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In May 2026, key developments included CDSCO clarifying the regulatory status of cosmetic products used as injectables, implementation measures aimed at streamlining clinical trial and regulatory processes, ICMR’s introduction of operational guidelines for single ethics review of multicentre research, NABH’s release of new accreditation standards for Ayush hospitals, and regulatory initiatives affecting digital health, advertising and food businesses. Judicial developments during the month also provided important guidance on medical negligence proceedings and protection of pharmaceutical trademarks.
This newsletter highlights key regulatory and policy developments relevant to pharmaceutical, biotechnology, medical device and healthcare sector stakeholders operating in India.
Key Takeaways
- CDSCO extends the reminder mechanism for long-pending applications on the SUGAM Portal.
- CDSCO clarifies that cosmetics cannot be manufactured, marketed or used as injectable preparations and may not be used for treatment purposes.
- CDSCO mandates parallel submission of clinical trial protocols to speed approvals.
- CDSCO introduces procedural measures to streamline clinical trial approvals and regulatory submissions.
- ICMR issues operational guidelines for single ethics review of multi-centre research studies.
- ASCI proposes a risk-based framework for labelling AI-generated content in advertisements.
- NABH releases revised accreditation standards for Ayush hospitals effective August 2026.
- DoCA clarifies the permissibility of displaying customary units alongside mandatory SI units under the Legal Metrology framework.
- FSSAI amends contaminant and residue standards applicable to specified food categories.
- The Supreme Court clarifies that legal heirs of deceased medical practitioners may be impleaded in consumer proceedings only in respect of surviving estate-based claims.
Pharmaceuticals
CDSCO Issues Reminder Mechanism for Long-Pending Portal Applications
The Central Drugs Standard Control Organization (CDSCO) issued a public notice addressing the backlog of long-pending applications on the SUGAM Portal where applicants have not responded to evaluation queries. CDSCO has now extended the structured reminder mechanism to GCT, BA/BE, Ethics Committee and Veterinary.
The structured reminder mechanism operates at fixed intervals, requiring applicants to respond to pending queries raised during evaluation. A series of three reminders are sent 30 days apart, followed by a fourth and final disposal notice informing them that their application stands rejected with fees forfeited.
Why this matters: It signals CDSCO's intent to actively clear its backlog and enforce accountability on applicants.
CDCSO Advisory PSUR Submission Timelines from Launch Date[DLL2.1]
CDSCO advisory clarifies that Periodic Safety Update Reports (PSURs) submission timelines for new drugs must begin from the date of actual market launch, not the date of regulatory approval.
It also directs that all dosage forms, formulations, and indications for a new drug should be consolidated into a single PSUR, with separate data presentations within it, to avoid duplicate submissions of PSUR applications.
Why this matters: Aligning PSUR reporting timelines with actual market launch is intended to ensure that post-marketing safety reporting is based on meaningful real-world exposure data and avoids unnecessary reporting obligations before a product reaches patients.
CDSCO Tightens Enforcement on GLP-1 Weight Loss Drugs
CDSCO circular directing all State and Union Territories Drug Controllers to strengthen enforcement against the unauthorized promotion and distribution of GLP-1 based weight loss drugs. Controllers are asked to monitor the entire supply chain, from manufacture to dispensing ensuring sales occur only through authorized channels and strictly in line with approved indications and labelling.
They are also directed to monitor all media platforms for non-compliant advertisements and take action under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, Drugs and Cosmetics Act, 1940 (D&C Act) and Rules made thereunder, along with undertaking coordination with Advertising Standards Council of India (ASCI) and other relevant agencies.
Pregablin added to Schedule H1 under Drugs Rules
Ministry of Health and Family Welfare (MoHFW) has notified the inclusion of Pregabalin under Schedule H1 of the Drugs Rules, 1945 (Drugs Rules).
Why this matters: This notification was introduced to curb the widespread misuse, illegal trafficking and abuse of the nerve pain medication particularly among youth.
Cosmetics
CDSCO Clarifies Cosmetics Not Permitted as Injectables or for Treatment
CDSCO has clarified that cosmetics (as defined under the D&C Act) are only meant to be applied externally (rubbed, poured, sprinkled, sprayed, introduced into, or applied to) and cannot be manufactured, marketed or administered as injectable preparations and may not be used for treatment purposes.
