Daily Intelligence for Industry Leaders

The National Dental Commission (NDC) has clarified that registered dentists must perform dental procedures only within the scope of their qualifications and clinical training. In an advisory dated June 9, 2026, the Commission emphasised that dentists must adhere to these professional boundaries and should not undertake procedures beyond their training. It has asked State Dental Councils and Tribunals to issue advisories or guidelines to registered dentists, ensuring that their clinical services remain aligned with their formal qualifications and training.

The Food Safety and Standards Authority of India (FSSAI) directed manufacturers to remove the description 'Energy Drink' from certain beverage products, citing concerns of misbranding and misleading claims. The directions were challenged before the Delhi High Court on the grounds that FSSAI had previously permitted the use of the description. The manufacturers also questioned the directions for having been issued without a show-cause notice or an opportunity of hearing.

On October 6, 2026, the Court stayed the impugned directions and permitted the sale of existing stock, while prohibiting further manufacture using the disputed description. By an order dated October 30, 2026, the Court clarified that cans manufactured before October 6 could also be filled and utilised. The interim arrangement will continue pending disposal of the petition.

The National Institute of Biologicals, PETA Science Consortium International and Institute for In Vitro Sciences has reportedly conducted practical training on non animal toxicity testing. The programme trained regulatory, research and pharmaceutical professionals in approaches using human cells, tissue models and computational tools to support biomedical research and pharmaceutical quality evaluation.

The Supreme Court has reserved its judgment in a petition questioning the procedure followed to declare patients brain-stem dead, particularly the reliance on the Apnea test. The petition alleges that patients may be incorrectly declared brain-stem dead to facilitate organ transplantation. He has argued that the Apnea test should not be the sole or primary basis for such a determination and that additional tests, including electroencephalography (EEG) and cerebral angiography, to assess the condition. The Supreme Court directed AIIMS, New Delhi, to constitute a three-member expert committee to review the protocols and recommend appropriate procedures.

The National Pharmaceutical Pricing Authority (NPPA) has announced a downward revision in the ceiling price of oxaliplatin injection (5 mg/ml, 10 ml vial) under the Drugs (Prices Control) Order, 2013, incorporating the applicable Wholesale Price Index (WPI) adjustment for 2026.

The revision reduces the regulated ceiling price for the scheduled formulation. Manufacturers and importers must issue revised price lists in Form V through IPDMS and provide copies to the concerned authorities and dealers, while complying with applicable reporting and discontinuation requirements.

The Food Safety and Standards Authority of India has issued draft rules proposing to permit chemically recycled polyethylene and polypropylene in food contact materials where equivalent to virgin material. Food grade recycled polymers may also be used in the outermost layer of multilayer packaging, subject to adequate barriers and prescribed migration limits. Comments are invited within 60 days.

India's Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, requiring manufacturers of drugs to authorise qualified personnel for batch release as per the GMP requirements. The proposal also introduces a prescribed Batch Release Certificate and batch-wise documentation covering manufacturing, testing and quality checks. Loan licensees and manufacturer of blood products would also be required to maintain batch-release records for every batch manufactured under their licences strengthening accountability for quality oversight even where manufacturing is undertaken at another licensee’s premises.

The US regulator has approved the removal of broad black box warnings from three estrogen patch products used to treat menopause symptoms. The decision follows a review of existing safety labelling and aims to ensure warnings appropriately reflect risks while improving access to hormone replacement therapies amid rising demand.

Karnataka High Court has recorded that the State government has undertaken not to insist on compliance with its October 1, 2026 circular requiring hospitals to disclose the purchase price, maximum retail price (MRP) and price charged to patients for medicines, medical devices and consumables. The circular, issued by the Karnataka Food Safety and Drugs Administration, also required hospitals to display this pricing information at billing and pharmacy counters.

Private hospitals had challenged the circular, reportedly arguing that the authorities lacked the legal power to compel disclosure of their procurement prices. The State informed the Court that the circular is under review and its implementation would not be insisted on until the next hearing on November 12, 2026. The Court has not yet decided the legality of the circular.

Telangana plans to introduce MRI services under the Public-Private Partnership (PPP) model across government hospitals within two years. Under the proposed arrangement, private operators will be responsible for installing, operating and maintaining MRI equipment.

The move aims to minimise service disruptions arising from equipment breakdowns and maintenance issues, while ensuring that patients referred by government doctors continue to receive MRI scans free of cost.

The Supreme Court in September 2026 had directed the Centre, States and Union Territories to implement the 2026 Guidelines for Organisation and Delivery of Intensive Care Services, formulated by the Directorate General of Health Services (DGHS). 

Pursuant to these directions, Andhra Pradesh's Director of Medical Education has reportedly directed all government general hospitals to upgrade their ICUs. Hospitals must complete structural modifications, including ICU location, size and nursing stations within nine months. Bedside facilities, non-emergency equipment and laboratory services must be provided within three months. Emergency equipment and imaging procurement orders must be issued within three months, with up to another three months for delivery and installation. Additional services must be introduced within one month. Level-I ICU standards are mandatory across these hospitals.

The Indian Pharmacopoeia Commission has identified suspected links between levetiracetam and gingival hypertrophy, and between xylometazoline or oxymetazoline and rebound nasal congestion. Healthcare professionals and patients are advised to monitor for these adverse reactions and report suspected cases to the Pharmacovigilance Programme of India through its prescribed reporting channels.

The Delhi High Court has directed the National Pharmaceutical Pricing Authority (NPPA), India's drug price regulator not to take coercive steps against a Pharma company over a ₹151.19 crore demand for alleged overcharging and interest on asthma medication. NPPA alleges that the company sold the drug above its applicable ceiling price under the Drugs (Prices Control) Order, 2013 (DPCO), which regulates prices of specified essential medicines. This was challenged by the company stating that its inhaler contains different drug strengths from those listed in the DPCO and therefore cannot be subjected to the same price ceiling. It also disputed recovery from 2016, as the comparable formulation's ceiling price was fixed only in 2019. The Court granted interim protection until January 11, 2027, finding a prima facie case in the company's favour.

The Central Consumer Protection Authority (CCPA) has penalised two bread manufacturers for misleading consumers with 100% whole wheat claims, as their products contained less than the prescribed 75% whole wheat threshold required for the “Whole Wheat Bread” declaration. The authority has also directed them to discontinue the misleading advertisements across print, electronic and social media and submit compliance reports within 15 days.

The Central Government has replaced the Prevention and Control of Infectious and Contagious Diseases in Animals Rules, 2010 with the new 2026 Rules, notified in October, 2026. Earlier, the Rules prescribed vaccination certificate formats, post-mortem procedures and methods for carcass disposal. The new 2026 Rules retain these requirements of the old Rules, while introducing portal based reporting of disease outbreaks by Village Officers and veterinarians, along with reporting of vaccination details and issuance of vaccination certificates through the Bharat Pashudhan portal. They also prescribe more detailed procedures for post mortem examinations, including submission of reports to the Central and State Governments within 12 hours. The Rules expand carcass disposal requirements to cover animals suspected of infection and introduce detailed record keeping obligations. They further establish a formal mechanism for complaints, adjudication and appeals, including procedures for imposing and recovering penalties for contraventions of the Act.

