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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 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

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 Food Safety and Standards Authority of India (FSSAI) has issued an advisory directing all milk producers (other than members of dairy cooperative societies) and milk vendors to obtain mandatory FSSAI registration or licensing before commencing or continuing operations. States and UTs have been instructed to conduct special registration drives and enforcement checks to ensure compliance and curb milk adulteration.
Source: shortlink.uk/1mYp6

2. Supreme Court reportedly declines plea seeking mandatory Nucleic Acid Amplification Testing in blood banks, stating medical policy decisions must rest with domain experts and governments. The Court noted financial implications and advised the petitioner to approach authorities, while concerns over transfusion transmitted infections and patient safety were highlighted.
Source: shortlink.uk/1mYnK

3. The Central Drugs Standard Control Organisation (CDSCO) has delegated key regulatory functions related to veterinary drugs to its zonal offices. Zonal offices will now process Test License (Form 11) applications for import and issue NOCs for Form 29 licenses for manufacturing veterinary drugs for testing or analysis, excluding biologicals.
Source: shortlink.uk/1sbtE

4. India’s Drugs Technical Advisory Board, in its 93rd meeting, 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/1mYo2
Source 2: shortlink.uk/1mYo4

5. The Food Safety and Standards Authority of India has reportedly encouraged plant-based food manufacturers to include QR codes on product labels to help consumers easily access ingredient lists and nutritional information. The regulator said the move currently voluntary can address label space limitations, improve transparency, and build consumer trust in the rapidly growing plant-based food sector.
Source: shortlink.uk/1mYof

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 clarified no proposal exists for a uniform nationwide pricing framework for medical devices. National Pharmaceutical Pricing Authority continues to regulate ceiling prices for essential devices like stents and knee implants under Drugs Prices Control Order, 2013, while monitoring non scheduled products and taking action against overcharging to safeguard consumer interests.
Source: shortlink.uk/1s0VO

2. The Ministry of Health and Family Welfare approved major reforms to strengthen food safety while improving ease of doing business. Measures include perpetual licences, higher turnover thresholds, deemed registration for street vendors, and risk based inspections, reducing compliance burden and enhancing regulatory efficiency
Source: shortlink.uk/1s0VY

3. The National Biodiversity Authority (NBA) of India has formed an expert committee to address invasive alien species threatening India’s biodiversity, ecosystems, agriculture, and health. It will create a national list, identify high-risk species, and recommend management strategies, research, and guidelines for prevention, control, and ecological restoration over a two-year period.
Source: shortlink.uk/1mOaJ

4. The Delhi High Court has issued notices to the government and CDSCO over alleged inaction on misuse of diabetes drug Ozempic for weight loss, citing non-compliance with earlier directives. The case raises concerns on regulatory oversight, off-label use controls, and potential compliance risks for pharma players amid rising scrutiny.
Source: shortlink.uk/1s0Wd

5. A Parliamentary panel has asked the Ministry of Defence to expedite pending payments to hospitals under the Ex-Servicemen Contributory Health Scheme, warning that delays are forcing private providers to opt out. The move aims to restore service continuity and protect healthcare access for over one crore beneficiaries.
Source: shortlink.uk/1mOaW

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 clarified no proposal exists for a uniform nationwide pricing framework for medical devices. National Pharmaceutical Pricing Authority continues to regulate ceiling prices for essential devices like stents and knee implants under Drugs Prices Control Order, 2013, while monitoring non scheduled products and taking action against overcharging to safeguard consumer interests.
Source: shortlink.uk/1mogz

2. The Ministry of Health and Family Welfare approved major reforms to strengthen food safety while improving ease of doing business. Measures include perpetual licences, higher turnover thresholds, deemed registration for street vendors, and risk based inspections, reducing compliance burden and enhancing regulatory efficiency
Source: shortlink.uk/1rAbJ

3. The National Biodiversity Authority (NBA) of India has formed an expert committee to address invasive alien species threatening India’s biodiversity, ecosystems, agriculture, and health. It will create a national list, identify high-risk species, and recommend management strategies, research, and guidelines for prevention, control, and ecological restoration over a two-year period.
Source: shortlink.uk/1mogO

4. The Delhi High Court has issued notices to the government and CDSCO over alleged inaction on misuse of diabetes drug Ozempic for weight loss, citing non-compliance with earlier directives. The case raises concerns on regulatory oversight, off-label use controls, and potential compliance risks for pharma players amid rising scrutiny.
Source: shortlink.uk/1mogP

