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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Government of India has launched Market Access Support under the Export Promotion Mission to strengthen global market access for Indian exporters. The initiative offers structured support for trade fairs, buyer seller meets, delegations and digital tools, prioritising small exporters, new markets, predictable planning and outcome driven export growth nationwide.
Source: h7.cl/1m6xR

2. The Food Safety and Standards Authority of India (FSSAI) issued an office order mandating a standardized format for food businesses operators, industry bodies, and other stakeholders to submit representations seeking food safety risk assessment. The move aims to ensure complete data submission, improve evaluation, enhance transparency, and speed up regulatory decision-making.
Source: h7.cl/1hakR

3. The Delhi High Court has granted an interim injunction restraining a manufacturer from selling biscuits bearing an identical name, shape and packaging to a registered trademark holder’s product. The court cited prima facie trademark infringement and passing off on triple identity and directed removal of infringing products from the market and e-commerce platforms.
Source: h7.cl/1m6y3

4. The Gujarat High Court has upheld a ruling by the Customs Authority for Advance Rulings allowing duty free import of inshell walnuts by treating the product as “dietary fibre.” The decision confirms that inshell walnuts qualify for exemption from Basic Customs Duty under the Transferable Duty-Free Import Authorization (DFIA) scheme.
Source: h7.cl/1m6y8

5. India’s major pharmaceutical company has signed an exclusive agreement with the other giant to introduce needle-free injection systems for IVF and gynaecology therapies across India. The high-pressure jet delivery tech aims to reduce pain, anxiety and improve patient compliance, with a targeted all-India rollout in FY 2026, addressing millions of injections in the growing fertility market.
Source: h7.cl/1hakq

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Health Ministry has prohibited the manufacture, sale and distribution of all immediate-release oral formulations containing Nimesulide above 100 mg, citing potential risks to human safety and availability of safer alternatives. The ban, issued under Section 26A of the Drugs and Cosmetics Act, takes immediate effect across India.
Source: h7.cl/1h4DA

2. The Ministry of Health and Family Welfare has issued draft rules to amend the Drugs Rules, 1945, proposing deletion of “Syrup” from Schedule K, following approval by the Drugs Consultative Committee. Once implemented, syrups would lose regulatory exemptions. Stakeholders are invited to submit objections within 30 days of the notification.
Source: h7.cl/1h4DF

3. India’s drug regulator reportedly cancelled the import licence of a hair loss product after it was promoted as a treatment for post chemotherapy hair loss and other medical conditions. Since the product was approved only as a cosmetic, such therapeutic claims were found misleading and in violation of cosmetic regulations.
Source: h7.cl/1h4DM

4. Leading oral nicotine pouch makers are seeking CDSCO approval to market high dose products as therapeutic nicotine replacement, raising concerns among regulators and health experts about addiction, youth initiation and long-term cardiovascular risks. The move could trigger stricter regulatory scrutiny in India’s pharma and public health landscape.
Source: h7.cl/1h4DN

5. The Telecom Regulatory Authority of India (TRAI) has issued recommendations to regulate the sale of foreign SIM/eSIM cards used in M2M/IoT devices meant for export, proposing a light-touch “International M2M SIM Service Authorisation” with online approval, no entry fees, and 10-year validity to boost exports, support Make in India
Source: h7.cl/1m0FU

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. India’s Drug Controller General (DCGI) has reaffirmed that the revised Schedule M good manufacturing practice norms will be enforced as scheduled from January 1, 2026, with no further extensions even amid industry calls for delays. The rule applies to all drug makers and aims to elevate quality standards, though many MSMEs cite compliance challenges and potential business impacts.
Source: h7.cl/1h1Ta

2. The Department of Pharmaceuticals has extended the deadline for manufacturers to apply under the Production Linked Incentive (PLI) Scheme for domestic manufacturing of critical KSMs, drug intermediates, and APIs until 16 January 2026. Applications must be submitted online through the designated portal, and all previously issued terms and conditions in the earlier notice will continue to apply.
Source: h7.cl/1lXQo

3. A plea filed recently in India’s Supreme Court, reportedly, argues that the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 is outdated. It seeks recognition of AYUSH doctors as registered medical practitioners and calls for reforms to curb misleading drug advertisements while allowing truthful, evidence-based information.
Source: h7.cl/1lXPt

