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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. Punjab’s Food and Drugs Administration (FDA) has cancelled a pharmaceutical manufacturer’s licence and ordered a nationwide product recall following findings that allegedly linked substandard oxytocin injections to maternal deaths. The action highlights increased scrutiny of GMP compliance and data integrity, signalling stricter enforcement where product quality deficiencies may endanger patient safety.
Source: shortlink.uk/1rjtj

2. Maharashtra’s FDA has uncovered a supply of falsely labelled “sterile” surgical gloves to government hospitals in Mumbai. The gloves were allegedly unsterilised due to company’s sterilization machine was malfunctioning, prompting raids and seizure of stock. The company responsible had attempted to recall the unsterilized surgical gloves before the raid with no success. Authorities are investigating licensing violations and whether proper recall procedures were followed.
Source: shortlink.uk/1rjtr

3. A U.S. federal court has allowed a proposed class-action lawsuit to proceed against a manufacturer of a children’s nutritional drink over allegations that its marketing and packaging misled consumers into believing the product was clinically proven to help children grow taller. The court held that product claims, combined with visual branding and advertising elements, could reasonably be interpreted by consumers as referring to height growth rather than general growth and development. The lawsuit alleges that consumers were misled regarding the product’s benefits, while the company maintains that its claims are scientifically supported and appropriately describe the product’s role in supporting children’s growth and development. The case will now proceed for further judicial consideration.
Source: shortlink.uk/1rjtH

4. India’s Directorate General of Foreign Trade has exempted Special Economic Zone (SEZ) units and developers from the applicability of conditions of Quality Control Orders (QCO) and Bureau of Indian Standards (BIS) rules. This exemption will be applicable on the permissible good imported like raw materials and capital goods which are authorized for SEZ operations. However, if these imported items or their resulting manufactured products are moved into the Domestic Tariff Area (DTA), they will be required to fully comply with all applicable QCO and BIS laws. Additionally, SEZ entities will have to submit a formal undertaking to the Development Commissioner at the time of import.
Source: shortlink.uk/1rjtg

5. The United States Food and Drug Administration is conducting a scientific safety review of mifepristone, the abortion pill, using existing drug safety systems. The review could influence future distribution requirements for the medicine. While the agency maintains that mifepristone is safe and effective when used as directed, abortion rights groups have criticized the review.
Source: shortlink.uk/1rjtT

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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 Supreme Court has held that access to trauma care is a fundamental right under Article 21, directing all States and UTs to unify emergency helplines under 112, establish trauma registries, operationalise cashless treatment for road accident victims, and enforce ambulance tracking standards within set timelines. The ruling significantly expands constitutional obligations on healthcare infrastructure, emergency services, insurers, and public health governance across India. It also needs to have physical and digital grievance redressal systems for good samaritans. This classification is not restricted to national highways but extends to state highways and district roads too.
Source: shortlink.uk/1qB9n

2. The government has reportedly referred 27 doctors to the National Medical Commission (NMC) for disciplinary action in connection with a pharmaceutical freebies case involving sponsored foreign trips under the guise of rendering of knowledge dissemination service. The matter relates to alleged acceptance of luxury travel and hospitality benefits linked to pharmaceutical promotional activities, with State Medical Councils now expected to examine the cases pursuant to violation of MCI Code of Ethics. The development intensifies scrutiny around pharma-doctor engagement practices, and enforcement of professional conduct regulations within the healthcare sector.
Source: shortlink.uk/1vZFF

3. The Central Consumer Protection Authority (CCPA) initiated regulatory action against unauthorized online sale of hazardous chemicals like ammonium nitrate, PETN, gun powder, and picric acid. Notices were issued to e-commerce platforms, seller details shared with PESO, and platforms began delisting products to ensure consumer safety and compliance
Source: shortlink.uk/1vZFK

4. Pharmaceutical manufacturers are increasingly focusing on contamination control infrastructure, particularly Air Handling Unit (AHU) filter maintenance systems, to support compliance with revised Schedule M requirements. Industry experts note that heightened regulatory expectations around hygiene, traceability, cross-contamination prevention, and cleanroom maintenance are driving interest in automated AHU filter cleaning and maintenance technologies.
Source: shortlink.uk/1vZFU

5. Government of India is reportedly planning to launch a dedicated childhood cancer registry which aims to systematically collect data on cancer cases in children in collaboration with the Indian Council of Medical Research (ICMR). India records around seventy-five thousand new cancer cases annually, many detected late. The government plans awareness, data collection, and collaborations to improve early diagnosis and treatment outcomes.
Source: shortlink.uk/1qB8R