5. A Parliamentary panel has asked the Ministry of Defence to expedite pending payments to hospitals under the Ex-Servicemen Contributory Health Scheme, warning that delays are forcing private providers to opt out. The move aims to restore service continuity and protect healthcare access for over one crore beneficiaries.
Source: shortlink.uk/1mogU

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 Union Health Ministry, has reportedly directed all academic and research institutions under its purview to refrain from sharing data, trial results, or research information with foreign agencies without prior approval. Sectors including pharmaceuticals, animal sciences, and plant biotechnology have been flagged by Indian intelligence agencies for unauthorised informal engagements.
Source: shortlink.uk/1mobc

2. Central Drugs Standard Control Organization (CDSCO) of India has issued a notice stating that Sodium Hyaluronate Eye Drops 0.3% w/v are being manufactured and marketed without mandatory approval. Since it is classified as a new drug, prior permission is mandatory under the New Drugs and Clinical Trials Rules, 2019. State and UT authorities have been directed to cancel approvals and report compliance.
Source: shortlink.uk/1rA6g

3. Food Safety and Standards Authority of India (FSSAI) has integrated a Food Recall module into its FoSCoS compliance portal, enabling enforcement authorities and food businesses to log and monitor recalls online. Consumers can now check recalled product details on the FoSCoS homepage, strengthening food safety oversight across India’s food supply chain.
Source: shortlink.uk/1rA6l

4. The Central Pollution Control Board (CPCB) has issued show cause notices under the Environment (Protection) Act, 1986 to PIBOs for failing to meet EPR targets for FY 2022–23. The entities are required to submit their response within 15 days of issuance of notice along with fulfilment of obligation. The response should be shared to CPCB on email id along with the hard copy to divisional head Delhi.
Source: shortlink.uk/1mobG

5. US FDA has issued a draft guidance to help companies reduce animal studies of experimental drugs and adopt non-animal testing tools such as newer methods, such as computer simulations and devices that mimic functions of human organs. This guidance is issued because it signals a strategic shift toward integrating non-animal data in preclinical studies, reshaping global expectations for safety evidence generation.
Source: shortlink.uk/1mobN

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 Directorate General of Foreign Trade (DGFT), has extended the Annual Remission of Duties and Taxes on Exported Products (RoDTEP) Returns filing deadline for FY 2023-24 from November 30, 2025 to March 31, 2026, with a ₹15,000 composition fee. Missing the extended deadline may lead to denial of RoDTEP benefits or scrip cancellations.
Source: h7.cl/1p1E2

2. The National Pharmaceuticals Pricing Authority (NPPA) has directed manufacturers and marketing companies to revise the Maximum Retail Prices (MRP) of 17 life-saving cancer drugs following their exemption from Customs Duty. Downward change in Duties/taxes should be passed on to consumers at the retail level, Form V must be submitted along with issue of to dealers and NPPA.
Source: h7.cl/1jXJ8

3. The Tea Board of India has issued updated guidelines for tea warehouse licence applications and renewals. The specifications that a warehouse must meet have been specified in the guidelines. Modifications of warehouse license is allowed only for floor area changes, and renewals can be auto-processed. Non-submission of requisite documents may lead to rejection without fee refund.
Source: h7.cl/1p1DR

4. Indian Council of Medical Research (ICMR) has reportedly directed that clinical trials in India focus on local genetics, diets, and lifestyles rather than rely on Western research. The move addresses rising lifestyle diseases and aims to produce more relevant evidence. Multicentre trials with government funding will study therapies suited for Indian patients, potentially improving effectiveness and access.
Source: h7.cl/1p1Ef

5. The Department of Pharmaceuticals has reportedly invited stakeholder comments on the amended list of 354 medical devices exempted from restrictions on global tender enquiries. The exemption, valid until March 31, 2027, allows public procurement agencies to source these devices internationally, subject to review of adequate domestic manufacturing capacity.
Source: h7.cl/1jXJk

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 has constituted a committee to develop a policy governing refurbished medical devices. The committee will examine the scope of refurbished medical devices, methodology to evaluate the safety, performance, and remaining useful life of refurbished medical devices & suggest guidance for waste disposal of such refurbished devices.
Source: h7.cl/1o8qd

2. Indian government has announced a tax holiday until 2047 for foreign companies that provide cloud services globally using data centres located in India. Further, there will be no risk of foreign firms’ global income being taxed in India solely because they use Indian data centres. This move is aimed at attracting long-term investment into India’s digital infrastructure.
Source: h7.cl/1o8qp

