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 added the National Human Rights Commission (NHRC) to a 2018 PIL enforcing the Mental Healthcare Act, 2017. It condemned inhumane practices like chaining mentally ill patients, noted failure to set up mental health authorities and review boards, and directed the Centre to file a detailed affidavit on steps taken to implement the Act nationwide.
Source: bit.ly/4lB9e3f

2. Indian government has initiated a formal investigation into the growing import of medical devices from China, targeting potential cybersecurity and patient data privacy threats. Rising imports across diagnostics, surgical instruments and IoT enabled monitoring systems have raised concerns over malware, or data misuse, prompting scrutiny from commerce and health authorities.
Source: bit.ly/3IFimWg

3. The Indian Council of Medical Research (ICMR) has issued an Expression of Interest inviting eligible organisations, companies and manufacturers for transfer of technology for commercial production of recombinant multi stage malaria vaccine, AdFalciVax, by August 17, 2025.
Source: bit.ly/4eWGiAi

4. The Delhi government plans to exempt restaurants and eateries from obtaining the mandatory health trade license from the Municipal Corporation of Delhi (MCD). Currently, obtaining this licence is a prerequisite for opening eateries in the city.
Source: bit.ly/46ld2B6

5. Delhi High Court has temporarily barred pharmaceutical company from manufacturing, selling importing, exporting or dealing a biosimilar of patented cancer immunotherapy drug after finding credible evidence of patent infringement and potential irreparable harm.
Source: bit.ly/46Vlkjh

TOP 5 HEALTH LAWS AND POLICY UPDATES

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

1. The Delhi High Court has restrained pharma company from using the trademark “Liv 333” for their liver-care product, finding it deceptively similar to established registered trademark “Liv.52” from 1957. The court noted that merely adding numerals doesn’t eliminate consumer confusion.
Source: bit.ly/44lGKV5

2. In the dispute over Geographical Indication between Chile and Peru over the alcoholic beverage “Pisco”, the Delhi High Court ruled that both nations have legitimate claims and no exclusive rights can be claimed, therefore, in order to prevent consumer confusion, each must use geographic labels, “Peruvian PISCO” and “Chilean PISCO”.
Source: bit.ly/4nJfqYI

3. India’s Food Safety and Standards Authority of India (FSSAI), has warned e-commerce platforms to strictly comply with food safety norms or face action. Key mandates include displaying FSSAI licenses, revealing warehouse details on FoSCoS, training food handlers via FoSTaC, uploading hygiene photos, and showing expiry dates online.
Source: bit.ly/3TsiWsz

4. During a consultation with NITI Aayog, MSME pharma associations sought regulatory and financial support for compliance with revised GMP norms, requesting deadline extensions and infrastructure aid, while the DCGI emphasized strict enforcement and responsibility for upholding quality standards.
Source: bit.ly/40GWTSJ

5. The Indian pharmaceutical sector faces legal and regulatory concerns due to high humidity altering the colour, smell, and taste of medicines, risking non-compliance with quality standards. Experts recommend compressed air dryers to ensure pharmaceutical products meet statutory purity and safety requirements.
Source: bit.ly/4nCEH6v

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 Pharmaceuticals has extended the application deadline for Round V of its Production-Linked Incentive (PLI) scheme to 21 June 2025, giving pharma companies additional time to apply. Applications can only be made online through the given link in the circular.
Source: bit.ly/4kn1e4J

2. The Delhi High Court has barred a leading Ayurvedic manufacturer from airing advertisements claiming superiority of its Chyawanprash, ruling that freedom of commercial speech doesn’t justify misleading claims for regulated drugs. It has further emphasized stricter scrutiny on drug-related marketing to prevent false efficacy claims and consumer deception.
Source: bit.ly/4kqs63F

3. The Madras High Court has clarified that importing Ayurvedic drugs into India does not require an import license, provided the products conform to the standards set for domestically manufactured equivalents. This precedent emphasizes regulatory alignment with Indian pharmacopoeia standards and could facilitate smoother market entry for Ayurvedic importers while ensuring consistent quality.
Source: bit.ly/4lgEXH2

4. The National Pharmaceutical Pricing Authority (NPPA) will change its official website from nppaindia.nic.in to nppa.gov.in effective 15 July 2025. The new domain will host all notifications, pricing orders, data systems, and circulars. Stakeholders are advised to update their records and bookmarks to ensure uninterrupted access to NPPA services during the transition phase. The old domain will temporarily redirect users.
Source: bit.ly/44AXWF9

5. The National Pharmaceutical Pricing Authority (NPPA) has issued an Order thereby fixing the ceiling prices for I.V. fluids (non-glass with special features). Now the product I.V. fluids (non-glass with special features) cannot be sold beyond the fixed prices.
Source: bit.ly/44gE4rR

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 Directorate General of Health Services (DGHS) will now manage doctor registrations in Delhi, following the dissolution of the Delhi Medical Council due to administrative irregularities. This move aims to centralize oversight and restore transparency in medical practitioner regulation.
Source: bit.ly/45sY77v

