Where Pharma and Healthcare meet Legal Expertise.

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 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.

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 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’.

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.

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, 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 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.

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 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 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.

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 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 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 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.

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 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 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 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 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 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.

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 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 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.

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.

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.

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 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 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.

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

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.

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 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

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.

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.

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.

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.

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 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.

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 Central Consumer Protection Authority (CCPA) has directed the immediateremoval 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 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.

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 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.

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.

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 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 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.

Maharashtra’s FDAcancellation 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 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.

The National Pharmaceutical Pricing Authority has proposed making manufacturers solely responsible for overpricing essential medicines, while removing prosecution risks for retailers, chemists and hospitals. The move is important as medicines may continue to be sold above revised prices, affecting affordability. The draft would remove action against downstream sellers for such violations.

The Delhi High Court granted interim protection to a packaged food company against licence cancellation by the FSSAI, which had objected to “100 per cent” claims on its atta product. The High Court held no cancellation decision would be taken pending resolution of jurisdictional questions, listing the matter for further hearing on September 9.

The Central Bureau of Narcotics (CBN) has signed a Memorandum of Understanding (MoU) with the Pharmaceutical Export Promotion Council for preventing the diversion of controlled substances, particularly Narcotics and Psychotropic Drugs. Under the agreement, the CBN will develop a non-binding voluntary code of Conduct, setting out recommended practices. The two sides will identify and recommend measures to streamline export procedures for compliant exporters.

The Indian Pharmacopoeia Commission has proposed revisions to several drug monographs for inclusion in the Indian Pharmacopoeia, including additional requirements for bacterial endotoxins, sterility and related quality tests. The revisions are important as they seek to strengthen quality standards and testing requirements for pharmaceutical products covered under the pharmacopoeia.

The Delhi High Court has restrained the use of ‘SMOOTH’ for a dairy-based yogurt drink, finding it prima facie deceptively similar to the registered ‘SMOODH’ trademark. The Court noted potential consumer confusion and prominence of ‘SMOOTH’ on packaging, and granted an interim injunction against its use pending further proceedings.

India’s health ministry has included the European Union (“EU”)among recognised regulatory jurisdictions under Medical devices rules, 2017. Now, EU-approved medical devices without predicate devices may qualify for a waiver from clinical investigation requirements in India, potentially facilitating faster regulatory approvals and market access.

The Indian Government has amended the Medical Devices Rules, mandating manufacturers outsourcing sterilisation to mention the sterilisation facility’s licence number on product labels, preceded by “Sterilization Sites Manufacturing License Number”, “Ster. Mfg. Lic. No.” or “S.M.L.” The move strengthens traceability while removing the need for a separate loan licence. Manufacturers get six months to update labels.

Bengaluru authorities have reportedly fined seven private medical establishments for violations of the Karnataka Private Medical Establishments Act, with registration licences of three facilities cancelled. Authorities have also ordered inquiries, warnings and undertakings to strengthen compliance among private healthcare establishments.

A Parliamentary Standing Committee has reportedly recommended decentralising licensing of Class A and B medical devices to State Licensing Authorities (SLAs), with greater autonomy based on quality assessments by QCI-approved notified laboratories. The move aims to strengthen state-level regulation, attract global manufacturers, expand testing infrastructure and improve access to safe medical devices.

The FSSAI has reportedly issued over 150 notices to major food business operators over misleading advertisements, false claims and labelling non-compliances of its laws and regulations in recent months. Twelve notices were issued to e-commerce companies, with one warehouse licence cancelled, while over 30 notices targeted food service establishments, with five licences suspended. FSSAI has stated that many companies have started taking corrective actions, following notice issued to these companies.

In the recent Draft Registration of Medical Practitioners and License to Practice Medicine (Amendment), Regulations 2026,  the Apex Medical Commission has proposed to include other information, including the active or inactive status of the doctor’s license to practice medicine and the details of disciplinary action taken against the doctor (if any) in the NMR. The Commission has invited objections and suggestions from stakeholders within 30 days of the Gazette notification.

The Government has restricted the manufacture, sale and distribution of fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, requiring a warning against their use in children below four years. The restriction now covers all formulations containing the two ingredients and follows recommendations from the expert committee and Drugs Technical Advisory Board

India’s Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to include Flupentixol, Zopiclone, Gabapentin and Carisoprodol under Schedule H1. Stakeholders may submit objections within 30 days. If finalised, the proposed amendments will take effect within 180 days after publication of the final rules.

