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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. Delhi High Court has held that English alphabets cannot be monopolised under trademarks law, refusing interim protection to the mark “A to Z” used for pharmaceutical products. The Court held the mark is descriptive, lacking distinctiveness, and cannot bar another company’s use of the letters A and Z, vacating an earlier injunction granted in favour of the company.
Source: h7.cl/1idmr

2. India’s Karnataka High Court has ruled that doctors with an MD in Anesthesiology do not require separate training to prescribe, possess, or dispense essential narcotic drugs for pain relief and palliative care, as Anaesthesiology comprises necessary training prescribed under NDPS Rule and no separate training is essential. The court directed authorities to grant certifications to hospitals designating such practitioners, allowing them to procure and prescribe narcotics.
Source: h7.cl/1idmx

3. Reserve Bank of India (RBI) recently notified the Foreign Exchange Management (Export and Import of Goods and Services) Regulations, 2026, unifying goods and services trade under one FEMA framework. The regulation mandate services-export reporting, strengthen bank monitoring, tighten delayed-proceeds norms, and ease compliance for MSMEs, reflecting services’ role in India’s external sector.
Source: h7.cl/1ncIW

4. India’s Central Government has issued a new Drug Procurement Policy under the Central Government Health Scheme (CGHS), introducing demand-driven bulk purchasing, enhanced quality assurance, and transparent drug procurement processes. The policy aims to ensure uninterrupted medicine access, optimize resource utilization, and strengthen supply chain resilience across all CGHS establishments.
Source: h7.cl/1ncJh

5. India’s central drug regulator approved a record number of Recombinant DNA (r-DNA) origin drugs in 2025, granting permission for 28 new drugs for manufacture and 44 for import and marketing, the highest in five years. Approvals included insulin, oncology and immunology products.
Source: h7.cl/1ncJy

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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 Kerala High Court ruled that brand ambassadors are not liable for unfair trade practices or deficient services under the Consumer Protection Act unless a direct transactional link with consumers is proven. Endorsers face penalties only for misleading advertisements, and are protected where due diligence to verify claims is demonstrated by law.
Source: h7.cl/1hJqC

2. State Drugs Regulator of Telangana has recently issued a stop-use advisory for a children’s syrup prescribed for allergies, hay fever, and asthma, after a CDSCO lab detected toxic ethylene glycol contamination. The public was advised to stop use immediately, report possession, and authorities ordered freezing of affected stocks to avert health risks.
Source: h7.cl/1mGN8

3. A Parliamentary Standing Committee has urged the Ministry of AYUSH to integrate allopathy and traditional medicine, recommending AYUSH departments in all AIIMS, stronger collaboration with the Health Ministry, and time-bound action to create a pluralistic, integrated healthcare system nationwide.
Source: h7.cl/1mGNc

4. The Bureau of Indian Standards has notified amendments to 22 Indian Standards covering dairy products, infant foods, milk substitutes, and special medical nutrition. Amendments were established from 15 December 2025, and existing standards will remain in force till 14 June 2026, giving business operators a defined transition period for compliance.
Source: h7.cl/1hJqz

5. The US Food and Drug Administration has relaxed the oversight of general wellness devices, clarifying that low-risk products such as fitness trackers and wellness apps will not be actively regulated as medical devices if they avoid disease-related claims. The move aims to reduce regulatory burden and encourage innovation in consumer and digital health technologies.
Source: h7.cl/1hJqP
Source: h7.cl/1hJqT

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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. The Indian government has withdrawn Quality Control Orders (QCOs) for critical materials like polypropylene and polycarbonate following an industry / NITI Aayog review, easing sourcing complexity for domestic medical-device manufacturers.
Source: h7.cl/1jJYy

2. The Supreme Court has requested the Centre and states to create a unified national policy under the Transplantation of Human Organs Act, citing stark inconsistencies across states in donor criteria, allocation norms and regulation. It also called for donor-welfare guidelines, uniform registry formats, brain-death reporting and swift establishment of organ-tissue organisations in lagging regions.
Source: h7.cl/1eVn7

3. India’s Union Commerce Ministry has sought detailed industry inputs on market access barriers for pharmaceutical exports to Russia, focusing on registration, market entry, price rules, and clinical trials, as it prepares submissions for upcoming talks in Moscow to strengthen India’s expanding pharmaceutical presence across Russia and the wider Eurasian region.
Source: h7.cl/1eVnb

4. The Indian government is reportedly considering tighter regulation of health insurance to curb soaring premiums, driven by rising medical costs and uneven claim payouts. Proposed measures include capping premiums, limiting agent commissions, and requiring stricter disclosure norms. Discussions are ongoing with the IRDAI, insurers, and hospitals to evaluate the measures.
Source: h7.cl/1eVnf

5. India’s leading food delivery platform is reportedly close to an agreement with restaurant associations to share customer contact details and ordering insights, subject to user consent. The move aims to resolve long-standing disputes over data access and could set a new industrywide model for platform restaurant data sharing.
Source: h7.cl/1jJZC