3. Indian Government has released first national evidence-based lung cancer treatment and palliation guidelines. It offers 15 recommendations to standardise diagnosis, treatment and palliative care, improve early detection, reduce treatment disparities and ensure consistent, patient-centred care across the country.
Source: h7.cl/1o8qA

4. India’s Ministry of Consumer Affairs issued show-cause notices to major edible oil companies for violating the amended Vegetable Oils Products, Production and Availability (VOPPA) Order, 2025. Companies failed to submit monthly production data and register on official portals. Authorities have warned that continued non-compliance could lead to inspections and confiscation under the Essential Commodities Act, 1955.
Source: h7.cl/1o8qN

5. The United States Food and Drug Administration has launched the PreCheck pilot program to strengthen domestic pharmaceutical manufacturing. The initiative offers early regulatory engagement for new manufacturing facilities, improving predictability, streamlining facility assessments and accelerating readiness to supply medicines for the United States market.
Source: h7.cl/1o8qS

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 Food Safety and Standards Authority of India has issued draft amendments to the Food Business Licensing Regulations mandating food manufacturers to keep daily production and raw-material records and to follow FIFO/FEFO storage norms. Retailers and non-manufacturers are exempt. The move strengthens traceability, inventory control, and food safety compliance. Public comments are invited within 30 days of Gazette publication.
Source: h7.cl/1iFOX

2. Madras High Court has ruled that the word “Vapo” is a descriptive and generic term derived from “vapour” and cannot be claimed exclusively by any party, rejecting petitions seeking cancellation of trademarks for “Vaporin” products. The Court held that the rival marks and trade dress are distinct and unlikely to cause consumer confusion.
Source: h7.cl/1nG6S

3. India’s Central Government has amended Uniform Consent Guidelines under the Air and Water Acts to simplify industrial approvals and cut delays. Key changes include consolidated consents covering multiple environmental laws, faster timelines for red-category industries, and Consent to Operate remaining valid until cancelled. Inspections, audits, and cancellation powers remain to ensure environmental compliance.
Source: h7.cl/1iFAP

4. The India–EU free trade agreement is set to eliminate duties on about 90% of European medical devices imported into India, reducing tariffs that earlier went up to 27%. The agreement is expected to lower costs and improve access to advanced technologies, Indian manufacturers are seeking regulatory alignment and mutual recognition to overcome non-tariff barriers.
Source: h7.cl/1iFAU

5. The India–EU Free Trade Agreement is expected to expand opportunities for Indian traditional medicine in Europe. In EU countries where no specific regulations exist, AYUSH practitioners will be allowed to offer services based on their Indian qualifications. The agreement also provides long-term certainty for setting up AYUSH wellness centres and clinics across EU member states.
Source: h7.cl/1iFAX

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 Drug Controller General of India (DCGI) has directed all State and UT Drug Controllers to regularly sample kumkum and colour powders at religious sites for testing for synthetic ingredients due to public health concerns. Kumkum is regulated as a cosmetic in Indian law and must meet BIS standards covering heavy metal limits, microbial safety, prescribed testing methods, and mandatory packaging and labelling requirements.
Source: h7.cl/1nnwz

2. India’s Ministry of Agriculture & Farmers Welfare has released the draft Pesticides Management Bill, 2025 to replace the Insecticides Act, 1968. The farmer-centric bill proposes stronger regulation of spurious pesticides, higher penalties, digital processes, mandatory lab accreditation, and promotion of biopesticides and indigenous manufacturing. Stakeholders can submit comments in the prescribed format by 4 February 2026.
Source: h7.cl/1inPA

3. The Tea Board of India has issued revised guidelines for registration of manufacturers of flavoured tea, reaffirming that every factory manufacturing flavoured tea must be registered as a bonafide manufacturer with the Tea Board. This makes the registration process for flavoured tea manufacturers clearer and more structured.
Source: h7.cl/1nnx8

4. The European Parliament has approved measures to strengthen EU supply of essential medicines by reducing dependence on non-EU countries. The proposals support domestic manufacturing through strategic projects, priority funding, EU-favoured procurement, joint purchasing, and coordinated stockpiles to prevent shortages of critical medicines such as antibiotics, insulin and vaccines.
Source: h7.cl/1nnwI

5. India’s Central Drug regulator has given approval to manufacture and sell a generic version of Ozempic (semaglutide) for diabetes, ahead of its patent expiry in March 2026. The company plans to launch 12 million injectable pens in the first year and partner locally for distribution. The company is also awaiting similar approval for the obesity drug Wegovy.
Source: h7.cl/1nnwM