The Centre has amended the Medical Devices Rules, 2017 to ease requirements for manufacturers that outsource sterilisation, removing the need for a separate loan licence where the sterilisation facility already holds a valid licence.

The Government has extended the transition period for mandatory India Conformity Assessment Scheme-Halal certification for specified meat and meat products exported to Egypt from six to nine months. The extension provides additional time for Egyptian Halal certification bodies to complete onboarding and accreditation requirements.

The National Medical Commission has proposed a unique identification number for every registered doctor, linking state and national records. The proposed system would allow doctors to practise across India without fresh state registration, while centrally tracking licence status, suspensions, cancellations and disciplinary proceedings through an electronically synchronised national register.

A Parliamentary panel has recommended a strategy to improve drug pricing data capture in remote regions through digital initiatives. Better coverage is important to ensure data and strengthen medicine price monitoring, particularly in areas affected by poor connectivity. Authorities may also explore real-time inventory tracking across the supply chain.

The National Medical Commission has proposed linking the National Medical Register with State Medical Registers to centrally track doctors’ licence status, suspensions, removals and other disciplinary actions pursuant to draft Registration of Medical Practitioners and Licence to Practice Medicine (Amendment) Regulations, 2026,. The proposed system aims to ensure that disciplinary action taken in one State is visible nationally and cannot be circumvented by practising elsewhere.

The Indian National Commission for Homoeopathy has clarified that homoeopathic practitioners cannot practice other systems of medicine, but may participate in government health programmes after completing training recognised by the competent government authority. The clarification comes amid ongoing controversy in Maharashtra over allowing BHMS doctors with additional pharmacology training to practise modern medicine.

FSSAI has reportedly announced that six food business operators took corrective action after receiving regulatory notices for violations. The measures taken included withdrawing misleading “vegan” and “healthy” label claims, halting production of non-standardised products, delisting items from their websites, and changing misleading trademarks. These charges were aimed at ensuring consumer safety and regulatory compliance.

The Supreme Court has issued 13 binding directions to strengthen bail and surety verification for foreign nationals accused in commercial quantity NDPS cases. The directions follow concerns over fake sureties and accused persons absconding after bail. Courts must now verify sureties, addresses and financial details more strictly before releasing such accused.

India’s Health Ministry has reportedly issued binding standards for the cosmetology clinics requiring them to be operated by registered dermatologists or plastic surgeons. Botox, fillers and chemical peels are classified as Level 1 procedures, while ablative lasers and surgeries face stricter infrastructure requirements.

The Government of India has proposed new regulations, The Prevention and Control of Infectious and Contagious Diseases in Animals Rules, 2026, for the prevention and control of infectious and contagious diseases in animals. The new draft expands on the rules established previously and emphasizes enhanced surveillance, timely reporting, and penalties for individuals who fail to report a contagious disease in cattle within a specified time frame.

Government is developing a new incentive framework for India’s nutraceuticals sector, consulting the food processing ministry, health ministry and Food Safety and Standards Authority of India (FSSAI). Government  may instead of a separate production-linked incentive (PLI) scheme, the government is reviewing lessons from the existing food-processing PLI before finalizing the framework.

A Comptroller and Auditor General audit reportedly found that the Food Safety and Standards Authority of India failed to impose crores of penalties on thousands of food businesses for non-filing or delayed filing of mandatory annual returns between 2017–18 and 2022–23. None had their licences suspended or cancelled as of August 2023.

The Delhi High Court has allowed a leading consumer goods company to sell existing stock of a cooling hair oil until September 30 amid a trade dress dispute with a competing personal care company. The Court retained the injunction, restricting sales to physical outlets, requiring e-commerce listings removal and recalling unsold stock.

The National Commission for Homoeopathy has clarified that Homoeopathic practitioners cannot practise other systems of medicine under Regulation 36(y) of the 2022 Code of Ethics. However, they may do so under National Health Programmes or government programmes where they have completed training or courses recognised by the competent authority. The clarification provides greater regulatory certainty on the circumstances in which Homoeopathic practitioners may participate in government health programmes involving other systems of medicine.

India National Highway Authority, NHAI has reportedly introduced stricter service standards for ambulances on national highways, requiring arrival at accident sites within 10 minutes for incidents within 10 km and hospital transport within one hour. The ambulances must also maintain prescribed medical equipment, medicines and trained personnel, with performance monitored through GPS and NHAI’s dashboard.

