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The Indian government has operationalised an inventory-based cross-border e-commerce export framework under the Foreign Trade Policy, 2023. The framework establishes a regulatory mechanism for inventory-based exports. Eligible e-commerce entities may now undertake export-only inventory operations through an Exporter-on-Record procuring goods from Indian Seller-on-Record entities.

India has launched the e-Pratyaropan portal and NOTTO mobile app to create a unified national system for organ donation and transplantation. The platform enables real-time waiting lists, transparent organ allocation, nationwide kidney swap matching, and outcome monitoring. This aims to improve coordination, efficiency, and access across the transplant ecosystem.

India's central drug authority, CDSCO has issued a revised guidance document on the common submission format for import and registration of bulk drugs and finished formulations in India. The document standardises submission requirements, clarifies regulatory expectations, and aims to streamline import and registration applications under the drugs regulatory framework.

The Supreme Court has dismissed the Revenue Department's excise duty demand, holding that the mere grouping, unpacking and repacking of imported products, without bringing into existence a new commercially distinct product, does not constitute "manufacture" under the Central Excise Act and therefore does not attract excise duty.

The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945 to empower drug licensing authorities to debar applicants who submit misleading, fake, or fabricated documents or information while seeking regulatory approvals. This action is in addition to existing legal penalties and reinforces accountability, transparency, and the integrity of the regulatory approval process.

The Indian Pharmaceutical Alliance (IPA) has reportedly sought the regularisation of "legacy" drugs that have been marketed in India for years but are absent from CDSCO's approval database. IPA cites regulatory gaps arising from historical state approvals and incomplete records, affecting products such as sodium valproate, carbamazepine and lithium carbonate.

The Supreme Court has directed the Ministry of Environment, Forest and Climate Change (MoEFCC) to frame comprehensive guidelines for the levy of environmental compensation under the Solid Waste Management Rules, 2026. The Court observed that a uniform framework is necessary to ensure consistent implementation of the "polluter pays" principle and avoid arbitrary imposition of environmental compensation by regulatory authorities. The guidelines are expected to bring greater certainty and consistency to the enforcement of environmental compensation provisions under the Solid Waste Management Rules, 2026

India's Department of Pharmaceuticals (DoP) has cancelled the Request for Proposal (RFP) for developing a Sectoral Plan for Efficient Logistics (SPEL) for pharmaceuticals, APIs and medical devices. The proposed study aimed to strengthen logistics infrastructure, address regulatory bottlenecks, improve supply chain efficiency and recommend policy interventions to support industry growth.

The Government has reportedly proposed mandatory blue strip labels for antimicrobial medicines to strengthen efforts against antimicrobial resistance and promote responsible antibiotic use. The proposal seeks to make antimicrobial medicines easily identifiable by healthcare professionals and patients. If implemented, manufacturers will be required to update product labels to incorporate the prescribed marking.

The Food Safety and Standards Authority of India has reportedly prohibited a leading consumer goods manufacturer from selling multiple food products carrying unverifiable “100 per cent” claims, citing misleading advertising and labelling violations. The company must immediately halt sales of affected products and submit a corrective action report within fifteen days.

The Bombay High Court criticised the Maharashtra FDA for suspending the food business licence of a four star hotel over the discovery of two insects, observing that the action appeared disproportionate in light of an otherwise satisfactory inspection report. The Court emphasised that regulatory enforcement must be fair, consistent and proportionate, and set aside the suspension order.

India's central government is reportedly considering a comprehensive national regulatory and patient safety framework for dental implants, implant biomaterials, artificial teeth and related implant systems. The proposed framework aims to strengthen regulatory oversight, improve quality and safety standards, and ensure greater accountability across the dental implant ecosystem amid rising adoption in India.

A Delhi court has ordered that charges be framed in a case involving the alleged illegal possession and seizure of codeine-based cough syrup under narcotics law, finding sufficient grounds to proceed to trial. The order clears the way for formal prosecution and further judicial proceedings in the matter.

A parliamentary panel has recommended that the Department of Pharmaceuticals regulate prices of trade generic medicines distributed through separate marketing channels, citing concerns over excessive markups and affordability in rural and remote markets. If implemented, the proposal could improve access to reasonably priced medicines through greater pricing oversight.

The Central Drugs Standard Control Organisation will launch the first phase of the Digital Drug Regulatory System within eighteen months. The integrated online platform will simplify regulatory approvals, improve transparency, strengthen medicine traceability, use artificial intelligence for faster processing, and help pharmaceutical companies meet compliance requirements through a single digital window.

The Maharashtra Food and Drug Administration (FDA) has identified several medicines allegedly being sold at excessive prices and plans to refer these cases to the National Pharmaceutical Pricing Authority (NPPA) for regulatory action. The FDA has also indicated that it will intensify surveillance of drug pricing and investigate instances of unreasonable mark-ups to strengthen compliance with pricing regulations.