The Karnataka Government has reportedly informed the Karnataka High Court that it would not enforce the circular requiring hospitals to disclose the landing or procurement price, MRP, patient charge and applicable taxes for medicines, medical devices and consumables on itemised bills. The circular is being re-examined following a legal challenge concerning its statutory basis, confidentiality of commercial arrangements and absence of adequate stakeholder consultation. Its implementation remains suspended until further court orders.

The US Food and Drug Administration (FDA) has issued revised draft guidance on how manufacturers should show that devices used to deliver medicines work properly. It covers devices such as syringes, autoinjectors, infusion pumps, inhalers and nasal sprays. The revised draft replaces the 2024 version and changes the term “Essential Drug Delivery Outputs” to “Essential Drug Delivery Device Performance Characteristics” (EDDCs). The guidance refers to the key features that ensure a device delivers the correct drug dose to the intended site and explains how manufacturers should test device performance, maintain quality during manufacturing and assess changes made after a product enters the market. The draft is non-binding. Comments may be submitted until January 28, 2027.

The Maharashtra Food and Drug Administration (FDA) had issued show-cause notices to three celebrity endorsers over advertisements for a mouth freshener, alleging that the campaign indirectly promoted a prohibited tobacco product. One of the endorsers has now reportedly approached the Bombay High Court, challenging the notice on grounds of arbitrariness, predetermination and violation of principles of natural justice and Article 14 of the Constitution. The petition also questions the legal provisions invoked and the regulator’s decision to proceed against the endorser rather than the manufacturer.

The National Pharmaceutical Pricing Authority (NPPA) has published the Maximum Retail Prices (MRPs) for 1,024 brands of non-scheduled anti-cancer medicines, effective November 9, 2026. The move aims to improve the affordability and accessibility of cancer treatment by rationalising trade margins. Manufacturers must ensure that the specified MRPs are implemented from the effective date.

Pharmacy associations across Karnataka have raised concerns over the improper disposal of expired, unused and unsold medicines, citing inadequate collection facilities and difficulties in returning expired stock. When discarded with household waste or poured down drains, these medicines can release harmful chemical residues, contaminate water, pose poisoning risks to people and animals, and contribute to antimicrobial resistance.

In May 2025, the Central Drugs Standard Control Organisation (CDSCO) had issued a guidance document which places responsibility on retailers to return expired stock to suppliers or manufacturers within 30 days of expiry, and calls on manufacturers to ensure its disposal within six months of expiry. The guidance also recommends collection facilities for unused medicines from the public.

Experts in Karnataka have raised concerns over inadequate monitoring of private hospitals for compliance with restrictions on reusing single-use medical devices, citing staff shortages, limited inspections and weak enforcement. The concerns arise against the backdrop of a national DGHS direction reiterating the prohibition on such reuse. The direction also highlights concerns over hospitals charging patients or claiming reimbursements for devices that may have been reused. Experts have called for dedicated regulatory officers, regular inspections and medical audits to strengthen oversight and protect patient safety.

A pharmaceutical manufacturer has voluntarily recalled 11 ophthalmic products and temporarily halted their production following quality concerns at its Assam manufacturing facility. The action follows reported regulatory findings of deficiencies in quality management systems, with the company undertaking corrective measures before resuming manufacturing and supplies.

The Central Government has added MDMB-FUBINACA, a synthetic cannabinoid to the Schedule of the Narcotic Drugs and Psychotropic Substances Act, 1985. The decision follows concerns regarding the substance’s nature, effects and potential for abuse,  taking into account amendments to the United Nations Convention on Psychotropic Substances, 1971.

The Bombay High Court has directed the removal of a pharmaceutical trademark from the Trade Marks Register after finding it deceptively similar to an existing mark used for a medicine treating a different medical condition. The Court held that differences in active pharmaceutical ingredients, therapeutic indications and prescription requirements do not eliminate the risk of confusion between medicinal products. It further clarified that manufacturing medicines in India exclusively for export constitutes use of the trademark in India under the Trade Marks Act, 1999. The removal has been deferred until 31 December 2026 to allow the manufacturer to rebrand and obtain necessary regulatory approvals. The judgment reinforces the heightened standard of scrutiny applicable to pharmaceutical trademarks, given the potentially serious consequences of medication errors

The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, mandating a minimum residual shelf-life of one year for imported drugs at the time of import, with biological drugs and radiopharmaceuticals permitted at 60% of their labelled shelf-life. The amendment aims to reduce the risk of importing medicines nearing expiry and ensure adequate shelf-life in the Indian supply chain.

The Indian Council of Medical Research has reportedly funded a four-year study examining genetic and immunological mechanisms underlying autoimmune diseases. Researchers will enrol families with multiple affected members, including at least one lupus patient, to identify shared disease pathways and potential therapeutic targets through genomic profiling and biological assessments.

The National Pharmaceutical Pricing Authority (NPPA), India’s drug pricing regulator, has clarified how pharmaceutical supplies qualify as “Government sales” under its trade margin rationalisation framework. According to the FAQs issued on October 23, 2026, a sale qualifies where either the Maximum Retail Price (MRP) is not printed on the product package or the package carries the label “For supply to Government; not for sale”.

The clarification follows NPPA’s October 17, 2026 order under the Drugs (Prices Control) Order, 2013, which rationalises trade margins for 137 identified non-scheduled anti-cancer medicines, with revised prices effective November 9, 2026. 

India’s Patent Office has reportedly rejected a patent application for a fixed-dose combination of three medicines used to treat drug-resistant tuberculosis. The applicant failed to establish patentability, while opponents argued that combining existing medicines into one pill lacked sufficient evidence of improved clinical outcomes, product stability and additional therapeutic benefits.

The National Pharmaceutical Pricing Authority (NPPA) has published revised maximum retail prices (MRPs) for 543 brands of non-scheduled anti-cancer medicines, effective 9 November 2026. The revision aims to improve the affordability and accessibility of cancer treatment by rationalising trade margins. Manufacturers must ensure that the revised MRPs are implemented from the effective date.

Maharashtra government has standardised charges for PET-CT scans and CT/MRI contrast agents at government hospitals, particularly those operating under the public-private partnership (PPP) model, to address inconsistent pricing and improve affordability. The prescribed rates include ₹10,250 for a whole-body PET-CT scan, ₹420–830 for CT contrast and ₹950 for MRI contrast. Patients are classified into three categories: eligible beneficiaries receiving free services, paying patients and patients sponsored or referred by other hospitals. Payments must be made through hospital billing desks, not directly to private operators. Hospitals must display rates and payment procedures in Marathi and English, while PPP operators must follow the prescribed pricing and contractual arrangements.