4. India is considering waiving customs duty on select pharmaceutical products manufactured in special economic zones and sold in the domestic market. The proposal aims to boost investment, strengthen domestic supply of critical medicines and vaccines, and support the pharmaceutical sector amid rising global trade pressures.
Source: h7.cl/1h1Ti

5. Australian health authorities had recently flagged concerns over counterfeit batches of anti-rabies vaccine circulating in India. The public sector manufacturer clarified that the issue pertained to a specific counterfeit batch identified in January 2025 which has since been removed from circulation. The company emphasized that genuine vaccines released through authorized channels remain safe.
Source: h7.cl/1lXPz

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. India’s government has reportedly updated the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) policy, mandating a 500-metre minimum distance between Jan Aushadhi stores in major urban centres to protect existing outlets’ financial viability while continuing expansion of affordable generic drugs across the nation. Major metros and million-plus cities are in scope; exemptions apply for government hospitals.
Source: h7.cl/1gK1R

2. The Parliamentary Panel on Health and Family Welfare has urged the Ministry of Ayush to introduce strict penal provisions against false and misleading advertisements, strengthen enforcement mechanisms, improve public awareness, ensure transparency in action taken, and prioritise establishment of Ayush institutes and Yoga Ashrams in underdeveloped states.
Source: h7.cl/1lEmX

3. The Food Safety and Standards Authority of India clarified that eggs sold in the country are safe for consumption and claims linking them to cancer are misleading. It stressed that nitrofuran residues are strictly regulated, trace detections pose no health risk, and consumers should rely on verified scientific evidence.
Source: h7.cl/1gK2z

4. India’s central food authority (FSSAI) has issued a Scheme of Testing for Packaged Drinking Water (PDW) and Mineral Water (MW) to ensure product safety after removing mandatory BIS certification. Effective January 1, 2026, all food business operators must follow detailed microbiological, chemical and packaging testing protocols and maintain compliant batch records via FSSAI-notified NABL labs.
Source: h7.cl/1lEoa

5. The WHO and India’s Ministry of AYUSH held a two-day technical meeting in New Delhi to develop a dedicated Traditional Medicine module within the International Classification of Health Interventions (ICHI), aiming to standardise Ayurveda, Siddha, and Unani globally. India is providing financial and technical support, with expert and member-state participation to strengthen evidence-based global health standards.
Source: h7.cl/1gK2s

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. A leading food products manufacturer has moved the Bombay High Court against a YouTube channel alleging that an online video falsely questioned the safety of its product despite regulatory approval. The company contends the content contradicts findings of the Food Safety and Standards Authority of India and seeks removal and restraint to prevent consumer misinformation.
Source: h7.cl/1lpNb

2. India’s Health Ministry has reportedly clarified that failing to prescribe medicines by their generic names constitutes professional misconduct and may attract disciplinary action under National Medical Commission (NMC) regulations. Doctors are required to prescribe drugs legibly and rationally, with State Medical Councils and the NMC empowered to act against violations.
Source: h7.cl/1lpNg

3. European Medicines Agency (EMA) released Revision 3 of its stability testing guideline for marketing authorisation variations. The update clarifies stability data expectations for post-approval changes, aligns with lifecycle management principles, and strengthens requirements for Type I and II variations, supporting quality, safety, and efficacy of medicinal products across the EU.
Source: h7.cl/1lpNi

4. The U.S. Food and Drug Administration has issued two guidance documents clarifying safety reporting responsibilities for sponsors and investigators in investigational drug and device studies, including IND, bioavailability (BA), and bioequivalence (BE) trials. The guidance provides detailed recommendations on adverse event reporting and safety data assessment in clinical research.
Source: h7.cl/1gvVH
Source: h7.cl/1lpNs

5. U.S. President Donald Trump has signed an executive order instructing federal agencies to reclassify marijuana from Schedule I to Schedule III, thereby easing its regulatory status to support medical research. He has also approved a pilot program enabling Medicare reimbursement for products containing CBD, a widely used non-psychoactive cannabis compound.
Source: h7.cl/1lpNy

