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The life sciences and healthcare industry in India continues to evolve through regulatory and policy developments. In March 2026, key developments included proposed frameworks for post-approval change management, revised standards for clinical establishments, regulatory action on the promotion of prescription drugs, and changes impacting food business licensing and registration. The Supreme Court has also continued to shape the legal framework governing end-of-life medical decision-making.
This update highlights key regulatory and policy developments relevant to pharmaceutical, biotechnology, medical device and healthcare sector stakeholders operating in India.
Key Takeaways
- MoHFW proposes a risk-based framework for reporting and managing post-approval manufacturing changes.
- CDSCO implements a “prior intimation” system to facilitate certain drug development activities.
- Proposed amendments seek to revise testing requirements for blood products.
- MoHFW proposes updated minimum standards for various clinical establishments based on service delivery models.
- CDSCO advises against direct or indirect public promotion of GLP-1 receptor agonists.
- The National Dental Commission has been constituted, replacing the Dental Council of India.
- The Supreme Court clarifies that clinically assisted nutrition and hydration constitutes medical treatment that may be withdrawn where continued intervention is futile.
Pharmaceuticals
Draft Amendment to Drugs Rules Introduces Framework for Post-Approval Changes
The Ministry of Health and Family Welfare (MoHFW) has issued a draft amendment to the Drugs Rules, 1945, introducing a structured framework for manufacturers to report and manage changes relating to the manufacturing process, excipients, packaging, shelf life, specifications, testing, or documentation.
The draft amendment establishes a three-level classification system based on the potential impact of changes on the identity, strength, quality, purity, or potency of a drug product:
- Level I (Major Change) - Requires prior approval from the licensing authority
- Level II (Moderate Change) - Requires prior approval from the licensing authority
- Level III (Minor Change) - No prior approval required (except for changes relating to shelf life); annual reporting to the licensing authority in the first quarter of each calendar year.
The amendments are proposed to be inserted into Rules 74, 74A, 74B, 78, 78A, 122P, and various License Forms. Notably, Rules 74A and 122P follow a modified approach, requiring notification within 30 days for certain changes, with prior approval required only for major changes.
Why this matters: If implemented, the proposed framework introduces a more structured and risk-based approach to post-approval change management, balancing regulatory oversight with operational flexibility.
Marketing Authorization and Grant of License for r-DNA Products
The Central Drugs Standard Control Organization (CDSCO) has revised the submission procedures for post-approval changes relating to marketing authorization of r-DNA products by transitioning the process to the SUGAM portal. Offline submissions are no longer permitted.
Separately, CDSCO has also transitioned the application process for grant of licenses in Form 28-D and Form 28-DA for r-DNA products to the ONDLS portal. Offline submissions are no longer permitted.
Link here (Market Authorization)
Proposed Amendment to Blood Product Testing Norms
A proposed amendment to the Drugs Rules seeks to revise testing requirements for blood products by omitting certain mandatory viral testing requirements at the final product stage.
CDSCO Advisory on Promotion of GLP-1 Receptor Agonists
CDSCO has issued an advisory directing manufacturers and importers of GLP-1 receptor agonists to strictly adhere to regulatory requirements governing manufacture and promotion.
The advisory prohibits direct or surrogate promotion to the public, including through digital channels and disease awareness campaigns, as well as any exaggerated claims regarding therapeutic efficacy or guaranteed outcomes.
Manufacturers and marketing authorization holders are also required to implement appropriate risk management plans.
Why this matters: The advisory reflects increased regulatory scrutiny over the promotion of prescription drugs, particularly in high-demand therapeutic areas such as weight management.
Surveillance of GLP-1 Drug Supply Chains
CDSCO has intensified surveillance of GLP-1 drug supply chains following concerns regarding unsupervised use and unauthorized sales. Inspections have been conducted across multiple entities involved in the supply chain.
The regulator has reiterated that such drugs are high-risk medications and should only be used under the supervision of qualified medical practitioners. Non-compliance may result in regulatory action, including license cancellation and prosecution.
