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TOP 5 HEALTH LAWS AND POLICY UPDATES

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

1. The Ministry of Health and Family Welfare mandates all WHO-GMP (COPP) certificate applications to be submitted exclusively through the ONDS Portal from June 15, 2025. Hard copy submissions will not be accepted. A step-by-step procedure and contact details for support have also been provided.
Source: bit.ly/3HWGXWd

2. CDSCO has informed all states and union territories that a loan license is no longer required for outsourcing sterilization of medical devices, provided the sterilization facility is licensed under MDR-2017. Manufacturers must submit documentation and include the sterilization site’s license number on labels of the device.
Source: bit.ly/44nGKCX

3. The Bombay High Court has issued an interim injunction restraining a company from using packaging, labels, bottles, and trade dress that closely resemble those of an established hair-oil brand. The court found that the packaging was “slavishly copied,” potentially misleading consumers and amounting to trademark infringement and unfair competition.
Source: bit.ly/4kd5DXM

4. The Andhra Pradesh High Court has ruled that under the Narcotic Drugs and Psychotropic Substances Act, 1985, “Ganja” refers only to the flowering or fruiting tops of the cannabis plant, explicitly excluding seeds and leaves when not accompanied by the tops.
Source: bit.ly/4ls1iRl

5. India’s Central Board of Indirect Taxes and Customs (CBIC), following DGTR recommendations, has slapped anti dumping duties for five years on four key chemicals from China—PEDA, acetonitrile, Vitamin A palmitate and insoluble sulfur—to shield domestic pharma, agro and rubber industries, signalling a strategic push to rebalance imports and promote local manufacturing.
Source: bit.ly/4lNeEYX

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 NPPA’s Multidisciplinary Committee, in its recent meeting has reportedly decided to co-opt experts from AIIMS, MAMC, SIC Safdarjung and NIPER to evaluate industry requests for a distinct ceiling price on cementless knee implants. Under Drugs Price Control Order, 2013, manufacturers may petition for separate pricing if their product shows innovation or superiority over existing variants.
Source: bit.ly/3HQpizr

2. The Bureau of Indian Standards (BIS) has introduced two important standards, IS/IEC 63203-201-1:2022 which outlines the standards for measurement methods for basic properties of conductive yarns used in wearable electronic textiles and, IS 19173 (Part 1):2025 which is aligned with IEC/TR 80002-1:2009, offers guidance on applying ISO 14971 to medical device software, strengthening risk management practices.
Source: bit.ly/4ejatBw

3. The National Human Rights Commission has reportedly directed AIIMS Delhi to submit a report within 15 days following allegations that neuroradiology doctors bypassed institutional procurement norms, referring patients to buy flow-diverter brain implants from a private vendor. The complaint highlights significant cost burden and potential human rights violations.
Source: bit.ly/4kY4PqY

4. The Customs, Excise, and Service Tax Appellate Tribunal (CESTAT), New Delhi Bench, ruled that packing or repacking parts of Vibratory Compactors and Wheeled Tractor Loader Backhoes does not constitute “manufacture” under Central Excise Act, so no excise duty is payable.
Source: bit.ly/4eispvP

5. The Sikkim High Court has ordered the State Government to conduct the periodic inspections of all industries including pharmaceutical companies to verify that no effluents are being discharged into rivers. The court also noted groundwater extraction and urged timely completion of the Sikkim Springs & Groundwater Regulation Bill, 2025.
Source: bit.ly/4k5z1yW

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 Ministry of Health and Family Welfare (MoHFW) is reportedly planning to integrate India’s Rare Donor Registry (RDRI) with the e-Rakt Kosh portal to streamline access to rare blood types like Bombay and Rh-null. This move connects over 4,000 rare blood donors with hospitals nationwide, improving response time and ensuring safer transfusions for patients with conditions like thalassemia and sickle cell disease.
Source: bit.ly/3HS9IDi

2. India’s Central Drugs Standard Control Organisation (CDSCO) has flagged 128 drug batches as Not of Standard Quality (NSQ) in its May 2025 alert. The list includes common medicines like paracetamol, dapagliflozin, dexamethasone, and others. Issues cited include assay failures, content non-uniformity, sterility, and misbranding. The alert aims to safeguard public health by informing stakeholders and enabling swift regulatory action.
Source: bit.ly/45wqAt3

3. Indian Council of Medical Research – National Institute of Immunohaematology has developed a low-cost, rapid test kit for Hemophilia A and Von Willebrand Disease. it will reduce the healthcare cost significantly and could become a worldwide solution for early diagnosis and treatment.
Source: bit.ly/4k5H4vR

4. A major eyewear company admitted before the Delhi High Court that it mistakenly used another company’s registered trademarks but had no intention of infringing them. The company removed all references. The court accepted this, recorded the admission, and issued a binding decree, formally closing the trademark-infringement case.
Source: bit.ly/43X8tvh

5. India’s Health Ministry has proposed including liver and heart transplants under the Ayushman Bharat PM-JAY insurance scheme, following recommendations from NOTTO (National Organ and Tissue Transplant Organization). Currently, only kidney transplants are covered, making life-saving procedures more accessible and affordable.
Source: bit.ly/4eePwYt

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 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

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 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

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. Government extends PLI scheme application deadline
The Government of India has extended the application deadline for the Production Linked Incentive (PLI) Scheme aimed at boosting domestic manufacturing of Critical Key Starting Materials (KSMs), Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs). Eligible entities can now apply until July 4, 2025.
Source: bit.ly/3SXjvKE

2. Draft of ghee fatty acid limits, new cheese powder standards, revised drinking water norms issued by India Food Ministry
India’s Ministry of Health and Family Welfare has released draft amendments to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Key changes include updated ghee fatty acid limits, new cheese powder standards, revised drinking water norms, and additive restrictions. Public comments are invited latest by 4th August, 2025.
Source: bit.ly/4k0CfDP

3. Kerala High Court Bans Single-Use Plastics in Tourist Areas and Public Events
The Kerala High Court has banned single-use plastics in ten major hilly tourist destinations and all public events across the state, effective October 2, 2025. The move aims to curb pollution, mandates water kiosks in tourist spots, and directs strict enforcement by multiple state authorities.
Source: bit.ly/3FY3dhK

4. Essential Drug Prices Surge by Up to 20% Amid Global Conflicts
Essential drug prices in India have increased by 10 – 20% as per a leading drug traders association. Geopolitical conflicts have reportedly disrupted supply chains, leading to shortage of key raw materials like aluminium foil, used in pharmaceutical packaging and has driven up production costs for medicines.
Source: bit.ly/43RDxMM

5. Bombay HC rules treaty can’t override customs law
India’s Bombay High Court has ruled that treaty provisions do not override national customs law unless formally incorporated, affirming the jurisdiction of Indian customs authorities that issued show cause notices for alleged misuse of import exemptions.
Source: bit.ly/4ljpx4t

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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. 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

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 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

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. 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

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) 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