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. An Indian pharmaceutical manufacturer has delayed commercial supplies of a recently launched diabetes therapy after identifying quality issues in certain production batches. The manufacturer is investigating the cause and implementing corrective measures, while confirming no impact on patient safety or existing regulatory filings.
Source: short-url.cc/1yS8o

2. India’s Rajasthan government has reportedly ordered the recall of Dinoprostone Gel, a labour-inducing medicine, after it failed quality testing. The state drug control department has directed the withdrawal of the affected batch and initiated regulatory action against the manufacturer. The recall reflects Rajasthan’s strengthened drug quality surveillance framework and is expected to increase regulatory scrutiny of pharmaceutical manufacturers supplying medicines under government procurement programmes.
Source: short-url.cc/1tkZK

3. India’s Ministry of Health and Family Welfare (MoHFW) has notified the amendment to the Drugs Rules, 1945, to designate Navi Mumbai as an additional port for the import of drugs under the prescribed regulatory framework. The amendment expands the list of notified ports for drug imports. The notification is expected to facilitate import operations, strengthen regulatory administration and improve logistical efficiency for pharmaceutical importers and other stakeholders engaged in the supply chain.
Source: short-url.cc/1tkZV

4. India’s Central Drugs Standard Control Organisation (CDSCO) has reportedly directed manufacturers to update the safety labels and prescribing information for several common antimicrobial drugs due to newly identified adverse reactions. The revised labels are intended to improve the safe use of these medicines by strengthening risk communication for healthcare professionals and patients, while reinforcing India’s pharmacovigilance and drug safety monitoring framework.
 Source: short-url.cc/1tk-1

5. India’s drug regulator, CDSCO, has reportedly proposed to bring mandatory registration for manufacturers and suppliers of pharmaceutical packaging materials and be governed under the Drugs Rules, 1945. A sub-committee will be set up to examine the necessity and feasibility for registered printing entities. Pharmaceutical packaging manufacturers are currently only indirectly regulated via drug manufacturers’ Schedule M vendor qualification systems, which regulators now deem inadequate to prevent misuse of genuine packaging.
Source: short-url.cc/1tk-6

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 mandated the renewal every five years mandatory for registration certificates and license held by fertility clinics and semen banks and every three years for surrogacy clinics through the National Registry Portal. This renewal shall attract non-refundable fees which may be doubled in case of failure to comply. This Notification aims to streamline regular inspections and adherence to prescribed standards. Government run institutes are exempted under Notification.
Source: short-url.cc/1sSzt

2. The Indian Ministry of Health and Family Welfare (MoHFW) has released the operational guidelines for national ambulance services (NAS), 2026 to strengthen emergency medical response and standardise ambulance services across the country. The guidelines prescribe consistent standards for ambulance infrastructure, staffing, equipment, response times, digital integration, and quality assurance. The initiative aims to improve timely access to emergency care and, ensure consistent delivery of pre-hospital emergency medical services nationwide.
Source: short-url.cc/1sSzU

3. The Supreme Court has held that deficiencies or inaccuracies in mandatory Form F records under the PCPNDT Act are not mere technical lapses but significant statutory violations. Upholding criminal proceedings against a medical practitioner, the Court reaffirmed the importance of strict record-keeping to prevent sex-selection practices and ensure effective enforcement of the law.
Source: short-url.cc/1ynLe

4. India’s Central Drugs Standard Control Organization (CDSCO) and Maharashtra Food and Drug Administration (FDA) have suspended operations at two blood centres in Mumbai and Thane after inspections revealed serious regulatory violations including compromise of the quality and safety of blood collection, storage, and distribution as per the Drugs and Cosmetics Act, 1940 and, the Drugs and Cosmetics Rules, 1945.
Source: short-url.cc/1ynLY

5. The Central Consumer Protection Authority (CCPA) has imposed a penalty on a food manufacturer for making misleading “100% Atta Bread” and “100% Whole Wheat” claims. The Authority held that the product’s labelling and advertisements were likely to mislead consumers regarding its composition as the product contained only about 87% whole wheat flour, and such claim would give an impression to that the product is wholly composed of wheat flour, thus amounting to a misleading advertisement. The action highlights the CCPA’s continued enforcement against deceptive food labelling and misleading marketing practices to safeguard consumer interests.
Source: short-url.cc/1sSAc

