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The life sciences and healthcare industry in India continues to evolve through regulatory and policy developments. In April 2026, key developments included the release of draft regulations on professional conduct and ethics for allied professionals and healthcare professionals, the proposed Jan Vishwas (Amendment of Provisions) Bill, 2026 aimed at decriminalizing minor regulatory violations across central acts, and draft amendments to the Medical Devices Rules, 2017 proposing testing and evaluation fees. Additionally, the Bombay and Delhi High Courts have ruled on deceptive similarity between 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
- The IPC released the National Formulary of India, 2026, which offers a comprehensive drug reference for healthcare professionals (HCPs).
- Minor regulatory violations may attract civil penalties, rather than imprisonment, under the Jan Vishwas (Amendment of Provisions) Bill, 2026.
- MoHFW proposed amendments to the Medical Devices Rules, 2017, including sterilization labeling requirements and standardized testing and evaluation fees.
- DoP amended Uniform Code for Marketing Practices in Medical Devices, 2024 to ease foreign HCP training requirements, replacing prior DoP approval with industry disclosure.
- NMC eased registration requirements for medical professionals serving in the Armed Forces.
- NCAHP published draft Registered Allied and Healthcare Professionals (Professional Conduct & Ethics) Regulations, 2026.
- FSSAI and the Ministry of Ayush clarified that only Ashwagandha roots, and its extracts may be used in health supplements, nutraceuticals and Ayush products.
- The Bombay High Court reinstated the injunction against Meghmani’s ‘ESIRAFT’, finding it deceptively similar to Sun Pharma’s ‘RACIRAFT’.
Pharmaceuticals
IPC releases the draft National Formulary of India, 2026
The Indian Pharmacopoeia Commission (IPC) published the draft National Formulary of India, 2026. The document provides a comprehensive pharmaceutical reference including drug monographs covering indications, dosage forms, contraindications, precautions and adverse effects.
Key recommendations include restrictions on prescribing cough syrups and cold medications to children below two years of age and requiring strict medical supervision for older children in light of recent contamination incidents.
Why this matters: The document serves as an important clinical reference guide for prescribers and HCPs.
Jan Vishwas (Amendment of Provisions) Bill, 2026
The Jan Vishwas (Amendment of Provisions) Bill, 2026 proposes decriminalization of minor procedural violations across multiple central legislations.
Among other amendments, minor procedural deficiencies under the Clinical Establishments Act, 2010 would attract civil penalties instead of criminal prosecution, while certain offences under the Drugs and Cosmetics Act, 1940 (D&C Act) would also shift toward monetary penalties.
Why this matters: The Bill reflects a broader shift toward civil and administrative enforcement mechanisms for procedural non-compliances, while reducing compliance burdens for businesses.
Draft Amendment Extends Rule 89 Exemption to Additional Drug Manufacturing Forms
The draft amendment to Rule 89 of the Drugs Rules, 1945 (Drugs Rules) expands the exemption provision to include seven additional license forms - Forms 25A, 25F, 28A, 28B, 28D, 28DA, and 28F.
Under the amended Rule 89, holders of any of these nine forms will be exempt from separately obtaining a Form 29 license to manufacture drugs for examination, test, or analysis.
Why this matters: A procedural redundancy requiring certain drug manufacturers to obtain a separate Form 29 license to manufacture drugs for testing or analysis will be eliminated.
Clinical Trials
CDSCO Implements Prior Intimation System for Form CT-05
CDSCO has implemented a Prior Intimation System for Form CT-05 (for export purposes only) in pursuance of the New Drugs and Clinical Trials (Second Amendment) Rules, 2026.
The system applies to single-dose bioavailability and bioequivalence studies in healthy volunteers, for oral dosage forms only, excluding cytotoxic, hormonal, narcotic, psychotropic, narrow therapeutic index, and highly variable pharmacokinetics drugs.
Eligible drugs must be approved in India or in the United States of America, European Union (EU), Japan, Australia, Canada or the United Kingdom. The application must be accompanied by Ethics Committee approval.
Applicants must submit Form CT-05 on the SUGAM portal, and the acknowledgment received upon submission will be treated as valid prior intimation.
Medical Devices
MDR Rules Amendment Expands EU Recognition and Mandates QMS Standards
The Ministry of Health and Family Welfare (MoHFW), vide draft amendment to the Medical Devices Rules, 2017 (MDR Rules), proposes to introduce a Quality Management System (QMS) as compliance standard for Class A medical devices’ manufacturers and importers and to allow fast-tracked approval route (without requiring fresh clinical trial in India) to approved medical devices from add EU countries.
MDR Rules Amendment Includes Sterilization Labeling and Test Fees
The MoHFW has proposed amendments to the MDR Rules to include labeling requirements for outsourced sterilization (manufacturers must display the sterilization site's license number on device labels) and standardized testing or evaluation fees at designated medical device testing laboratories with an automatic 5% annual increase in prescribed cost (by way of a Ninth Schedule to the MDR Rules).
