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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. Bureau of Indian Standards is reportedly launching a scientific study on plastic food-packaging safety amid escalating temperatures and prolonged food delivery-times across India. The initiative will evaluate practical performance of materials like PET, recycled PET, polycarbonate and laminated films under heat and humidity, and may prompt revisions to the Food Safety and Standards (Packaging) Regulations, 2018 and higher compliance demands for food-delivery platforms.
Source: rb.gy/rl81wz

2. Punjab health authorities have directed all civil and district hospitals and medical colleges to immediately suspend and quarantine all batches of the anti-haemophilia Factor IX concentrate after reports of adverse reactions. The action is a precautionary step while the Punjab Health Systems Corporation (PHSC) conducts laboratory tests to assess the product’s safety and quality.
Source: urli.info/1jkBD

3. India’s Delhi High Court has refused to allow a major consumer health company to sell remaining stocks of an ORS-type beverages, upholding regulatory ban imposed by the Food Safety and Standards Authority of India (FSSAI) on products marketed as oral rehydration solutions without meeting WHO-recommended composition standards or obtaining proper regulatory approval.
Source: urli.info/1jkBP

4. The National Organ and Tissue Transplant Organisation (NOTTO) under the Ministry of Health and Family Welfare has reportedly revised guidelines so that COVID-19 testing is no longer mandatory for asymptomatic organ donors or recipients, except in lung transplant procedures where RT-PCR remains essential.
Source: urli.info/1jkBW

5. The Pharmacy Council of India has reportedly directed state pharmacy councils to submit updated lists of registered pharmacists, including registration validity, email IDs, mobile numbers, etc. by November 30, 2025. The direction follows the July 31 deadline delay and aims to support the Health Professional Registry under the Ayushman Bharat Digital Mission.
Source: urli.info/1jkBz

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 Trade and Economic Partnership Agreement (TEPA) with the European Free Trade Association (EFTA), effective October 1, 2025, reportedly excludes medical devices and pharmaceuticals from duty concessions, keeping them protected to safeguard domestic industries. While 92.2% of EFTA and 82.7% of India’s tariff lines are liberalised, sensitive healthcare products will face phased tariff reductions over 5–10 years.
Source: https://short-url.org/1hoSo

2. Central drug regulator (CDSCO) is reportedly set to conduct nationwide inspections and audits of cough syrup manufacturing units after child deaths in Madhya Pradesh were linked to toxic syrups. States and union territories have been directed to submit lists of manufacturers for surveillance, aiming to strengthen quality control and prevent contamination-related tragedies.
Source: https://short-url.org/1cGQR

3. Department of Pharmaceuticals has launched sensitisation programmes to guide pharmaceutical and medical technology companies on the amended Promotion of Research and Innovation in Pharma-MedTech Sector scheme. The sessions will help companies to understand the revised guidelines, and digital application process to ensure smooth participation.
Source: https://short-url.org/1cGR3

4. India’s Central food authority has issued a draft amendment to Packaging regulations 2018 to restrict the use of Poly- and perfluoroalkyl substances (PFAs) in food contact materials. It also states that food materials made with polycarbonate and epoxy resins must be free from Bisphenol A (BPA) and its derivatives. Objections / suggestions are awaited from the industry stakeholders for a period of 60 days from the date of publication.
Source: https://short-url.org/1hoTb

5. State drug inspectors are reportedly seeking enforceable powers to arrest and detain offenders, aiming to curb the growing menace of spurious drugs. The demand follows the recent incident involving contaminated cough syrup sold to paediatric patients, which resulted in multiple child deaths.
Source: https://short-url.org/1hoTt

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 authority has mandated manufacturers of pharmaceuticals to comply with strict testing of raw materials and excipients of every batch and each batch of final product and maintaining records. During inspections, State and UT Drug Controllers will inspect the licensee’s batch release records, ensure there is a robust vendor qualification system, and confirm that raw materials are sourced only from approved vendors.
Source: https://short-url.org/1csET

2. Central Drugs Standard Control Organization (CDSCO) has launched a 100-day awareness campaign on the Goods and Services Tax reduction on medicines and medical devices. Chemists and druggists associations are directed to encourage their members to display awareness posters at pharmacies. Compilation of photographs of the activities undertaken are to be submitted to CDSCO’s headquarter.
Source: https://short-url.org/1csHq

3. The Department of Consumer Affairs has granted three-month permit to leading FMCG, personal care, and medical device firms to use preprinted packaging despite labelling errors. Corrections such as unit sale price, company name, or customer care information must be declared using stamping, stickers, or online printing.
Source: https://short-url.org/1csCZ

4. India has notified its first binding Green House Gas (GHG) emission intensity targets for aluminium, cement, chlor-alkali, and pulp & paper sectors under the GHG Emission Intensity Target Rules, 2025. Industries must reduce emissions per output unit, trade carbon credits, and face penalties for non-compliance, boosting market-driven decarbonization.
Source: https://short-url.org/1habB