The National Pharmaceutical Pricing Authority (NPPA), the government body responsible for regulating medicine prices in India, has clarified that pharmaceutical companies must publish newspaper advertisements for all products whose prices are reduced under its trade margin rationalisation (TMR) exercise. The advertisements must state both the pre-revised and revised Maximum Retail Prices (MRPs). Companies may choose whether to include products whose prices remain unchanged.

The clarification forms part of the FAQs issued on October 23, 2026, following NPPA’s October 17 order rationalising trade margins for 137 identified non-scheduled anti-cancer medicines under the Drugs (Prices Control) Order, 2013. The revised prices take effect on November 9, 2026. By requiring both prices to be disclosed, NPPA seeks to make price reductions transparent and help consumers identify the change. Pharmaceutical companies should ensure that their newspaper advertisements accurately reflect the revised MRPs.

The Advertising Standards Council of India (ASCI), in its July–September 2026 review, examined 61 nutraceutical advertisements and found 31 in violation of its Code. Another 29 advertisements were modified or withdrawn by advertisers without contesting the complaints, while one case remains under process. The review covered claims relating to weight management, skincare, respiratory health and disease management, including claims that could suggest therapeutic benefits.

The key concern is whether advertisers can substantiate the claims made for their finished products. ASCI identified instances where ingredient-level research was relied upon without adequate product-specific evidence, alongside exaggerated efficacy claims and promises of disease-related benefits. From a compliance perspective, businesses should ensure that claims are supported by reliable evidence relevant to the product itself and do not imply treatment or reversal of medical conditions without appropriate substantiation.

The petitioner has reportedly raised concerns before the Supreme Court of India regarding the amended transgender rights law’s impact on women’s reservations, prison accommodation, sports participation and criminal procedure safeguards. The Court sought the respondents’ response and tagged the matter with pending petitions challenging the validity of the 2026 amendment.

India’s National Ambient Air Quality Standards (NAAQS), last revised in 2009, remain unchanged as the Central Pollution Control Board (CPCB) continues to review recommendations for updated pollution thresholds. Reportedly, according to a response to an RTI query dated October 26, 2026, a revised report submitted by IIT Kanpur on December 16, 2025, remains under consideration by a steering committee constituted in May 2020. The review is intended to assess existing pollutant limits and consider additional parameters in light of evolving scientific evidence.

The Maharashtra Government has reportedly deployed handheld devices to screen medicines supplied through government health facilities for suspected spurious or substandard products. Flying squads will conduct random monthly checks using the devices, which provide preliminary results within minutes. Flagged samples must undergo confirmatory testing at NABL-accredited laboratories before regulatory or enforcement action is initiated.

The National Pharmaceutical Pricing Authority (NPPA), the government body responsible for regulating drug prices in India, has clarified that manufacturers are not required to recall, re-label or re-sticker anti-cancer drug stocks released in the market before implementation of revised maximum retail prices (MRPs), provided they can ensure price compliance at the retailer level.

The clarification forms part of the FAQs issued in connection with the trade margin rationalisation (TMR) exercise for identified non-scheduled anti-cancer medicines. It provides operational relief to manufacturers dealing with pre-existing market inventory, while making clear that the relaxation is conditional on compliance with the revised prices at the retail level.

The Ministry of Health and Family Welfare has proposed an amendment to the Drugs Rules, 1945, introducing revised microbial contamination limits under Schedule M of the Drugs Rules, 1945, for sterile drug manufacturing. The amendment seeks to strengthen environmental monitoring standards across manufacturing areas, including air, surface and personnel testing, supporting improved contamination control and product quality.

Karnataka’s pharmaceutical trade body has reportedly urged a drug manufacturer to halt direct supplies to pharmacies, hospitals and medical shops at preferential rates, alleging that such practices disadvantage authorised stockists. It has called for uniform trade schemes, transparent verification procedures and stronger supply-chain traceability to ensure fair competition.

The National Pharmaceutical Pricing Authority (NPPA) has clarified that recalling, relabeling or re-sticking existing stocks of anti-cancer medicines to reflect revised maximum retail prices (MRPs) is not mandatory, provided manufacturers and importers ensure price compliance at the retailer level. This clarification reduces the operational burden and costs associated with recalling and relabeling existing stocks for manufacturers and importers.

The Keralam Legislative Assembly has unanimously passed the Keralam Senior Citizens’ (Care and Protection of Rights) Bill, 2026, proposing a comprehensive framework for senior citizens aged 60 and above. The Bill mandates registration of care centres, introduces caregiver training and certification, and extends regulatory oversight to home-care agencies and digital platforms. It also requires medical practitioners and care centres to report suspected abuse, neglect or exploitation, with specified cases reportable within 48 hours. Abuse, abandonment and illegal possession of residents’ property may attract imprisonment and fines. 

The Supreme Court has reportedly criticised the Centre and the Drug Controller General of India (DCGI) for delays in taking action against pharmaceutical companies allegedly continuing to manufacture and sell Liposomal Amphotericin B under expired emergency permissions granted during the COVID-19 pandemic. The permissions were introduced in 2021 to address shortages of the drug, used to treat mucormycosis or black fungus. The case raises questions about the DCGI’s enforcement of licence conditions and the consequences of continued manufacturing after emergency permissions expire. The Court has not yet ordered a ban or recall; the final directions are awaited.

The National Human Rights Commission (NHRC) has issued an advisory recommending measures to improve women’s safety at workplaces and public spaces. The recommendations cover sexual harassment awareness, infrastructure, bystander intervention, police response, survivor support, cybercrime and long-term reforms.

The advisory calls for functional Internal and Local Committees under the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013, and annual submission of inquiry reports to District Officers by enterprises covered under the Act. It also recommends security and safe transport for women working night shifts, alongside gender audits of workplaces and public spaces. The NHRC has requested concerned authorities to submit action-taken reports within two months.

Nagaland’s Drugs Control Administration has reportedly directed courier operators to disclose medicine consignments to district drug control authorities. However, the original order has not been independently located in the public domain, leaving key aspects of the directive unverified.

 The directive can help authorities track medicine shipments and identify potentially illegal online sales. From a regulatory standpoint, the effectiveness of such a reporting mechanism will depend on the scope of consignments covered, the frequency and format of disclosures, and the consequences of non-compliance.

