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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 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

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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 Delhi High Court has recently ruled that businesses cannot justify failure to reduce prices after a GST rate cut by claiming to have increased the product quantity, especially when such changes are made without informing consumers. Continued non-compliance may lead to GST registration cancellation under anti-profiteering provisions.
Source: short-url.org/1gqnP

2. Central Drugs Standard Control Organization (CDSCO) has clarified that combi-packs of lyophilized injections with standard diluents (e.g., sterile water or saline) used for over four years will not be treated as new drugs, allowing State Licensing Authorities approval. Combi-packs with different diluents will still require CDSCO approval as new drugs.
Source: short-url.org/1gqnS

3. The Ministry of Labour and Employment has released draft Factories Workers Rules under the OSHW Code, 2020, inviting comments until 6th November 2025. The rules mandate safety, health, and welfare measures, including sanitation, ventilation, separate facilities, first-aid, nutrition, and emergency preparedness, with obligations varying by workforce size.
Source: short-url.org/1gqo1

4. Over the next five years, drugs worth $236 billion globally are slated to lose patent protection, paving the way for generic drugs and biosimilars. This “patent cliff” allows Indian pharma to capture market share, grow revenues, and lower drug costs for patients globally.
Source: short-url.org/1gqo6

5. Over the past five years, National Medical Commission (NMC) Ethics & Medical Registration Board has dismissed 162 appeals filed by patients/families alleging medical negligence. India’s Central Health Ministry has now reportedly begun a review of this, planning to consult with NMC to understand and address potential procedural bias.
Source: short-url.org/1bLfY

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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 Delhi government’s ban on sending genetic samples outside the city for prenatal tests like NIPT and PGT, reportedly, faces strong opposition from diagnostic labs in Delhi. The labs have raised concerns that it will overload local labs, cause delays, increase costs, and limit access for patients in NCR and nearby states, urging reconsideration of the directive.
Source: short-url.org/1gmX1

2. The Bombay High Court has in a customs case held that allowing re-testing of seized goods is a trade facilitation measure. Denials must be rare and when made should be supported by written reasons. The court emphasized that refusal to retest should not be the norm.
Source: short-url.org/1gmXa

3. The Indian government will reportedly require all hospitals, both public and private, to include an Adverse Drug Reaction reporting form in every patient admission record. This under the Pharmacovigilance Programme of India aims to standardise monitoring of drug safety and better protect patients from adverse effects.
Source: short-url.org/1bHWo

4. The Committee for Control and Supervision of Experiments on Animals (CCSEA) has clarified that beagle dogs procured from breeders registered with State Animal Welfare Boards or State Animal Husbandry Departments are strictly for breeding colonies, not for experimentation. For testing, dogs must be sourced from CCSEA registered establishments.
Source: short-url.org/1bHWu

5. To ease certificate issuance delays, India’s central drug licensing authority reportedly has plans of shifting data verification in the CoPP (Certificate of Pharmaceutical Product) process to later stages instead of initial stage and conduct verification themselves bypassing initial scrutiny by state regulators.
Source: short-url.org/1gmXq

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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 World Anti-Doping Agency will reportedly classify non-diagnostic use of carbon monoxide to its prohibited method list while preserving its controlled medical and diagnostic use. WADA reportedly said that its use could increase erythropoiesis – the process of creating new red blood cells.
Source: short-url.org/1bq0M

2. The Indian Supreme Court has recently clarified that under the Maintenance and Welfare of Parents and Senior Citizens Act, 2007, the applicant’s eligibility as a senior citizen is determined on the date of filing the application, not when it is adjudicated. The ruling ensures timely recognition of rights and prevents denial of benefits due to procedural delays.
Source: short-url.org/1g4st

3. The Kerala High Court has called on the State Government to consider setting up dedicated Narcotic Drugs and Psychotropic Substances courts in every judicial district to clear the pending cases and enable speedy trials as there are only two special courts currently operational.
Source: short-url.org/1g4sw

4. Odisha government plans to expand Ayurvedic infrastructure by launching integrated AYUSH hospitals, Panchakarma centers, and Ayurvedic colleges. The state aims to boost Ayurvedic education, treatment, and preventive healthcare under the National AYUSH Mission to ensure wider public access.
Source: short-url.org/1g4sC

