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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 recently amended the Legal Metrology (Packaged Commodities) Rules, 2011, mandating all e-commerce entities selling imported products to display country-of-origin details through searchable and sortable filters. The amendment, will take effect from July 1, 2026 to ensure transparency.
Source: short-url.org/1p5FU

2. The Central Consumer Protection Authority has imposed a penalty on an e-commerce platform for listing a toy for sale that failed to meet mandatory quality control order for toys and Bureau of Indian Standards requirements. The Authority held the platform liable for unfair trade practices and directed strict compliance and improved consumer grievance disclosures.
Source: short-url.org/1k0GC

3. The Supreme Court of India has expressed dissatisfaction with FSSAI’s affidavit and urged it to seriously consider introducing mandatory front-of-pack warning labels on packaged foods high in sugar, salt, and saturated fats, citing global norms and public-health concerns. The bench has asked FSSAI to report back within weeks, signalling heightened regulatory scrutiny on nutritional transparency.
Source: short-url.org/1k0CS

4. The Indian government is reportedly set to introduce stringent blood centre regulations to curb ‘professional donor’ rackets and unsafe practices by restricting licences to registered voluntary/charitable organisations, barring family-run entities, and mandating ethical, operational and social accountability standards. The overhaul prioritises voluntary donations, audited infrastructure, and rigorous screening to reduce transfusion infection risks and enhance public health outcomes.
Source: short-url.org/1k0GD

5. The Indian government has granted a transitional exemption under the Electrical Appliances (Skin or Hair Care) Quality Control Order, 2023. The exemption applies to goods ordered before 6 March 2025 and the Bill of the Landing and the Bill of Entry are dated on or before 180 days from the QCO came into force. The importers will be exempted from the requirement provided they submit specified import documents to BIS within seven days of clearance.
Source: short-url.org/1p5FD

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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 has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019, proposing to remove the provision dealing with the provisional registration of Ethics Committees. The designated authority will now directly grant final registration in Form CT-03 after scrutiny of Form CT-01, or reject with written reasons.
Source: h7.cl/1oifC

2. Bulk Drug Manufacturers Association of India has launched a marketing portal enabling Indian pharmaceutical companies to promote and source active pharmaceutical ingredients, intermediates, pallets, and contract development and manufacturing services, supporting both domestic and international markets through an integrated vendor management system with no cost registration for buyers.
Source: h7.cl/1oifJ

3. The Department of Pharmaceuticals has extended the deadline for submitting applications under the Common Facilities for Medical Device Clusters (CFMDC) sub-scheme to 15 February 2026. The scheme supports shared testing infrastructure for medical devices, including cardiac and orthopaedic implants, infusion pumps, imaging equipment, and Class B, C, and D IVDs.
Source: h7.cl/1jfLz

4. The Maharashtra government has issued a resolution by introducing a new fee structure at state-run hospitals from effective from January 16, 2026. ₹5 for OPD registration, ₹10/day for inpatient admission, and up to ₹40,000 for major surgeries like joint replacements. Diagnostic services, ICU care, and ambulance services also have updated charges. Implementation across hospitals is pending.
Source: h7.cl/1oiwW

5. The Indian Pharmacopoeia Commission is reportedly taking efforts to develop more biosimilar in alignment with governments Biopharma Shakti initiative. This move aims to align Indian quality standards with global benchmarks and strengthen the country’s biologics and biosimilars ecosystem.
Source: h7.cl/1jfLU

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 Central Government has issued draft amendments to the Drugs Rules, 1945, proposing mandatory blue vertical strip on the left side running throughout the body of the label on all antimicrobial drugs and their preparations. The move aims to enhance identification and promote responsible antimicrobial use, with stakeholder comments invited within thirty days.
Source: h7.cl/1iBM0

2. The Kerala High Court has ruled that the title “Doctor” is not exclusive to medical doctors and can be used by physiotherapists and occupational therapists. The Court held that neither the NMC Act nor state law grants doctors an exclusive right over the “Dr.” prefix, which traditionally denotes advanced learning.
Source: h7.cl/1nBW7

3. India’s ministry of consumer affairs has notified amendments to the Legal Metrology Rules, tightening standards for manual blood pressure devices. Effective January 7, 2026, the rules set stricter accuracy limits, ban unsafe connectors, and mandate durability, safety, and environmental stress testing. Manufacturers must update design, labelling, and documentation, and obtain fresh model approvals to continue selling these devices in the Indian market.
Source: h7.cl/1nBWi

