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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.

The Ministry of Health and Family Welfare has placed Pregabalin under Schedule H1 of the Drugs Rules, 1945, amid concerns over its rising misuse for sedative, euphoric, and dissociative effects, particularly among youth. The move seeks to strengthen regulatory control by restricting over-the-counter access and ensuring sale only against valid prescriptions with stricter monitoring and record-keeping requirements.
Source: shortlink.uk/1vI8d

India’s Madras High Court ruled that a mother need not undergo DNA testing to donate a kidney to her son when official records establish their biological relationship. The court set aside the transplant approval rejection and directed authorities to permit the donation immediately. This humanitarian interpretation reinforces that documentation standards should prioritise life saving procedures over rigid procedural requirements, potentially influencing future authorization committee decisions on donor recipient relationships.
Source: shortlink.uk/1vI8z

India’s central food authority is moving towards a centralised food surveillance system deploying third party agencies for sample collection, centralised laboratory testing, and digital alerts for faster regulatory action. The framework requires 50% of samples from organised supply chains. The shift signals a technology driven overhaul of food safety governance, raising compliance and traceability expectations for manufacturers, retailers, and supply chain operators.
Source: shortlink.uk/1vI8l

4. Global pharmaceutical companies are increasingly shifting high-value clinical research, regulatory, pharmacovigilance, and innovation-led functions to India as the country evolves from a low-cost outsourcing destination into a strategic global research and development hub. The shift could accelerate investments in clinical research infrastructure, advanced therapies, AI-enabled drug development, and specialised talent while strengthening India’s competitiveness as a global life sciences and biotech hub.
Source: shortlink.uk/1qk9u

5. The Competition Commission of India (CCI) has rejected allegations of monopoly and excessive pricing against 12 private hospitals in Delhi, ruling that higher prices alone do not prove abuse of dominance. The regulator found hospitals operated within competition norms, allowed external procurement, and charged within MRP, dismissing decade-long complaints.
Source: shortlink.uk/1vI8q

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 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 rejected a cosmetics import registration certificate and barred the importer from seeking fresh registrations for one year over alleged submission of fabricated documents under the Cosmetics Rules, 2020. The move underscores stricter regulatory scrutiny and tougher enforcement of compliance standards in India’s cosmetics import sector.
Source: shortlink.uk/1vfpf

2. India’s Punjab and Haryana High Court has upheld the conviction of a clinic owner under the Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act 1994, observing that lapses in maintaining mandatory records, including Form ‘F’, cannot be treated as minor procedural defects. The Court emphasized that proper documentation is central to enforcement of the PCPNDT framework aimed at preventing female foeticide and preserving regulatory oversight of diagnostic practices. This is important as the ruling reinforces strict compliance expectations for clinics, diagnostic centres, and healthcare establishments operating under the PCPNDT regime. The judgment signals that deficiencies in statutory records may attract penal consequences even where procedural irregularities in inspection or search are alleged.
Source: shortlink.uk/1vfr5

3. Parliamentary Standing Committee has reportedly recommended expansion of Regional Raw Drug Repositories under the National Medicinal Plants Board, particularly in biodiversity-rich regions, to support documentation, authentication, conservation, and sustainable utilisation of medicinal plants used in Ayush systems. The recommendation reflects continued policy attention toward strengthening medicinal plant infrastructure and raw material quality within the herbal and phytopharmaceutical ecosystem.
Source: shortlink.uk/1pTkP

4. The Central Consumer Protection Authority (CCPA) of India has launched a probe into the online sale of an allegedly unregistered herbicide on major e-commerce platforms, citing concerns over regulatory non-compliance and inadequate product disclosures. The action underscores rising scrutiny of hazardous products sold online and may push platforms to strengthen seller verification and compliance mechanisms.
Source: shortlink.uk/1vfpx

5. The Bombay High Court held that although infringement relief was unavailable in the “OCTRIDE” and “OTIDE” dispute due to both marks being registered, passing off protection could still be granted under common law. The Court cited the marks phonetic similarity, the Plaintiff’s prior goodwill and market reputation, and the heightened risk of confusion in pharmaceutical products.
Source: shortlink.uk/1pTl0