India's major manufacturer of eye drops has reportedly voluntarily recalled a batch of eye drops in India after contamination concerns were identified during quality checks. The company initiated the recall as a precautionary measure, informed the concerned authorities, and advised distributors to withdraw the affected batch while reiterating its commitment to patient safety and product quality.

FSSAI has reportedly intensified enforcement against three food businesses and has ordered recall of raisins for excessive pesticide residues; suspended Pharmaceuticals’ manufacturing licence over critical compliance failures and prohibition order for marketing as a food supplement with misleading claims of folic acid syrup and non-compliance of FSSAI Regulations, 2016. These actions were taken to protect consumers and warned of strict consequences for violations.

The Gujarat High Court has stayed the 13-month suspension of three dermatologists imposed by the Gujarat Medical Council for allegedly accepting pharmaceutical company-sponsored foreign trips and other benefits. The Court granted interim relief pending final adjudication of the doctors' challenge to the disciplinary action. The case underscores ongoing judicial scrutiny of medical ethics enforcement and doctor–pharma relationships.

FSSAI has reportedly suspended the licence of a manufacturing unit after finding serious non-compliances, including deficiency with Good Manufacturing Practices, hygiene standards, and food safety systems. Citing gross violation of the Food Safety and Standards Act, 2006, and risk to public health, the regulator ordered immediate cessation of operations until deficiencies are rectified.

The Parliamentary Standing Committee on Chemicals and Fertilisers has reportedly urged the Department of Pharmaceuticals to urgently amend the Drugs Prices Control Order, 2013 to enable Trade Margin Rationalisation for life-saving medicines, particularly anti-cancer drugs. The Committee stressed that timely implementation is essential to improve affordability and reduce excessive trade margins.

The Gujarat High Court has stayed the 13-month suspension of three dermatologists imposed by the Gujarat Medical Council for allegedly accepting pharmaceutical company-sponsored foreign trips and other benefits. The Court granted interim relief pending final adjudication of the doctors' challenge to the disciplinary action. The case underscores ongoing judicial scrutiny of medical ethics enforcement and doctor–pharma relationships.

Food Safety and Standards Authority of India (FSSAI) has directed the withdrawal of certain nutraceutical products over misleading health claims and non-compliant labelling. The action underscores heightened regulatory scrutiny of health and nutrition claims. Food businesses should review product labels, advertisements and promotional materials to ensure compliance with applicable food safety and claims regulations.

India's Ministry of AYUSH has notified amendment to drugs rules, introducing perpetual manufacturing and loan licences, a Standard Product Code for AYUSH medicines, digital labelling through QR codes and barcodes, risk- based inspections, revised GMP requirements, and a framework for provisional shelf life based on accelerated stability studies. The AYUSH drug manufacturers to benefit from revised licensing and compliance framework.

The Central Drugs Standard Control Organization has introduced stringent cybersecurity, Software Bill of Materials (SBOM), quality management systems, and software lifecycle controls for medical device software. Manufacturers and importers must implement secure development practices, continuous vulnerability monitoring, post-market surveillance, and timely security updates aligned with global software safety standards.

India’s central food authority, FSSAI reportedly has suspended the licence of food manufacturer after inspections which revealed alleged alteration of manufacturing and expiry dates, fraudulent re-labelling, misleading declarations, and unsubstantiated "organic" claims. The regulator also recovered equipment allegedly used for label tampering, considering the products prima facie unsafe and a threat to consumer health. 

The Central Pollution Control Board has issued comprehensive guidelines for recycling of 1waste lead acid and lithium-ion batteries under the Battery Waste Management Rules, 2022. The guidelines prescribe infrastructure, operational, environmental, safety, emission, monitoring, and reporting requirements to strengthen compliance, resource recovery, and environmentally sound battery recycling practices.

The CDSCO has cancelled the registration certificates of seven Ethics Committees under the New Drugs and Clinical Trials Rules, 2019, following risk-based inspections that identified serious deficiencies and major non-compliances with the NDCT Rules, Good Clinical Practice (GCP) guidelines and other regulatory requirements. The action follows inspection reports, show cause notices and evaluation of corrective actions, and is aimed at strengthening ethical oversight and safeguarding the rights, safety and well-being of clinical trial participants.

India's Central Pollution Control Board (CPCB) has issued comprehensive guidelines prescribing procedures for the collection, handling, storage, packaging, labelling, and transportation of waste batteries under the Battery Waste Management Rules, 2022. The guidelines aim to strengthen environmental safety, improve traceability, minimise fire and leakage risks, and standardise waste battery management across stakeholders.