A parliamentary committee has proposed a new framework to bring unregulated medical devices under statutory price capping. This step is critical to reduce exorbitant out-of-pocket patient expenses and control wide price variations in essential medical implants. Under the proposed system, high-priority devices will face immediate maximum retail price ceilings or restricted trade margins.

FSSAI has cautioned influencers and celebrities against promoting food products with unverified or misleading health claims, such as “boosts immunity.” The Regulator stressed that the products to be endorsed must have claims that are truthful, verified and comply with laws must be verified by the content creators else these violations could invite action under the Food Safety and Standards Act, 2006, and the Advertising and Claims Regulations, 2018.

Medical device companies, patient safety groups and healthcare providers have opposed the draft Bill, arguing that medical devices are fundamentally different from pharmaceuticals and require a distinct regulatory framework. Stakeholders have warned that treating devices like medicines could increase compliance burdens and adversely affect manufacturing, innovation and access to advanced technologies.

A parliamentary standing committee has urged the Health Ministry to develop a comprehensive national strategy for chronic kidney disease, focusing on prevention, early detection, treatment and long-term care. It flagged severe shortages of nephrologists, urologists and trained dialysis technicians, recommending stronger primary healthcare and trained physicians to supervise dialysis units.

The Food Safety and Standards Authority of India has reportedly seized around 18,000 boxes of liquor bottles in Bengaluru after finding that PET bottles lacked mandatory markings indicating that the recycled plastic was suitable for food contact. The action highlights increased regulatory scrutiny of recycled plastic packaging and labelling compliance.

The Indian Council of Medical Research and Central Drugs Standard Control Organization have proposed standard protocols for evaluating Scrub Typhus IgM rapid diagnostic tests and enzyme-linked immunosorbent assays. The protocols aim to establish consistent requirements for assessing diagnostic accuracy, reliability and performance in India.

The Supreme Court will reportedly frame comprehensive guidelines for hospitals on providing medical assistance to crime victims. The proposed guidelines are expected to ensure timely treatment, protect victims’ rights, and clarify hospitals’ responsibilities, with the Court likely to issue detailed directions following further consideration.

Following a Kerala High Court ruling upholding regulatory action against deceptive discount displays at medical shops, pharmacy trade bodies in several states are advocating stricter enforcement against misleading price hoardings. The Delhi-based RDCA has advised retailers to remove exaggerated discount claims, ensure authorised sourcing and maintain transparency in retail pricing and invoices.

A District Consumer Commission has held a hospital liable for deficiency in service after finding unhygienic amenities and contaminated food were provided to patient recovering from a Caesarean delivery under a maternity care package. The ruling underscores that hospitals must maintain promised standards of hygiene and patient care.

India’s central drug authority, CDSCO, has directed State and Union Territory drug regulators to identify and take action against manufacturers and marketers of unapproved drug products containing Enclomiphene and its combinations. The regulator has reiterated that such products cannot be manufactured or marketed without the required regulatory approval, reinforcing compliance under India’s drug regulatory framework.

The Telangana High Court dismissed an appeal against cancellation of an oil palm factory zone allotment, holding that the allottee had failed to establish a processing unit within the stipulated 24-month period despite repeated opportunities. Observing unsatisfactory plantation performance and rejecting reliance on belated compliance steps, the Court ruled that continued non-compliance meant the Company could not expect the allotment to carry on indefinitely.

The Centre has informed the Supreme Court that the rule requiring private hospitals to charge within government-determined rate ranges is constitutionally valid, although the rates have not yet been finalised due to a lack of consensus among States. The framework could reduce variations in hospital charges and improve transparency for patients.

CDSCO has clarified that applications for permission to import and market new drugs not approved anywhere in the world, where Phase III Global Clinical Trials (GCTs) are ongoing or completed with Indian subjects, must be processed by its Investigational New Drug (IND) Division. Applicants are required to submit such applications to CDSCO Headquarters, New Delhi, under the NDCT Rules, 2019.

The Minister of Health & Family Welfare has defended the Clinical Establishments framework before the Supreme Court, stating that regulation of clinical establishments and standardisation of treatment charges are necessary to curb excessive pricing of medical services and protect patients. The matter raises important questions on the extent of government authority to regulate pricing in private healthcare establishments.