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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 extended the deadline for registered Producers, Importers, Brand Owners (PIBOs) and Plastic Waste Processors (PWPs) for filing annual returns under the Plastic Waste Management Rules, 2016 until 31st January 2026. The previous deadline for filing of annual returns was November 30, 2025.
Source: h7.cl/1iapl

2. India’s Central Pollution Control Board (CPCB) has issued a notice clarifying implementation of Extended Producer Responsibility (EPR) guidelines for plastic packaging, permitting regulated inter-category certificate purchases only until FY 2025–26. Producers, importers, and brand owners will then be prohibited from cross-category adjustment of surplus EPR certificates and barred from using end-of-life certificates for recycling targets.
Source: h7.cl/1n9HG

3. The Union Health Minister has directed CDSCO and the Department of Pharmaceuticals to find a workable solution to industry concerns over revised Schedule M GMP norms. The revised guidelines necessitate structural and layout changes to facilities, setting up rigorous quality control systems, and training personnel. The Ministry is considering deadline extensions or relaxations following consultations with industry bodies, particularly for small and medium manufacturers facing compliance issues.
Source: h7.cl/1n9HM

4. The High Court of Allahabad has dismissed petitions by directors and officials of a major drug manufacturer challenging summons for alleged violations under the Drugs and Cosmetics Act after a test analysis found samples to be of substandard quality. The analysis found the presence of ethylene glycol in cough syrup, a toxic industrial chemical. The Court found the summons lawful, as the officials were responsible for the company’s business conduct.
Source: h7.cl/1n9HR

5. India’s Delhi High Court has upheld the rejection of a foreign drug manufacturer’s patent application for a nematode-based cancer detection method, ruling it a non-patentable diagnostic process under the Patents Act, 1970. The court said the invention performs essential diagnostic steps and cannot bypass exclusion by being labelled as screening or in-vitro testing.
Source: h7.cl/1iar0

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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

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 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

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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 (FSSAI) has issued the Draft Food Safety and Standards (Alcoholic Beverages) Amendment Regulations, 2025, proposing tighter standards for special wine. The draft introduces a 0.3% sugar tolerance for “Brut” sparkling wine, removes “special wine used,” and makes standard-drink labelling mandatory. A format for public comments has been shared, and feedback is open until 3rd January 2026.
Source 1: urli.info/1jcbJ
Source 2: urli.info/1eoEY

2. The Central Drugs Standard Control Organisation (CDSCO) has reportedly instructed state drug controllers to immediately initiate inspections under the revised Schedule M for the manufacturing units that have not applied for extensions. For manufacturing units that have applied for extensions, the effective date for revised Schedule M implementation is January 1, 2026. The directive follows recent safety lapses, including the fatal cough-syrup incident.
Source: urli.info/1eoDR

3. The Goa Directorate of Food and Drugs Administration (DFDA) has directed all retail pharmacies to display QR codes to facilitate reporting of adverse drug reactions (ADRs) through the Indian Pharmacopoeia Commission’s ADR Monitoring System. QR codes must be prominently displayed to enable consumers and healthcare professionals to report ADRs.
Source: urli.info/1jcb0

4. The Indian Pharmacopoeia Commission, in partnership with NITI Aayog and the Central Tuberculosis Division, will reportedly develop new monographs for the anti-tuberculosis medicines delamanid, pretomanid and the rifapentine-isoniazid fixed-dose combination to enhance quality standards, support rational use and strengthen adverse-drug-reaction reporting.
Source: urli.info/1jcaF

5. The Food Safety and Standards Authority of India (FSSAI) has issued an advisory clarifying stating that honey samples exceeding the permissible 80 mg/kg limit for Hydroxymethylfurfural (HMF) shall be classified as “Substandard”, not “Unsafe.” The clarification follows the Scientific Panel’s view that current research is insufficient to determine health risks from higher HMF levels.
Source: urli.info/1eoD4

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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. Kerala Deputy Drugs Controller (Ayurveda) has issued a stern warning to a prominent Ayurvedic drug manufacturer, for violating Rule 170 of the Drugs and Cosmetics Rules, 1945. This rule mandates that manufacturers obtain prior approval from state licensing authorities before advertising their products, aiming to prevent misleading promotions of AYUSH drugs.
Source: bit.ly/3H0LSoi

2. The All India Organization of Chemists & Druggists has cautioned against the Centre’s plan to expand the over-the-counter (OTC) drug list, warning that unsupervised use of routine medicines could pose serious health risks and lead to misuse without expert medical guidance.
Source: bit.ly/3H2vB2n