The list of generally not recognized as safe (GNRAS) and restricted ingredients is published by the Bureau of Indian Standards. No false or misleading claims may appear on cosmetic labels, and manufacturers' inscriptions on containers, labels, or wrappers cannot be altered or defaced.
Violations such as use of prohibited ingredients, misleading claims on labels, use of cosmetics for treatment, or cosmetic injections are punishable under the D&C Act and Cosmetics Rules, 2020.
Why this matters: The notice reflects increasing regulatory scrutiny of aesthetic and cosmetic procedures and reinforces the distinction between cosmetic products and regulated drugs or medical devices.
Clinical Trials
CDSCO Interim Procedure for CT-16 Import Applications for BA/BE Export Studies
CDSCO notice addresses the lack of system linkage between the Prior Intimation application (Form CT-05) submitted on the Sugam Portal and the Form CT-16 filed for import application of Reference Listed Drug/ Investigational Medicinal Product intended for conduct of BA/BE studies for export purposes.
As an interim measure, applicants must now submit a standalone Form CT-16 application through the NSWS portal along with six specified documents. This arrangement does not waive compliance under New Drugs and Clinical Trials Rules, 2019 (NDCT Rules).
CDSCO Advisory on Parallel Submission and Processing of Clinical Trial Applications[DLL4.1]
CDSCO advisory instructs applicants to submit Clinical Trial protocols simultaneously to both CDSCO and concerned Ethics Committees registered under NDCT Rules, rather than sequentially. Registered Ethics Committees are directed to independently review and process Clinical Trial protocols submitted to them without awaiting prior approval from the Central Licensing Authority.
Why this matters: The advisory seeks to facilitate concurrent review by CDSCO and registered Ethics Committees, potentially reducing overall approval timelines for eligible clinical studies.
Link Here | News Article 1 | News Article 2
Clinical Research
ICMR Guidelines for Single Ethics Review of Multicentre Research
Indian Council of Medical Research’s (ICMR) Operational Guidelines for Single Ethics Review of Multicentre Research in India are an addendum to its National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017. It establishes a streamlined process for ethics committees to conduct a unified review across multiple research sites, minimizing duplication and strengthening coordination.
The guidelines apply to all types of multicenter biomedical and health research, covering studies where sites undertake identical protocol activities as well as those where different sites handle distinct components of the same study, such as participant recruitment, interventions, data analysis or data management. Applicability to regulatory clinical trials, remains subject to the D&C Act, NDCT Rules, and other applicable regulations.
Why this matters: Fragmented ethics committee approvals have long delayed multicenter research in India; these guidelines address this by creating a single, consistent review process that speeds up study initiation without compromising participant protection.
Professionals
PCI Circular on Exclusive Inspection Authority over Pharmacy Institutions
The Pharmacy Council of India (PCI) has instructed all State Governments, Universities, and related authorities to stop conducting inspections of pharmacy institutions after getting the approval of PCI, as this power vests exclusively with PCI under Section 16 of the Pharmacy Act, 1948. Two High Court rulings, from the Bombay High Court (Nagpur Bench) and the Karnataka High Court, confirm that State authorities lack jurisdiction to conduct such inspections, and that issuing an No Objection Certificate (NOC) does not confer ongoing inspection authority. Where complaints arise concerning a pharmacy institution, authorities must forward them to PCI for appropriate action.
Recognition of Medical Practitioners under the Code on Social Security, 2020
A Gazette notification S.O. 2352(E) issued by the Ministry of Labour and Employment under the Code on Social Security, 2020 (Social Security Code), officially recognizing persons with a recognized medical qualification, registered with the National Medical Commission, the National Commission for Indian System of Medicine, or the National Commission for Homoeopathy, or their respective Autonomous Boards and State Medical Councils as "medical practitioners" for the purposes of Chapter IV of the Social Security Code.
Advertisements
ASCI AI Advertising Guidelines Provides a Risk-Based Labelling Framework
The ASCI Draft Guidelines for Responsible Labelling of Synthetically Generated Content in Advertising establish a risk-based framework that categorizes AI-generated advertising content into high, medium, and low risk tiers.
High-risk content is prohibited altogether, as such advertisements violate the ASCI Code even where an AI label is used. Medium-risk content requires mandatory labelling where AI use materially influences consumer decisions and where non-disclosure would mislead consumers. Low-risk content requires no labelling, as it has no material impact on consumers' ability to make informed choices.
