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The National Medical Commission (NMC) has clarified that doctors cannot use celebrities, influencers, patients or other third parties to promote professional services through testimonials or endorsements. The restriction aims to prevent patient solicitation and commercialisation of medical practice. Doctors and medical institutions remain responsible for promotional content they authorise or knowingly permit, including digital communications.

The restriction aims to prevent indirect advertising and preserve ethical standards in medical practice.

The draft Prevention of Cruelty to Animals Rules, 2026 proposes institutional approval for mild and moderate experiments, while requiring central approval for severe and non-recovery experiments involving animals other than rodents and lagomorphs. It also permits conditional exceptions for using certain protected, wild-caught and stray animals.

The Bombay High Court discharged a hospital trust’s managing trustee from prosecution over a substandard ophthalmic drug. It held that a trust is not a “company” under the Drugs and Cosmetics Act, 1940, and designation alone cannot establish criminal liability without specific allegations of involvement.

Delhi's Drugs Control Department issued an advisory directing oncology hospitals to maintain records of anti-cancer drugs and safe disposal of empty vials to prevent misuse, diversion, illegal resale and counterfeiting. Hospitals are required to procure drugs from licensed dealers, dispose empty containers after use as per Biomedical waste management rules 2016, strengthen internal controls and report suspected counterfeit drugs or illegal activities to the drugs control department.

The Food Safety and Standards Authority of India (FSSAI) is reportedly considering regulatory changes requiring e-commerce and quick-commerce platforms to display manufacturing dates, expiry dates and batch numbers on food product listings. The proposed measures aim to improve consumer transparency, product traceability and food safety across online food supply chains. However, implementation may be challenging due to real-time inventory changes, data integration across sellers and warehouses, and increased technology and compliance costs.

The National Medical Commission (NMC) clarified that registered medical practitioners may electronically sign laboratory, pathology and radiology reports remotely. This addresses uncertainty over remote authentication. Doctors must review sufficient clinical information and remain responsible for what they sign. Healthcare establishments must secure records and maintain audit logs.

The GST Council has recommended amending Section 17(5) of the CGST Act, 2017, to allow input tax credit on free samples and goods destroyed or written off due to expiry as required by law.

The change if allowed could reduce tax costs for pharmaceutical manufacturers and ease the financial burden of mandatory write-offs.

The Kerala High Court has reportedly directed the Union of India to make the Data Protection Board of India to become functional within eight weeks, while addressing privacy concerns over passenger data collected through digital airport systems. The Court observed that citizens’ privacy was being compromised and suggested that Voter ID may also be accepted as proof of identity for air travel, alongside Aadhaar and Driving Licence.

The Ministry of Fisheries, Animal Husbandry and Dairying has notified The Animal Feeds and Feed Ingredients (Quality Control) Order, 2026 on October 7, 2026. The manufacturers and importers of common salt and cattle licks for animal consumption, mineral mixtures for supplementing and Dicalcium Phosphate will have to obtain BIS registration under compulsory registration scheme before manufacturing and importing in India. General implementation (other than micro and small enterprises) begins on 1 April 2027, with phased deadlines for small enterprises from1 July 2027 and micro enterprises from 1 October 2027.

The government has amended Schedule E(1) of the Drugs Rules, 1945, retaining cannabis under the poisonous substances list for traditional medicines. The revised entry removes “Linn.” from the botanical name Cannabis sativa, potentially requiring label revisions for Ayurvedic medicines containing cannabis leaves.

The Ministry of Agriculture and Farmers Welfare has prohibited the registration of Paraquat Dichloride, a herbicide used to control weeds, citing risks to human health and animals. Effective September 22, 2026, all existing registration certificates stand cancelled. The Registration Committee must recover these certificates, while state governments are responsible for implementing the prohibition.

India's central medical device authority, CDSCO has published a draft guidance document for manufacturers of in-vitro diagnostic medical devices and invited stakeholder comments within 15 days from the date of this guidance document. The draft aims to clarify regulatory requirements and support manufacturers in navigating India’s medical device framework. 

After India's drug price regulator capped markups on cancer medicines, news show that an Indian medical device industry body has sought a similar cap for medical devices. Earlier caps on prices left importers' margins out, so imported devices could carry a much higher retail price than Indian-made ones. The body pushed for making import the first point of sale, providing parity between Indian and foreign manufacturers. To this effect, the body has said that it is ready to work with the Government authorities.

The Drugs Controller General of India (DCGI) has reportedly sought an explanation from the Indian Pharmacopoeia Commission (IPC) after the seventh edition of the National Formulary of India (NFI 2026) listed drugs or formulations not approved by CDSCO. The discrepancy involves at least five drugs or variants, including methylene blue, flumazenil, folinic acid, pyridostigmine and alteplase. The issue raises concerns about regulatory verification and the reliability of an authoritative reference used by healthcare professionals for prescribing and administering medicines.

The government has amended Schedule E(1) of the Drugs Rules, 1945, exempting listed drugs of plant origin when used to prepare specified traditional formulations, including Bhasma, Parpam, Kushta, Thalsman, Sindhuram and Chendooram. The exemption is limited to these specified preparations and does not automatically extend to all formulations containing these ingredients.

A Tamil Nadu consumer commission has reportedly held a wellness clinic liable for deficiency in service for failing to justify retaining payment for an incomplete cryotherapy package. The Commission emphasised the need for proper treatment records and found the clinic unable to establish satisfactory service delivery or justify retaining fees for unused sessions.

Indian Government has approved a cap on supply and sale margins for non-scheduled anti-cancer drugs. The measure is intended to reduce medicine prices and improve affordability. DGHS will finalise the medicines covered, following which NPPA will decide and issue the notification.

Food Safety and Standards Authority of India (FSSAI) has issued notices to nutraceutical manufacturers over their protein supplement which claims to protect muscle in people on GLP-1 weight-loss and diabetes drugs. The Regulator questioned the claims of the product's multiple benefits & purity. The Regulator found the name of the product implying a link to these drugs, potentially misleading buyers. Online platforms selling the product also received notices.

The National Accreditation Body for Cold Chain Management (NAB-CCM) has released a White Paper proposing stronger implementation of Good Storage and Distribution Practices (GSDP) across India's pharmaceutical supply chain. The White paper among other things recommend establishing a multi-stakeholder Cold Chain Community Committee and Advisory Board, evaluating a standardised temperature-sensitive product indicator, and introducing documented end-to-end accountability across the distribution chain. The central objective is to ensure that medicines retain their quality in transit until they reach the patient.