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 District Consumer Disputes Redressal Commission-II, Chandigarh passed an Order in favour of the consumer for automatically levying a service charge and without obtaining the consent of the consumer; further, the opposite party refused to remove the said charge upon objection. The opposite party did not appear in the Consumer Court, hence, an ex-parte Order was passed. The opposite party was directed to refund ₹129 collected towards service charge and pay a lump-sum compensation of ₹5,000 towards harassment and litigation expenses within 45 days of receipt of the order.
Source: short-url.cc/1ymfE

2. India’s finance ministry has extended the customs duty exemption on imports of specified petrochemical products used in pharmaceutical manufacturing such as chemicals, plastics, textiles, packaging, and automotive manufacturing in view of the continuing global supply disruptions. The extension is intended to ensure the uninterrupted availability of essential raw materials, support domestic pharmaceutical production, and help mitigate input cost pressures.
Source: short-url.cc/1ymfK

3. India’s Central Consumer Protection Authority (CCPA) has imposed a ₹1 lakh penalty on a major beverages manufacturer for making a misleading “100% tender coconut water” claim. The authority held that the product’s labelling and advertising had the potential to mislead consumers regarding its composition, constituting a misleading advertisement and unfair trade practices under the consumer protection Act, 2019. The authority directed the company to discontinue the impugned advertisements and imposed a monetary penalty.
Source: short-url.cc/1sR6o

4. The Indian Multi-Disciplinary Committee of experts advised the National Pharmaceutical Pricing Authority to fix ceiling prices for intravenous fluids with advanced safety packaging at fifteen percent above existing regulated prices. If accepted, the proposal would encourage adoption of safer packaging technologies while ensuring these essential medicines remain subject to price regulation.
Source: short-url.cc/1sR6v

5. The Central Pollution Control Board (CPCB) has issued a notice directing registered battery waste recyclers to upload GST e-invoices for the sale of recovered key battery metals and metal compounds on the Battery Waste EPR Portal for EPR Certificate generation. EPR Certificates generated on the basis of non-GST e-invoices after 30 June 2026 will not be considered valid and may constitute non-compliance under the Battery Waste Management Rules, 2022.
Source: short-url.cc/1ymg3

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. A major food manufactured in the USA has removed all certified artificial colours from its food and beverage portfolio successfully, achieving its goal of fully eliminating them by the middle of this year. This move was announced in June 2025 and was confirmed that more than 90% of its U.S. portfolio was already free from synthetic dyes. These reformulated products have started arriving for consumption in the USA.
Source: short-url.cc/1xs6v

2. Hong Kong’s Department of Health has announced that medical gases will be regulated as pharmaceutical products from June 14, 2026, requiring manufacturers, wholesalers, and retailers to obtain relevant licences. Products containing nitrous oxide and nitric oxide will be classified as prescription medicines. Non-compliance may result in fines, imprisonment, and other regulatory enforcement actions.
Source: short-url.cc/1rZJs

3. The U.S. Food and Drug Administration (FDA) has issued warning letters to multiple entities for alleged violations of current Good Manufacturing Practice (CGMP) requirements and for the unlawful marketing of GLP-1 receptor agonist drugs through telehealth platforms. These warnings address firms that do not meet quality standards and telehealth providers promoting unapproved products for weight loss. The FDA emphasised compliance with manufacturing, quality, and marketing rules, and cautioned that failure to address the identified violations could result in further regulatory action.
Source: short-url.cc/1xs6F

4. India’s Central government has amended the marine export laws for export administration, effective from 9th June 2026. To modernize export administration, the notification mandates online registration workflows and establishes revised fee schedules. The legislative intent is to digitize statutory record-keeping and enforce strict compliance protocols governing ownership transfers, facility modifications, and dealer licensing across vessels, processing plants, and storage premises.
Source: short-url.cc/1rZJV

5. The World Health Organization has urged countries to shift from visual inspection and cytology-based screening to Human Papillomavirus testing for cervical cancer prevention. The updated recommendation highlights superior accuracy in detecting high-risk infections and supports wider adoption of affordable, locally developed Human Papillomavirus tests to accelerate cervical cancer elimination efforts.
Source: short-url.cc/1xs6P

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 based company has issued a nationwide recall of its powdered infant formula after the FDA and CDC contacted the company about three infant botulism cases involving babies who had consumed its formula. The affected infants in California, Washington, and Pennsylvania were hospitalized and treated with FDA-approved treatment, with no deaths reported. No formula has tested positive for the bacteria; the recall was made as a precaution.
Source: short-url.cc/1rUTh