2. India’s Enforcement Directorate has launched investigations into four pharmaceutical companies based out of state of Uttar Pradesh on suspicion of diverting tramadol. These firms are alleged to have supplied the controlled painkiller for unauthorized distribution, intensifying efforts to curb drug misuse.
Source: bit.ly/443Z5EJ

3. Australia’s health regulator has issued over A$600,000 in fines across multiple medicinal cannabis companies for unlawful advertising, including unapproved health claims. The crackdown highlights strict compliance requirements for prescription-only medicines.
Source: bit.ly/3GazC4x

4. To prioritize domestic supply and reduce China dependence, India has instructed state miner IREL to halt rare earth magnet exports. The move supports local EV and tech industries amidst global magnet shortages.
Source: bit.ly/40erxT8

5. Maharashtra state government reinstates a ₹600 cap on ELISA test for dengue and chikangunya specifically in Pune city amid rising cases and has issued fresh directives to all hospitals and laboratories.
Source: bit.ly/3TxKCvW

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 West Bengal Legislative Assembly has passed a new Bill which is an amendment to the Clinical Establishments Act, 2017. The new Bill empowers the State to regulate treatment costs in private clinics, enforce fixed and package rates, streamline licensing, and mandate electronic medical records to ensure consumer protection and transparency.
Source: bit.ly/4k87Cg8

2. India’s Consumer Affairs Ministry has reportedly directed edible oil manufacturers and importers to reduce retail prices in order to pass the benefits of the recent import duty cuts to consumers. Although the new rates are in effect, supply chain delays may postpone noticeable price reduction until late June.
Source: bit.ly/3I5h5Hm

3. Federation of Indian Pharmacist Organizations (FIPO) has urged the Union Health Ministry to reject Drug Technical Advisory Board’s draft permitting sale of 16 OTC drugs (like paracetamol, clotrimazole) through unlicensed outlets without pharmacist oversight, citing risk to public safety.
Source: bit.ly/4kNtMoO

4. The 20 Nifty Pharma firms held a record ₹48,913 cr in cash as of March 31, doubling FY20 levels, and added over ₹10,200 cr in FY25. The cash reserves are aimed at funding M&A, expanding into complex therapy areas to transition into higher-margin, innovation-driven sectors.
Source: bit.ly/4kRGMdg

5. The U.S. FDA has launched a pilot program to accelerate drug reviews for companies aligned with national health priorities, such as pandemic readiness and essential drug supply. Selected firms will benefit from enhanced FDA engagement and early submissions, expediting approvals without compromising safety standards.
Source: bit.ly/3HQPWrH

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. Directorate General of Foreign Trade (DGFT)Trade Connect ePlatform has reportedly expanded the ‘Source from India’ portal to include all pharma Status Holder exporters with valid IECs. This upgrade enhances global discoverability, boosts buyer-supplier connectivity, and further promotes India’s position as a key player in global pharmaceutical trade.
Source: bit.ly/3Ts7gWt

2. The global pharma market is reportedly shifting toward specialty drugs like biologics and oncology therapies. India, while leading in generics, is investing heavily in biosimilars, innovation, and digital health—strengthening its dual role in high-volume supply and cutting-edge pharmaceutical R&D.
Source: bit.ly/4n6JKvN

3. Association of Southeast Asian Nations (ASEAN) has issued new harmonised guidance for medical device classification and borderline products. The update refines risk categories (A–D), defines ambiguous products, and promotes faster regulatory approvals, supporting pharma-medtech innovators in expanding across the Southeast Asian market.
Source 1 : bit.ly/43P2g4t
Source 2 : bit.ly/3HKZ8xN

4. The Confederation of Indian Alcoholic Beverage Companies has reportedly expressed their concern Maharashtra’s government to revisit its decision to raise excise duty on Indian-made foreign liquor(IMFL), country liquor, and imports by up to 50–85%. Industry leaders warns this could trigger a surge in illicit trade, harm legal sales, and reduce long-term state revenues despite short-term ₹14,000 crore projections.
Source: bit.ly/4jQJ3UN

5. The U.S. Food and Drug Administration (FDA) has finalized guidance to streamline the pre-submission facility correspondence (PFC) process for priority abbreviated new drug applications (ANDAs). By submitting complete and accurate facility information at least 60 days before ANDA submission, applicants can qualify for an expedited 8-month review timeline.
Source: bit.ly/4jRpNq0

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 reportedly exempted imported pharmaceutical high-density polyethylene (HDPE) medical-grade plastic from mandatory quality certification under Bureau of Indian Standards regulations to facilitate the production of syringes and IV cannulas and a steady supply of essential products in the healthcare sector.
Source: bit.ly/4ldtUOp

2. The Department of Pharmaceuticals (DoP) has reportedly declined to reveal the names of 30 doctors who accepted ₹1.91 crore worth of foreign trips from major pharmaceutical company. Citing privacy concerns, the DoP resisted disclosing details despite National Medical Commission (NMC) being asked to act. The decision has sparked criticism over transparency and ethical accountability in healthcare.
Source: bit.ly/3G400gp