India's central drug licensing authority, CDSCO has directed State and UT Drug Controllers to strictly enforce the testing requirements under the Drugs Rules, 1945. The manufacturers are required to test every batch of raw materials, including active pharmaceutical ingredients and excipients, in their own laboratory or a laboratory approved by the Licensing Authority. This includes critical excipients such as propylene glycol, glycerol and sorbitol. Every batch of finished formulation must also be tested, with records maintained as prescribed under Schedule U. The latest direction reinforces inspections, vendor qualification and sourcing from reliable, approved suppliers. Manufacturers should ensure documented batch-wise testing and compliance before releasing products into the market.

The National Pharmaceutical Pricing Authority (NPPA) has clarified that manufacturers of anti-cancer drugs covered by trade margin rationalisation can avail annual price increases under Paragraph 20(1) of DPCO, 2013, from implementation of revised MRP by November 9, 2026, or 12 months after the last MRP revision if unchanged. The clarification provides manufacturers with greater certainty on price revision timelines following trade margin rationalisation.

The Central Drugs Standard Control Organisation (CDSCO), through a communication dated 27 October 2026, has directed State and UT Drug Controllers to ensure compliance with the Digital Monitoring System on the Online National Drugs Licensing System (ONDLS) portal for specified high-risk pharmaceutical-grade solvents. Manufacturers and relevant vendors/suppliers are required to register on the portal and upload batch-wise information, including quantities manufactured and supplied, Certificates of Analysis (CoAs), vendor details and onward distribution records. A system-generated No Objection Certificate (NOC) must be obtained before distribution of covered batches. The materials include glycerin, propylene glycol, sorbitol and other specified solvents and excipients. The measure strengthens end-to-end traceability of pharmaceutical-grade raw materials, particularly in light of concerns over contamination of cough syrups with diethylene glycol (DEG).

The Keralam Government reportedly plans to introduce legislation to regulate charges levied by private hospitals, with a proposed committee tasked with preparing a draft Bill for consideration by the State Legislative Assembly. The proposed framework is intended to improve transparency in hospital billing and address the cost of medicines, diagnostic tests, room rent and medical procedures. 

 The proposal remains at the preparatory stage; the reported announcement does not establish any new binding price controls on private hospitals. If enacted, the legislation could introduce additional obligations concerning pricing transparency and patient billing.

The Central Drugs Standard Control Organisation has cancelled a cosmetic registration after finding claims that the product “dissolves fat cells” and “reduces their size.” The authority considered these claims beyond the scope of cosmetics and found the importer’s response to the show-cause notice unsatisfactory, resulting in cancellation of the registration certificate.

Karnataka’s Health Minister reportedly announced plans to formulate a policy preventing hospitals from withholding deceased patients’ bodies over unpaid bills, following a meeting with private hospital representatives. Discussions also covered excessive billing, essential medicine costs, unauthorised price increases and insurance claim simplification to strengthen patient protection and healthcare affordability.

The Department of Pharmaceuticals (DoP), through an order dated 22 October 2026, has constituted a committee to review the effectiveness of the existing framework of the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), governing pharmaceutical marketing practices and recommend measures to strengthen its implementation and enforcement. 

The committee will examine the existing monitoring and enforcement mechanisms, identify gaps and recommend measures to improve compliance. It will also consider whether additional statutory, regulatory or other legal measures are necessary. The committee’s recommendations may inform future changes to the regulation and enforcement of pharmaceutical marketing in India.

The Kerala High Court has ruled that patients facing grave medical emergencies cannot be expected to verify hospital empanelment before seeking life-saving treatment, dismissing an appeal against medical reimbursement under a post-retirement scheme. This is important because strict empanelment requirements may impede timely emergency care. The ruling reinforces that the urgency of treatment and nature of the illness must be considered when deciding reimbursement claims.

The Government of Maharashtra, through its Food Safety Commissioner, has approached the Bombay High Court, alleging that the Central Government and FSSAI created a parallel enforcement regime that encroaches upon State powers. The petition specifically contests the May 2023 circular barring State FDA officers from inspecting or taking enforcement action against establishments holding Central licenses. It argues that the restriction curtails State oversight of major food businesses and seeks a stay on the circular and restoration of inspection and enforcement authority.

India's central drug authority, CDSCO, has issued a public notice following a WHO alert concerning falsified DEFITELIO (defibrotide) 80 mg/ml concentrate for infusion, batch No. 24GC01A, expiring April 2027. Although this batch was never supplied to India and it has no marketing authorisation in India, healthcare professionals, hospitals, pharmacies and distributors should remain vigilant, verify product authenticity and immediately report any suspected stock found for sale or distribution to the relevant State/District Drugs Control Authority and CDSCO.

The Directorate General of Health Services (DGHS) has directed states and Union Territories to enforce a prohibition on reusing medical devices and disposable surgical items meant for one-time use. The directive follows reports of hospitals sterilising and reusing such items, particularly in cardiology, oncology, nephrology and neurosurgery. The DGHS has warned that this practice can expose patients to infections, device malfunction and other complications.

The DGHS has also raised concerns that, in some instances, patients and government authorities were charged the full cost of these items even when they had been reused. The letter states that the practice may violate applicable provisions of the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, the Clinical Establishments Act, 2010, and relevant infection-control and biomedical-waste management requirements. The DGHS has directed health authorities to maintain strict vigilance, monitor healthcare establishments and take necessary action against non-compliance. 

The Kerala High Court has reportedly sought responses from the Centre and the Kerala Government on whether an order was issued to a social media company to block the Facebook page of an independent Malayalam digital news platform. The petition alleges that the page was restricted under Section 79(3)(b) of the Information Technology Act, 2000, without disclosing the underlying order, identifying the specific unlawful content or providing an opportunity to challenge the action. The case raises questions about transparency and procedural safeguards in content-blocking actions under the IT Act and the IT Rules, 2021. The key issue is whether affected users must be informed of the underlying order and its basis to enable an effective legal challenge. 

The Central Drugs Standard Control Organisation (CDSCO), India’s national drug regulatory authority has cancelled the registration of a Gujrat based Ethics Committee, for non-compliance with the New Drugs and Clinical Trials Rules, 2019. The action takes the total number of Ethics Committees whose registrations have been cancelled by the regulator to eight. Ethics Committees review and approve clinical trial protocols and oversee trials to protect participants’ rights, safety and well-being.

The Bureau of Indian Standards introduced voluntary standard IS 19493:2025 for hospital billing to improve transparency through itemised charges, package inclusions and patient details. Civil society experts have reportedly urged the government to make it mandatory, as adoption remains limited. The Clinical Establishments (Central Government) Rules, 2012, requires establishments to display service rates and charge within Central Government-prescribed ranges, determined in consultation with States. However, these ranges remain unfinalized till today. Mandatory implementation could improve patient understanding of healthcare costs, reduce billing disputes and support more informed financial decisions, although it may not directly prevent overcharging.

The Indian Drug Manufacturers’ Association has reportedly invited pharmaceutical and biotechnology companies, researchers and intellectual property professionals to participate in the consultation on the draft 2026 pharmaceutical patent examination guidelines. Stakeholders are encouraged to submit feedback to help improve clarity and consistency in patent examination practices in India.

