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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. 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

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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. 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

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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. Through an FIR filed by a health activist, it was found that thirty doctors from nine states were found guilty of accepting luxury foreign trips worth ₹1.9 crore from a pharma company. While 27 names were sent to the NMC, several state medical councils failed to act. The NMC has now sent reminders to State Medical Councils of Assam, Delhi, Karnataka, Kerala, Telangana and WB to expedite action and warning it may intervene if delays persist, to ensure accountability and compliance across medical practice.
Source: shortlink.uk/1wLSY

2. India’s central government is reportedly considering to extend the customs duty exemption on critical petrochemical inputs used by the pharmaceutical industry beyond the current June 30, 2026 deadline. The proposal is being examined in view of continued supply chain disruptions and rising input costs linked to the ongoing geopolitical tensions in West Asia. The duty relief, originally introduced as a temporary measure in April 2026, covers several petrochemical products that serve as key raw materials and intermediates for pharmaceutical manufacturing. Government officials have indicated that an extension may be considered if prevailing conditions continue to impact the availability and cost of essential inputs.
Source: shortlink.uk/1rkQs

3. The Government is reportedly working on a proposal to strengthen the financial viability of Jan Aushadhi Kendras by revising the incentive structure, increasing retailer margins, extending credit periods, and addressing losses arising from expired inventory. Under the proposed measures, product margins for Kendra operators may be gradually increased to as much as 50%, while credit periods for retailers could be extended from 45 days to 75 days to ease working capital requirements. The plan also contemplates mechanisms for absorbing losses on expired medicines and enhancing support across the supply chain. These measures are aimed at improving inventory availability, supporting sustainable operations of Kendras, and facilitating the continued expansion of the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) network across the country.
Source: shortlink.uk/1wLTd

4. The Madras High Court has ruled in favour of a pharmaceutical innovator company in a patent infringement dispute concerning the export of an Active Pharmaceutical Ingredient (API). The Court held that the defendant’s export activities were not protected under the Bolar exemption as the defendant failed to produce regulatory documentation demonstrating that the exports were solely for purposes permitted under the provision. The Court further held that a prior consent decree entered into by the defendant operated as issue estoppel, preventing it from subsequently challenging the validity of the patent. Consequently, the Court granted relief restraining the infringing activities and reaffirmed the evidentiary requirements for entities seeking to rely on the Bolar exemption for export-related activities.
Source: shortlink.uk/1wLTi

5. The Delhi High Court has issued notice in a trademark infringement and passing off suit filed by a pharmaceutical company alleging that several medicinal product marks adopted by the defendants are deceptively similar to its registered and applied-for trademarks. The plaintiff contends that the impugned marks are likely to cause confusion and deception among consumers, particularly in the pharmaceutical sector where a higher standard of care is required to avoid medication errors. Considering the plaintiff’s application for interim relief, the Court has sought a response from the defendants and directed them to file their reply within three weeks. The matter will now proceed for consideration of the plaintiff’s request for an ex-parte ad-interim injunction and other reliefs.
Source: shortlink.uk/1wLTw

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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. The Employees’ State Insurance Corporation (ESIC) has launched a centralized online patient feedback system across its hospitals and dispensaries nationwide to strengthen patient-centric healthcare delivery. The digital platform enables beneficiaries to submit feedback on healthcare services received at ESIC facilities, facilitating real-time monitoring of patient experiences and service quality. The initiative will help identify service gaps, support continuous quality improvement, and strengthen the overall healthcare experience for insured persons and their dependents.
Source: shortlink.uk/1rjWU

2. The Himachal Pradesh High Court has quashed criminal proceedings against a liquor manufacturer arising from the transport of liquor consignments where authorities found two liquor cases without a valid permit and bottles bearing batch numbers different from those specified in the permit. The Court observed that the batch-number discrepancies resulted from inadvertent labelling errors by workers, with no evidence of adulteration or revenue loss to the government. Holding that only the transport of the two unpermitted liquor cases constituted an offence, the Court compounded the matter and imposed a monetary penalty, while allowing separate departmental action for licence-condition violations to continue.
Source: shortlink.uk/1wKXJ

3. The Ministry of Health and Family Welfare has notified an amendment to Schedule V of the Drugs Rules, 1945, substituting the unit for folic acid from “mg” (milligram) to “mcg” (microgram). The amendment will come into force six months from the date of its publication in the Official Gazette.
Source: shortlink.uk/1rjX4

4. The Ministry of AYUSH has amended the NCISM appointment rules to reduce the minimum experience required for appointment as Secretary to the Commission from 15 years to 7 years. The amendments also clarify that serving government officials appointed to NCISM or its Autonomous Boards will be treated as being on deputation and provide alternative provident fund coverage where General Provident Fund subscription is unavailable. This strengthens the institutional and human-resource framework of the NCISM, which oversees standards in Indian systems of medicine.
Source: shortlink.uk/1rjWU

