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 Food Safety and Standards Authority of India (FSSAI) has extended the provisional enrolment of 63 Non-Food Production (NFP) Units for collection used cooking oil from Food Business Operators (FBOs) until 31st July 2026. FSSAI may cancel enrolment for non-compliance of SOPs, order, guidelines or submission of false information or based on findings of inspections.
Source: bit.ly/45sysu7

2. The Ministry of Chemicals and Fertilizers has withdrawn the Quality Control Orders for Acetic Acid, Methanol, and Aniline, which were originally issued in 2019 and set to take effect from August 3, 2025. The immediate removal of mandatory BIS certification is expected to ease sourcing and compliance for the pharmaceutical sector.
Source: bit.ly/4kYKjpl

3. The Ministry of Environment, Forest & Climate Change has notified an Amendment to the Environment Protection Rules, 2025, introducing stricter emission and effluent standards for pesticide manufacturing units. New limits on pollutants such as COD, BOD, heavy metals, HCl, benzene, and methanol will enforce tighter pollution control compliance effective immediately.
Source: bit.ly/4odOlNx

4. A recent Indian Council of Medical Research (ICMR) study reveals that just 28.5 % of cancer patients in India receive radiotherapy, while the ideal rate should be around 58.4 %. India currently has 794 radiotherapy machines, but needs between 1,585 and 2,545 to meet demand. The council recommended urgent expansion.
Source: bit.ly/46sqsv3

5. Bihar’s Health Minister has inaugurated a state-level Anti-Fraud Unit Dashboard to monitor claims under Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana and the Chief Minister Jan Arogya Yojana to curb fraudulent hospital billing and establish a robust framework for transparency, accountability, and monitoring.
Source: bit.ly/3TTo5tQ

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 Ministry of Environment, Forest and Climate Change (MoEF&CC) has extended the deadline for filing Annual Returns under the Battery Waste Management Rules, 2022 until 30 September 2025. The previous deadline for filing of Annual Returns was 30 June 2025.
Source: bit.ly/46qdfmG

2. The Indian Government is reportedly set to enforce a Minimum Import Price (MIP) on approximately 10 critical pharmaceutical raw materials including Key Starting Materials (KSMs), Active Pharmaceutical Ingredients (APIs), and drug intermediates used in antibiotics and cholesterol medicines primarily imported from China
Source: bit.ly/3II4D0P

3. The Union Health Ministry is reportedly recommended to remove wholesale licensing requirement for household liquid antiseptics by reclassifying them separately from stronger, hospital-grade variants. This aims to make these products more affordable and widely available in retail stores.
Source: bit.ly/3GEEJdP

4. The Department of Biotechnology (DBT) is inviting proposals to establish Image Informatic Centres aimed at creating AI-powered imaging biobanks. These centres will collect and annotate diagnostic images linked with clinical data to develop AI algorithms for improved disease diagnosis and precision medicine.
Source: bit.ly/3GWmVuG

5. India’s Supreme Court has directed the central government to provide an office space within four weeks for the National Task Force (NTF) set up to address the mental health crisis among students, particularly in medical and higher education institutions. The NTF has faced hurdles in functioning due to the lack of physical infrastructure.
Source: bit.ly/44JT1mr

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 Medical Commission has directed all medical colleges to form and register adverse event monitoring committee chaired by the medical superintendent under the Materiovigilance Programme with Indian Pharmacopoeia Commission to monitor, assess and prevent adverse events from medical devices by July 31, 2025.
Source: bit.ly/3TI4mxc

2. The Maharashtra government paused its decision to let homeopaths prescribe modern medicine, forming a 7-member committee to review the issue within two months. The move comes amid strong opposition from medical associations concerned about public safety and standards. The matter remains pending in Bombay High Court.
Source: bit.ly/4lYxuMI

3. India’s Ministry of Environment, Forest and Climate Change has notified the Environment (Protection) Fourth Amendment Rules, 2025, introducing revised emission norms for thermal power plants. Based on plant categorization, sulphur dioxide emission standards have been prescribed, along with timelines and penalties for non-compliance, including environmental compensation.
Source: bit.ly/40iWJRx

4. The District Consumer Commission in Ernakulam, Kerala, found a fertility clinic guilty of unfair trade practices and service deficiency for giving misleading assurances about IVF success rates. The Commission awarded ₹2.66 lakh in compensation the couple, emphasizing that such conduct is a breach of duty owed to consumers, violating their right to truthful information and fair services.
Source: bit.ly/4lzmghO

5. The recently signed “One Big Beautiful Bill” introduces stricter Medicaid work and eligibility verification from 2027, in addition to funding cuts that may force insurers to exit low-margin markets. The Congressional Budget Office warns this could leave 7.8 million Americans uninsured by 2034, while driving up premiums and administrative burdens.
Source: bit.ly/4ls9HEN

