schedule H.
The amendments came into force upon publication of the notification.
Pricing Control
NPPA directs MRP revision following customs duty exemption on certain life-saving drugs
Following the Government's decision to exempt customs duty on 17 life-saving drugs, the National Pharmaceutical Pricing Authority (NPPA) issued an Office Memorandum dated 10 February 2026 directing manufacturers to revise the maximum retail prices (MRPs) of these medicines.
The direction aims to ensure that the benefit of the customs duty exemption is passed on to consumers.
Drugs covered by the notification include several oncology therapies, such as Ibrutinib, Dabrafenib, Trametinib, Ipilimumab, Ribociclib, Venetoclax
Manufacturers are required to revise MRPs and submit updated price lists to NPPA in accordance with the Drugs (Prices Control) Order, 2013.
Why this matters: Pharmaceutical companies marketing these products in India should ensure timely revision of MRPs and related regulatory filings to remain compliant with NPPA requirements.
Clinical Trials
Draft NDCT Amendments Introduce Framework for Post-Approval Quality Changes
The Ministry of Health and Family Welfare (MoHFW) has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019 proposing a structured regulatory framework governing post-approval quality changes.
The proposed amendments classify manufacturing and quality-related changes into three categories, based on their potential impact on the identity, strength, quality, purity, or potency of the drug product, based on their potential impact on the identity, strength, quality, purity, or potency of the drug product:
- Level I - Major changes
- Level II - Moderate changes
- Level III - Minor changes
Major and moderate changes would require prior approval from the licensing authority, while minor changes (except those related to the shelf life of the drug substance or drug product) may be implemented without prior approval and reported annually.
Why this matters: If implemented, the proposal will introduce a structured lifecycle management framework for approved drugs and may require companies to revisit internal regulatory change management processes.
Proposed Streamlining of Ethics Committee Registration
The MoHFW has also proposed amendments to Rule 17 of the NDCT Rules to simplify the registration process for Ethics Committees involved in biomedical and health research.
Under the proposed framework, the requirement for provisional registration would be removed. Instead, the designated authority would scrutinize the documents and information furnished with the application submitted in Form CT-01 and grant final registration in Form CT-03 if satisfied with the documentation submitted or reject the application with reasons recorded in writing.
If implemented, the amendment would streamline the Ethics Committee registration process by eliminating the interim provisional registration stage.
Medical Devices
CDSCO Issues Draft Guidance on Import of IVD Medical Devices
CDSCO has issued a draft Guidance outlining regulatory requirements for import of in-vitro diagnostic (IVD) medical devices into India through the CDSCO MD Online portal and the National Single Window System.
The Guidance outlines the regulatory framework under the Medical Devices Rules, 2017, including risk-based classification of IVD devices (from Class A to D), applicable import licensing pathways (Test, Fresh, Endorsement, and Retention licenses), the roles of stakeholders and documentation requirements for import applications.
The document also highlights common compliance issues identified by regulators during the review of import applications as well as compliance responsibilities of foreign manufacturers and authorized Indian agents.
Why this matters: The guidance provides practical insight into CDSCO expectations and may help importers address regulatory queries more effectively during the approval process
Stakeholder Consultation on Global Tender Enquiry Exemption List for Medical Devices
The Department of Pharmaceuticals has invited stakeholder comments on proposed amendments to the Global Tender Enquiry (GTE) Exemption List for medical devices.
The proposed changes follow the revised list of 354 medical devices issued by the Ministry of Finance under Rule 161(iv) of the General Financial Rules, 2017. The list allows procurement through global tender enquiry notwithstanding the INR 200 crore procurement threshold.
The revised list incorporates nomenclature updates suggested by the MoHFW and includes several advanced diagnostic, surgical and critical care devices.
Why this matters: The GTE exemption framework continues to be a key policy instrument supporting domestic medical device manufacturing and procurement.
Government Initiatives and Digital Health
Government measures addressing air pollution-related health risks
The MoHFW has announced measures aimed at addressing the growing public health burden arising from air pollution, particularly respiratory diseases. A Technical Expert Group chaired by the Director General of Health Services has been constituted to develop policy and clinical recommendations.
National guidelines for lung cancer treatment and palliation
The Department of Health Research (DHR) has issued National Evidence-Based Guidelines for Lung Cancer Treatment and Palliation, containing 15 evidence-based recommendations tailored to the Indian healthcare context.
Launch of SAHI and BODH Digital Health Initiatives
At the India AI Impact Summit 2026, the MoHFW launched two digital health initiatives:
- SAHI - Strategy for Artificial Intelligence in Healthcare for India
- BODH - Benchmarking Open Data Platform for Health AI
SAHI establishes a governance framework for the responsible and transparent deployment of artificial intelligence technologies in healthcare. BODH, developed jointly with IIT Kanpur and the National Health Authority, enables benchmarking of health AI models using anonymized real-world datasets to assess performance and reliability.
Both initiatives align with the broader digital health infrastructure being developed under the Ayushman Bharat Digital Mission.
National Action Plan on Antimicrobial Resistance 2.0
The Government of India has released the updated National Action Plan on Antimicrobial Resistance (NAP-AMR 2.0), aligning India's policy framework with global efforts to address antimicrobial resistance.
The updated plan adopts a “One Health” approach encompassing human health, animal health, agriculture and environmental sectors. It emphasizes enhanced surveillance, responsible antimicrobial use, infection prevention and control, strengthened research initiatives and awareness among healthcare professionals and the public.
Accreditation
NABH Revises Implementation Plan for Entry-Level Hospital Certification Standards
The National Accreditation Board for Hospitals and Healthcare Providers (NABH) has issued a revised implementation plan for the second edition of its Entry-Level Certification Standards for Hospitals.
The revised standards introduce updated evaluation criteria across three categories (Core, Commitment and Excellence) which apply progressively based on hospital size (bed strength), applicant category and certification cycle.
Key Judicial Development
Supreme Court Clarifies Regulatory Framework for Stem Cell Therapy
In Yash Charitable Trust and Others v. Union of India and Others (2026 INSC 96), the Supreme Court examined whether stem cell therapy for Autism Spectrum Disorder (ASD) could lawfully be offered as a routine clinical service. The Court held that stem cell therapy for ASD cannot be administered as a standard clinical treatment outside an approved clinical trial or research framework.
The Court relied on recommendations issued by the National Medical Commission and national stem cell research guidelines, which conclude that stem cell therapy for ASD remains an unproven intervention.
Why this matters: The ruling reinforces regulatory oversight over stem cell-based therapies and underscores that experimental therapies must be administered only within approved clinical research settings.
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