Why this matters: The amendment ensures traceability of sterilization sites on the device labels and it standardizes medical device testing costs at select laboratories.
DoP amends UCMPMD to Ease HCPs Foreign Training, Travel and Hospitality
The Department of Pharmaceuticals (DoP) issued a circular amending the Uniform Code for Marketing Practices in Medical Devices, 2024 (UCMPMD). The amendment revises the framework governing foreign training of HCPs as well as related travel and hospitality provisions.
Foreign training should be for the limited purpose of advanced clinical training or demonstrations by experts where the equipment or experts are unavailable in India and subject to the company disclosing full programme details to the relevant Industry Association at least one month in advance.
The pre-existing exception allowing travel and hospitality for ‘Continuing Medical Education’ or ‘Continuing Professional Development’ speakers and training participants continues, but without the earlier requirement of DoP approval. Where the UCMPMD is silent, the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023 will prevail.
Why this matters: It replaces burdensome prior DoP approval for foreign HCP training, travel, and hospitality with simple industry disclosure and narrows the scope of situations warranting foreign training.
Price Control
NPPA Fixes MRP for 42 Drug Formulations
The National Pharmaceutical Pricing Authority (NPPA) issued a notification fixing maximum retail prices for 42 pharmaceutical formulations under the Drugs (Prices Control) Order, 2013. The prices cover a broad range of drug categories including cardiovascular medicines, anti-diabetics, antibiotics, psychiatric and neurological formulations, hormonal therapies, nutritional supplements, and steroids, amongst others.
NCAHP Publishes Draft Professional Conduct & Ethics Regulations
The National Commission for Allied and Healthcare Professions (NCAHP) has published draft Registered Allied and Healthcare Professionals (Professional Conduct & Ethics) Regulations, 2026. It sets out duties for registered allied professionals and HCPs covering patient care, informed consent, confidentiality, medical records, fee transparency, and prohibition of fee-splitting and product endorsements.
The regulations have chapters dedicated to responsibilities and duties of HCPs, professional misconduct and establishing a grievance redressal process.
Three guidelines are annexed covering the Code of Ethics, informed consent procedures, and conduct on social media.
Why this matters: It establishes a unified ethical conduct framework for India's largely unregulated allied healthcare workforce, bringing accountability to many professionals who directly impact patient safety.
Accreditation
NABL Amends Accreditation of Software & IT System Testing Laboratories
The National Accreditation Board for Testing and Calibration Laboratories (NABL) has amended Specific Criteria for Accreditation of Software & IT System Testing Laboratories. The criteria have expanded its scope to include emerging technologies such as artificial intelligence (AI), large language models, software as a medical device, blockchain, internet of things, embedded systems, post-quantum cryptography, and cyber-physical systems.
Quality parameters, process and resource requirements were significantly enhanced to address risk controls, tool validation for emerging tech domains, and ethical/bias considerations.
Why this matters: It strengthens India's accreditation standards for testing AI, cybersecurity, and emerging tech systems.
Legal Metrology
GATC Fee Clarification for Verification of Weights and Measures
Ministry of Consumer Affairs issued a circular clarifying fees charged for verification of weights and measures by the Government Approved Test Centres (GATCs) under the Legal Metrology (GATC) Rules, 2013.
Manufacturers designated as GATCs cannot charge for verifying their own products but may charge up to the maximum fees prescribed in the Fifth Schedule for re-verification.
Third-party GATCs are capped at the same maximum for both verification and re-verification, with any lower fees required to be displayed on the GATC portal.
Why this matters: It prevents fee disputes and ensures pricing accountability across India's weights and measures verification ecosystem.
Public Policy
DCC Meeting Discusses Policies for Drug Regulatory Reforms
The 68th Drugs Consultative Committee (DCC) meeting covered 17 agenda items. Key decisions included approving the development of a real-time digital portal for tracking pharmaceutical products regulated under the Narcotics Drugs and Psychotropic Substances Act, 1985.
DCC recommended making CCTV installation at medical stores mandatory through amendments to the Drugs Rules, along with the development of a centralized digital system for real-time data monitoring.
Several reform proposals, including retail pharmacy deregulation and debarment of license-cancelled premises/ promoters, from further licensing under D&C Act were referred to sub-committees.
Why this matters: The DCC meeting provides insight into potential regulatory changes we might witness that will address drug misuse, tighten pharmacy oversight, and digitize tracking of controlled substances.
Health Insurance
IRDAI Constitutes Sub-committee on Health Insurance
Insurance Regulatory and Development Authority of India (IRDAI) has constituted a sub-committee under the Insurance Advisory Committee to review India's private health insurance landscape, covering aspects like coverage, product design, claims experience, and consumer grievances.