4. India’s Bombay High Court has quashed a prosecution after finding serious delays in drug sample analysis beyond the mandatory 60-day limit prescribed under the Drugs Rules. The Court made strong observations regarding the laxity of the Drugs Department, holding that such lapses endanger public health by allowing sub-standard drugs to circulate.
Source: h7.cl/1iBMQ

5. The Tamil Nadu Chemists and Druggists Association has formally complained to the Pharmaceuticals and Medical Devices Bureau of India (PMBI) alleging that Jan Aushadi Kendras across the state are violating scheme guidelines by selling locally procured patented and generic medicines and operating multiple licences per individual. PMBI has confirmed such local sourcing is prohibited and attracts disciplinary action.
Source: h7.cl/1nBWD

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 Central Government has amended the New Drugs and Clinical Trials Rules, 2019 to streamline manufacture of new and investigational drugs for testing purposes. The amendment permits limited manufacturing for analytical and non-clinical testing based on prior intimation, except for specified high-risk categories, and reduce timelines from ninety to forty-five working days.
Source: h7.cl/1iiiB

2. India’s Food Safety and Standards Authority (FSSAI) has proposed amendments to its licensing regulations to tighten compliance. Delayed filing of the annual Food Safety Compliance Return beyond 31 May will attract graded penalties, and non-filing beyond 180 days will lead to deemed licence suspension. The draft also clarifies storage practice and record-keeping requirements for manufacturers, with exemptions for non-manufacturers and retailers. Public comments are invited latest by 19th March 2026.
Source: h7.cl/1nhPE

3. India’s Central Insecticides Board and Registration Committee has decided that pesticides highly sensitive to acidic or alkaline water must carry specific label and leaflet instructions on optimal water pH. Applicants and registrants have been advised to ensure compliance while seeking registration and finalising labels.
Source: h7.cl/1iiiN

4. India’s Health Ministry has asked the National Medical Commission (NMC) to examine and take appropriate action regarding appeals filed by individuals who are not registered medical practitioners against decisions made by State Medical Councils. This could affect rights of patients and the public to seek redress against decisions affecting healthcare practice and professionals.
Source: h7.cl/1iiiS

5. The Committee for Control and Supervision of Experiments on Animals (CCSEA) has issued a structured inspection schedule and standard operating procedures for animal facilities of Clinical Research Organisations and research and development laboratories. It mandates three inspections over a year, clarifies roles of IAEC nominees, and introduces standard feedback and confidentiality requirements.
Source: h7.cl/1nhPP

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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 CDSCO has issued detailed FAQs to enhance public awareness regarding the Drugs and Cosmetics (Compounding of Offences) Rules, 2025. The FAQs clarify the procedure for compounding offences, the stage at which an application may be filed, and the information and documentation required to support such applications.
Source: shorturl.at/Mkg3L

2. India’s Central Drug Authority has notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025.
Stakeholders intending to apply for compounding of offences under these rules are required to submit the application in the prescribed format as a physical copy, along with an advance copy via email to raj[dot]shree64[at]cghs[dot]nic[dot]in, addressed to the Compounding Authority.
Source: h7.cl/1mrDG

3. India’s Delhi High Court directed the Central Health Ministry to respond by January 20, 2026 to a contempt plea alleging illegal operations of online health service aggregators. The petition claims these platforms violate the Clinical Establishments Act by functioning without mandatory registration, posing risks to public health and regulatory compliance.
Source: h7.cl/1hvu5

4. The Delhi government will declare human rabies a notifiable disease, requiring mandatory reporting of all suspected, probable and confirmed cases by government and private healthcare facilities. The move aims to strengthen disease surveillance, enable timely intervention, and support the capital’s goal of eliminating rabies-related human deaths.
Source: h7.cl/1hvts

5. A major infant nutrition manufacturer has initiated a large-scale recall of select infant formula products across multiple countries after detecting a potential toxin contamination linked to a supplier ingredient. No illnesses have been reported. The company is strengthening supply chains, activating alternate suppliers, and increasing production to ensure uninterrupted availability.
Source: h7.cl/1msn9

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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 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

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 amended the Cosmetics Rules, 2020 introducing clearer expiry labelling, redefining terms, updating recordkeeping norms, and empowering authorities to suspend or cancel licences. Notable changes include labelling for exports, new batch record rules, and designation of the Central Cosmetics Laboratory.
Source: short-link.me/1aoFG