The Supreme Court is examining concerns over the high prices patients pay for medicines and medical consumables supplied by hospitals. The concern is whether hospitals are charging excessive mark-ups over their purchase costs and whether stronger price controls are needed.

In its latest response, the Centre has reportedly told the Court that reliable data on hospitals’ purchase costs and patient charges is lacking, making it difficult to determine the extent of these mark-ups. It has also flagged a legal hurdle: existing price-control rules do not cover every product sold by hospitals. Any wider controls would therefore require both evidence of the problem and clear legal authority to regulate the products concerned.

The Food Safety and Standards Authority of India (FSSAI) has initiated proceedings over misleading labelling on a packaged pomegranate juice product. The product contains 4% pomegranate juice concentrate and 12% apple juice concentrate. 

The regulator has initiated adjudication proceedings after finding the label claim “Equivalent to 100% Fruit Juice (Reconstituted)” non-compliant. Under its 3 June 2024 advisory, FSSAI directed food businesses to remove “100% fruit juice” claims from reconstituted juices because adding water to fruit concentrate does not justify presenting the product as 100% fruit juice.

The Food Safety and Standards Authority of India (FSSAI) has issued a show-cause notice regarding a cranberry extract supplement over unapproved disease-risk claims and misleading advertising.

The regulator identified claims like “Supports Urinary Tract Health” as Disease Risk Reduction (DRR) and health claims. Under the Food Safety and Standards (Advertising and Claims) Regulations, 2018, reduction of disease risk claims require prior FSSAI approval. The "100% Natural" claim directly violates FSSAI's advisory dated 28 May 2025 prohibiting "100%" claims on food products.

Uttar Pradesh Food Safety and Drug Administration has reportedly sought re-testing of blood stocks transferred in bulk between blood banks, signalling tighter regulatory scrutiny of blood handling and distribution. The move is important because existing screening may not adequately address risks arising during storage and transportation, highlighting the need for stronger quality control across the blood supply chain.

The National Pharmaceutical Pricing Authority (NPPA) has clarified that manufacturers of anti-cancer drugs covered by trade margin rationalisation must submit Form V and Annexure-I (Format for submission of revised MRP by the manufacturer) through the Integrated Pharmaceutical Database Management System (IPDMS) within seven days of publication of the Order, even if the maximum retail price (MRP) remains unchanged. The revised prices for the identified non-scheduled anti-cancer drugs will take effect from 9 November 2026. The clarification reinforces manufacturers’ reporting obligations under the Drugs (Prices Control) Order, 2013

Punjab’s Health Department reportedly plans to intensify inspections of chemist shops to curb the unauthorised sale of pregabalin amid concerns over its misuse and dependence. In September 2024, the state had restricted the sale and stocking of pregabalin formulations exceeding 75 mg. Subsequent enforcement action between April 2025 and August 2026 included seizures and the suspension and cancellation of licences. Separately, the Centre has notified pregabalin under Schedule H1, effective 12 November 2026, introducing stricter prescription, recordkeeping and labelling requirements. Pharmaceutical distributors and pharmacies should review their compliance processes and prepare for enhanced regulatory scrutiny.

Researchers of a tech-giant have reportedly developed an AI system that progressively gathers patient history, evaluates examination findings, recommends investigations and updates diagnostic hypotheses.  The entity plans to test the tool for triage in emergency department waiting rooms. In India, AI software intended for medical diagnosis may qualify as a medical device under the Medical Devices Rules, 2017, depending on its intended purpose and functionality. Commercial deployment may therefore require applicable licensing and evidence of safety and performance, including software validation and clinical evidence.

The Food Safety and Standards Authority of India (FSSAI) has issued a notice to a food and wellness company over claims on Complan’s packaging and online listings, including “2X Faster Growth”, “Supports Concentration and Memory” and “Pro Immunity + 34 Vital Nutrients”. Under the Food Safety and Standards (Advertising and Claims) Regulations, 2018, food claims must be scientifically substantiated. FSSAI sought evidence for the “clinically proven 2X growth” and immunity claims and flagged “Growth Comes in 4 Flavors” as non-compliant.

The Karnataka High Court has quashed criminal proceedings against a fertilizer dealer accused in a case involving fertilizer samples that failed to meet prescribed quality standards. The case arose after a Fertilizer Inspector collected samples from the dealer’s shop and sent them for laboratory testing. Although the report found the samples to be substandard, the Court noted that the complaint did not explain how the dealer was responsible for their production or quality, particularly since they had been collected from sealed bags. Holding that the dealer could not be held criminally liable merely by virtue of his role, the Court quashed the proceedings against him.

The Kerala High Court has dismissed an appeal by the Bureau of Indian Standards (BIS) against the acquittal of a veneer manufacturing firm and its partners accused of possessing a spurious ISI mark. The prosecution alleged that officials found a roller bearing a fake ISI mark and a similar mark on the factory wall. However, no manufactured product bearing the mark was seized or produced before the court. The Court held that the Bureau of Indian Standards Act, 1986, penalise the "use" of a spurious standard mark, not "mere possession" of an object capable of affixing it. It upheld the acquittal, finding no evidence that the mark had been used on manufactured goods.

The Food Safety and Standards Authority of India (FSSAI) has issued notices to an influencer and four international food and healthcare companies over an Instagram Reel ranking five infant formula products and promoting their purported benefits. The Reel featured NAN-Pro 1, Aptamil Premium 1, Similac Advance 1, Enfamil A+ Stage 1 and Dexolac 1, attributing benefits such as stronger immunity, brain development and easier digestion to the products.

FSSAI has alleged violations of the Infant Milk Substitutes Act, 1992, and the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. The Infant Milk Substitutes Act, 1992 restricts the advertising and promotion of infant milk substitutes. Even if a product claim may be scientifically supported, that does not automatically make its promotion lawful.

The Food Safety and Standards Authority of India (FSSAI) has issued a notice to a food company seeking scientific substantiation for the claim that whey protein in Lactogen Pro 1 Powder is “easy to digest”.  The infant formula is intended for babies from birth to six months when breastfeeding is not possible or the product is used for top-feeding. Under the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, and Regulation 4 of the Food Safety and Standards (Labelling and Display) Regulations, 2020, infant food claims must meet relevant regulatory standards. FSSAI has sought supporting evidence and asked why action should not be initiated under the Food Safety and Standards Act, 2006. The notice is not a final finding of non-compliance.

The notice only initiates regulatory scrutiny; it does not establish that the claim is false.