The Central Government has proposed requiring prior sanction for advertising drugs specified under Schedules H, H1 and X. The draft amendment seeks to regulate advertisements of these prescription medicines and will be considered after the 30-day stakeholder consultation period.

The Supreme Court has directed the Union Government to constitute a committee to recommend statutory regulations to curb unethical marketing practices by pharmaceutical companies, including the offering of gifts, hospitality, sponsored travel and other inducements to doctors. The committee must examine the adequacy of the existing regulatory framework, including the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), 2024, and assess the effectiveness of existing monitoring and enforcement mechanisms.

The government has approved a 30%-of-MRP trade-margin cap on non-scheduled anti-cancer medicines, projecting price reductions of up to 70% and annual patient savings of ₹2,500 crore. A DGHS committee will finalise coverage before NPPA notification.

The government has amended Schedule E(1) of the Drugs Rules, 1945, revising the list of poisonous substances used in Ayurveda, Siddha, Sowa-Rigpa and Unani medicines. The revised schedule expands the list of substances of plant, animal and mineral origin and specifies that any ingredient not listed but containing arsenic or mercury as a chemical constituent shall also be treated as a Schedule E(1) drug.

The Pharmaceutical Research and Manufacturers of America (PhRMA), a US drug industry body has sued to cancel a government rule making drugmakers pay rebates on some medicines priced higher in America than abroad. The legal challenge here is whether the government can tie medicine prices to overseas prices, using a pilot program, without new legislation bypassing the US Congress. The rule takes effect starting January 2027. 

The Central Drugs Standard Control Organisation (CDSCO) has cancelled the import registration certificate held by an Indian agent for cosmetic products of an international haircare brand, with immediate effect. The cancellation follows a request by the agent after the brand decided to discontinue the registration for business and administrative reasons and confirmed that the products covered under the certificate would no longer be imported into India.

The Orissa High Court has reportedly sought the Odisha government’s response to a writ appeal challenging the state’s ban on food products containing tobacco or nicotine. The appeal follows an August 21 judgment upholding the January 2026 notification prohibiting the manufacture, processing, packaging, storage, transportation, distribution and sale of such products, including gutkha and pan masala. The appellant has primarily challenged the classification of chewing tobacco as “food” under the Food Safety and Standards Act, 2006.

The GST Council may reportedly consider exempting imported medicines and specialised foods used to treat additional rare diseases from IGST, potentially lowering the final cost of high-priced therapies. The move could also have implications for medicines covered by the Drugs (Prices Control) Order, 2013: while an IGST exemption would not by itself change an NPPA-fixed ceiling price or retail price under the DPCO, it could reduce the MRP payable by patients by removing the tax component.

The National Medical Commission has issued new guidelines regulating advertising, publicity and digital communications by registered medical practitioners and hospitals, effective immediately. The guidelines prohibit misleading or exaggerated claims, patient solicitation, paid or misleading testimonials, promotional endorsements of medical devices and diagnostic products, and certain influencer-led or AI-assisted promotions. They also require compliance with applicable data-protection requirements for digital personal data. 

India’s National Medical Commission has prohibited doctors and hospitals from using AI-generated patient testimonials, clinical outcomes or endorsements for advertising through a Public Notice dated October 06, 2026, and have come into effect immediately. The guidelines also restrict unverifiable claims, paid manipulation of online rankings and payment-linked patient referrals. The requirements have come into effect immediately, with graded disciplinary action for violations.

The US Nuclear Regulatory Commission has proposed new guidance on the release of patients treated with radioactive materials that could create additional compliance hurdles for radioligand therapies such as Novartis’ Pluvicto. Under the draft methodology, a full six-dose course of Pluvicto would exceed the proposed release threshold, potentially requiring longer hospital stays or patient-specific radiation calculations. Industry and medical groups have raised concerns that the changes could particularly affect community treatment centres and limit access to the therapy.

The Drugs Consultative Committee of India (DCC) has agreed that cough syrups should have warning labels against use in children below the age of four years, indicated in red. The Committee found that cough syrups are still given to young children despite an advisory, and opined that the pictures of infants, toddlers and similar suggestive depictions should not appear on labels. Cough syrup manufacturing businesses should monitor the enforcement of this recommendation to adhere to timely compliance.

The Maharashtra FDA has reportedly cancelled the drug sale and distribution licences of a major pharmaceutical manufacturer’s Pune warehouse over violations involving packaging, storage, documentation and recall requirements. The action highlights increased scrutiny of supply-chain compliance and reinforces that regulatory obligations extend beyond manufacturing to warehousing and distribution.

The Drugs Consultative Committee (DCC) has recommended integrating drug licence retention fee payments with the Online National Drugs Licensing System (ONDLS), enabling automatic electronic acknowledgements and a searchable database. Separate retention certificates and repeated submission of documents should generally not be required unless specifically prescribed under the Drugs Rules, 1945. This could reduce regulatory paperwork and administrative burdens for drug licence holders and improve standardisation of licence retention processes across States.

The Drugs Consultative Committee has recommended a comprehensive action plan to prevent diversion of pharmaceutical preparations containing narcotic drugs and psychotropic substances. A reliable national database on their manufacture, sale, stocking and enforcement is needed. States and Union Territories would submit monthly data in a uniform format, followed by a common digital platform.

The DCC deliberated on bringing all sterile drug products under the Central Licence Approving Authority (CLAA) scheme, recognising the high-risk nature of sterile products and the need for specialised regulatory scrutiny. The Committee recommended constituting a sub-committee to examine the proposal's feasibility, including the legal implications of changing the existing division of licensing responsibilities and joint inspections. The proposal could expand central oversight of sterile drug licensing, potentially standardising scrutiny and inspections across States, subject to further review and a final decision.

The Health Minister of Kerala has reportedly planned to introduce legislation to regulate treatment costs in private hospitals, with a four-member committee preparing the draft. The move aims to improve affordability and transparency amid concerns over hospital bills. The proposed framework may cover medicines, diagnostics, room rent and procedures, alongside upfront cost information and itemised billing.