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Central Pollution Control Board (CPCB) has notified the establishment of a National Control Room (NCR) to coordinate and monitor nationwide enforcement of the ban on identified single-use plastic items. The NCR will support clarity, compliance tracking, stakeholder guidance, state control room reporting, inspections and awareness campaigns.
Source: h7.cl/1lmmL

2. The National Medical Commission has directed medical colleges to establish committees to monitor prescription practices, emphasising clear and legible handwriting and the use of generic drug names. The directive aims to strengthen patient safety, promote rational prescribing, and integrate these practices into medical education nationwide.
Source: h7.cl/1lmm6

3. Food Safety and Standards Authority of India has reportedly directed all states and Union Territories to launch a nationwide enforcement drive against adulteration and misbranding of milk, paneer and khoya. The move follows repeated detections and aims to protect public health through strict inspections and penalties across country.
Source: h7.cl/1gsAC

4. More than 60% of registered small and medium pharmaceutical units in India reportedly risk shutting down by December 2025 due to non-compliance with revised GMP (Schedule M) quality standards. Industry stakeholders warn of potential medicine shortages, job losses, and export disruptions if compliance challenges are not addressed promptly.
Source: h7.cl/1gsAd

5. The EU’s Medical Device Coordination Group has issued new guidance clarifying criteria for qualifying breakthrough medical and IVD devices under MDR/IVDR. It defines key criteria such as significant clinical benefit, unmet medical need, and innovation level, aiming to harmonize interpretation across authorities and support early regulatory engagement without lowering safety or evidence requirements.
Source: h7.cl/1lmli

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. India’s food regulator, FSSAI, has reportedly initiated a nationwide surveillance drive to collect and test egg samples (branded and unbranded) for banned antibiotics like nitrofurans. Additionally, FSSAI is also scrutinising declarations such as ‘100% chemical-free’, ‘antibiotic-free’, ‘100% pure’, or ‘fresh’, checking compliance with permissible labelling declarations.
Source: h7.cl/1gl8j

2. India will host the Second World Health Organization Global Summit on Traditional Medicine in New Delhi from 17 to 19 December 2025, bringing global leaders together to strengthen science-based, ethical and sustainable integration of traditional medicine into national health systems and the global health policy framework.
Source: h7.cl/1leF9

3. India’s Parliamentary Standing Committee on Health & Family Welfare has reportedly called on the National Medical Commission (NMC) to issue clear guidelines to establish new medical colleges in states with fewer than 100 MBBS seats per million population, addressing uneven seat distribution, high costs, faculty shortages and access gaps in medical education.
Source: h7.cl/1gl9d

4. The Indian Council of Medical Research has reportedly funded a pan India clinical trial, Intermittent PARP Inhibitor Regimen in Ovarian Cancer, to evaluate intermittent dosing of the PARP inhibitor rucaparib in ovarian cancer, aiming to reduce treatment costs and side effects while maintaining clinical efficacy and improving patient access.
Source: h7.cl/1leFj

5. The Telangana Drugs Control Administration conducted a statewide inspection of retail medical shops and raided an unlicensed fertility centre, issuing notices to 180 outlets and seizing multiple medicines, reinforcing enforcement against illegal drug sales and violations of the Drugs and Cosmetics Act, and ensuring patient safety across the state.
Source: h7.cl/1gl8A

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Ministry of Health and Family Welfare has published a draft amendment to the Medical Devices Rules, 2017, proposing changes to labelling requirements for non-sterile and non-measuring medical devices, along with other regulatory updates. Stakeholders’ comments are invited within 30 days of publication of the draft Rules.
Source: h7.cl/1ghFK

2. India’s Bureau of Indian Standards has notified IS 19493:2025 on hospital bill formats, effective 8 December 2025. The standard specifies mandatory and optional billing elements for hospitals, nursing homes, diagnostic centres, and outpatient clinics, aiming to ensure uniformity, transparency, prevent overcharging, and improve clarity for patients and insurers nationwide.
Source: h7.cl/1ghFQ

3. The Supreme Court of India has issued notices to the Centre and all states on a PIL seeking to declare cancer a notifiable disease nationwide. The move aims to ensure uniform reporting, strengthen surveillance, and improve early detection and patient care through a centralized digital registry amid fragmented state-level data.
Source: h7.cl/1ghG2