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. India’s central drug licensing authority (“CDSCO”) has issued a detailed FAQ document clarifying procedural and compliance requirements relating to prior intimation for Bioavailability (BA) and Bioequivalence (BE) studies for drugs meant for export purposes, under the amended provisions introduced through a notification. The guidance addresses limitations, submission timelines, documentation expectations, and regulatory processes for study sponsors and contract research organisations.
Source: shortlink.uk/1pHxP

2. The Central Drugs Standard Control Organisation (CDSCO) is reportedly working on regulatory guidelines for the use of high-risk solvents amid concerns over Propylene Glycol and its toxic impurities, Diethylene Glycol (DEG) and Ethylene Glycol (EG), in paediatric oral medicines like cough syrups. The move aims to strengthen quality checks, improve ingredient oversight, and prevent future contamination-related public health incidents.
Source: shortlink.uk/1v3ev

3. The Karnataka High Court has stayed the FSSAI advisory restricting the use of Ashwagandha leaves and leaf extracts in health supplements, providing interim relief to nutraceutical and wellness companies using such ingredients in their products. The Court observed that such restrictions may require amendments instead of being introduced through an advisory mechanism alone. This is important as the advisory had created restrictions for manufacturers operating in the nutraceutical and Ayush sectors using Ashwagandha. The order temporarily allows continued use of Ashwagandha leaf extracts while the larger regulatory and legal validity of the restriction is examined.
Source: shortlink.uk/1v3eB

4. India’s drug regulator has directed all 4,153 licensed blood banks to register on ONDLS portal on priority, as part of HIV infections in children due to contaminated transfusions linked to unsafe transfusions. Every blood center must register itself regardless of the status of their license.
Source: shortlink.uk/1v3eQ

5. The European Union has included India in its revised draft list allowing continued export of Indian aquaculture products from September 2026, bringing major relief to India’s seafood industry after the country’s earlier exclusion in 2024. The decision follows India’s compliance with European food safety and antimicrobial regulations.
Source: shortlink.uk/1v3eW

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 National Health Authority is developing a national artificial intelligence policy for healthcare to guide wider use of technology to address health challenges including diagnostics, public health programmes, and digital health platforms. This will be a major shift toward structured, large-scale adoption of technology in India’s health system. It can improve access, efficiency, and data-driven decision-making across public healthcare delivery.
Source: shortlink.uk/1tzfD

2. India’s Central government has directed states to uniformise package rates for common medical procedures, adopt uniform treatment guidelines, and implement digital claims processing through the National Health Claims Exchange to improve billing transparency and reduce pricing variations across private hospitals. These disparities have been identified in driving higher insurance premiums and affecting affordability.
Source: shortlink.uk/1ohsz

3. The Bombay High Court delivered a judgment after scrutinising enforcement under the Drugs (Prices Control) Order (DPCO), holding that overcharging determinations and recovery demands must strictly adhere to statutory methodology, including correct price fixation, computation, and grant of hearing. Finding procedural infirmities and inadequate reasoning, the Court set aside the demand and directed fresh adjudication, reinforcing due process and curbing arbitrary.
Source: shortlink.uk/1tzfM

4. The Central Drugs Standard Control Organization (CDSCO) has issued a regulatory communication outlining updated requirements related to drug approvals, compliance, and regulatory submissions for industry stakeholders. This is important as increased regulatory scrutiny may impact approval timelines and documentation standards. Companies may now need to review regulatory submissions, strengthen compliance processes, and align product lifecycle strategies with evolving CDSCO expectations.
Source: shortlink.uk/1tzfQ

5. The Drugs Technical Advisory Board has approved a proposal to amend the Medical Devices Rules, 2017 to introduce a definition of reportable events and mandate adverse event reporting, including for in-vitro diagnostic devices. This is important as it strengthens post-market surveillance and device safety oversight. Manufacturers and importers may now need enhanced reporting systems and tighter compliance processes.
Source: shortlink.uk/1ohsK

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. Bombay High Court restrained use of the mark Esiraft, finding it deceptively similar to an existing registered trademark Raciraft and likely to cause consumer confusion. The ruling reinforces strict standards on phonetic and visual similarity, strengthening protection against trademark infringement and passing off in the pharmaceutical sector.
Source: shortlink.uk/1sTZo