CDSCO is seeking the DGHS’s opinion and data on the manufacture and use of mercury-based topical antiseptics, including Merbromin, before deciding whether to continue their exemption under Schedule K of the Drugs Rules, 1945. The review considers patient safety and clinical need, alongside India’s obligations under the Minamata Convention on Mercury. The outcome could affect the regulatory status and continued availability of mercury-containing topical antiseptics in India.

ICMR has invited proposals to establish Centres for Advanced Research focused on developing priority medical devices and diagnostic technologies addressing identified healthcare needs. The initiative aims to accelerate indigenous development of affordable, accessible and clinically relevant technologies while strengthening India’s medical device ecosystem. Eligible institutions can now submit proposals covering multiple priority technologies, with applications open until November 15, 2026.

Beverage manufacturers have reportedly challenged FSSAI’s restriction on using “energy drink” and similar descriptions for high-caffeine beverages before the Delhi court. They contend that the direction was issued without prior notice and would have serious commercial consequences. The petitioners have sought to have the restriction set aside.

The Supreme Court of India declined to entertain a petition seeking measures to tackle the manufacture and sale of fake medicines, including time-bound investigations, standard procedures for search and seizure, and faster forensic reports. Without examining the merits, the Court directed that a copy of the petition be forwarded to the regulatory authorities for consideration.

The United States government issued tariff waivers on specific specialty and lifesaving pharmaceutical products imported from 20 partner nations, prominently including India. The waiver addresses growing domestic drug shortages and rising healthcare costs in the US market. The policy reinforces India's position as a reliable supplier of cost effective, high quality specialty medicines to Western healthcare systems.

The High Court of Karnataka ruled that drug control authorities cannot suspend a pharmaceutical distribution license simultaneously while issuing a show-cause notice. Due process requires giving the licensee a fair opportunity to respond before imposing any suspension. Pharmaceutical businesses can challenge immediate license suspensions if regulatory authorities fail to provide a preliminary hearing prior to enforcement action.

The Central Drugs Standard Control Organisation has directed manufacturers of Fludrocortisone formulations to add hypokalaemia, or low blood potassium levels, as an adverse drug reaction in the prescribing information leaflet and promotional literature. The direction follows safety signal assessment by the Pharmacovigilance Programme of India and expert review.

The Supreme Court of India issued notice on a legal challenge concerning whether a patent's 20-year term should be calculated from the grant date rather than the filing date. Under current statutory provisions, the 20-year clock begins at filing, which patentees argue reduces their commercial exclusivity window when regulatory decisions are delayed.

The Supreme Court of India reportedly raised critical questions regarding the wide disparity between the procurement/trade price of non-scheduled medicines and the Maximum Retail Price (MRP) charged to consumers. While essential drugs are regulated under the National Pharmaceutical Pricing Authority (NPPA), non-scheduled drugs often carry significant profit markups. The bench inquired why the government cannot impose a mandatory ceiling capping the MRP of non-scheduled drugs at a fixed margin, specifically suggesting 16% above the price at which the retailer purchases the product.

The Directorate General of Foreign Trade (DGFT) has extended Minimum Import Price (MIP) restrictions on two active pharmaceutical ingredients, ATS-8 and Sulfadiazine API. The price floor prevents foreign dumping, curbs under-invoicing, and protects domestic bulk drug manufacturing capacity.

The Kerala High Court has held that the Centre may invoke provisions of patents act to manufacture patented medicines and supply them to patients on a non-commercial basis where government intervention is warranted, including cases of exorbitant pricing. The Court directed the Centre to collect data and assess the affordability of patented life-saving medicines before deciding whether to invoke the provision. The ruling could have wider implications for access to high-cost patented medicines.

The Haryana Food and Drugs Administration’s investigation into suspected spurious blood-pressure tablets has reportedly expanded to the manufacturing and supply network, resulting in further arrests. A joint search with the Delhi Drugs Control Department also uncovered an unlicensed stockist and recovered additional suspected spurious tablets.

The Delhi High Court has ruled that a formal declaration under Rule 124 is not mandatory to invoke Section 11(2) of the Trade Marks Act, 1999, which protects well-known trademarks from similar marks even for unrelated goods or services. Proprietors may establish well-known status through evidence in individual proceedings.

Delhi anti-curreption authorities have reportedly arrested a pharmaceutical distributor over allegations of manipulating medical procurement for government hospitals. Investigators allege that he established companies through associates, coordinated with suppliers and officials, and helped secure contracts without following prescribed procedures. The case involves procurement of medical equipment, medicines and surgical consumables.
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India's Central Government has prohibited the registration of Paraquat Dichloride under the Insecticides Act, 1968, effective from publication of the Order in the Official Gazette. Existing registration certificates are cancelled, and registrants must return their certificates. State Governments are directed to implement the prohibition under applicable laws and rules.

The Supreme Court has stayed the Delhi High Court’s directions permitting Goods and Services Tax authorities to examine data seized from an advocate’s office. The Court questioned how investigators could themselves identify and segregate material protected by attorney-client privilege, and issued notice to the Union Government and GST authorities.

The Madras High Court has dismissed FSSAI’s review petition seeking recall of its earlier order requiring warnings regarding possible micro/nanoplastic contamination in PET water bottles and packets of sugar and salt. The Court has therefore retained its earlier direction concerning warning labels.

The United States Food and Drug Administration has issued draft guidance setting out recommendations for premarket submissions for robotically assisted surgical devices. It covers non-clinical testing, clinical data and labelling, with the aim of creating a more consistent review framework for devices that combine robotic technology with surgical instruments. Comments are invited until 24 November 2026.

The Supreme Court has reserved its order on a plea seeking mandatory front-of-pack warning labels for packaged foods high in sugar, salt and fat. The Court questioned FSSAI’s proposed 365-day voluntary compliance period and raised concerns regarding the need for another stakeholder consultation.

The Bombay High Court has sought responses from the Centre and Maharashtra authorities on a challenge to the 50-year upper age limit for intending mothers under the surrogacy framework. The petition was filed after a 54-year-old woman was denied an eligibility and essentiality certificate for surrogacy following unsuccessful IVF and embryo-transfer attempts.

The Bombay High Court has held that the National Pharmaceutical Pricing Authority cannot impose a blanket price ceiling on a drug formulation without following the price-fixation mechanism prescribed under the Drugs (Prices Control) Order, 1995. The ruling limits regulatory pricing action where the prescribed statutory mechanism for calculating and notifying a formulation-specific ceiling price has not been followed.