ICMR and CDSCO have jointly drafted performance evaluation protocols for Scrub Typhus IgM ELISA and RDT kits under the Medical Devices Rules, 2017. Stakeholders can submit comments to ivdevaluation@gmail.com until 25th August 2026, after which the protocols will be finalized with minimal scope for further changes.

A parliamentary committee has reportedly endorsed Punjab’s public-private partnership model for subsidised diagnostic services, citing its potential to reduce healthcare costs. It recommended a standardised national framework enabling states to outsource high-cost diagnostic and dialysis services at capped rates, improving affordability and access to quality healthcare.

Medical device companies are raising concerns over a proposed bill that could bring medical devices within a regulatory framework similar to pharmaceutical products. Industry stakeholders argue that devices differ fundamentally from medicines in terms of technology, manufacturing, risk classification and lifecycle, and therefore require a distinct regulatory approach**.** The development could have significant implications for India’s medical-device regulatory framework and compliance requirements.

CDSCO under the Drugs Rules, 1945 issues an amendment for the requirement for obtaining a Form 29 licence for manufacturing drugs for examination, test or analysis. The proposed amendment expands the existing reference to manufacturing licences to cover specified categories under Forms 25A, 25F, 28A, 28B, 28D, 28DA, 28E and 28F, bringing greater clarity to Form 29 requirements for these licence holders.

The Food Safety and Standards Authority of India has amended the Food Safety and Standards (Packaging) Regulations, 2018, prescribing specific packaging requirements for pan masala. Permitted materials include plastic-free paper, paper board and naturally derived materials, as well as tin or glass containers. Aluminium foil, metallised layers and synthetic polymers are prohibited.

The Central Bureau of Investigation has registered a case involving a CDSCO official and a pharma executive over alleged bribery linked to regulatory clearances. The investigation may lead to increased scrutiny of interactions between regulatory officials and applicants during the processing of drug-related clearances.

The Food Safety and Standards Authority of India (FSSAI) has issued draft amendments to the Food Safety and Standards (Safe Food and Balanced Diets for Children in School) Regulations, 2020. The proposal introduces ICMR Dietary Guidelines 2024 thresholds for identifying foods high in added fat, added sugar and salt in school settings.

The Central Pollution Control Board (CPCB) has informed the National Green Tribunal that it will take action against States and Union Territories failing to comply with biomedical waste deep-burial requirements. The CPCB has issued communications to concerned authorities, with further enforcement action proposed if compliance is not achieved within eight weeks.

Maharashtra FDA has issued a comprehensive compliance order for all licensed blood centres, mandating strict adherence to the Drugs & Cosmetics Act, 1940 and Rules, 1945, including Schedule F Part XII-B norms. It covers testing, storage, donor criteria, e-RaktKosh reporting, and warns of strict legal action against non-compliant centres.

The Delhi High Court has reportedly temporarily stayed the food regulator’s order stopping a major Indian consumer goods company from selling food products carrying “100 per cent” claims. The company argued that it was not given prior notice or an opportunity to present its case.

CDSCO has invited stakeholder comments on proposed operational guidelines for a single Ethics Committee review of multi-centre research in India. The initiative seeks to streamline ethics review across multiple research sites while maintaining appropriate ethical oversight and participant protection, potentially reducing duplication and delays in multi-centre studies.

India’s central food authority, FSSAI is reportedly considering a nutrition-table approach instead of mandatory front-of-pack warning labels for packaged foods high in sugar, salt and fat. The proposal has drawn concern from public-health experts, who argue that consumers may struggle to interpret detailed nutritional information. The issue remains under consideration following Supreme Court intervention.

Maharashtra’s FDA Commissioner has banned manufacture, storage, distribution and sale of analogue/non-dairy paneer statewide for one year under Section 30(2)(a) of the Food Safety and Standards Act, 2006. Food service establishments must not use, prepare, serve, store, sell, or present analogue/non-dairy paneer as genuine paneer, as doing so is misleading to consumers and constitutes an unfair trade practice. Any contravention of this Order shall be punishable under the applicable penal provisions of the FSS Act, 2006.

A Parliamentary Committee has reportedly recommended examining the feasibility of reintroducing a cost-based pricing mechanism for medicines through statutory amendments where significant price disparities or excessive mark-ups are observed. The recommendation seeks to address pricing distortions that may not be captured under the existing market-based pricing framework.