5. The U.S. Department of the Treasury’s OFAC has sanctioned two Indian nationals, and their India-based pharmacy for supplying hundreds of thousands of counterfeit prescription pills laced with fentanyl and methamphetamine to U.S. consumers.
Source: short-url.org/1g4sI

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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 Department of Pharmaceuticals is planning to impose a Minimum Import Price (MIP) on certain active pharmaceutical ingredients and intermediates including potassium clavulanate to deter cheap imports (especially from China) and strengthen domestic raw material production under the PLI scheme.
Source: short-url.org/1fZwh

2. The Delhi High Court has allowed the company to use of the phrase “why settle for ordinary Chyawanprash” in advertisements, but directed removal of the reference “made with 40 herbs”, deeming it disparaging. The court said the remaining claim is permissible as puffery and not misleading.
Source: short-url.org/1fZwo

3. The Bombay High Court has quashed the drug regulator’s stop-production orders against two pharmaceutical companies. The court found the actions violated statutory procedures and denied the companies a fair hearing. However, it clarified that regulators may take fresh action if proper procedures are followed.
Source: short-url.org/1fZwB

4. Telecom Regulatory Authority of India has issued the draft Telecommunication (Broadcasting and Cable) Services Interconnection (Addressable Systems) (Seventh Amendment) Regulations, 2025, seeking stakeholder inputs by 6 October 2025. The draft mandates annual financial year audits, stricter infrastructure sharing rules, and aims for enforcement from 1 April 2026.
Source: short-url.org/1fZwO

5. The Directorate General of Trade Remedies has rescheduled the oral hearing in the anti dumping sunset review of methyl acetoacetate imports from China to October 8, 2025. The review will decide if duties must continue to prevent dumping and protect domestic industry.
Source: short-url.org/1fZwV

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 Control Board mandates real-time photographic monitoring of pharmaceutical effluent emissions, requiring automatic uploads to central portals. Non-compliance may trigger instant penalties and plant shutdowns forcing pharma CEOs and founders to implement on-site imaging systems immediately or risk regulatory sanctions.
Source: short-url.org/1beOU

2. The Indian Pharmacopoeia Commission has inaugurated the 5th National Pharmacovigilance Week (17–23 Sept 2025) themed “Your Safety, Just a Click Away: Report to PvPI”. The initiative aims to encourage broader participation in adverse drug reaction (ADR) reporting by healthcare professionals and patients to strengthen pharmacovigilance.
Source: short-url.org/1beP1

3. Telangana’s health department has sealed 115 pharmacies attached to corporate hospitals after discovering critical breaches such as no registered pharmacists on duty, absence of purchase-sale records, stocking expired drugs, and improper storage of thermolabile medicines. Authorities have issued notices to hospital managements and warned of strict legal action under pharmacy and drug laws.
Source: short-url.org/1fSXe

4. US President reportedly advised pregnant women to avoid paracetamol (Tylenol), citing suspected links to autism. The U.S. FDA has begun label-revision to reflect “possible association,” though causation isn’t proven. However, the WHO, EU regulators, and medical experts emphatically refute the claim, stating evidence remains inconsistent and insufficient to establish causality.
Source: short-url.org/1bePe

5. U.S. officials are reportedly exploring the launch of a branded web portal potentially called “TrumpRx” that enables consumers to search for prescription medicines and purchase them at discounted prices directly from manufacturers.
Source: short-url.org/1fSUh

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 Indian Central Government has eased GST rate revision compliance for manufacturers and importers allowing them to voluntarily affix revised price stickers on unsold stock manufactured before September 22, 2025, without obscuring the original price. Mandatory newspaper advertisements have been waived and only circulars to dealers and retailers are needed. Old packaging can be used until March 31, 2026, with price corrections allowed.
Source: short-url.org/1fjNU

2. Food Safety and Standards Authority of India (FSSAI) will be conducting a nationwide enforcement drive in October 2025 targeting 13 whole and powdered spices after a 2024–25 surveillance found substandard quality, contaminants, and labelling lapses. Only manufacturing units will be inspected, with samples tested in NABL-accredited labs. States authorities are required to submit reports by 20 November 2025.
Source: short-url.org/1aHQi

3. The Drugs Control Department of Delhi has directed all manufacturers and marketers of drugs, formulations, and medical devices to revise MRPs as per reduced Goods and Services Tax (GST) rates effective 22 September 2025. Revised price lists must reach retailers, and billing systems must be updated to reflect new GST rates.
Source: short-url.org/1fjO6