The Food Safety and Standards Authority of India (FSSAI) has issued a notice to a global food company over claims made for its NAN Excella Pro Stage 1 infant formula, which is an infant starter milk formula designed for babies from birth up to 6 months of age when they are not breastfed. FSSAI considered the claim “5 HMOs helps support normal immune system” potentially contrary to Regulation 10(1) of the Food Safety and Standards (Advertising and Claims) Regulations, 2018, which prohibits claims linking food suitability to preventing, alleviating, treating or curing a disease, disorder or particular physiological condition unless specifically permitted.

The Karnataka Government has reportedly directed departments facing staff shortages to engage authorised third-party agencies to conduct inspections, audits and certifications within prescribed timelines. The initiative covers Legal Metrology, Food Safety and Drugs Administration, and the Department of Factories and Boilers.

However, outsourcing does not transfer statutory enforcement powers to private agencies. Powers to collect food and drug samples, seize goods and initiate prosecutions will remain with government officials. Departments will use agency reports to identify high-risk establishments for targeted enforcement.

The Union Health Ministry has reportedly issued a circular declaring the Pharmacy Council of India’s regulations on government pharmacists’ recruitment, promotions and service conditions invalid, citing the absence of prior government approval. The Ministry states that the Council can regulate pharmacy education but cannot independently decide how government pharmacists are recruited, promoted or paid.

The Supreme Court of India quashed the blacklisting and product debarment imposed on a drug supplier after authorities failed to follow the mandatory procedure for confirmatory testing by a second laboratory. The Court held that delays attributable to the State caused the disputed batches to expire, depriving the supplier of an effective opportunity to challenge the adverse quality reports through retesting.

India's Ministry of Agriculture and Farmers’ Welfare has formally notified 16 livestock and dog breeds for specified States and nationwide purposes, for animal husbandry, breeding, conservation, production and trade. Building on ICAR’s breed-registration process, the notification strengthens official breed recognition. For livestock businesses, breeders and traders, this can improve breed identification, support targeted breeding and conservation programmes, and help establish clearer breed-specific market positioning.

Rising use of GLP-1 weight-loss drugs is reportedly driving demand for dietary supplements such as fibre, collagen, probiotics and electrolytes, as users seek to manage side effects including nausea, fatigue and constipation. The trend, amplified by social media influencers, has raised concerns over product safety, unverified health claims and limited pre-market scrutiny in the US. Regulators are considering tighter oversight of dietary ingredients. The trend highlights the need for stronger scrutiny of influencer-led health marketing, particularly for products targeting GLP-1 users.

The Bombay High Court has held that import restrictions under the Foreign Trade Policy must be assessed with reference to the shipment date, rather than customs clearance or bill-of-entry filing dates. The ruling protects importers from subsequent policy changes affecting goods already dispatched, ensuring that newly notified restrictions are not applied retrospectively to consignments shipped before publication.

The Food Safety and Standards Authority of India (FSSAI) has sanctioned prosecution against an Indian biscuit manufacturer after an inspection found that cattle-feed bran was being used as a fibre source in biscuit manufacturing, alongside hygiene and storage deficiencies. The company’s FSSAI licence had been suspended.

Separately, Nepal has banned the import, sale and distribution of the manufacturer’s biscuits and ordered a recall of existing stocks over food safety concerns. The case highlights how domestic food safety enforcement can have cross-border consequences, prompting foreign regulators to take independent action to protect consumers.

The Food Safety and Standards Authority of India (FSSAI) has proposed amending the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, to prohibit adding sucrose and fructose to foods intended for infants up to six months of age. Under the existing regulation, sucrose and fructose are permitted when needed as a carbohydrate source, provided their combined amount does not exceed 20% of total carbohydrates.

The proposed amendment would remove this exception for the specified age group. The draft has been issued for public consultation, allowing stakeholders to submit objections or suggestions before the amendment is finalised.

The Telangana Standards Authority for Food and Essential Drugs (TG SAFE) has warned that unapproved weight-loss drugs and experimental peptides sold through online platforms and social media may pose serious health risks. Products named in the advisory include retatrutide, orforglipron, tesamorelin, BPC-157 and GHK-Cu. These products have not undergone the required regulatory review by the Central Drugs Standard Control Organization (CDSCO) and TG SAFE to establish their safety, efficacy and quality for the intended use.

TG SAFE has cautioned that such products may be fraudulent. counterfeit, mislabelled or contaminated, particularly when sold by unregulated suppliers. It has advised doctors not to procure, prescribe or administer these products in violation of applicable requirements and warned that violations may invite action under the Drugs and Cosmetics Act, 1940, and its rules. 

The National Medical Commission (NMC) has withdrawn the Maintenance of Standards of Medical Education Regulations, 2023, with immediate effect, removing the specific framework that prescribed penalties for non-compliance by medical colleges.

Introduced in September 2023, the regulations required colleges to disclose information on infrastructure, faculty strength and clinical training facilities. They also allowed penalties of up to ₹1 crore per violation for medical institutions and ₹5 lakh for faculty members or administrators submitting false declarations, alongside measures such as admission restrictions and withdrawal of accreditation. 

However, colleges must continue submitting Annual Disclosure Reports (ADR) under the National Medical Commission Act, 2019. The ADR allows the NMC’s undergraduate and postgraduate medical education boards to assess whether a college meets prescribed standards by reviewing its infrastructure, qualified faculty, clinical training facilities, teaching methods, student assessment systems and student feedback.

The Directorate General of Foreign Trade (DGFT) has amended the export policy for prepared culture media. Prepared culture media are nutrient-rich formulations designed to grow, isolate, and study microorganisms like bacteria and fungi in laboratories and industrial settings. These products are used to grow or maintain microorganisms, including viruses, and plant, human or animal cells. Export for these remains freely permitted. However, if the importing country requires certificates, exporters must follow the prescribed process.

The Chemicals and Allied Products Export Promotion Council (CAPEXIL) will issue a Shipment Clearance Certificate for each consignment. It must include details such as the exporter, product, invoice number, quantity, port of loading and destination. After shipment, the exporter must provide a Health Certificate to the buyer, containing details of the product, its packaging, origin, destination, vessel, departure date and applicable health requirements. The amendment takes immediate effect.

The Karnataka State Registered Pharmacists Association (KSRPA) has reportedly urged the State Food and Drug Administration to examine pharmaceutical companies’ “Buy 1, Get 1 Free” schemes and clarify how free units should be accounted for when calculating the actual purchase cost of medicines. It was questioned whether the cost of free units should be spread across the total quantity purchased to calculate a lower per-unit cost, or whether the additional medicines should be supplied to patients free of charge. Hospitals and bulk purchasers may retain the financial benefit instead of passing the savings on to patients. The association also flagged large gaps between retailers’ purchase prices and printed MRPs, calling for stricter scrutiny of medicine pricing under the Drugs (Prices Control) Order, 2013.

The Food Safety and Standards Authority of India (FSSAI) has issued an advisory for businesses dealing health supplements and nutraceuticals to comply with mandatory labelling requirements for products containing plant and botanical ingredients or their extracts.