The Food Safety and Standards Authority of India has proposed a single-phase rollout of front-of-pack warning labels for packaged foods high in sugar, fat or salt, with a red hexagonal warning identifying the nutrient of concern. FSSAI has sought approximately four months to issue and finalise the draft regulations, including a 60-day consultation process.

The Bombay High Court has quashed an order removing two doctors from the medical register after finding that the choice of one recognised surgical procedure over another could not, by itself, establish medical negligence. The Court relied on Supreme Court precedent that a doctor acting with reasonable skill and competence cannot be held negligent merely because another treatment option may have been preferred. The ruling reinforces that professional disagreement over treatment choice does not, by itself, justify disciplinary action where the chosen procedure was recognised and performed with reasonable competence.

The Merchant Shipping (Medicines, Medical Stores, Appliances and Medical Officers) Rules, 2026 have come into force, replacing the earlier framework governing medicines and medical supplies on Indian ships. The rules prescribe requirements for medicine chests, medical equipment, medical kits, records and periodic inspection, and apply to specified Indian ships undertaking international voyages and coasting trade.

The Insurance Regulatory and Development Authority of India (IRDAI) has issued a draft consultation paper. The proposal seeks to set strict commission caps for insurance agents and intermediaries. As flexible spending limits failed to curb high sales costs, the regulator plans to enforce fixed, effort-based commission ceilings and tighter supervision to lower distribution expenses across all sales channels. 

The United States Food and Drug Administration (US FDA) has issued a direct final rule clarifying that validated non-animal testing methods can be used for preclinical drug safety evaluations. The rule updates regulatory terminology from animal tests to nonclinical tests, supporting the adoption of cell based assays, organ on chips, and computer models in human drug development applications.

The Food Safety and Standards Authority of India (FSSAI) has proposed draft regulations prohibiting the manufacture and sale of non-dairy analogue products under the name "paneer". Under the proposed draft, businesses licensed under the analogue dairy category must discontinue using the term paneer in product nomenclature, labelling, menu cards, and marketing materials to prevent consumer deception.

The High Court of Jammu and Kashmir and Ladakh held that accused drug manufacturers are not required to make a formal request before a Magistrate to invoke sample re-analysis safeguards under the Drugs and Cosmetics Act, 1940. Written notification to the drug inspector controverting the analyst report within 28 days sufficiently obligates authorities to send samples to the Central Drugs Laboratory.

Medical technology associations and hospital bodies have reportedly supported Trade Margin Rationalisation (TMR) following a Maharashtra Food and Drug Administration (FDA) survey revealing large price mark-ups on medical consumables. Industry representatives backed establishing clear guidelines on permissible gaps between procurement costs and printed maximum retail prices, while distinguishing complex technologies from commoditised consumables.

The Insurance Regulatory and Development Authority of India (IRDAI) has issued a draft consultation paper. The proposal suggests commission clawbacks by insurers and aims to establish public accountability, inform prospective buyers, and alert future employers about an agent's mis-selling history.

Public disclosure of mis-selling records and mandatory clawbacks will require insurers and corporate intermediaries to overhaul agent recruitment background checks and strengthen compliance.

The High Court of Jammu and Kashmir and Ladakh held that communicating an intention to controvert a Government Analyst report within the statutory 28-day period displaces its conclusive evidence value under the Drugs and Cosmetics Act, 1940. Failing to re-analyze the sample at the Central Drugs Laboratory before shelf-life expiration deprives the accused of statutory safeguards, invalidating the prosecution. 

The Drugs Technical Advisory Board (DTAB) has recommended amending the Eighth Schedule of the Medical Devices Rules, 2017 to grant sale exemptions for specific medical devices. The proposed change covers medicated dressings in first-aid kits, self-test devices such as glucometers, pulse oximeters, and pregnancy kits, and small device quantities brought for trade exhibition displays.

India’s FSSAI has issued a draft Notification which has proposed prohibiting the manufacture and sale of products made from non-milk constituents as paneer. Existing products licensed or registered as dairy analogues must discontinue using “paneer” in their nomenclature, labelling and marketing. Stakeholders may submit objections or suggestions within 60 days of the Gazette’s public availability.

The Drugs Technical Advisory Board has recommended to formally require applications for post-marketing clinical investigations to be submitted in Form MD-22, accompanied by the prescribed fee and information specified in the Seventh Schedule. The proposal also recommends a INR 1 lakh fee for permission to conduct such investigations. The amendment would provide a defined regulatory and fee framework for post-marketing clinical investigations of medical devices.

India’s Drugs Technical Advisory Board has recommended amending the Drugs Rules, 1945 to mandate blood-centre registration on the e-RaktKosh portal and authenticate donors through ABHA/Ayushman Bharat Digital Mission ID or Aadhaar-linked OTP. The move aims to strengthen donor traceability, enable post-donation follow-up and help identify high-risk or deferred donors.

The Drugs Technical Advisory Board has recommended prohibiting the manufacture, sale and import of Lindane in India. The recommendation follows its review of international regulatory status and the availability of alternative treatments in India.

The Drugs Technical Advisory Board (DTAB) considered a proposal to exempt imported first-aid kits for captive consumption by industries including automobile and hospitality sectors from import and sale licensing requirements under the Medical Devices Rules, 2017. The proposal contemplates exemption from import licensing requirements under Chapter V and sale licensing under Chapter XI, subject to conditions including a minimum residual shelf life of 60% and compliance with applicable standards. The kits would also be restricted from resale.

The Drugs Consultative Committee is set to consider a proposal to bring all sterile drug products, including small-volume parenterals, under central licensing. Currently, only specified categories of sterile medicines are centrally licensed, while others fall under state authorities. The proposal cites contamination risks, variations in state-level scrutiny and inspections. If adopted, the proposal could significantly expand central regulatory oversight and standardise licensing, inspection and compliance requirements for manufacturers of sterile medicines.

The Drugs Technical Advisory Board (DTAB) has recommended amending the Medical Devices Rules, 2017 to introduce a separate definition for in vitro diagnostic (IVD) medical devices, aligned with global regulatory standards. The change is important because IVDs currently lack a distinct definition, creating greater clarity on their regulatory scope.