It aims to recommend measures for promoting innovation, combating fraud, and suggesting convergence with public health schemes, incorporating recommendations from the Confederation of Indian Industry on insurer-provider conduct, medical inflation, and the National Health Claims Exchange.
Food Laws (Select Regulatory Developments)
FSSAI Streamlines Import Clearance with Simultaneous Inspection and Fee Payment
The Food Safety and Standards Authority of India (FSSAI) has issued a public notice announcing a change to the fee payment workflow within the Food Import Clearance System. Going forward, Importers/Customs Brokers can now make the requisite fee payment after the visual inspection, but before the final clearance certificate is generated.
Why this matters: It streamlines the food clearance workflow, improving operational efficiency and reducing clearance time.
FSSAI Clarifies Permitted Use of Ashwagandha
FSSAI clarified that only Ashwagandha roots and its extracts are permitted for use in health supplements and nutraceuticals and has reiterated that Ashwagandha leaves in any form, whether crude or extract, are not permitted under FSSAI regulations. The Ministry of Ayush has reinforced this directive, citing safety concerns around higher concentrations of reactive withanolides (particularly Withaferin-A) in Ashwagandha leaves.
Key Judicial Developments
Sun Pharmaceutical Industries Ltd. v. Meghmani Lifesciences Ltd. & Anr. (2026: BHC-OS:9214-DB)
The Bombay High Court (Division Bench) reinstated the injunction against Meghmani’s use of the mark ‘ESIRAFT’, holding it deceptively similar to Sun Pharma’s ‘RACIRAFT’.
Applying the principles laid down in Cadila Health Care Ltd. v. Cadila Pharmaceuticals Ltd., the Court emphasized that stricter scrutiny applies to medicinal products where consumer confusion may impact public health.
Why this matters: The judgment reinforces the stricter standard applied by courts while assessing deceptive similarity in pharmaceutical trademarks, particularly where phonetic similarity may create risks to public health.
Novo Nordisk A/S & Anr. v. Dr. Reddy’s Laboratories Limited (CS(COMM) 317/2026)
The Delhi High Court disposed of Novo Nordisk’s trademark infringement, passing off and dilution action against Dr. Reddy's concerning the mark ‘OLYMVIQ’ for semaglutide injections, which Novo Nordisk alleged was deceptively similar to its registered mark ‘OZEMPIC’.
The matter was settled after Dr. Reddy's undertook to immediately cease use of OLYMVIQ, withdraw its pending trademark applications for that mark, and transition to ‘OLYMRA’.
The Court permitted sale of existing stock within 30 days in public interest and decreed the suit in terms of the settlement.
Sun Pharma Laboratories Limited v. Intas Pharmaceuticals Limited (CS(COMM) 39/2023)
The Delhi High Court held that Intas’ use of ‘BEVATAS’ infringed Sun Pharma’s registered mark ‘BEVETEX.’ Sun Pharma had registered BEVETEX in 1983 and used it since 2015, while Intas adopted BEVATAS in 2016.
Intas argued the drugs differed in salt, formulation, price, and administration and also raised delay and non-use/hoarding defenses. The Court found the marks structurally and phonetically similar and held that a stricter standard applies in pharmaceutical cases because public health is paramount.
It rejected Intas’ defenses, permanently restrained use of BEVATAS or any deceptively similar mark for medicinal and pharmaceutical preparations for human use.
Tridoss Laboratories Pvt. Ltd. & Anr. v. Union of India & Ors. (2026: BHC-OS:9377-DB)
The Bombay High Court set aside NPPA’s demand notice and the consequential recovery notice issued under Section 267 of the Maharashtra Land Revenue Code, 1966. The case concerned alleged overcharging of Theophylline CR 300 mg under the Drugs (Price Control) Order, 1995.
The Court held that the action, initiated over 10 years after the relevant sales period, was vitiated by gross delay and breach of natural justice, particularly because the product had been discontinued and the company no longer had the relevant records.
The Court further held that the ceiling price for Theophylline SR 300 mg could not be applied to Theophylline CR 300 mg, since Theophylline CR 300 mg had not been specifically notified during the relevant period.
Why this matters: It confirms that drug price-control recovery cannot be enforced after inordinate delay or by equating distinct formulations not specifically notified, especially without hearing or reasons.
Editor's Insight
Recent developments indicate continued regulatory focus on decriminalization of procedural non-compliances, tighter controls over misuse-prone substances, easing foreign training for HCPs, and strengthening of pharmaceutical trademark protection. Regulators also continue to pursue digitization and streamlining of approval and compliance frameworks across the healthcare ecosystem.
Companies operating in the pharmaceutical, biotechnology, medical device and healthcare sectors should closely monitor these developments, as they may affect 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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