3. Small scale pharma companies have opposed CDSCO’s new export NOC rules, calling them burdensome for them. They warn of losing export markets to competing countries and seek an extension for Schedule M compliance and a tribunal to resolve regulatory disputes efficiently.
Source: bit.ly/3GZoac9

4. Experts have reportedly identified certain fixed-dose combinations (FDCs) in personal care products such as aloe vera, jojoba oil, and orange oil, as irrational and potentially harmful, recommending their prohibition to safeguard public health.
Source: bit.ly/3SGKh9N

5. The U.S. Food and Drug Administration (FDA) is reportedly initiating action to remove from the market unapproved concentrated fluoride drugs for infants and toddlers, citing concerns over microbiome disruption, thyroid issues, weight gain, and possible IQ decline.
Source: bit.ly/4doJeVr

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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 National Medical Commission (NMC) has reportedly not initiated any action against 30 doctors involved in a pharma freebies case. An RTI response reveals that the Department of Pharmaceuticals has not directed action, despite earlier findings of violations by the pharmaceutical company sponsoring lavish trips.
Source: bit.ly/44xs6e4

2. The Indian Pharmacopoeia Commission (IPC) has announced changes to certain monograph titles and synonyms in the upcoming Indian Pharmacopoeia (IP) 2026 which is effective from July 2026. Manufacturers have been advised to assess the impact on existing products and start taking necessary steps to update the label.
Source: bit.ly/4dtuq8p

3. India’s Ministry of Health has reportedly raised concerns that only a small fraction of small and medium-sized pharmaceutical companies have applied to the government for an extension of the timeline to comply with the Revised Good Manufacturing Practices (GMP) under Schedule M and to submit their facility upgradation plans. With the 12th May 2025 deadline approaching, state health secretaries have been asked to coordinate with local manufacturers and ensure timely compliance.
Source: bit.ly/4ka44u3

4. The Government of Odisha has reportedly announced plans to draft a state-wide mental health policy, including early intervention frameworks and counselling centres, to address rising mental health issues particularly among vulnerable groups such as youth and the elderly
Source: bit.ly/44peMIy

5. The European Medicines Agency (EMA) has officially recognized suicidal thoughts as a potential side effect of a medication commonly used to treat male pattern baldness. While the EMA maintains that the benefits of the drug continue to outweigh the risks, it has mandated that all 1 mg packages include a patient card highlighting these risks.
Source: bit.ly/3SgZLBr

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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 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

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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 Ministry of Health and Family Welfare (MoH&FW) has released the Drugs Amendment Rules, 2025, extending the deadline for implementing revised Good Manufacturing Practices (GMP) under Schedule M for small and medium drug manufacturers until December 31, 2025. Manufacturers are required to submit an application to the Central Licensing Authority for seeking the extension within three months of the notification.
Source: bit.ly/4gCo0U8

2. The Supreme Court has virtually summoned the Chief Secretaries of Andhra Pradesh, Delhi, and Jammu & Kashmir to explain their failure to act on misleading medical advertisements. The Court found these states non-compliant with previous orders on enforcing Rule 170 of the Drugs Rules, which prohibits advertisements of Ayurvedic, Siddha, or Unani drugs without licensing authorities’ approval.
Source: bit.ly/42Sm6vn

3. India’s National Medical Commission (NMC) has clarified that the Telemedicine Practice Guidelines 2020 do not allow Registered Medical Practitioners (RMPs) to remotely authenticate pathology and radiology lab reports without physical presence and supervision. This follows an RTI application which sought clarification on the use of cloud-based technologies like Telepathology and Teleradiology for signing and authenticating lab reports.
Source: bit.ly/40VinKX

4. India’s Ayushman Bharat Digital Mission (ABDM) has made significant strides, with millions of Ayushman Bharat Health Accounts (ABHA) created and a large number of health records linked to ABHA. This is part of the mission’s effort to build an interoperable digital health ecosystem. Thousands of health facilities have registered on the Health Facility Registry (HFR), and many healthcare professionals are now listed on the Healthcare Professional Registry (HPR). The mission also focuses on supporting rural areas through technology interventions like telemedicine, enhancing access to healthcare services.
Source: bit.ly/41ektXT

5. The European Medicines Agency (EMA) has introduced a standard procedure for manufacturers of certain high-risk medical devices to receive scientific advice on their intended clinical development strategy and proposals for clinical investigations. This initiative aims to enhance safety and performance by offering expert guidance on regulatory requirements before devices are submitted for approval. The move is designed to foster innovation while ensuring that devices meet rigorous standards.
Source: bit.ly/4jWxfRZ