The Drugs Technical Advisory Board has recommended amending the Drugs Rules, 1945, to exempt liquid antiseptics from sale licence requirements, subject to conditions. The exemption would apply where products are manufactured by licensed manufacturers, contain no substances specified in Schedules G, H, H1 or X, and are sold in the original, unopened containers of the licensed manufacturer.

India’s Drugs Technical Advisory Board has recommended amending Rule 31 of the Medical Devices Rules, 2017, to exempt manufacturers from obtaining a Test Licence for devices made solely for testing, examination, evaluation, demonstration or training. The proposal could ease regulatory requirements for limited-purpose medical device manufacturing. 

The Drugs Technical Advisory Board has recommended restricting the qualification of the “competent person” for wholesale licences to registered pharmacists. The proposal would tighten eligibility for wholesale drug licences and could affect existing businesses that rely on non-pharmacist competent persons. 

The Jammu & Kashmir and Ladakh High Court held that stringent bail restrictions under the NDPS Act were not attracted in a case involving alleged cultivation of opium poppy, as no small or commercial quantity is prescribed for such cultivation. The conveys that if businesses are cultivating opium within the prescribed limits, they cannot be called up under the provision of NDPA Act.

The Bangalore District Chemists and Druggists Association has reportedly urged retailers to procure medicines only from authorised stockists and legitimate distribution channels amid an ongoing investigation into alleged counterfeit, relabelled and repackaged medicines. Retailers have also been advised to verify invoices, batch numbers, expiry dates and manufacturer details. The association’s advisory is not itself a new statutory requirement. 

The Bombay High Court has directed that a challenge to suspension of food licence should be first pursued as per the statutory appeal before the FDA Commissioner before seeking writ relief from the High Court. The decision reinforces the requirement to exhaust the available remedy as per the law before directly approaching the courts.

India's Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011 have been amended to prescribe a 14 day timeline for regulatory sample reports and five days for import samples. Laboratories must use FSSAI-prescribed methods, and where none exists, may use validated methods recognised by specified international bodies. The amendment takes effect on 1 April 2027. The amendment makes both the testing methodology and timelines more structured, giving food businesses a clearer framework for challenging delays or departures from prescribed analytical methods.

Maharashtra Food and Drug Administration reportedly found large gaps between procurement prices and printed Maximum Retail Prices in hospitals and sought National Pharmaceutical Pricing Authority and Department of Pharmaceuticals intervention to consider price regulation under the Drugs Price Control Order, 2013. The action seeks to extend price regulation beyond scheduled medicines to commonly used hospital consumables. Whether these products can be brought within the DPCO framework, and what pricing mechanism may apply, will depend on action by the competent central authorities. 

The Government of Maharashtra has reportedly approved a ₹4,250-crore health reform programme for 2026-2031, focused on strengthening primary, secondary and tertiary care, digital health systems, disease prevention and early screening.

The Central Consumer Protection Authority (CCPA) has found a ride hailing app in it’s booking interface was using prompts which encouraged users to increase payments to have a better chance of the ride getting confirmed. CCPA has flagged this practice as dark pattern and has directed discontinuation of such prompts and practices, following a sector-wide examination of advance tipping and dynamic pricing.

The Punjab and Haryana High Court has held that an administrative clarification bringing a device under ambit of a notified medical device is not tenable in law. The judgment raises a broader regulatory concern around products that remain outside statutory notification, including spectacles and toothbrushes, despite being regulated as medical devices in other jurisdictions, and the role of administrative convenience in such exclusions.

Madhya Pradesh’s Food and Drug Administration (MP FDA) is using food-delivery platform data, customer ratings and order activity to identify high-footfall restaurants and hotels for priority inspections. FSSAI’s inspection framework does not identify customer ratings, online popularity or order volumes as food-safety risk parameters. The concern is whether the MP FDA can treat commercial visibility indicators, such as customer ratings and order volumes, as a basis for prioritising food-safety inspections.

The National Medical Commission has proposed amendments to the Registration of Medical Practitioners & Licence to Practice Medicine Regulations, 2023. The proposed amendments introduce changes to National Medical Register registration, licence renewal and appeals, including online processes and time-bound consideration of challenges to registration or licensing decisions. Stakeholders have sought an automated online renewal system and a transparent, time-bound online mechanism for challenging rejection of registration or licence applications.

A roundtable convened by the General Pharmaceutical Council in the United Kingdon on fake online pharmacies and unregulated medicines has highlighted the need for stronger coordination between regulators, technology platforms and other stakeholders to tackle websites selling counterfeit or unauthorised medicines. The discussion focuses on improving detection, information-sharing, enforcement and consumer protection across the online medicines supply chain.

The National Commission for Protection of Child Rights has again summoned the India head of a social media platform as part of its formal inquiry into allegations involving advertisements linked to Child Sexual Exploitative and Abuse Material.  The proceedings underscore increasing regulatory scrutiny of platform systems for detecting, reporting and responding to child sexual exploitation content. 

The Allahabad High Court has held that large-scale slaughterhouses require a FSSA licence and cannot rely only on a registration certificate. A registration certificate, GST or Udyam registration, laboratory reports, municipal NOC or even a pending licence application cannot substitute the statutory licence required under the Food Safety and Standards Act, 2006. 

For slaughterhouse operators, registration is sufficient only within the prescribed petty-business limits; larger operations must obtain and maintain the appropriate FSSAI licence before commencing or restarting operations.

The office of the Controller General of Patents, Designs and Trademarks (CGPDTM) has invited comments and suggestions from stakeholders on the Draft Manual of Patent Office (Practice & Procedure), 2026. The Draft Manual incorporates provisions introduced through the Patents (Amendment) Rules, 2024, the Jan Vishwas Act, 2023 and the SHANTI Act, 2025. It also reflects the 2025 CRI Guidelines and recent case law, while continuing the focus on automation, IT-enabled processes and electronic handling of patent applications.

The office of the Controller General of Patents, Designs and Trademarks (CGPDTM) has invited comments and suggestions from stakeholders on the Draft Manual of Trademark Office (Practice & Procedure), 2026.

The Trade Marks Office has released a revised draft Manual of Trade Marks Practice and Procedure for stakeholder comments. The Draft Manual of Trade Marks incorporates the Trade Mark Rules, 2017; modernises the trademark filing workflow by formally digitising several of the protocols; includes references to recent case laws; expands on the procedure related to oppositions; and adds a new chapter 7 on ‘concept of claiming prior user and well-known marks’.