2. The Union Health Ministry’s decision to remove cough syrups from the Schedule K exemption may encourage a shift towards Ayurveda, Siddha and Unani remedies, particularly in rural areas where access to doctors and licensed pharmacies is limited. Industry experts expect demand for Ayush cough syrups to rise as access to conventional cough syrups require a prescription for purchase.
Source: short-url.cc/1rUTs

3. IHLD MedTech to reportedly establish a nationwide network of specialized wound-care Centers of Excellence under its Wound Heal Plus initiative. This is important as chronic and non-healing wounds, particularly among diabetic patients, remain a major healthcare challenge. The network will expand access to advanced wound management, rehabilitation, and AI-enabled patient monitoring services.
Source: short-url.cc/1rUTw

4. US FDA has approved updated safety labelling for an OTC weight-loss drug, adding warnings about rare risks of acute kidney injury and kidney stones. The change is important as it alerts consumers and healthcare providers to potential kidney complications, especially among users with kidney disease or a history of kidney stones.
Source: short-url.cc/1xn6Q

5. A recent inspection by the Telangana Medical Council has reignited discussions on the scope of practice and legality of dentists in relation to aesthetic and hair transplantation procedures. The NMC stated that only trained medical professionals should conduct these non-emergency procedures. The NDC allowed oral and maxillofacial surgeons to perform them with proper training. Furthermore, the Telangana Medical Council confirmed that dentists lack the training for such procedures.
 Source: short-url.cc/1xn6U

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. Maharashtra FDA Commissioner Tukaram Mundhe issued an Order on June 12, 2026 barring hospitals, doctors, and affiliated pharmacies from compelling patients to buy medicines exclusively from in-house pharmacies. Prescriptions must be handed directly to patients which gives the patients an option to pick pharmacy of their choice. This restriction put by hospitals on the choice of the patient to purchase medicines from their choice of a pharmacy amounts to unfair trade practices under the Consumer Protection Act, 2019. Further, hospitals must now display notices stating patients of their right to purchase medicines from any licensed pharmacy of their choice in English and Marathi.
Source: shortlink.uk/1xhAz

2. The Jharkhand High Court has directed a complete ban on the conduct of the “two-finger test” in all hospitals, medical colleges, and healthcare institutions across the State. Reiterating established legal and medical principles, the Court observed that the practice is unscientific, violates the dignity, privacy, and bodily autonomy of survivors of sexual assault, and has no evidentiary value in determining consent or sexual history. The Court directed the concerned authorities to ensure strict compliance with existing guidelines and legal standards governing the medical examination of sexual assault survivors, while emphasizing the need for survivor-centric and trauma-informed medical care. The ruling reinforces the prohibition on the use of the test and underscores the obligation of healthcare institutions to adhere to prescribed medico-legal protocols.
Source: shortlink.uk/1xgoW

3. The Telangana Drugs Control Administration has reportedly intensified enforcement against illegal medicine distribution by raiding an unauthorized supplier of cardiac stimulant injections and an unlicensed medical shop. Authorities warned against unauthorized sales and supply of prescription medicines.
Source: shortlink.uk/1rOoZ

4. The Supreme Court has reaffirmed that strict compliance with the PCPNDT Act, 1994 is essential to prevent sex-selective practices and female foeticide. The Court held that deficiencies in mandatory records, including Form F, are not mere technical errors but substantive violations. Emphasising the Act’s objective, it observed that accurate documentation is a crucial safeguard for effective monitoring, enforcement, and prevention of unlawful sex determination practices.
Source: shortlink.uk/1xgqd

5.India’s Ministry of Health and Family Welfare has notified an amendment to Drugs Rules, 1945 dated June 9, 2026. The amendment removes the term “Syrups” from Item (7) under Serial No. 13 of Schedule K of the Drugs Rules, 1945. This means that now syrups will be sold under a sales license only. Schedule K specifies certain classes of drugs and categories of persons or institutions that are exempt from specific provisions of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder, subject to prescribed conditions. The amendment came into force on the date of its publication in the Official Gazette.
Source: shortlink.uk/1rOqd

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 has increased the ceiling prices of Anti-Tetanus Immunoglobulin 250 International Units and 500 International Units injections by 50 percent exercising its extraordinary powers. The revision follows concerns over rising production costs and aims to ensure continued availability of these essential life-saving medicines.
Source: short-url.cc/1ymqX