A lot of a sterile injectable antibiotic has been voluntarily recalled after particulate matter, identified as cardboard, was detected in the infusion solution. The contamination poses risks including vascular occlusion, immune reactions and organ damage if administered intravenously, underscoring the importance of stringent manufacturing quality controls and post-market surveillance.

NITI Aayog has proposed a National Policy on Caregiving, including a National Caregiver Council to accredit caregivers, standardise training and regulate the sector. It also recommended a dedicated caregiver cadre and digital portal. The move aims to professionalise care services, create skilled employment, boost women’s workforce participation and support India’s growing elderly population.

West Bengal health department has reportedly barred 11 blood banks from organising blood donation camps pending an investigation into alleged regulatory violations, including unauthorised camps and suspected illegal transfer of blood components. The affected facilities may continue accepting voluntary walk-in donations but require prior approval for large intra-state blood transfers.

The Ministry of Road Transport and Highways has proposed additions of two-wheeled road ambulances Central Motor Vehicles Rules, 1989 to provide emergency response in rural, remote and hilly terrain. The draft introduces uniform safety, construction, registration, and fitness standards to strengthen last-mile emergency medical response. The draft has been opened for a 30-day public consultation period, after which the rules will be finalized.

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 manufacturer has reportedly challenged the Food Safety and Standards Authority of India before the Bombay High Court against its order restricting sales of a rum product over alleged labelling violations. The company maintains its labels comply with regulations and industry practice, while describing the dispute as an industry-wide regulatory issue.

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.

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.

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.

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.

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.

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.

India’s Delhi Anti-Corruption Branch (ACB) reports have alleged ₹600 crore procurement scam involving the directorate general of health services (DGHS) and the central procurement agency (CPA). The scam includes claims of changing tender rules, using fake companies, and raising prices for medical supplies. Items like X-ray machines, bedsheets, and ORS sachets were bought at much higher prices than usual. Three officials have been arrested, and the investigation continues to uncover more information.

The Department of Pharmaceuticals has strengthened record-keeping requirements under the Drugs (Prices Control) Order, 2013. Manufacturers must maintain records relating to APIs, bulk drugs, formulations, and other prescribed information for at least seven financial years, with records retained until the conclusion of any pending proceedings, if any.

The Department of Pharmaceuticals has amended the Drugs (Prices Control) Order, 2013 to introduce Form IA for intimating new drug launches. The amendment simplifies the launch process for existing manufacturers by replacing the requirement for fresh retail price approval with a post-launch intimation within one month.

The Ministry of Health and Family Welfare has notified amendments to the Drugs Rules, 1945, expanding their scope to expressly cover cell or stem cell-derived products, gene therapeutic products, and xenografts alongside recombinant DNA (r-DNA) derived drugs. The amendments take effect from the date of publication in the Official Gazette.

India’s Central Drugs Standard Control Organisation (CDSCO) is undertaking a nationwide reconciliation exercise to identify and authenticate missing drug approvals from 1945, including legacy products approved by State Licensing Authorities (SLA) before 1988. Manufacturers will be required to submit historical approval records to help create a comprehensive national repository, address gaps in the CDSCO approval database, improve regulatory oversight, and verify that older formulations comply with current safety and efficacy standards.

The Department of Pharmaceuticals has amended the Drugs (Prices Control) Order, 2013 to permit separate ceiling or retail prices for therapeutically justified variants of the same drug. The amendment recognizes differences in packaging, pack size, dosage compliance, and dosage form while determining regulated prices.

The Department of Pharmaceuticals has clarified the framework governing overcharging liability under the Drugs (Prices Control) Order, 2013. Manufacturers demonstrating compliance with prescribed price communication requirements will have their liability restricted to the quantity of stock actually overcharged by distributors or retailers, providing greater regulatory certainty.

The Food Safety and Standards Authority of India (FSSAI) has issued notices to six beverage manufacturers over the use of the term “energy drink” and related misbranding and misleading claims. The regulator observed that there is currently no notified standard for products classified as “energy drinks” under the Food Safety and Standards framework, and objected to promotional claims suggesting functional or therapeutic benefits, such as boosting energy or enhancing focus. The action reinforces FSSAI’s ongoing efforts to ensure compliance with food labelling and advertising regulations and to prevent misleading claims that may deceive consumers.