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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

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 Environment, Forest and Climate Change has extended the deadline for filing annual returns by Producers, Importers, and Brand Owners (PIBOs) of plastic packaging for 2024–2025 until November 30, 2025.
Source: short-url.org/1bS0C

2. The Delhi High Court, while deciding a trademark dispute, ordered customs at Mundra port to inspect containers suspected to contain dental-hygiene products which are allegedly packaged in deceptively similar manner to a leading brand’s red blue trade dress. The court found a prima facie likelihood of dilution of goodwill but withheld injunctive relief until confirmation from customs.
Source: short-url.org/1gxoM

3. Pursuant to over 3,000 complaints concerning the non-passage of tax cuts or “dark patterns” in discounting and price presentation, the government has reportedly summoned top e-commerce firms for hiking the prices or not reducing prices after recent GST reduction, even after September 22, 2025. It is scrutinising over 50 product categories and expects visible consumer price relief during the festive season.
Source: short-url.org/1bS2N

4. The Government of India has extended the RoDTEP (Remission of Duties and Taxes on Exported Products) scheme beyond September 30, 2025, until March 31, 2026. This scheme refunds hidden duties and taxes to exporters. It covers DTA (Domestic Tariff Area) units, Advance Authorisation holders, SEZ units, and EOUs at existing rates within the approved budget.
Source: short-url.org/1bS1c

5. The Delhi High Court has quashed an FIR against a manufacturer of medicines and injections that “may cause serious harm to the patient.” The Court held that only Drug Inspectors can prosecute offences under the Drugs and Cosmetics Act. Police registration of such FIRs was deemed beyond jurisdiction.
Source: short-url.org/1bS1W

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 Consumer Affairs Ministry has permitted manufacturers, packers, and importers to revise MRPs on unsold pre-packaged goods post-GST changes, reflecting only the tax difference. Original MRP must remain visible. Revisions via stickers or stamping are allowed. Conditions include newspaper ads, dealer notifications, and apply until December 31, 2025, or stock exhaustion which ever is earlier.
Source: short-url.org/1dU94

2. The Department of Consumer Affairs has proposed an amendment to the Legal Metrology (Approval of Models) Rules, 2011, introducing a validity period of 10 years for domestic and 5 years for imported model approvals. Public comments are invited before October 9, 2025 through emails.
Source: shorturl.at/7wExv

3. The Soybean Processors Association of India has reportedly objected to FSSAI’s ‘Eat Right India’ post promoting olive oil, calling it elitist and biased. They argue it undermines public confidence in affordable, nutritious local oils like soybean and mustard, and urge its withdrawal to protect consumer trust and national interests.
Source: shorturl.at/zkeaL

4. The FSSAI has constituted a committee to modernize India’s organic-food and agricultural products’ regulatory framework by revising certification rules, usage of the India Organic label, and aligning standards with global benchmarks. While the scope spans organic agricultural products, the authority has not provided a timeline for rollout.
Source: shorturl.at/AQnA5

5. The Retail Distribution Chemist Alliance (RDCA) has cautioned that the shift reducing GST on most medicines from 12% to 5%, effective September 22, 2025, is financially unviable for pharmacies due to unrecoverable input tax credit, risking severe medicine shortages without urgent relief.
Source: shorturl.at/oAEhB

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. Several global pharmaceutical companies have approached the European Commission demanding assistance in maintaining operations in the EU and to help Europe keep the pharma industry including measures to compensate them for the cost of pharmaceutical innovations. This move comes in the face of threatened U.S. tariffs on imports.
Source: bit.ly/3RgXrK6

2. A pharma giant has allegedly breached the UK’s Prescription Medicines Code of Practice Authority (PMCPA) for its cancer drug’s misleading prescribing information, which failed to clearly state that women using hormonal contraceptives needed to take additional measures to prevent pregnancy while on the drug.
Source: bit.ly/4lzu3MO

3. India’s Department of Pharmaceuticals (DoP) has invited expression of interest for selecting an agency to conduct a comprehensive study of India’s pharmaceutical and medical device supply chains, in order to identify regulatory hurdle.
Source: bit.ly/42zIx6O

4. Central Drugs Standard Control Organisation has directed States and Union Territories to urgently stop the manufacture, sale, and distribution of 35 unapproved Fixed Dose Combinations licensed without safety and efficacy evaluation under New Drug and Clinical Trials rules, 2019. Authorities must investigate, take action, and report compliance to ensure public health and regulatory consistency.
Source: bit.ly/4cw43hg

5. China has amended its GB 9685 standard for additives in food contact materials. The changes include expanded use in silicone rubber, revised usage limits, updated additive names, and new safety calculations. These updates, effective March 2025, aim to improve consumer safety and industry compliance.
Source: bit.ly/4cGqBfE

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 developed ONDLS Portal for receiving applications from small and medium scale pharmaceutical manufacturers who wish to avail benefit of extension from requirement to comply with new Good Manufacturing Practices (GMP) under revised Schedule M. Such applications must be strictly submitted online before lapse of three months from February 11, 2025. Submission of hard copy applications will no longer be accepted.
Source: https://bit.ly/4iEFh0U

2. The Indian Ministry of Health is working with Bureau of Indian Standards (BIS) to develop a standardized invoice format for hospitals, nursing homes, clinics and diagnostic centers. Once notified, clinical establishments will have to follow a standard invoice format with detailed and transparent breakdown of charges incurred by patient.
Source: https://bit.ly/4c4CM5w