2. India’s central food authority, FSSAI, has reportedly issued show-cause notices to eight food companies in India. One such notice was issued for deceptive branding. This Notice was issued because a brand used the claim “plant-based vegan” on the packaging which was not approved under FSSAI license obtained. Such claims have higher chances of misleading the consumers by using marketing tactics to create false impressions of the brand.
Source: short-url.cc/1ymr2

3. India’s central food authority, FSSAI, has reportedly advised Food Business Operators (FBOs) to immediately discontinue the use of metallic pins, staples, and wires in food packaging materials, citing potential risks of physical contamination and consumer injury. The regulator has urged businesses to review their packaging processes and adopt safer alternatives such as food-grade adhesives, tapes, or other secure packaging methods that do not compromise food safety. The advisory forms part of FSSAI’s ongoing efforts to strengthen food safety practices and reduce the risk of foreign matter contamination across the food supply chain.
Source: short-url.cc/1sRhw

4. The Central Drugs Standard Control Organisation (CDSCO) mandates that all manufacturers and importers of hair colour cosmetics strictly adhere to the Cosmetics Rules, 2020, and applicable Bureau of Indian Standards (BIS). To safeguard public health, stakeholders must ensure absolute compliance with statutory labelling requirements, ingredient restrictions, and mandatory caution statements. Furthermore, any alterations to a product’s composition, quality specifications, or label must be formally reported to the appropriate Central or State Licensing Authority.
Source: short-url.cc/1sRhD

5. The National Pharmaceutical Pricing Authority (NPPA) has revised upward the ceiling prices of BCG, Measles Rubella and Measles vaccines pursuant to a review order. The change reflects the Department of Pharmaceuticals’ view that the 17.1% monopoly reduction should not apply to vaccines, supporting continued vaccine availability.
Source: short-url.cc/1ymqX

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 Drugs Standard Control Organization has directed state regulators to strengthen enforcement against the use of Chloramphenicol and Nitrofurans in food-producing animals. The move follows continued detection of these substances in export consignments, leading to international rejections and raising concerns over regulatory compliance and export competitiveness.
Source: shortlink.uk/1wKBT

2. The Food Safety and Standards Authority of India (FSSAI) has notified the Food Safety and Standards (Prohibition and Restrictions on Sales) Amendment Regulations, 2026, which came into force upon publication in the Official Gazette on 23 May 2026. Through the amendment, FSSAI has omitted clause (8) of sub-regulation 2.3.14 of the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, following consideration of stakeholder comments received on the draft regulations issued in October 2024. The amendment formally revises the existing regulatory framework governing restrictions on the sale of specified food products under the Food Safety and Standards Act, 2006.
Source: shortlink.uk/1wKCp

3. The US FDA has launched a safety study of the abortion pill, also called mifepristone, potentially enabling new restrictions on its distribution and use. The FDA has further said for mifepristone to be safe and effective. Officials say the review is already underway and science based. The study will analyse existing data and could influence abortion access policies. Abortion right was legalised through the Supreme Court’s 2022 ruling which overturned Roe v. Wade.
Source: shortlink.uk/1rjC6

4. A pharmaceutical manufacturer has received a Warning Letter from the United States Food and Drug Administration (USFDA) concerning its formulation manufacturing facility in Baddi, Himachal Pradesh. The regulatory action was issued following a review of records submitted under the US Federal Food, Drug, and Cosmetic Act and is not linked to any on-site inspection of the facility. The observations relate to the use of purified talc that did not meet the current United States Pharmacopeia (USP) requirements. The company has stated that the Warning Letter is not expected to impact ongoing operations or product supplies from the facility and has committed to undertaking the necessary corrective actions and responding to the USFDA within the prescribed timelines. The facility was last inspected by the USFDA in August 2025 and subsequently received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) classification.
Source: shortlink.uk/1wKCB

5. Hospitals across India are reportedly facing shortages of key chemotherapy drugs, including cisplatin and carboplatin, disrupting cancer treatment schedules and forcing patients to search for alternative supplies. The shortage has been linked to supply chain constraints and rising input costs, raising concerns about continuity of care and treatment outcomes.
Source: shortlink.uk/1wKCH