2. The U.S. Food and Drug Administration (USFDA) has released draft guidance on using next-generation sequencing (NGS) to assess gene therapy safety, detecting off-target edits, evaluating insertional mutagenesis, assessing vector integration sites, and ensuring genomic integrity. This is important as it strengthens detection of unintended genetic changes. If finalized, developers must adopt validated NGS methods and enhanced data reporting in IND submissions.
Source: shortlink.uk/1sTZq

3. The Food Safety and Standards Authority of India (FSSAI) has introduced flexibility in payment timing for visual inspection and laboratory testing charges under the FICS/SWIFT system, allowing importers to make payments after inspection instead of upfront. This is important as the move improves cash-flow management, reduces clearance delays, and enhances ease of doing business. Importers should now align internal payment and clearance workflows to leverage the revised process and avoid procedural bottlenecks.
Source: shortlink.uk/1sTZu

4. The U.S. Food and Drug Administration issued a warning to a major medical supply manufacturer over defective angiographic syringes used in heart procedures following multiple complaints related to device disconnections and potential patient and clinician safety risks. The company recalled the syringes in March 2026 but the FDA warned that failure to address the violations could result ‌in seizure of products, court action or financial penalties.
Source: shortlink.uk/1nEv0

5. The U.S. Food and Drug Administration has asked a weight-loss drug giant manufacturing giant to submit additional safety data for its newly approved oral weight-loss pill, including post-marketing studies on liver injury, cardiovascular risks, delayed gastric emptying, and drug presence in breast milk. This highlights tightening of post-market surveillance scrutiny, and evolving safety requirements for next-generation weight-loss therapies.
Source: shortlink.uk/1sTZz

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. National Pharmaceutical Pricing Authority (NPPA) has exempted Nafithromycin 400 mg tablets from price control under DPCO, 2013 for five years. The exemption starts from launch or patent expiry, whichever is earlier. This allows flexible pricing, but the company must report launch date and price details to the authorities
Source: shortlink.uk/1mYOh

2. The Centre has set April 30, 2026 as the final deadline for private hospitals to complete empanelment under the Central Government Health Scheme. Hospitals failing to sign the Memorandum of Agreement (MoA) by the deadline will be de-empanelled from May 1, losing eligibility to treat CGHS beneficiaries or submit reimbursement claims.
Source: shortlink.uk/1mYOm

3. US pharmaceutical companies have reportedly opposed price caps imposed by the National Pharmaceutical Pricing Authority (NPPA) of India, seeking blanket exemption for patented medicines. Industry stakeholders argue that current controls reduce prices by nearly 50% post-patent expiry, discouraging innovation and limiting availability of advanced therapies in India.
Source: shortlink.uk/1mYOq

4. The Karnataka Department of Health and Family Welfare, in collaboration with National Institute of Mental Health and Neurosciences, released a draft policy to tackle student mobile addiction. The proposal caps recreational screen time at one hour daily, introduces digital wellness committees, and mandates teacher training and counselling support to address rising mental-health concerns among adolescents.
Source: shortlink.uk/1mYOs

5. India’s Ministry of Finance has reportedly temporarily exempted customs duty on forty petrochemical and chemical inputs until June 30, aiming to stabilise supply chains disrupted by Middle East tensions, ease cost pressures on pharmaceuticals and manufacturing sectors, and support industry facing sharp increases in raw material and packaging costs.
Source: shortlink.uk/1mYOu

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. India’s central government has warned pharmacies, clinics, and online platforms of licence cancellation, fines, and legal action for unauthorised sale of GLP-1 weight-loss drugs. Regulators flagged misuse amid rising availability of generic semaglutide, reiterating that prescriptions are restricted to endocrinologists, internal medicine specialists, and cardiologists only, with nationwide inspections already underway.
Source: shortlink.uk/1mYE-

2. The Delhi High Court granted a 30 day stock clearance window to the pharmaceutical manufacturer for its diabetes drug under the existing brand, following its agreement to adopt a new name. Thereafter, unsold inventory will be supplied free to government hospitals under supervision, with immediate cessation of all commercial use.
Source: shortlink.uk/1mYF1

3. A Hyderabad-based paediatrician has criticised a company for introducing similar-looking packaging following the Food Safety and Standards Authority of India crackdown on misleading ORS branding. The doctor alleged that despite rebranding, the product retains strong recall value, potentially misleading consumers and raising ongoing public health concerns over confusion between therapeutic ORS and commercial electrolyte drinks.
Source: shortlink.uk/1mYF3