The guidelines prioritize consumer outcomes over technology regulation. These guidelines align with the Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Amendment Rules 2026 (referred to as ‘SGI Rules’) amended on February 10, 2026. Importantly, all advertisements using AI must comply with the entirety of the ASCI Code.
Healthcare Facilities
MoHFW Issued Guidelines for Intensive Care Services
MoHFW has issued guidelines for organizing and delivering intensive care services across three ICU levels. It outlines suggested minimum standards for infrastructure, equipment, staffing, and clinical services tailored to each level's patient acuity and care complexity, while encouraging institutions to exceed these minimum standards wherever feasible.
Revised National Guidelines on Fire Safety in Healthcare Facilities
MoHFW issued the National Guidelines on Fire and Life Safety in Healthcare Facilities, 2026, it provides a comprehensive framework covering fire prevention, detection, suppression, evacuation, governance, and staff training for all healthcare facilities. It aligns with the National Building Code, 2016 and aims to institutionalize a culture of fire safety to protect patients, staff, and infrastructure across Indian hospitals.
Accreditation
NABL Accreditation Requirements for Diagnostic Labs and Imaging Centers
The government has made full National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation mandatory for the Central Government Health Scheme (CGHS) empanelment of standalone diagnostic labs and imaging centers across all cities, with a one-year grace period for facilities in Tier III cities, North East states, and Jammu & Kashmir that hold entry-level NABL certification or Quality Control of India recommendation, failing which they will be removed from empanelment.
Notably, if imaging services fall within the scope of NABL accreditation, a separate National Accreditation Board for Hospitals and Healthcare Providers (NABH) accreditation is not required. Additionally, super specialty hospitals must ensure their in-house laboratories are NABL-accredited to meet the eligibility criteria.
NABH Releases Draft CGHS & ECHS Empanelment Checklists
NABH with the approval of CGHS and Ex-Servicemen Contributory Health Scheme (ECHS) authorities, has released draft empanelment checklists for five types of standalone healthcare centers: Chemotherapy, Physiotherapy, Dialysis, Palliative Care, and Speech & Hearing for public feedback.
New NABH Accreditation Standards for Ayush Hospitals
NABH has released new Accreditation Standards (1st Edition) for Ayush hospitals, effective August 1, 2026, applicable uniformly across all AYUSH disciplines. The rollout follows a phased plan where new and renewal applications submitted from August 1, 2026, must use the new standards.
In-progress applicants who paid fees or completed pre-assessment before July 31, 2026, may choose between old and new standards at the Final Assessment stage. For surveillance assessments, hospitals due before October 31, 2026, have the option to choose, while those due after must use the new standards. All accreditation cycles under the new standards carry a 4-year validity.
Legal Metrology
DoCA Clarifies Use of Customary Units alongside SI Units under LM Act
The Department of Consumer Affairs (DoCA) has clarified that while the International Standard of Units (SI Units) and the metric system remain the legally mandatory units of weight and measure prescribed under the Legal Metrology Act, 2009 (LM Act) and the Rules made thereunder, customary units such as inches, feet, square feet, yards, and dozens may be displayed alongside them as supplementary information to facilitate ease of understanding and commercial convenience.
The SI Unit must be declared prominently, and the supplementary customary unit must not replace it or create any ambiguity or mislead consumers regarding quantity, dimension, area, volume, number, or measurement. In case of any inconsistency or dispute, the declaration in SI Units will prevail.
Government Initiatives
Swasth Bharat Portal Launched to Streamline India's Digital Public Health Infrastructure
The Government has announced the launch of the Swasth Bharat Portal as part of ongoing efforts to strengthen digital public health infrastructure and improve interoperability across healthcare systems. The initiative seeks to facilitate integration of healthcare platforms and reduce administrative burden through a unified digital interface.
MoHFW Launches JANANI to Strengthen Maternal and Child Healthcare Digitally
The MoHFW has launched the JANANI digital platform aimed at strengthening maternal and child healthcare through digital record management and monitoring of service delivery. The platform is intended to support continuity of care and integration with existing public health initiatives.