Under the Consumer Protection (E-Commerce) (Amendment) Rules, 2026, taking effect from 1 January 2027, e-commerce platforms advertising a discount must show the current price and the lowest price offered in the previous 30 days. This could make promotional pricing more difficult where businesses frequently change prices across sales periods. Platforms will need reliable systems to track historical prices and substantiate discount claims.

Businesses will no longer have complete flexibility in how they present “discounts”. They will need to substantiate the reference price with actual 30-day pricing data.

The Indian Government has amended the Consumer Protection (E-Commerce) Rules, 2020 through the Consumer Protection (E-Commerce) (Amendment) Rules, 2026, covering pricing, sponsored listings, search results, dark patterns, product disclosures, consumer information and grievances. The amended rules have been notified and will apply from 1 January 2027.

E-commerce businesses have a transition period to review pricing practices, sponsored listings, search algorithms, grievance processes and consumer disclosures and align their systems with the amended Rules before they take effect.

The Consumer Protection (E-Commerce) (Amendment) Rules, 2026 require e-commerce entities to comply with the existing Guidelines for Prevention and Regulation of Dark Patterns, 2023, conduct an annual self-audit and display a compliance certificate. The amendment therefore adds a recurring compliance requirement for practices such as false urgency, basket sneaking, subscription traps and drip pricing. 

The Consumer Protection (E-Commerce) (Amendment) Rules, 2026 expand the information marketplaces must display about goods and sellers, including country of origin, best-before or use-before dates, return shipping costs and government-issued identification numbers such as GSTIN or MSME registration numbers. The amended requirements will apply from 1 January 2027.

Under the Consumer Protection (E-Commerce) (Amendment) Rules, 2026, effective from 1 January 2027, platforms cannot manipulate search results in a manner that misleads consumers or reduces the relevance of results to their searches. The provision brings greater scrutiny to how products are ranked and displayed on online marketplaces. Businesses may need to review ranking algorithms and commercial arrangements where payments or other business interests influence product visibility.

How a platform ranks and displays products is now a compliance issue, particularly where commercial interests or payments may affect search visibility.

Under the Consumer Protection (E-Commerce) (Amendment) Rules, 2026, effective from 1 January 2027, e-commerce platforms must clearly disclose when products or services are sponsored. Platforms now will not be able to make paid visibility look like organic search results. Their advertising and ranking interfaces will need clearer separation between sponsored and ordinary listings.

The Patent Office has published the Guidelines for Examination of Computer Related Inventions (CRIs), 2025, providing updated guidance on how patent examiners should assess computer-related inventions. The guidelines aim to improve consistency and clarity in examination of CRI applications.

Bombay High Court passed an interim direction restraining a trainee doctor from publishing further social media posts concerning a hospital after the hospital approached the Court with a defamation claim over allegations of harassment and excessive working hours. The Court has issued notice, and the underlying allegations remain to be decided in the proceedings.

The Government is continuing consultations with farmer organisations before finalising the proposed new Seed Bill, aimed at tightening controls over fake and substandard seeds. No fixed date has yet been announced for introducing the Bill in Parliament.

The Food Safety and Standards Authority of India has told the Supreme Court that it will consider requiring front-of-pack warning labels where a packaged food is high in even one nutrient of concern, such as sugar, salt or fat, moving away from its earlier two-nutrient trigger. The Court has sought further information before deciding the framework. The proposal is not final yet, but food businesses should factor in the possibility of a wider labelling requirement. 

The National Pharmaceutical Pricing Authority has approved 20 Form-IV intimations for discontinuation of scheduled formulations for FY 2025-26. The reasons cited include low or no market demand, declining market share, availability of competing products, portfolio optimisation and difficulties in sourcing APIs.

The Supreme Court has reserved its order on a plea seeking statutory regulation of pharmaceutical marketing practices and freebies to doctors. The Centre informed the Court that it will constitute a three-member committee to examine whether a statutory framework is necessary to address unethical practices by pharmaceutical companies. Until then, the UCPMP 2024 will continue to govern the sector.

The proceedings could determine whether India moves from the existing UCPMP framework towards a legally enforceable statutory regime governing pharma-doctor interactions and promotional practices.

The Bombay High Court has dismissed a private hospital’s claim for damages after a senior doctor resigned with seven days’ notice instead of the three months required under his contract. The Court held that damages under Section 73 of the Indian Contract Act require proof of actual loss, and the hospital had not shown that the doctor’s departure caused the claimed business loss. The judgment reinforces that a contractual breach does not automatically justify damages. Hospitals and other employers seeking compensation for premature departures will need to show actual, provable loss and evidence of reasonable steps taken to reduce that loss.

A government sub-committee has recommended retaining the 2020 notification permitting doorstep delivery of medicines, instead of withdrawing it as sought by chemists. The panel has instead suggested stricter enforcement to prevent online sale without valid prescriptions and ensure compliance with the notification. The recommendation would preserve the existing legal route for doorstep delivery while increasing compliance expectations for pharmacies and digital platforms, particularly around prescription verification and sale procedures.

The Bombay High Court has restored a hotel’s FSSAI licence after a re-inspection found it 97% compliant with food safety requirements, despite an earlier suspension for deficiencies. The Court held that once the deficiencies are rectified, the suspension should be revoked, while continued monitoring can ensure compliance with food safety requirements. The ruling makes clear that licence suspension is not meant to continue as a penalty after a food business has corrected the identified deficiencies and achieved compliance.

The State Consumer Disputes Redressal Commission, Bihar passed an Order that held gynaecologist liable and to monetarily compensate the patient’s husband after a patient died due to her unborn baby's death in the womb due to medical negligence. The Commission ruled that relying purely on ultrasound reports and ignoring the patient’s symptoms is against the established norm of medical practise and not relied upon alone. The gynaecologist must pay a lumpsum compensation and the cost of litigation with an interest to the patient’s husband.

The Directorate General of Foreign Trade has reportedly introduced an Open API facility for Certificates of Origin, allowing pharmaceutical exporters to integrate ERP and accounting systems with the online certification platform. The initiative can reduce manual data entry, streamline certificate applications, minimize repetitive tasks and improve overall processing efficiency for exporters.