4. The US FDA clarified that compounded versions of GLP-1 weight-loss and diabetes drugs can only be produced during official shortages. With supply stabilising, compounders must stop manufacturing copycat versions once drugs are removed from the shortage list. The regulator warned of enforcement action against non-compliant pharmacies and telehealth providers.
Source: shortlink.uk/1sbL5

5. India’s Drugs Technical Advisory Board, has recommended amending the Drugs Rules, 1945 to introduce licensing provisions for drug marketers. The move aims to strengthen regulatory oversight and monitoring of entities that market drugs manufactured by other companies under their own label.
Source 1: shortlink.uk/1mYF8
Source 2: shortlink.uk/1mYFb

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 Government is preparing a policy response after seeking inputs from the pharmaceutical industry on the ongoing shortage and price surge of critical solvents and chemicals. Industry reported sharp increases in inputs like isopropyl alcohol and other petrochemical-based solvents, impacting production costs and supply continuity, prompting urgent intervention and long-term supply-chain stabilisation measures.
Source: shortlink.uk/1mYxw

2. The Delhi High Court has reserved its verdict on an interim plea filed by Asian News International in a copyright infringement case against OpenAI. The case questions whether copyrighted news content can be used to train AI models like ChatGPT without permission, marking a first-of-its-kind legal challenge in India.
Source: shortlink.uk/1mYy0

3. The Government is considering invoking the Essential Commodities Act, 1955 to regulate prices of bulk drugs and active pharmaceutical ingredients amid supply disruptions linked to West Asia tensions. The Department of Pharmaceuticals is consulting industry stakeholders to curb hoarding, stabilize prices, and ensure uninterrupted medicine production.
Source: shortlink.uk/1mYxH

4. The Food Safety and Standards Authority of India has released FAQs on the Food Safety and Standards (Licensing and Registration of Food Businesses) Amendment Regulations, 2026, clarifying key reforms including perpetual licence validity, revised turnover thresholds, expanded petty food business definition, and risk-based inspections to simplify compliance and strengthen food safety oversight.
Source: shortlink.uk/1sbDB

5. The Food Safety and Standards Authority of India has notified the Food Safety and Standards (Labelling and Display) First Amendment Regulations, 2026, introducing revised labelling exemptions, non-retail container requirements, and updated warning declarations. The amendments will come into force from 1 July 2027, giving industry transition time for compliance.
Source: shortlink.uk/1mYxL

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 National Pharmaceutical Pricing Authority (NPPA) has notified a 0.64956% increase in the Wholesale Price Index (WPI) for 2025 over 2024. Importers and manufacturers of Scheduled drugs and medical device are now permitted to increase the prices on the basis of WPI without prior approval from the government from April 1, 2026.
Source: shortlink.uk/1mYsg

2. The Central Drugs Standard Control Organization (CDSCO) has clarified that all IVF-related devices, including sperm washing kits and intrauterine insemination tools, are regulated as medical devices under the Drugs and Cosmetics Act. Import, manufacture, and sale of these devices require proper licensing to ensure compliance and prevent unauthorized trade.
Source: shortlink.uk/1mYsj

3. India’s Central Drug authority, (CDSCO) has streamlined the procedure for review and processing Written Confirmation certificate (WCC) applications submitted through the SUGAM portal for export of Active Pharmaceutical Ingredients (API) to EU for human use. The move aims to improve efficiency aligning with EU GMP compliance requirements under Article 46(2)(b) of Directive 2001/83/EC.
Source: shortlink.uk/1sbyd

4. The National Medical Commission (NMC), following a Supreme Court of India ruling, now limits stem cell therapy to approved conditions only, so far there are 32 approved conditions. Unproven uses outside clinical trials are banned, with strict ethical rules and legal action to prevent misuse and protect patients.
Source: shortlink.uk/1mYsV

5. The Central Consumer Protection Authority (CCPA) has directed hotels and restaurants to stop adding charges such as “LPG charges” and “fuel cost recovery” to customer bills, terming the practice an unfair trade practice, and warning of strict action. The CCPA clarified LPG and electricity, are part of running a business and should be factored into final menu prices.
Source: shortlink.uk/1mYt2