Unapproved Sodium Hyaluronate Eye Drops
CDSCO has directed that Sodium Hyaluronate Eye Drops 0.3% w/v, classified as a “new drug”, must not be manufactured or marketed without prior approval from the Central Licensing Authority.
State and Union Territory regulators have been directed to revoke any existing permissions granted for this formulation.
Guidance on Dossier-Based Licensing of Drugs
CDSCO has issued guidance on dossier-based licensing aimed at standardizing the grant of manufacturing licenses across State Licensing Authorities.
The guidance introduces a checklist-based framework for submissions, covering both facility-related and product-specific requirements.
Why this matters: A standardized approach is likely to improve consistency and transparency in licensing decisions, while requiring manufacturers to align internal documentation processes with prescribed formats.
CDSCO Streamlines WCC Process for API Exports to the EU
CDSCO has streamlined the process for issuance of Written Confirmation Certificates (WCCs) for Active Pharmaceutical Ingredients exported to the European Union.
The revised process introduces defined timelines for review at zonal offices and headquarters, supported by standard operating procedures.
Medical Devices
Mandatory Licensing for IVF and ART Medical Devices
CDSCO has clarified that medical devices used in IVF and ART procedures fall within the regulatory framework under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017.
The regulator has noted instances of unlicensed sale of such devices and clarified that no such devices may be imported, manufactured, distributed, or sold without the requisite license.
Pricing Control
NPPA Fixes Retail Prices of New Drug Formulations
The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices for 20 new drug formulations under the Drugs (Prices Control) Order, 2013. The new formulations include cardiovascular, anti-diabetic, ophthalmic, and anti-infective combinations.
WPI based MRP Increase for 2025
The government has notified a Wholesale Price Index (WPI) increase of 0.64956% for 2025. Manufacturers may increase the MRP of scheduled formulations accordingly without prior approval.
Revision of Ceiling Prices for Scheduled Formulations
NPPA has revised ceiling prices for scheduled formulations under the National List of Essential Medicines (NLEM), effective April 1, 2026.
Link here (Price revision for scheduled formulations under NLEM 2022)
Link here (Price revision for scheduled formulations under NLEM 2015)
Clinical Trials
Implementation of “Prior Intimation” System
CDSCO has implemented a “prior intimation” system for certain analytical and non-clinical testing activities under the New Drugs and Clinical Trials (Amendment) Rules, 2026.
Acknowledgements generated through the portal or via email will be treated as valid prior intimation.
The circular reiterates that prior intimation system is not applicable to sex hormones, cytotoxic drugs, beta-lactam drugs, biologics containing live microorganisms, or narcotic and psychotropic substances. For these excluded categories, the prior approval system shall remain applicable.
NMC Advisory on Stem Cell Therapy
The National Medical Commission and Indian Council of Medical Research have issued an advisory mandating compliance with the Supreme Court’s ruling on stem cell therapy.
Stem cell therapies are permitted only for disease conditions specified in the list of MoHFW approved indications as standard care, and otherwise only within the context of approved research. Stem cell research needs to be conducted in compliance with prior approval of either CDSCO or Department of Health Research depending on the level of manipulation of stem cells.
Medical practitioners and medical colleges are directed to comply with the advisory against unauthorized stem cell treatments.
Food Laws (Select Developments)
Licensing and Registration of Food Businesses
The Food Safety and Standards Authority of India (FSSAI) has issued amendments to simplify licensing and registration processes, introduce perpetual licenses, and implement risk-based inspection frameworks. The scope of "Petty Food Business Operator" has been expanded by removal of the turnover and production capacity thresholds and inclusion of street food vendors and food trucks operators. Instant registration is available upon document submission and businesses registered under the Street Vendors (Protection of Livelihood and Regulation of Street Vending) Act, 2014 are deemed registered under the FSA, provided they comply with hygiene standards under Schedule 4. Licenses under the FSA will now have perpetual validity, unless suspended, cancelled or surrendered. A new risk-based inspection framework dictates audit frequency and nature of inspection.