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

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

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. India’s Ministry of Environment, Forest and Climate Change has issued the draft Plastic Rules to mandate the use of recycled plastic in plastic packaging from FY 2025-26. Category-wise targets are specified, and CPCB may allow exemptions in cases involving statutory or technical constraints along with a three-year carry-forward for shortfalls in initial compliance. Stakeholders can submit objections to the draft within 60 days.
Source: bit.ly/4e0zhxV

2. Active Pharmaceutical Ingredients (API) prices, which surged during the COVID-19 pandemic, are now declining, easing cost pressures on India’s pharmaceutical industry. As the sector relies heavily on imports from China, the drop in raw material costs is improving profit margins and providing much-needed relief to drug manufacturers.
Source: bit.ly/4dOkypE

3. The Ministry of Agriculture and Farmers Welfare has made amendment to Insecticides Rules, 1971 and introduced the new labelling requirement. Labels must follow new formats by pack size, include QR codes, safety warnings, and detailed info in Hindi and English. The said amendment comes into effect from June 3, 2025, with a phased compliance timeline for industry implementation.
Source: bit.ly/45hnclP

4. Indian Government has launched the ‘Ayush Nivesh Saarthi’ portal to attract global investment in traditional medicine. The platform offers a unified interface for investors, integrating policy frameworks, incentive schemes, and investment-ready projects. This initiative aims to position India as a global hub for traditional medicine and wellness
Source: bit.ly/45bCTe5

5. The European Medicines Agency (EMA) has published a draft guideline for public consultation, offering recommendations on including or retaining pregnant and breastfeeding individuals in clinical trials. The aim is to generate reliable clinical data to support informed, evidence-based treatment decisions for these populations.
Source: bit.ly/43xtYCH

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 government has directed state-run hospitals to procure medicines and consumables exclusively through the Central Procurement Agency (CPA), aiming to streamline procurement and reduce costs, as earlier methods through direct purchases or via the cart feature on the Government e-Marketplace (GeM) portal often resulted in inflated pricing.
Source: bit.ly/4krkAX0

2. Central Pollution Control Board (CPCB) has reportedly initiated action against pan masala brands in Delhi for using plastic sachets to pack and store tobacco and pan masala. Companies may face fines unless they switch to eco-friendly packaging alternatives, per CPCB directives.
Source: bit.ly/4kJM7CW

3. Public health and consumer organisations are reportedly urging the government to add mandatory warning labels on the front of packaged food products that are high in salt, sugar, and fat. They want the Health Star Rating system to be scrapped, saying it misleads people and protects food companies.
Source: bit.ly/3ZjbNOu

4. The Delhi Pollution Control Committee (DPCC) has issued a Standard Operating Procedure (SOP) to streamline the imposition and recovery of environmental compensation from violators of environmental norms. The SOP mandates timely issuance of show cause notices within five days of inspection, a 15-day response window for violators, and follow-up actions within 30 days.
Source: bit.ly/3ZjTVmx

5. India’s Health Ministry is reportedly expanding Schedule H under the Drugs Rules, 1945, raising the number of prescription-only drugs from 536 to over 700. This includes remdesivir, dexamethasone, favipiravir, ivermectin, and mebrofenin etc. The move aims to curb antimicrobial resistance by restricting OTC sales, covering drug classes like cardiovascular, neurological, respiratory, anesthetic, immunological, NSAIDs, and sterile formulations
Source: bit.ly/3ZKZACb

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 Pollution Control Board (CPCB) has extended the deadline for filing E-Waste EPR returns till June 30, 2025, and mandates audits for all registered entities to strengthen rule compliance and traceability.
Source: bit.ly/4k8KbE8

2. Food Safety and Standards Authority of India has proposed reforms to ease food license renewals, including fixed renewal dates (Jan 15, Apr 15, Jul 15, Oct 15), 10-year validity for Trade/Retail businesses, and a 3-year minimum for registrations. These aim to standardize compliance, reduce admin burdens, enable bulk renewals. Stakeholders have been invited to submit feedback by 30th June, 2025.
Source: bit.ly/3SBuv09

3. The Drugs Controller General of India (DCGI) has revoked import registrations of several cosmetic products containing salicylic acid concentrations exceeding the prescribed limit, in violation of the Cosmetics Rules, 2020.
Source: bit.ly/4kyzz1e

4. India’s Kerala High Court rules that prescribing medicines and tests over the phone doesn’t constitute gross negligence, reinforcing protections for doctors against unwarranted criminal liability.
Source: bit.ly/4dybNQy

5. India’s Central Drugs Standard Control Organisation (CDSCO) has identified numerous MSME pharmaceutical firms in India producing substandard drugs, with April data revealing about 60 samples failing quality standards. Affected products include eye drops, anaesthetics, and supplements.
Source: bit.ly/4jirNHr