The National Commission for Protection of Child Rights has decided to initiate a formal inquiry into alleged gaps in Meta’s child safety policies and its handling of child sexual abuse material. The move follows the Commission finding Meta’s response inadequate, with the company’s India head also summoned for questioning. The inquiry can increase compliance scrutiny for social media platforms around child protection, content moderation and the handling of child sexual abuse material in India.

The Bombay High Court directed the Maharashtra FDA to promptly revoke suspension or cancellation of a food business licence once identified deficiencies are rectified and compliance is confirmed. The Court held that compliant establishments should not be forced into litigation and cannot suffer further business losses due to regulatory inaction. 

The Calcutta High Court has set aside a longstanding conviction, observing that only low fat content alone does not establish that curd is adulterated. Adulteration must be supported by evidence demonstrating harm, unfitness for consumption, or satisfaction of the statutory definition. The Court also cited shortcomings in sample handling and evidentiary proof.

The Supreme Court has ruled that prior land possession is not mandatory to apply for environmental clearance for common biomedical waste treatment facilities. This is important because requiring land possession upfront could delay the clearance process and project development. Applicants can now seek environmental clearance while progressing toward securing the required land.

The Supreme Court has laid down a three-stage framework to determine when an individual’s conduct and mens rea can be attributed to a company. Courts must first examine the company’s constitutional documents to identify the authority for the relevant act, then consider whether that authority was delegated, and finally, if neither answers the question, whether the purpose of the law requires the employee’s actions to be attributed to the company. The framework gives courts a structured way to assess corporate criminal liability. Merely holding a particular position is not, by itself, enough for attribution, although the person’s status may still be relevant depending on the circumstances and the purpose of the statute.

The Supreme Court of India has held that criminal proceedings against a company cannot be quashed merely because the individual employee or officer involved has not been identified or made an accused. The Court clarified that the allegations must still show, at least prima facie, that someone acted for the company and that the circumstances support the required mens rea. The ruling raises the compliance stakes for companies because criminal exposure cannot be avoided simply by showing that no particular employee has been named. 

The Bombay High Court has reportedly denied interim relief against an food regulator's order restricting sales of a rum product in Maharashtra after regulators found external rum flavouring was used without declaring it as flavoured rum. The manufacturer submitted three revised labels proposing compliance changes, while the court deferred further consideration.

The National Medical Commission has reiterated that stem cell therapy may be offered as routine clinical care only for approved indications under applicable ICMR/DHR/MoHFW guidelines. Any unauthorised administration, prescription, promotion or advertisement beyond these indications may constitute professional misconduct and attract disciplinary action following due process. The advisory strengthens regulatory oversight of stem cell therapies and reinforces that uses beyond approved indications must remain within an appropriately approved clinical research framework.

Karnataka's Food Safety and Drug Administration reportedly conducted simultaneous raids at two unlicensed e-commerce storage facilities in Anekal and Devanahalli, acting on intelligence about illegal pharmaceutical storage and distribution. Officials seized unauthorised medicines stored without valid drug licences worth lakhs.

CBIC has prescribed seven mandatory checklists for Customs verification of imported cosmetics, drugs, medical devices and IVDs before granting Out-of-Charge in PGA facilitated bills of entry.  Pending integration of regulatory documents with SWIFT 2.0, Customs officers must verify applicable licences, registrations, permissions and supporting documents. Importers are advised to upload required records on e-SANCHIT. 

Parliamentary Standing Committee has flagged the shortage of specialised neonatal and paediatric care in district hospitals, calling the mandatory prior-consent letter for transferring critical patients to empanelled facilities flawed and life-threatening. The neonatal and paediatric care means the care of infants and children respectively. Committee has recommended abolishing this requirement and setting up self-sufficient paediatric care units in all district hospitals.

The Punjab and Haryana High Court has upheld cancellation of a drug licence over excess, unaccounted psychotropic medicines, holding that the absence of evidence of sale does not excuse stock discrepancies. The ruling reinforces the need for pharmacies to maintain complete, verifiable records of controlled medicines. It signals that unexplained inventory mismatches can independently invite regulatory action, making robust stock reconciliation and documentation critical for continued licensing.

India’s drug regulator has flagged a batch of a widely used rabies vaccine as “Not of Standard Quality” after a field sample failed potency testing. The seized vials also showed discrepancies in labelling, packaging, QR-code verification and licence details, prompting an investigation into whether the product is spurious. The incident highlights the public-health risks posed by counterfeit vaccines and the need for stronger supply-chain traceability, batch verification and regulatory surveillance

India's central food authority, FSSAI has reportedly urged the Madras High Court to review its direction requiring drinking water, sugar and salt sold in plastic packaging to carry a prominent warning that they may contain micro/nanoplastics. The regulator has sought reconsideration of the labelling requirement, which could significantly affect food and beverage packaging practices.

Gujarat’s Food and Drug Control Administration has cancelled pharmaceutical licences following intensive investigations into the sale and manufacture of counterfeit and illegal medicines. The action forms part of the state’s zero-tolerance approach to activities that compromise public health and strengthens regulatory oversight of pharmaceutical operations.

The National Pharmaceutical Pricing Authority is reportedly revising its internal guidelines for pharmaceutical overcharging cases following amendments to the Drugs (Prices Control) Order, 2013. The proposed framework would limit manufacturers’ liability to stock actually overcharged through identified distributors or retailers, where manufacturers have complied with previous price revisions.

India's Central Consumer Protection Authority (CCPA) has found misleading or inadequate disclosures in claims relating to annual maintenance contracts, warranty benefits and refund policies, following complaints about water purifier after-sales service. The CCPA has directed stronger consumer disclosures, better grievance handling and availability of genuine spare parts. The order reinforces that consumer facing claims must clearly disclose material conditions, while companies must have effective systems for handling warranties, repairs and complaints.

The Telangana High Court has directed the State Health and Medical Department to file a detailed affidavit on action taken against the alleged sale of MTP kits without prescriptions or supervision by registered medical practitioners. The PIL raises concerns over unrestricted access to medical abortion medicines and compliance with statutory safeguards governing their sale and use. The matter highlights increased judicial and regulatory scrutiny of the distribution of MTP kits and enforcement of prescription and medical-supervision requirement

Major Indian drug manufacturer has voluntarily recalled 5,082 tubes of clobetasol propionate cream in the US after the product failed to meet content uniformity specifications. Manufactured at its Pithampur facility in India, the recall is classified as Class II by the US FDA, indicating potential temporary or medically reversible adverse health consequences.