3. The Karnataka State Pollution Control Board (KSPCB) has clarified that Biomass Briquette/Pellet manufacturing plants do not fall under the scope of the EIA Notification, 2006, which governs environmental impact assessments for specified projects.
Source: bit.ly/4n20u7l

4. The government of India is reportedly tightening oversight of online pharmacies offering rapid deliveries amid concerns over unverified prescriptions, safety, and compliance. A regulatory review is underway to enhance consumer protection and control the proliferation of unregulated digital pharma services.
Source: bit.ly/3G1nDpZ

5. India’s Uttarakhand High Court has quashed a case against a leading Ayurvedic drug manufacturer and its founders over alleged misleading medical advertisements claiming to cure conditions such as diabetes and high cholesterol. The Court cited lack of specific evidence or expert reports to support the allegation that the claims were misleading.
Source: bit.ly/3HZK8vW

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 has requested India to remove import duties and relax stringent price controls on medical devices and relax rules on data localization policy with an aim to boost trade between nations.
Source: bit.ly/45hYyBt

2. The Central Pollution Control Board has introduced a step-by-step complaint module for changing login credentials on the Plastic Packaging Extended Producer Responsibility portal, easing access for affected companies.
Source: bit.ly/4e1NJWh

3. India’s Health Ministry mandates purchase invoice billing or provision of CGHS supplied medicines for Central Government Health Scheme claims, squeezing private hospital margins and prompting sector backlash
Source: bit.ly/3HT7nI4

4. Indian pharma companies increasingly deploy blockchain and smart contracts to enhance serialisation, ensure Drug Supply Chain Security Act (DSCSA) compliance, curb counterfeit drugs, automate supplier processes and reinforce production quality and security.
Source: bit.ly/3SRv85J

5. The Ministry of Consumer Affairs has issued further FAQs to provide clarity on the implementation of the Legal Metrology (Packaged Commodities) Rules, 2022. Key clarifications include guidelines on the declaration of MRP, labelling requirements for weighing machine, declaration regarding Institutional sale etc.
Source: bit.ly/440O2w7

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) plans to consult subject matter experts to determine a separate pricing structure for cementless knee implants, aiming to ensure affordability and accessibility for patients requiring these advanced medical devices.
Source: bit.ly/43XywRM

2. The Indian Pharmaceutical Alliance (IPA) has expressed opposition to the government’s recent directive limiting the entry of medical representatives into Central government hospitals, arguing that such restrictions could hinder the dissemination of critical medical information to healthcare professionals.
Source: bit.ly/4kDnNCZ

3. The Ministry of Electronics and Information Technology (MeitY) is considering the discontinuation of the bundled consent mechanism, proposing stricter regulations to enhance data privacy and security standards in digital platforms.
Source: bit.ly/4kE8qdH

4. India has asserted its stance on protecting pharmaceutical innovations, countering recent patent infringement allegations from Switzerland, and emphasizing the country’s commitment to safeguarding public health interests.
Source: bit.ly/4n66Lzd

5. The U.S. Department of Agriculture is set to introduce new dietary guidelines for schools, aiming to reduce added sugars and sodium in meals, promote plant-based options, and support local agriculture, thereby enhancing student health and nutrition.
Source: bit.ly/3Hzzv2P

TOP 5 HEALTH LAWS AND POLICY UPDATES

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

1. The Indian government is reportedly preparing to ramp up oversight of quick commerce platforms following a series of hygiene and food safety lapses at their dark store facilities. FSSAI plans to conduct unscheduled surprise inspections nationwide to enforce stricter compliance, particularly concerning hygiene and the sale of near-expiry products.
Source: bit.ly/43QmomR

2. The Department of Pharmaceuticals (DoP) has revised its 2024 guidelines for its Capacity Building and Skill Development sub scheme under the Strengthening of Medical Device Industry initiative. New criteria include minimum admission thresholds at least 30% in the first year and 50% in subsequent years failure of which results in withdrawal of funding.
Source: bit.ly/4dW0OR2

3. The Supreme Court of India ruled that the right to shut down a business is part of Article 19(1)(g), subject to reasonable restrictions like protecting workers and following legal procedures. It emphasized that authorities cannot delay valid closure requests or overstep their powers.
Source: bit.ly/4e2FABh

4. The Indian Pharmaceutical Association has reportedly urged reforms in e-prescription rules to prevent misuse through repeated use of digital prescriptions. It recommends a mandatory ‘dispensed’ stamp, encrypted prescriptions or direct doctor-to-pharmacy transmission, but experts warn this could restrict patient rights, access, and create pharmacy monopolies.
Source: bit.ly/4ejdfa1

5. FSSAI has released the Draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2025, proposing new standards for cheese powder, removing “fish” from the animal definition, and banning additives in atta, rice, millet, and mixed millet flours. Public feedback is invited until August 8, 2025.
Source: bit.ly/4e8UW7i