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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 Indian Pharmacopoeia Commission (IPC), traditionally responsible for preparing standards for medicines, is now reportedly expanding its role to prepare standards for medical devices in collaboration with the Bureau of Indian Standards (BIS). It has also begun auditing medical device companies and is developing monographs which will outline standards and specifications for medical equipment. This initiative aims to enhance India’s credibility in medical device manufacturing and support export growth.
Source: short-url.org/1c9pE

2. The Telangana High Court set aside a blanket injunction order in a trade secret dispute, holding that confidential information and trade secrets must be clearly identified and proven. It ruled that the trial court erred by granting a blanket restraint and directed a fresh hearing in accordance with law.
Source: short-url.org/1gQnE

3. The Indian government has amended the export policy for rice (both Basmati and non-Basmati) to non-EU European countries, removing the requirement for Export Inspection Council (EIC) certification until April 2, 2026. The EIC certification will, however, remain mandatory for exports to the EU, the UK, Iceland, Liechtenstein, Norway, and Switzerland.
Source: short-url.org/1gQlT

4. The Pharmaceuticals Export Promotion Council (Pharmexcil) has asked pharma exporters to submit cases of delayed or non-payment by overseas buyers to help frame a Standard Operating Procedure (SOP). This SOP aims to streamline the process of addressing payment-related grievances and Pharmexcil’s timely intervention.
Source: short-url.org/1c9p-

5. Tamil Nadu Food and Drugs Administration (FDA) is investigating the license of a local cough syrup manufacturer following child deaths in Madhya Pradesh linked to contaminated cough syrup produced by the company. The scrutiny in Tamil Nadu began after a formal request from the Madhya Pradesh Drugs Control Authority and the state drug regulator. In response to these incidents, India’s Union Health Ministry has issued an advisory urging the rational use of pediatric cough syrups banning them for children under two years, advising caution for older children, and promoting rest and hydration as preferred treatments.
Source: short-url.org/1gQng
Source: short-url.org/1c9qC

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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 Food Safety and Standards Authority of India has issued the first amendment to Food Products Standards & Food Additives Regulations, introducing norms for meat sausages, dehydrated tarragon, changes in packaged drinking water specifications, and revisions to food colour and additive rules. The regulations take effect from 1 February 2026.
Source: bit.ly/44C2uMH

2. The Supreme Court of India has recently ruled that stem cell banking including enrolment, collection, processing, and storage of umbilical cord blood qualifies as a healthcare service. It held that such services support preventive and therapeutic care, and are therefore exempt from service tax.
Source: bit.ly/3Ixa7eK

3. India’s Central Drug Authority (CDSCO) has released a guidance document outlining the process for manufacturers to obtain a No Objection Certificate (NOC) for exporting unapproved or approved new drugs. Key updates include mandatory online applications, one-time registration valid for a year, detailed reconciliation and a 7-day NOC issuance timeline.
Source: bit.ly/4kLR6CO

4. India’s Women & Child Development Ministry has issued an advisory to states urging them to curb edible oil usage amid rising obesity and non communicable diseases. It also reiterates previous guidance to limit added salt, sugar, and synthetic additives in Anganwadi nutrition provisions.
Source: bit.ly/4m37IH3

5. In India–EU trade negotiations, the EU seeks substantial tariff reductions on medical devices, automobiles, wine, spirits, meat, poultry, and stronger IP protections. Automotive and med tech duties currently up to 10% are in focus. India is pushing for reciprocity, including non tariff barrier reductions under phased FTA talks.
Source: bit.ly/4lZN8Hu

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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 Ministry of Health and Family Welfare mandates all WHO-GMP (COPP) certificate applications to be submitted exclusively through the ONDS Portal from June 15, 2025. Hard copy submissions will not be accepted. A step-by-step procedure and contact details for support have also been provided.
Source: bit.ly/3HWGXWd

2. CDSCO has informed all states and union territories that a loan license is no longer required for outsourcing sterilization of medical devices, provided the sterilization facility is licensed under MDR-2017. Manufacturers must submit documentation and include the sterilization site’s license number on labels of the device.
Source: bit.ly/44nGKCX

3. The Bombay High Court has issued an interim injunction restraining a company from using packaging, labels, bottles, and trade dress that closely resemble those of an established hair-oil brand. The court found that the packaging was “slavishly copied,” potentially misleading consumers and amounting to trademark infringement and unfair competition.
Source: bit.ly/4kd5DXM

4. The Andhra Pradesh High Court has ruled that under the Narcotic Drugs and Psychotropic Substances Act, 1985, “Ganja” refers only to the flowering or fruiting tops of the cannabis plant, explicitly excluding seeds and leaves when not accompanied by the tops.
Source: bit.ly/4ls1iRl