Food Laws (Select Developments)
FSSAI Mandates ePAAS Portal for All Prior Approval Applications
Food Safety and Standards Authority of India (FSSAI) Office Order mandates that all applications for prior approval and risk assessment (covering non-specified foods and food ingredients, claims, Ayurveda Aahara, FSMP, vegan endorsement, r-PET, etc.) must be submitted exclusively through the electronic Product and Claim Approval Application System (ePAAS) digital portal effective June 1, 2026. No manual, offline, or email-based applications will be accepted thereafter.
FSSAI Amends Contaminant and Residue Limits
Final FSSAI notification amending the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011, effective December 1, 2026. On metal contaminants, Lead and Cadmium limits are extended to cover pulse flours in addition to pulses, and a tiered testing protocol is introduced for arsenic in fish oils. For crop contaminants, the aflatoxin entries for oilseeds and oils are restructured for clarity, and the Saffrole limit is updated to specifically apply to foods and beverages containing mace and/or nutmeg kernel. Further, Trimethoprim and Oxolinic acid limit is updated to specifically apply to seafood.
Key Judicial Development
Kumud Lall v. Suresh Chandra Roy (Dead) Through LRs and Others (2026 INSC 443)
The dispute arose from allegations of medical negligence against Dr. P.B. Lall in relation to treatment of the complainant’s wife, who allegedly lost vision in one eye. During pendency of the complainant’s revision before the National Consumer Disputes Redressal Commission (NCDRC), Dr. Lall died, raising the issue whether his legal heirs could be substituted.
The Supreme Court held that, under Section 13(7) of the Consumer Protection Act, 1986 read with Order XXII Civil Procedure Code, 1908 and Section 306 of the Indian Succession Act, 1925, the doctor’s legal heirs can be brought on record, but only in respect of claims that survive against the deceased’s estate. The Court clarified that personal injury claims abate, while claims for or against the estate survive depending on the nature of the claim, and overruled the broader approach in NCDRC’s decision in Balbir Singh Makol v. Sir Ganga Ram Hospital and Others (2001 (1) CPR 45). It remitted the matter to the NCDRC to determine negligence and identify the maintainable estate-based claims within six months.
Why this matters: The judgment clarifies that legal heirs of a deceased medical practitioner may be impleaded only in respect of claims that survive against the estate of the deceased and not in relation to personal injury claims that abate on death.
Sun Pharma Laboratories Limited v. United Biotech Private Limited (IA-L-19536-2025 & IA-5318-2025)
The Bombay High Court considered Sun Pharma’s interim injunction application, along with United Biotech’s application to vacate the earlier ex parte ad-interim order, in a pharmaceutical trademark dispute concerning Sun Pharma’s mark OCTRIDE and United Biotech’s mark OTIDE, both used for Octreotide Acetate products.
The Court held that no infringement action would lie against United Biotech’s registered mark OTIDE unless Sun Pharma could show that the registration was ex facie illegal, fraudulent, or such as to shock the conscience of the Court, which it failed to establish. The Court also held that Sun Pharma could derive no assistance from its earlier OCTIDE mark because that registration had lapsed in 2008 and had never been commercially exploited.
However, the Court found a prima facie case of passing off. It held that OCTRIDE and OTIDE when compared as a whole, were phonetically similar, and in relation to medicinal products, even a bare possibility of confusion is material because of the stricter standard applicable to pharmaceutical marks. The Court accepted Sun Pharma’s material as sufficient, to show prior goodwill and reputation, rejected the defense of acquiescence. The Court granted an interim injunction restraining United Biotech from using OTIDE, OCTIDE, or any deceptively similar mark so as to pass off its goods as those of Sun Pharma.
Why this matters: The judgment reinforces the importance of passing-off protection in the pharmaceutical sector and demonstrates that registration of a trademark may not, by itself, defeat a passing-off claim where goodwill, reputation and a likelihood of confusion can be established.
Editor's Insight
Recent developments indicate a continuing regulatory focus on process efficiency, patient safety, transparency and responsible promotion across India’s life sciences and healthcare ecosystem. Regulators are increasingly leveraging digitization and streamlined approval pathways while strengthening oversight of high-risk products, clinical research, healthcare delivery systems and food businesses. Judicial developments during the month also reinforce patient protection principles and the importance of balancing commercial interests with broader public health considerations.
Companies operating in the pharmaceutical, biotechnology, medical device and healthcare sectors should continue to 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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