3. India’s Supreme Court has held that even in consumer contracts which contain arbitration clauses, a consumer has the right to decide whether to pursue arbitration or approach the consumer forum for resolution of consumer dispute. The Court further reiterated that consumer disputes are non-arbitrable unless the consumer voluntarily opts for arbitration.
Source: https://bit.ly/4c4CPOK

4. The Directorate General of Foreign Trade (DGFT) has decided to withdraw the Remission of Duties and Taxes on Exported Products (RoDTEP) Scheme benefits for exports arising from Advance Authorizations (AAs), Special Economic Zones (SEZs), and Export Oriented Units (EOUs).
RoDTEP Scheme helps pharmaceutical exporters to get refund on taxes and duties on export.
Source: https://bit.ly/4c43M59

5. The Food Safety and Drug Administration (FDA) of Karnataka has reportedly increased inspections to address the issue of adulteration of tea powders and spices.
The decision has been taken due to reports of addition of harmful substances in food products, with the goal of reducing health risks to the public.
Source: https://bit.ly/4cjrdrr

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 Central pollution regulator has issued a Notification extending the deadline to 31st December 2024, for submitting quarterly filings for the FY 2023-24 for all entities registered under the Hazardous and Other Wastes (Management and Transboundary Movement) Amendment Rules, 2022.
Source: bit.ly/49ahqlK

2. A District Consumer forum in the State of Maharashtra has held that the refusal of returns by a e-commerce service provider, under a blanket “no-returns” policy constituted a “unfair trade practice” and awarded compensation to consumer whose return of sub-standard product had been rejected.
Source: bit.ly/417xJxQ

3. In a recently published response to a query received by it under the Right to Information Act, 2005, the Delhi Medical Council clarified that, since only medical practitioners registered with the council and having recognized qualifications in Allopathic medicine are permitted to practice medicine in Delhi: Dentists, who are registered with the Dental Council are not licensed to perform aesthetic and cosmetic treatment which is not medically necessary.
Source: bit.ly/3ZbT0Ur

4. After considerable negotiation, India has signed the final act of the Riyadh Design Law Treaty which aims to establish protections for Industrial Design patents, the treaty specifies procedural guardrails which member states can adopt into their own local design patent protection regulations.
Source: bit.ly/3CXRxcH
Source: bit.ly/4f5AYJz

5. The United States Supreme Court has declined to hear petition by manufacturers of tobacco products, challenging the decision of the Federal Government of the United States to include graphic visual warnings on cigarette packets.
Source: bit.ly/415u1EU

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 National Pharmaceutical Pricing Authority (NPPA) has directed drug manufacturers to reduce the maximum retail price (MRP) of three crucial cancer drugs i.e., Trastuzumab Deruxtecan, Osimertinib, and Durvalumab. This is in line with reduction of customs duty and GST rates on these medications.
Source: bit.ly/4fBQ3Dd

2. Delhi High Court has granted a permanent injunction against a pharma company which had imitated the design and presentation of a drug manufactured by another pharma company. This ruling highlights the requirement for pharma companies to ensure a distinctive packaging to avoid copyright Infringement claims.
Source: bit.ly/40AprhH

3. The All India Organization of Chemists and Druggists (AIOCD) has urged the Drug Controller General of India (DCGI) to restrict a partnership between a rapid delivery platform and an e-pharmacy, citing concerns over regulatory and quality compliance issues that could potentially jeopardize patient safety.
Source: bit.ly/4fDJEqS

4. The Himachal Pradesh High Court has directed the state government to implement a QR code system to assess the quality of medicines in the state. This QR code will provide consumers with key information about the medicine, including production and expiry dates, unit details, batch numbers, and component specifics in order to enhance consumer awareness and transparency in medicine quality.
Source: bit.ly/3YE20Bw

5. UK government is set to launch ‘World-First’ Genomics-Led pandemic warning system. The system will utilize the technology to flag and monitor potential outbreaks of bacterial or viral diseases.
Source: bit.ly/4fBdyw6

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 environment, forest and climate change has recently issued an office memorandum stating a revised list of high end and high value used / refurbished medical equipment for import. MRI, CT and radiography devices are some of the new inclusions in the list. This may lead to unchecked import of refurbished medical devices in India, and potentially risk patient safety. This will also negatively impact Make in India Initiatives. (Order attached).
Source: bit.ly/4hqd4ea

2. The Central Consumer Protection Authority (CCPA) has given the quick e-commerce companies a notice of 15 days for violations related to packaged product disclosures mandated under the Legal Metrology Act, which mandates online and offline retailers to display key product information, maximum retail price, expiration date, weight, manufacturer details, etc on packaged goods. This re-emphasises regulatory stance on consumer safety and disclosure requirements.
Source: bit.ly/3YEp5oF

3. The Central Board of Indirect Taxes and Customs (CBIC ) under the aegis of Ministry of Finance has issued Notification No. 69/2024-Customs (N.T.) dated October 23, 2024, updating the tariff values for imported commodities such as that of edible oils such as Palm Oil and Soya, brass scrap, gold, silver etc (Notification attached).
Source: bit.ly/3BUSmm7

4. Institutions of the Council of Scientific and Industrial Research (CSIR) has designed ‘FluoriPCR’, a device which will help test for food adulteration and presence of bacteria, viruses and fungi etc in food items, increasing the affordability to conduct such tests.
Source: bit.ly/3YqBBah

5. Medical Device Coordination Group (MDCG) has updated the guidance on the application of MDR requirements to ‘legacy devices’ and ‘old’ devices, taking into account the amendments to Regulation (EU) 2017/745 on medical devices (MDR) has been amended by Regulation (EU) 2023/607
Source: bit.ly/3YGoCm7