5. The National Pharmaceutical Pricing Authority (NPPA) is considering raising prices of key platinum-based cancer drugs like cisplatin and carboplatin after manufacturers flagged steep increases in raw material costs, especially platinum. Authorities are balancing concerns over patient affordability with the risk of supply shortages if prices remain unchanged.
Source: shortlink.uk/1wKXQ

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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 Directorate General of Foreign Trade(DGFT), issued a Public Notice dated 1 June 2026 and has notified six new Standard Input Output Norms (SIONs) under the Chemical and Allied Product Group for specified pharmaceutical products. The notification enables Regional Authorities to grant Advance Authorisations without case-specific referrals to the Norms Committee, thereby reducing processing timelines, ensuring uniformity in approvals, and promoting ease of doing business for pharmaceutical exporters.
Source: shortlink.uk/1q-yS

2. The Delhi High Court directed CDSCO to review safety concerns over semaglutide injections within two months. A patient petition claims that manual calculation of dosage deviates from global pre-filled pen standards, risking overdose, underdose, and misuse. CDSCO must determine if approval aligns with patient safety and international practices.
Source: shortlink.uk/1q-xi

3. The Indian government is reportedly drafting new organ transplant rules to introduce Donation after Circulatory Death (DCD) and strengthen frameworks for organ swaps and brain-stem death donations. The proposed reforms aim to expand the donor pool, standardise transplant procedures, and improve access to life-saving organ transplants.
Source: shortlink.uk/1q-z5

4. The Maharashtra State Consumer Disputes Redressal Commission has held that obtaining a patient’s signature on a pre-printed consent form without adequately disclosing the nature of the procedure, associated risks, possible complications, and available alternatives does not constitute valid informed consent. The Commission observed that a mere signature on a standardised form cannot satisfy a doctor’s duty of disclosure and ruled that failure to obtain proper informed consent amounts to a deficiency in service. While the Commission found no evidence of medical negligence in the performance of the surgery or post-operative care, it held the medical practitioner liable for not securing valid informed consent and awarded compensation.
Source: shortlink.uk/1q-za

5. The Central Drugs Standard Control Organisation has directed pharmaceutical manufacturers to establish and maintain pharmacovigilance systems in line with revised Schedule M requirements. Companies must maintain dedicated adverse reaction monitoring mechanisms, appoint qualified pharmacovigilance officers and keep detailed records, with compliance subject to regulatory inspections.
Source: shortlink.uk/1q-xq

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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 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

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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 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

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 Drugs Standard Control Organisation (CDSCO) has issued a public notice under the Drugs and Cosmetics Act, 1940 and Cosmetics Rules, 2020, prohibiting use of cosmetics as injectable preparations by consumers, professionals, or aesthetic clinics. The notice flags four key violations: use of GNRAS or prohibited ingredients per BIS standards, misleading or false labelling claims, tampering with manufacturer inscriptions, and use of cosmetics for treatment purposes beyond their statutory scope of cleansing, beautifying, promoting attractiveness, or altering appearance.
Source: shortlink.uk/1vo9D

2. The Karnataka High Court has stayed criminal proceedings in a case involving the alleged sale of pirated books on an e-commerce marketplace, with the platform arguing that it functions solely as an intermediary and does not directly control third-party seller listings. The development brings renewed focus to intermediary liability and the extent of safe harbour protections available to e-commerce platforms under Indian laws.
Source: shortlink.uk/1vo9I

3. The High Court of Himachal Pradesh has quashed criminal proceedings against a pharma unit initiated by a Central drug inspector, holding that prosecution for manufacture, sale and distribution of drugs lies with State authorities and not the Central Government. The ruling clarifies the limits of enforcement powers of central drug regulator and may affect similar cases initiated by CDSCO against pharmaceutical manufacturers.
Source: shortlink.uk/1q0Oz

4. The Central Drugs Standard Control Organisation has reportedly initiated a review of concerns raised by retail chemists over the functioning of electronic pharmacies. Following assurances from the regulator, several state pharmacy associations have declined to participate in the proposed nationwide strike to avoid disruption in the supply of essential medicines and protect patient interests.
Source: shortlink.uk/1vo9S

5. A US federal jury found a major pharmaceutical company liable for delaying a generic version of a blockbuster constipation drug through an anticompetitive “pay-for-delay” arrangement. The verdict awarded nearly USD 885 million in damages and heightened scrutiny of delayed generic entry practices. The ruling may increase antitrust, litigation, and compliance risks for pharmaceutical companies globally.
Source: shortlink.uk/1q0OM