4. The Bangalore District Chemists and Druggists Association has warned that Goods and Services Tax 2.0 will force pharmacy retailers to absorb losses as they sell old stock at reduced maximum retail prices without input tax credit. It urged authorities to assure no penalties during the transition until December 31, 2025.
Source: short-url.org/1aHQy

5. India’s Federation of Pharmaceutical Merchant Exporters (FPME) has urged exporters to share feedback on the challenges faced with the new dual-use No Objection Certificate (NOC) system introduced by CDSCO via the Sugam portal. Reportedly, The new process has caused delays and increased documentation requirements, impacting export efficiency. FPME has urged Pharmexcil to address these issues with regulatory authorities to streamline export compliance.
Source: short-url.org/1fjOk

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. Central Board of Indirect Taxes and Customs (CBIC) has issued Notification revising GST rates effective September 22, 2025, after the 56th GST Council meeting. The GST rates for medical devices, drugs, food, beverages, and cosmetics have been notified.
Source: short-url.org/1f8PY

2. India’s Central Drugs Standard Control Organization (CDSCO) and Indian Council of Medical Research (ICMR) have issued a unified national protocols for evaluating in-vitro diagnostic kits for Chikungunya, Dengue, Zika and others. These guidelines set strict criteria on sensitivity, specificity, and quality, ensuring accurate diagnostics and strengthening regulatory oversight to improve access to quality-assured diagnostic kits in India.
Source: short-url.org/1f8Q4

3. The National Medical Commission has advised medical colleges to strengthen rabies case management via regular training, surveillance, and community outreach. Colleges must guarantee continuous supply of anti-rabies vaccine (ARV) and anti-rabies serum (ARS), maintain a register of animal bite exposure cases, and report suspected rabies cases through state nodal officers via IHIP under IDSP.
Source: short-url.org/1f8Qh

4. The Directorate General of Health Services is set to introduce new regulations establishing minimum standards for medical sample collection and transportation. These standards aim to ensure that blood, urine, and swab samples are handled by trained professionals and transported under proper conditions, including maintaining a cold chain, to prevent contamination and ensure accurate test results.
Source: short-url.org/1f8Qw

5. The Drugs Control Administration (DCA), Telangana suspended licences of 165 medical shops and permanently cancelled seven for retailing MTP kits without valid prescriptions or licensed supervision. 800+ inspections revealed violations including OTC sales of abortifacient drugs (mifepristone, misoprostol), lack of required records, and dispensing without qualified pharmacists.
Source: short-url.org/1f8QF

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. General insurers are reportedly urging the Indian Finance Ministry to exempt commissions on health insurance from the 18% GST and reinstate input tax credit (ITC), arguing that commissions part of procurement costs should be treated like reinsurance commissions. Without relief, premiums could increase by ₹3-5 per ₹100 cover, hitting India’s ₹40-50k crore retail health insurance market.
Source: short-url.org/1antS

2. India’s Supreme Court has allowed Major Electronics company to be exempted from customs duty on its G Watch W7 imports from South Korea, even though it was classified under the higher duty category (CTH 8517). The court held that a certificate of origin from a country with which India has a full customs duty exemption agreement is sufficient to claim such exemption.
Source: short-url.org/1anu0

3. India’s Tamil Nadu Medical Council (TNMC) has issued a notice classifying “conversion therapy” as a professional misconduct. It warned that doctors attempting to alter a person’s sexual orientation or gender identity will face strict disciplinary action, including suspension or cancellation of their medical license, reinforcing ethical practice and safeguarding LGBTQIA+ rights across the medical community.
Source: short-url.org/1anvQ

4. Private hospitals in India are locking horns with insurers over reimbursement rates and delayed settlements as medical inflation surges. Some renowned hospitals have suspended cashless services in August. Policyholders are bearing the financial burden amid this impasse.
Source: short-url.org/1anuR

5. The Supreme Court ruled that under the NDPS Act, failure to produce the bulk of seized contraband at trial doesn’t fail the prosecution’s case, provided inventory, sample-drawing and forensic report are properly documented. The court emphasized that only in exceptional cases, where procedural breach undermines the case’s core, should retrial be ordered.
Source: short-url.org/1anv0