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 Consumer Affairs met with major edible oil industry associations on 20 May 2026 to discuss standardizing pack sizes between 200 ml and 20 litres. The initiative aims to enhance consumer protection, ensure transparency in pricing, and prevent misleading packaging. Associations representing 90% of the sector supported the proposal, recommending exemptions for minor oils and packs below 200 ml, with a three month transition period for implementation.
Source: shortlink.uk/1vJbr

2. The Central Drugs Standard Control Organisation (CDSCO) has clarified that Form CT-16 applications for import of Reference Listed Drugs (RLDs) or Investigational Medicinal Products (IMPs) for export-oriented BA-BE studies may be submitted on a standalone basis through the NSWS portal. The clarification addresses operational issues due to lack of system linkage between CT-05 prior intimation applications and CT-16 applications on the SUGAM portal.
Source: shortlink.uk/1vJby

3. The Karnataka Pharma Retailers & Distributors Organization (KPRDO) has urged the government to immediately curb misleading advertisements and aggressive promotional practices relating to prescription, life-saving, and scheduled medicines, particularly across social media platforms. The organisation has also called for the creation of a specialised enforcement team and digital monitoring mechanism to address regulatory violations under the Drugs & Cosmetics Act and the Drugs & Magic Remedies Act. The recommendations could also intensify scrutiny on pharmaceutical advertising, online promotional activities, pharmacy practices, and trade compliance across the healthcare and pharma sectors.
Source: shortlink.uk/1vJbD

4. India’s central food authority has notified the Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulations, 2026, revising contaminant limits across pulses, edible oils, seafood, oilseeds, and nutmeg containing products. Updated standards cover heavy metals, aflatoxins, veterinary drug residues, and inorganic arsenic in fish oils, effective from 1 December 2026. Food businesses, seafood exporters, and nutraceutical companies must review and strengthen quality assurance systems, testing protocols, and sourcing controls to ensure compliance.
Source: FSSAI Gazette Notification, Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulations, 2026
Source: shortlink.uk/1vJbI

5. India’s Himachal Pradesh High Court has ruled that criminal liability cannot automatically be imposed on all directors or partners of a pharmaceutical company without specific averments establishing individual roles in business conduct. The judgment tightens procedural and evidentiary requirements for regulators prosecuting ‘Not of Standard Quality’ and spurious drug cases, potentially making enforcement actions under the Drugs and Cosmetics Act more legally complex for drug regulators and enforcement agencies.
Source: shortlink.uk/1vMU6

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 Consumer Affairs has clarified that customary units such as inches, feet, yards and square feet may be used only as supplementary declarations alongside standard SI units under the Legal Metrology framework. The clarification aims to ensure uniformity in trade practices while preventing misleading or ambiguous quantity declarations for consumers.
Source: shortlink.uk/1vwL3

2. FSSAI plans to centralize food surveillance by separating sampling from enforcement, reducing state officers’ discretionary powers. Neutral agencies will collect samples, with results uploaded to a national database for quick alerts. This aims to enhance transparency, consistency, and consumer safety while ensuring enforcement remains with state authorities.
Source: shortlink.uk/1vwJ8

3. The Supreme Court has directed Delhi authorities to urgently frame a Standard Operating Procedure (SOP) ensuring private hospitals built on concessional government land provide free treatment to Economically Weaker Section (EWS) patients, addressing widespread non-compliance with the mandate of reserving 10% inpatient beds and 25% outpatient services.
Source: shortlink.uk/1q97l

4. The CDSCO has directed state and Union Territory drug regulators to closely monitor surrogate advertising and promotional activities related to prescription GLP-1 drugs used to treat obesity and metabolic disorders. The regulator has cautioned against indirect promotional practices, including disease-awareness campaigns and digital outreach, that could influence public demand for prescription-only medicines. The move signals intensified regulatory scrutiny of marketing, distribution, and promotion, and may also lead to stricter compliance expectations for pharmaceutical companies, digital platforms, wellness clinics, and marketers involved.
Source: shortlink.uk/1q96J

5. The Indian Council of Medical Research (“ICMR”) has introduced a single-window approval mechanism for medical research studies, replacing the earlier fragmented process requiring approvals from multiple ethics committees and institutions. The framework is intended to streamline ethics clearances, reduce procedural delays, and accelerate approvals for multicentric and collaborative research projects.
The development is significant for India’s clinical research ecosystem as it is expected to improve regulatory efficiency, transparency, and coordination in study approvals.
Source: shortlink.uk/1q96K