Under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, labels must identify the plant part used and carry the applicable cautionary statements. For example, neem leaf products must carry the prescribed warning against use by men and women planning to conceive.

The Maharashtra government has reportedly expanded coverage for PET-CT scans under the Mahatma Jyotirao Phule Jan Arogya Yojana (MJPJAY) and Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY), following demands from patients and empanelled hospitals. ET-CT scans have been added as an additional diagnostic procedure to 63 cancer treatment packages, up from 44 earlier. The scan has also been approved as a standalone or primary diagnostic procedure for 13 selected cancer categories.

The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has established an Exclusivity Board to improve the clarity and consistency of decisions granting drug market exclusivity. The Board will review selected cases involving five-year new chemical entity exclusivity, three-year clinical investigation exclusivity and biological products, including disputes over eligibility and the scope of protection. Exclusivity can delay competing products from entering the market. More consistent decisions can help drug developers understand the scope of their protection and help generic manufacturers assess when competition may be possible.

The Central Government has allowed registered tobacco growers in Andhra Pradesh to sell excess flue-cured Virginia (FCV) tobacco during the 2026–27 crop season. The extra tobacco can be sold to registered traders through auctions authorised by the Tobacco Board.

The amount growers must contribute to the Tobacco Fund depends on how much they exceed their quota (the Tobacco Fund is the Tobacco Boards’ Growers’ Welfare Scheme, for the educational, social and health welfare of the registered FCV tobacco growers and their dependent family members):

• Up to 5% above quota: 1% service charge on sale proceeds.

• More than 5% and up to 10% above quota: ₹2 per kg plus 5% of sale proceeds.

• More than 10% and up to 20% above quota: ₹2 per kg plus 10% of sale proceeds.

• More than 20% above quota: ₹2 per kg plus 15% of sale proceeds.

The service charge of 1% applies separately in all cases. In simple terms, growers can sell their extra tobacco, but the more they produce beyond their quota, the higher their contribution to the Tobacco Fund.

The National Pharmaceutical Pricing Authority has allowed qualifying anti-cancer drugs supplied free under manufacturer-run Patient Assistance Programmes to be excluded from trade margin calculations, subject to record-keeping and undertaking requirements. Government sales are also excluded from price-to-stockist calculations. The framework clarifies how manufacturers must determine regulated retail prices across different sales channels.

The National Pharmaceutical Pricing Authority has extended a 30% trade margin cap to 137 non-scheduled anti-cancer drugs, including patented formulations and combination products, irrespective of strength, dosage form or route of administration. The move brings patented cancer medicines within the scope of exceptional price intervention in public interest, expanding regulatory oversight of anti-cancer drug pricing.

The All India Chemists and Distributors Federation (AICDF) has opposed the Centre’s draft proposal to make CCTV cameras mandatory at licensed retail pharmacies, citing additional costs for small shop owners including cameras, storage equipment and maintenance. In semi-urban and rural areas, frequent power outages could also force pharmacies to invest in generators or other backup power systems.

The Ministry of Health and Family Welfare had issued a draft notification proposing an amendment to Rule 65 of the Drugs Rules, 1945 requiring non-wholesale supply of medicines against prescriptions from registered medical practitioners to take place under CCTV surveillance, with recordings retained for at least three months.

The federation contends that CCTV cameras cannot verify handwritten prescriptions or authenticate doctors. It has urged the Health Ministry to withdraw the draft and introduce a mandatory e-prescription framework instead.

The US Food and Drug Administration (FDA) issued final guidance clarifying how pharmaceutical companies should label and submit apps used with prescription medicines. Apps linked to medical devices, such as asthma inhalers, should generally be described in the medicine’s prescribing information. Standalone apps, such as dose reminders and symptom trackers, need to be included if essential for safe and effective use or supported by evidence of clinical benefit. 

The National Pharmaceutical Pricing Authority (NPPA) has capped trade margins at 30% for 137 non-scheduled anti-cancer drugs under Paragraph 19 of the Drugs (Prices Control) Order, 2013. The revised prices will take effect from 9 November 2026.

Manufacturers must calculate revised maximum retail prices (MRPs) using the prescribed formula based on the March 2026 price to stockists or distributors.  Manufacturers must submit revised price details to NPPA and the relevant State Drug Controller within seven days of publication. They must also maintain existing production levels and notify NPPA before reducing production or discontinuing a product. Non-compliance may lead to recovery of overcharged amounts with interest.

The Food Safety and Standards Authority of India (FSSAI) has proposed amendments to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011, prescribing maximum residue limits (MRLs) in tea of 20 mg/kg for acetamiprid and 50 mg/kg for imidacloprid. Stakeholders may submit objections or suggestions within 60 days of the draft notification’s publication. The proposed limits would establish tea-specific pesticide residue standards, with implications for tea producers, processors and testing laboratories’ residue monitoring and compliance practices.

Maharashtra FDA has issued a comprehensive compliance order for spice manufacturers, processors, packers, wholesalers, retailers, e-commerce operators and food service establishments. It requires spice powders and blended spices to be packed and sealed at the place of production, restricting loose sales. The order prohibits ethylene oxide sterilisation and unauthorised colours, including metanil yellow, rhodamine B, Sudan dyes and lead chromate. It also strengthens requirements for hygiene, labelling, traceability, laboratory testing and food safety licensing across the supply chain.   

The Food Safety and Standards Authority of India (FSSAI) has reportedly issued an advisory directing food businesses to maintain prescribed temperature and hygiene conditions while storing and transporting khoa, paneer, meat and fish. This is important because improper handling can promote microbial growth, spoilage and food contamination, posing risks to public health. The advisory requires businesses to follow prescribed food safety practices during storage and transportation to minimise contamination risks.

The West Bengal Health Department has reportedly directed government and private hospitals to classify and display ICU bed availability at prominent locations. Beds must be categorised into three levels, with Level 1 distinguishing ventilator and non-ventilator beds. This classification will consider equipment, monitoring facilities, patient space, staffing ratios and round-the-clock doctor availability.

India has issued draft pharmaceutical patent examination guidelines aimed at curbing evergreening and facilitating timely access to generic medicines. The guidelines clarify standards for assessing novelty, inventive step and incremental innovations, reinforcing scrutiny of patent applications. The proposals seek to balance pharmaceutical innovation with competition and public health interests.

The Supreme Court has reportedly urged the Centre to ensure that social media platforms comply with their legal duty to report child sexual abuse material directly to Indian police authorities. The proceedings concern alleged failures to implement the Court’s 2024 ruling, which held that reporting such material to a foreign organisation alone does not meet the requirements of Indian law.

The Maharashtra Food and Drug Administration (FDA) has suspended the licences of three Mumbai blood banks after wristwatches were allegedly offered to blood donors at a donation camp. The practice violates guidelines requiring blood donation to remain voluntary and non-remunerative. Blood banks and camp organisers must ensure that donor engagement initiatives do not constitute gifts or inducements, potentially attracting regulatory action.