5. India’s Central Board of Indirect Taxes and Customs (CBIC), following DGTR recommendations, has slapped anti dumping duties for five years on four key chemicals from China—PEDA, acetonitrile, Vitamin A palmitate and insoluble sulfur—to shield domestic pharma, agro and rubber industries, signalling a strategic push to rebalance imports and promote local manufacturing.
Source: bit.ly/4lNeEYX

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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. Directorate General of Foreign Trade (DGFT)Trade Connect ePlatform has reportedly expanded the ‘Source from India’ portal to include all pharma Status Holder exporters with valid IECs. This upgrade enhances global discoverability, boosts buyer-supplier connectivity, and further promotes India’s position as a key player in global pharmaceutical trade.
Source: bit.ly/3Ts7gWt

2. The global pharma market is reportedly shifting toward specialty drugs like biologics and oncology therapies. India, while leading in generics, is investing heavily in biosimilars, innovation, and digital health—strengthening its dual role in high-volume supply and cutting-edge pharmaceutical R&D.
Source: bit.ly/4n6JKvN

3. Association of Southeast Asian Nations (ASEAN) has issued new harmonised guidance for medical device classification and borderline products. The update refines risk categories (A–D), defines ambiguous products, and promotes faster regulatory approvals, supporting pharma-medtech innovators in expanding across the Southeast Asian market.
Source 1 : bit.ly/43P2g4t
Source 2 : bit.ly/3HKZ8xN

4. The Confederation of Indian Alcoholic Beverage Companies has reportedly expressed their concern Maharashtra’s government to revisit its decision to raise excise duty on Indian-made foreign liquor(IMFL), country liquor, and imports by up to 50–85%. Industry leaders warns this could trigger a surge in illicit trade, harm legal sales, and reduce long-term state revenues despite short-term ₹14,000 crore projections.
Source: bit.ly/4jQJ3UN

5. The U.S. Food and Drug Administration (FDA) has finalized guidance to streamline the pre-submission facility correspondence (PFC) process for priority abbreviated new drug applications (ANDAs). By submitting complete and accurate facility information at least 60 days before ANDA submission, applicants can qualify for an expedited 8-month review timeline.
Source: bit.ly/4jRpNq0

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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. USA has requested India to remove import duties and relax stringent price controls on medical devices and relax rules on data localization policy with an aim to boost trade between nations.
Source: bit.ly/45hYyBt

2. The Central Pollution Control Board has introduced a step-by-step complaint module for changing login credentials on the Plastic Packaging Extended Producer Responsibility portal, easing access for affected companies.
Source: bit.ly/4e1NJWh

3. India’s Health Ministry mandates purchase invoice billing or provision of CGHS supplied medicines for Central Government Health Scheme claims, squeezing private hospital margins and prompting sector backlash
Source: bit.ly/3HT7nI4

4. Indian pharma companies increasingly deploy blockchain and smart contracts to enhance serialisation, ensure Drug Supply Chain Security Act (DSCSA) compliance, curb counterfeit drugs, automate supplier processes and reinforce production quality and security.
Source: bit.ly/3SRv85J

5. The Ministry of Consumer Affairs has issued further FAQs to provide clarity on the implementation of the Legal Metrology (Packaged Commodities) Rules, 2022. Key clarifications include guidelines on the declaration of MRP, labelling requirements for weighing machine, declaration regarding Institutional sale etc.
Source: bit.ly/440O2w7

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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 Department of Pharmaceuticals (DoP) has reportedly issued a communication to all pharmaceutical associations directing them to comply with the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024. As per the directive, companies must submit a self-declaration and marketing expenditure disclosure for the financial year 2024–25 by 31st July 2025
Source: bit.ly/4jvX8Xq

2. The Ministry of Commerce and Industry authorised Ayushexcil, the Ayush Export Promotion Council under Appendix 2E of Foreign Trade Policy 2023 to issue non-preferential Certificates of Origin for Ayush products, streamlining exports and boosting global trade.
Source: bit.ly/4dM0fsZ

3. India’s pharmaceutical sector is expected to remain stable despite the U.S. Executive Order introducing a “Most Favoured Nation” pricing model, which seeks to cut branded drug prices by 30–80% by aligning them with the lowest OECD country prices. CRISIL Ratings reports that strong domestic demand and a focus on generics will help India’s pharma industry withstand these pricing pressures.
Source: bit.ly/45Lwd6y

4. India launches International Biomed Cross (IBC) to create a global network of biomedical engineers for rapid repair, maintenance, and remote support of critical medical equipment during health emergencies and disasters, ensuring uninterrupted healthcare services in underserved and crisis-affected regions.
Source: bit.ly/45Lwd6y

5. The U.S. President Trump has reportedly revoked a Biden-era policy under the Emergency Medical Treatment and Labor Act (EMTALA), 1986 that required hospitals to provide emergency abortions, even in states with abortion bans. This move creates legal uncertainty for hospitals and may limit emergency abortion care for pregnant women.
Source: bit.ly/4mMt1xF