Why this matters: The amendments aim to streamline registration and licensing procedures for small and informal food businesses as well as strengthen food safety oversight and hygiene standards.
Revised Turnover Thresholds for Food Businesses
FSSAI has revised turnover thresholds determining registration and licensing requirements for food businesses.
For food businesses having a turnover up to INR 1.5 crore they would be require registration, those with turnover between INR 1.5 crore and INR 50 crore will require a state license, and those exceeding INR 50 crore will require a Central license.
Why this matters: Businesses may need to reassess their licensing category and ensure compliance with revised thresholds.
Amendments to Packaging Regulations
Draft amendments propose updated definitions and requirements relating to food packaging materials, including food contact material, food grade contact material, modified atmosphere packaging, food packaging, non-intentionally added substances, and aseptic packaging.
Amendments to Labelling and Display Regulations
Amendments (to be effective from July 1, 2027) introduce revised labelling requirements and exemptions across various food product categories. Labelling exemptions for nutritional products have been broadened. Non-retail container labelling requirements have been significantly restructured.
Health supplements and Nutraceuticals with insignificant energy contribution in tablet, pills and capsule format are exempted from macronutrient declarations where, packages of 100 square centimeters or less are formally exempted from displaying notified FSSAI logos, and Infant Nutrition products are exempted from per-serve recommended dietary allowances declarations.
Clinical Establishments
Updated Minimum Standards for Clinical Establishments
MoHFW has proposed updated minimum standards for clinical establishments based on service delivery models. These include standards for clinics or polyclinics for consultation, with dispensaries, with observation and short stays, and with diagnostic support services. Additionally, it introduces specific minimum standards for sample collection centres and mortuaries.
Why this matters: The proposal aims to standardize quality and safety benchmarks across healthcare facilities.
NABH Certification Standards for Emergency Departments
NABH has issued revised certification standards, with new applications under the previous version no longer accepted after March 31, 2026.
Mandatory registration on e-RaktKosh Portal
CDSCO has mandated registration of blood centres on the e-RaktKosh portal to enable real-time monitoring.
Blood Centres are also required to regularly update availability of blood stock and blood components on the Portal along with information on blood donors and monthly reports.
Why this matters: This enhances transparency and improves emergency response capabilities.
Practitioner Commission
Constitution of National Dental Commission
The National Dental Commission has been constituted, replacing the Dental Council of India.
Why this matters: This represents a structural shift in regulation of dental education and professional standards.
NCAHP Amendment Rules
The National Commission for Allied and Healthcare Professions has issued the NCAHP (Amendment) Rules, 2026 which introduce term limits, governance requirements, and financial reporting obligations for the Commission and its members.
Why this matters: The changes strengthen governance and accountability within the Commission.
Key Judicial Development
In the case of Harish Rana v. Union of India and Others (2026 INSC 222), the Supreme Court considered the legality of withdrawing life sustaining treatment from a patient who was in a persistent vegetative state for more than thirteen (13) years after sustaining a traumatic brain injury. The Supreme Court held that “Clinically Assisted Nutrition and Hydration” (CANH), constitutes “medical treatment” as opposed to basic care, and that life-sustaining treatment may be withdrawn where continued medical interventions were futile, as they were only sustaining the patient’s vegetative state.
The Court reaffirmed that the right to die with dignity forms part of Article 21 and called for a statutory framework governing end-of-life decision-making.
Why this matters: The judgment provides clarity on withdrawal of life-sustaining treatment and reinforces the legal framework governing end-of-life care in India.
Editor's Insight
Recent developments reflect increased regulatory focus on post-approval change management, responsible promotion of prescription medicines, streamlining of clinical trial processes, and reforms in food licensing and compliance frameworks. Judicial developments continue to shape the legal framework governing end-of-life medical decision-making in India.
Companies operating in the pharmaceutical, biotechnology, medical device and healthcare sectors should monitor these developments closely, as they may have implications for regulatory strategy, compliance, and product lifecycle management in India.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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