4. A pharmaceutical innovator has appealed a Delhi High Court order permitting an Indian manufacturer to produce and export semaglutide to markets where patent protection has lapsed. The court declined interim relief, allowing exports to continue.
Source: h7.cl/1lb5k

5. The Ministry of Information and Broadcasting stated that the Information Technology Rules 2021 safeguard free speech while curbing fake and misleading digital content. Publishers of news must follow a Code of Ethics, intermediaries must prevent false information, and a grievance mechanism and fact checking by Press Information Bureau ensure accountability nationally.
Source: h7.cl/1ghGa

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Competition Commission of India has ordered three Maharashtra liquor trade associations to cease anti-competitive practices, including influencing prices and restricting market access. The CCI found the groups violated the Competition Act and directed them to stop such conduct, though no monetary penalties were imposed.
Source: h7.cl/1g7kN

2. The Punjab government has issued strict new directives for private hospitals to curb exploitation, including mandated humane treatment protocols and safeguards in sensitive situations like patient death. The move aims to strengthen patient rights and accountability in healthcare delivery amid public concerns over unethical practices.
Source: h7.cl/1l0ob

3. Karnataka’s Health Minister has reportedly cautioned private hospitals against conducting unnecessary caesarean deliveries for financial gain, stating that violations under the Karnataka Private Medical Establishments Act may attract penalties up to fifty thousand rupees and potential cancellation of registration, following due process, if establishments fail to comply with regulatory directions.
Source: h7.cl/1l0p7

4. The All India Organisation of Chemists and Druggists has reportedly urged the Prime Minister to halt illegal e-pharmacy operations and withdraw proposed drug regulations, warning that unregulated online medicine sales, especially antibiotics, violate key laws and dangerously accelerate antimicrobial resistance, creating a significant threat to India’s public health system.
Source: h7.cl/1l0o0

5. The Indian Medical Parliamentarians’ Forum has reportedly warned that funding gaps and delays in India’s Rare Disease Policy are disrupting life-saving enzyme therapy for Lysosomal Storage Disorder patients. Over 60 patients have exceeded the ₹50-lakh cap and nearly 100 face imminent treatment loss, prompting urgent calls for expanded funding and sustained government support.
Source: h7.cl/1g7iS

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. India’s Finance Ministry has amended the Narcotic Drugs and Psychotropic Substances Rules, 1985 to replace Form 4A and revise Form 5, tightening procedures for import and export of narcotic drugs. The new rules mandate stricter documentation, separate accounting, monthly returns, transport permits, export-only restrictions, and compulsory surrender of unused morphine, codeine, thebaine and their salts to government facilities.
Source: h7.cl/1l0Dd

2. The Finance Ministry has authorized 15 pharma companies to import morphine, codeine, thebaine and their salts solely for producing export-bound formulations under strict conditions including use within 180 days, limits on waste, and surrender of unused material. The order is valid until December 31, 2027, with import certificates valid for 180 days.
Source: h7.cl/1g7yD

3. The Delhi High Court recorded an undertaking that a major Indian pharmaceutical company will not sell its semaglutide-based drug in India until March 20, 2026 when the secondary patent on the medicine is set to expire of another pharma company, while permitting it to manufacture and export the product to markets where no patent rights exist. The company’s assurance was noted by the court amid ongoing patent disputes, with similar relief previously granted to another domestic manufacturer in related proceedings.
Source: h7.cl/1g7xa

4. The Consumer Protection (Amendment) Bill, 2025, proposes to expand the definition of unfair trade practices to include nondisclosure of key terms and dynamic pricing, algorithmic manipulation of consumer behaviour, and the use of complex barriers that impede cancellations, returns, or opting out of services, thereby strengthening India’s legal framework against dark patterns.
Source: h7.cl/1l0Ca

5. India will reportedly invite the World Health Organization to audit and rate its drug regulatory system, aiming to strengthen quality oversight and restore global confidence in its pharmaceutical sector. The initiative follows recent safety concerns and seeks to align national processes with international regulatory maturity standards.
Source: h7.cl/1l0Ce