The Supreme Court has warned States of possible contempt proceedings for failing to implement its directions on menstrual hygiene in schools. The Court has recognised menstrual health as a fundamental right under Article 21 and has sought accountability from States for delays in implementing the required measures.

The directions require access to free sanitary napkins, functional toilets, washing facilities and menstrual hygiene management corners in schools. The proceedings highlight the need for authorities responsible for school infrastructure and education services to ensure these requirements are implemented.

The Delhi High Court permanently restrained social media pages from misusing a doctor’s identity and a hospital’s trademarks in fabricated videos promoting medical treatment, including artificial intelligence-generated content. It directed Meta and Google to remove or block identified videos and allowed the plaintiffs to report similar content through affidavits for independent assessment by the platforms, addressing personality rights and public health risks.

The Indian Pharmacopoeia Commission (IPC), which sets out the official quality standards for all drugs manufactured, imported, and consumed in India, has clarified that the National Formulary of India (NFI) 2026 is a guidance document, not a legally binding regulatory instrument or a substitute for statutory approvals. This clarification comes after the Drugs Controller General of India (DCGI) asked for an explanation following reports that the 7th edition of the formulary listed certain drugs and formulations that lacked CDSCO approval. 

The IPC reaffirmed that the NFI (which was last updated in 2021) does not override existing drug laws, and healthcare professionals must continue following statutory regulations and their own professional judgment when prescribing medicines.

India’s central drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has clarified that a manufacturer who wishes to export an already-approved recombinant DNA (r-DNA) product need not approach CDSCO for a Export No Objection Certificate (NOC). Previously, such a manufacturer would have had to amend its existing manufacturing license if it wanted to manufacture r-DNA product for export purposes, and as a pre-requisite to making the manufacturing license application, it would have had to approach the CDSCO for Export NOC. This particular requirement, of approaching CDSCO for export NOC prior to applying for manufacturing license, has been relaxed in cases where the r-DNA product is already approved and the manufacturer is seeking export NOC only to export same product under a different marketing name. This development is expected to expedite the timeline for manufacturers of r-DNA products to procure manufacturing license for export purposes for already approved products.

The National Medical Commission’s Guidelines on Ethical Advertising and Public Communication, effective October 6, 2026, permit hospitals to publish factual, objective and verifiable information about their facilities, services and charges. However, hospital communications must not solicit patients, make unverifiable claims or use promotional portrayals of individual doctor. The guidelines further specify that using an RMP’s photograph or image in a manner constituting self-advertisement, solicitation or promotional publicity is prohibited. Hospital’s  will therefore now be required to reassess use of HCP images in advertising materials.

The Supreme Court has reportedly sought responses from the Centre and States on pleas seeking mandatory age verification at liquor outlets and a ban on alcohol sold in inconspicuous packaging, including tetra packs and sachets. The pleas raise concerns that fruit-like packaging may mislead minors and facilitate underage drinking.

The Pharmacovigilance Programme of India has identified adverse-reaction signals associated with nine reported drug-safety findings across multiple therapeutic categories. The update links commonly prescribed medicines with visual, electrolyte, cardiovascular, dermatological and neurological reactions, reinforcing the need for continued post-marketing surveillance and clinical vigilance among healthcare professionals.

The Delhi High Court has reportedly sought responses within six weeks from food safety authorities on a petition seeking action against non-dairy substitutes sold or served as paneer without adequate disclosure. The issue highlights potential gaps in food labelling compliance, consumer awareness and enforcement of prescribed product standards. If stricter action follows, it could lead to enhanced inspections, product sampling and greater scrutiny of restaurants and food businesses, reinforcing the need for transparent disclosure of dairy substitutes.

India’s Cabinet Secretariat has reportedly asked the Health Ministry to examine coronary stent safety concerns following reports of quality-related withdrawals in Sri Lanka. The reported risks include stent dislodgement, thrombosis and improper expansion, potentially causing serious risks to patients undergoing coronary interventions. The review may lead to closer scrutiny of stent safety, traceability and post-market surveillance in India.

India's Directorate General of Foreign Trade has extended the existing Minimum Import Price (MIP) condition on imports of glufosinate and its salts until 12 April 2027. Glufosinate and its salts are an active ingredient used in herbicides. Under this condition, imports with a combined CIF value (cost, insurance and freight) and applicable anti-dumping duty below ₹1,154 per kg remain restricted, while imports meeting or exceeding this threshold remain free, subject to conditions. The measure continues the import restriction introduced in April 2026 and aims to protect Indian agrochemical manufacturers from lower-priced imports for fairer competition and stability in the domestic market.  

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.

The Drugs Controller General of India reportedly announced coordinated inspections of cough syrup manufacturing units by central and state drug authorities. Non-compliant facilities may face stringent action, including licence cancellation. The regulator also plans response timelines for corrective-action notices, with manufacturing licence suspension for delays.

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 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 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 Delhi Drugs Control Department has issued an advisory directing oncology hospitals to maintain strict records of anti-cancer drugs and ensure the safe disposal of empty vials to prevent their misuse, diversion, illegal resale, and counterfeiting. Under the advisory, hospitals must procure drugs exclusively from authorized and licensed sources, maintain detailed documentation, including batch numbers, invoices, and patient administration records, and verify authenticity via barcodes and manufacturer verification systems. Furthermore, used empty vials and ampoules must be rendered unusable immediately by crushing, mutilating, or defacing labels before disposal under Bio-Medical Waste Management Rules, 2016, while internal controls, audits, and surveillance must be strengthened to report any suspicious activities to regulatory authorities promptly.

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 National Medical Commission (NMC) has clarified that registered medical practitioners must electronically sign laboratory, pathology and radiology reports remotely using means approved under Information Technology Act, 2000 (IT Act, 2000). Scan of a hand signature, or authentication using email-driven commercially available means such as DocuSign, do not qualify as Electronic Signature or Digital Signature under IT Act, 2000. Aadhar based OTP authentication is recognized as valid e-signature. Digital Signature Certificates are also recognized as valid means of authentication under IT Act, 200. Healthcare establishments must secure records and maintain audit logs.

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 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 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.

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.

National Pharmaceutical Pricing Authority (NPPA), the authority responsible for controlling the prices of medicines in India has approved a cap on sale margins for non-scheduled anti-cancer drugs. Non-scheduled anti-cancer drugs are cancer medicines whose prices are not fixed directly by the government, allowing companies to set their own retail rates. This measure is intended to reduce medicine prices and improve affordability. Directorate General of Health Services, the technical advisory body under India's Ministry of Health will finalise the medicines covered, following which NPPA will decide and issue the notification.

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.

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.

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. 

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 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.

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.