2. In order to enhance ease of doing business, India’s central drug authority (CDSCO) has streamlined the process of issuance of Dual Use NOC through Sugam Portal for importing bulk drugs for non-medicinal use. Further to reduce the compliance burden, CDSCO has initiated issue of 1 year NOC, subject to prescribed conditions for such drugs. The new online Dual use system will be effective from 31st August 2025.
Source: short-link.me/1aoEr

3. The Food Safety and Standards Authority of India (FSSAI) has mandated all food business operators such as restaurants, cafes, dhabas and cloud kitchens to display their licence or registration along with a QR code linking to the Food Safety Connect app. This helps consumers access details, lodge complaints and provide feedback, promoting transparency and accountability.
Source: short-link.me/1aoOH

4. The Indian government enacted the Vegetable Oil Products, Production and Availability (VOPPA) Regulation Order, 2025, replacing the 2011 framework. It mandates mandatory registration for all vegetable oil producers, monthly online reporting of production, stocks, sales, and pricing, and grants authorities inspection and enforcement powers to boost market transparency and curb hoarding.
Source: short-link.me/1aoEM

5. Karnataka’s Health & Family Welfare Department has filed 29 legal cases under the Drugs & Cosmetics Act, and has served show-cause notices to 231 pharmacies for dispensing prescription drugs without prescriptions; simultaneously, authorities have flagged food vendors using synthetic colors and have issued warnings.
Source: short-link.me/1aoEW

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. Medical device companies have raised concerns over Uniform Code for Marketing Practices for Medical Devices (UCMPMD) and have approached the Department of Pharmaceuticals, citing overreach and operational challenges, particularly in the context of a DGHS advisory that restricted medical representative’s interactions with HCPs in government hospitals.
Source: bit.ly/3InfXiu

2. India’s Central Drugs Standard Control Organisation (CDSCO) is working on making drugs/medicine packaging more readable. The move aims to improve visibility of key details like expiry dates and dosages, addressing concerns over hard-to-read glossy labels. Proposed measures include clearer print standards and digital aids such as voice-enabled QR codes and Braille cards to enhance accessibility and consumer safety.
Source: bit.ly/46oMIpA

3. India’s Drugs Consultative Committee (DCC) has agreed to amend the Drugs Rules, 1945, to include Good Distribution Practices (GDP) guidelines for pharmaceutical products as a separate schedule. The decision follows detailed deliberations and stakeholder consultations to align with revised WHO guidelines.
Source: bit.ly/4lxABuC

4. The U.S. FDA is reportedly planning to revise the labeling for all extended-release stimulants prescribed for attention-deficit hyperactivity disorder (ADHD), requiring inclusion of a “limitation of use” section with a statement on higher rates of adverse reactions in children younger than six years.
Source: bit.ly/4l2REoA

5. The European Commission has amended its regulation to allow electronic instructions for use (eIFUs) for all medical devices intended for professional use, not just high-risk ones. Paper instructions are still required if the device could also be used by patients. eIFUs must be linked in Eudamed (the European medical device database).
Source: bit.ly/4lcdMx1

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 Punjab & Haryana High Court mandates state government to notify rules under Mental Healthcare Act, 2017 within 60 days, addressing a 7-year delay that hampers effective implementation and delivery of mental health services.
Source: bit.ly/4k3CEpU

2. India’s Central Drugs Standard Control Organisation (CDSCO) has issued a guidance document outlining the procedure for obtaining a Free Sale Certificate (FSC) for licensed medical devices in India. It simplifies the regulatory process for submitting an application and obtaining the FSC from the Central Licensing Authority.
Source: bit.ly/3FbKQW9

3. Food Safety and Standards Authority of India (FSSAI) mandates that FBOs with expired licenses or registrations in FY 2024–2025 must submit a Closure Report via the FoSCoS portal. The report must confirm no ongoing business or provide details of a new license. Reasons for non-renewal must be stated to ensure transparency and traceability in licensing.
Source: bit.ly/3Se67kQ

4. India’s Department for Promotion of Industry and Internal Trade (DPIIT) has extended the implementation of the Quality Control Order (QCO) for household and commercial electrical appliances to March 19, 2026. The update includes relaxations for Micro, Small and Medium Enterprises, R&D and export units, supporting quality and ease of business.
Source: bit.ly/4ksMTEb

5. The Drugs Control Department of Kerala has taken an action against a private hospital for illegally stocking and selling Physician’s sample medicines at inflated prices, highlighting that sample medicines can neither be stocked nor sold by hospitals.
Source: bit.ly/3FieSaJ