The Uttar Pradesh Food Safety and Drug Administration, Madhya Pradesh’s regional drug administration, Ayush officials and police have reportedly jointly uncovered an illegal drug manufacturing operation in Ujjain, involving production of an allopathic medicine under an Ayurvedic licence. The case highlights patient risks from unlicensed manufacturing and cross-state distribution. Authorities are tracing the wider supply network.   

Several tubes of clobetasol propionate cream have been voluntarily recalled in the US after the product failed to meet content uniformity specifications. The affected batch was manufactured in India, and the recall has been classified as Class II, indicating potential but generally temporary or reversible health risks. The recall highlights the importance of robust quality-control systems and content uniformity testing for pharmaceutical products manufactured in India for export markets.

The Central Consumer Protection Authority (CCPA) has directed the immediate removal of online listings for facilitating the online listing, hosting, advertising and sale of Ammonium Nitrate that do not comply with substance classified as an explosive under the Explosives Act, 1884 and heavily fined the company. The Authority reiterated that consumers rely on product listings and descriptions when making online purchasing decisions, and that e-commerce platforms must exercise appropriate due diligence in relation to regulated products.

The Delhi High Court has rejected a plea challenging rights associated with the “REDDY” trademark. The Court’s decision provides relief to the existing trademark holder and reinforces the importance of established trademark rights, particularly where a mark has acquired significant recognition in the pharmaceutical sector.

The Rajasthan Drug Control Department seized medicines and pharmaceutical raw materials worth nearly ₹4 crore from an unlicensed warehouse in Bhiwadi. Around 1,500 cartons were recovered, including medicines, packing material and sensitive raw materials. Nine medicine samples were collected for testing, highlighting serious violations involving unlicensed storage and distribution.

India's central cosmetics authority has cancelled cosmetic registration certificates for a cosmetic company after an investigation found unregistered products sold through e-commerce platforms, incorrect registration numbers on labels, and an unauthorised warehouse relocation. The firm acknowledged the violations, leading to cancellation under the Drugs and Cosmetics Act, 1940 and Cosmetics Rules, 2020.

The Government has introduced the Ninth Schedule through the Medical Devices (Second Amendment) Rules, 2026, establishing prescribed fees for specified medical device tests and evaluations. Charges for unspecified tests will be determined by laboratories, with an annual five percent increase.

The Indian Pharmacopoeia Commission has issued a user manual for reporting medical device adverse events through the Adverse Drug Reactions Monitoring System under the Materiovigilance Programme of India. The manual standardises reporting and supports systematic collection, assessment and monitoring of medical device safety information, strengthening India’s post-market surveillance framework.

The Delhi High Court has directed a six-month forensic audit into alleged dissipation of listed company shares during enforcement of a long-pending foreign arbitral award, upheld earlier by the Supreme Court. A chartered accountancy firm has been appointed to reconstruct transaction records, including share pledges, transfers and fund flows involving banks and related entities, to determine whether assets were deliberately moved to evade enforcement, or genuinely lender-driven.

India has reportedly urged Brazil to establish more predictable and transparent regulatory processes to facilitate pharmaceutical trade and improve market access for Indian drug manufacturers. Discussions focused on reducing regulatory barriers and strengthening cooperation between the two countries, with greater regulatory certainty expected to support exports of quality and affordable medicines.

Maharashtra's FDA cancellation of a pharma company's wholesale distribution licence due to irregularities related to packaging, storage and recall of Schedule H drug was withdrawn. The Bombay High Court withdrew a pharma firm's licence cancellation, ruling it unfair and against "principles of natural justice" since the company was summoned on a public holiday and its licence was cancelled when no representative appeared. The Court shall pass an order upon the FDA issuing a fresh show-cause notice to the Company.

The Central Pollution Control Board has directed producers, importers, brand owners, manufacturers, sellers and plastic waste processors covered under the Plastic Waste Management Rules, 2016, to register on the Common EPR Portal. The move is important as covered entities cannot conduct business without registration. Stakeholders must now complete portal registration before carrying out operations.

Indian central Health ministry has amended the Medical Devices Rules, 2017 to expressly require manufacturers and importers of Class A non-sterile and non-measuring medical devices to self-certify compliance with applicable standards and Quality Management System (QMS) requirement. The amendment strengthens quality controls for these devices under the registration framework.

The Ministry of Health and Family Welfare, through NOTTO, has issued national guidelines aimed at standardising the diagnosis and certification of brainstem death across hospitals. The guidelines provide a uniform framework for certification, including clinical assessment and special circumstances, with the objective of improving consistency and supporting deceased-organ donation.

The Government of India is reportedly developing an ecosystem to support domestic manufacturing of advanced medical devices, including magnetic resonance imaging machines, by 2028. The initiative aims to reduce import dependence, strengthen domestic supply chains, promote research and innovation, attract investment, and position India as a competitive global medical device manufacturing hub.

The government is considering policy support and financial incentives to help chemical exporters reduce dependence on the US market and expand into Europe, Southeast Asia, Africa and Latin America. The proposed product-region strategy would also encourage a shift towards higher-value specialty, green and pharmaceutical chemicals. The move could strengthen the resilience of India’s chemical sector by reducing export concentration and supporting Indian manufacturers.

The Directorate General of Foreign Trade (DGFT) has revised the export policy for specified wheat and wheat flour products from “Prohibited” to “Free” with immediate effect. The change covers wheat under HS Codes 10011900 and 10019910, and wheat flour, atta, maida and related products under HS Code 11010000.

The Maharashtra Food and Drug Administration has reportedly withdrawn its order cancelling a pharmaceutical company’s drug licence after the Bombay High Court criticised the regulator for denying a fair hearing. The regulator will now issue a fresh notice and reconsider the matter through due process before deciding on further action.

The Orissa High Court held that a qualified cannot be barred from conducting ultrasonography at clinics located in two different districts, especially when a no-objection certificate has been issued by his employer. The Court granted relief to Radiologist and set aside the District Advisory Committee's order, which prevented the Radiologist from conducting ultrasonography at a private clinic.