5. India’s Central Drug Regulator, CDSCO, has issued a notice inviting stakeholder comments to address disparities in new drug approvals. While the first applicant must conduct full local clinical trials and bioequivalence studies, subsequent applicants gain approval based solely on chemical, pharmaceutical, and bioequivalence data. This creates inequality in regulatory burden and costs. CDSCO seeks feedback by November 7, 2025, to develop fairer drug approval policies.
Source: https://short-url.org/1csDm

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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 National Pharmaceutical Pricing Authority has ordered drug and medical device importers, manufacturers, and brand owners to revise MRPs from September 22, 2025, in line with GST Council decisions. Firms must issue revised price lists, inform dealers, retailers and consumers about the reduction in GST rates, and publish advertisements, while re-labelling old stocks is optional if compliance at the retail level is ensured.
Source: short-url.org/19LMW

2. Directorate General of Health Services (DGHS) has revoked its earlier order barring physiotherapists from using the “Dr” prefix, after receiving recommendations from the National Commission for Allied and Healthcare Professions (NCAHP) and facing strong objections from professional bodies. The previous directive, said physiotherapists are allied health professionals and not entitled to use “Dr” to prevent misleading patients. DGHS stated the matter requires further examination.
Source: short-url.org/19LN2

3. With new GST rates kicking in from September 22, 2025, FMCG companies are urging the government to allow sales of products in current packaging (with old MRP) but at revised lower prices. They warn that forcing re-packaging could lead to over ₹2,000 crore in packaging waste and major losses across supply chains.
Source: short-url.org/19LNc

4. The Supreme Court has asked all Indian state governments to reply in four weeks about how they are enforcing the Pre Conception and Pre Natal Diagnostic Techniques Act, giving data since May 1, 2015, on prosecutions, acquittals, and appeals, after noting that many acquittals are never challenge.
Source: short-url.org/1ekQ6

5. India’s Union Minister of State for Health has reportedly inaugurated the National Virus Research & Diagnostic Laboratory (VRDL) Conclave 2025, announcing a new portal and protocols for in-vitro diagnostics (IVD) validation. The initiative aims to speed up and simplify validation. India is also expanding VRDL capacity, bio-safety labs, and outbreak surveillance.
Source: short-url.org/19LNy

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 authority has launched a new CT 04 application module on its SUGAM online portal, streamlining the issuance of import licences for cell & gene therapeutic products to simplify and accelerate regulatory compliance and imports.
Source: bit.ly/3TGuNmR

2. A Central Drugs Consultative Committee panel has noted consumer complaints over unreadable expiry dates, tiny fonts, glossy packaging, and generic-brand confusion on medicinal products. It recommends forming a DCGI-led sub committee including a packaging expert to overhaul labelling norms and evaluate regulatory requirements for packaging suppliers under Drugs Rules, 1945.
Source: bit.ly/3IpVF8h

3. Food Safety and Standards Authority of India (FSSAI) has recently directed licensing authorities to audit annual returns filed by food business operators on the FoSCoS platform. Authorities have been directed to flag inconsistencies, permit revisions via updated portal features, and enforce penalties for false declarations.
Source: bit.ly/4lpGH0p

4. The Central Board of Indirect Taxes and Customs has mandated that customs officers verify the registration of plastic raw material importers on the Centralized Extended Producer Responsibility (EPR) Portal before clearing consignments. This directive aligns with the Plastic Waste Management (Amendment) Rules, 2024.
Source: bit.ly/3TYREu9

5. The Government of India has reportedly planned to transfer the National Health Claims Exchange (Insurance claims platform) from the health ministry to the finance ministry under Insurance Regulatory and Development Authority’s oversight to combat inflated hospital bills for insured patients.
Source: bit.ly/40hID2M

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 Indian Medical Association (IMA) has challenged the Maharashtra government’s decision allowing homeopaths to prescribe allopathic medicines after six months of certified training, calling it a threat to public health. The IMA has filed a petition in the Bombay High Court, urging an expedited resolution of the matter.
Source: bit.ly/4kl20ip

2. A government panel, the Drugs Consultative Committee (DCC) under CDSCO, has directed State Licensing Authorities not to issue manufacturing licenses for new drugs without prior approval from the Central Licensing Authority (CLA), as mandated by New Drugs Clinical Trial Rules 2019.
Source: bit.ly/3GC8A6l

3. India’s NITI Aayog has setup an expert panel to review quality concerns in India’s pharmaceutical manufacturing. It will assess regulatory gaps and challenges across 3,000 companies and 10,500 units. The goal is to align production with global standards, boost compliance, and ensure patient safety to uphold India’s global medicine supplier status.
Source: bit.ly/3GvWBHB

4. The Drugs Consultative Committee (DCC) has recommended inclusion of detachable Braille cards and voice-enabled QR codes on medicine packaging to enhance accessibility for visually impaired patients. The proposal aims to standardize inclusive labeling across pharma products, aligning with patient-centric and accessibility-first regulatory reforms.
Source: bit.ly/3TttpUw

5. The Drugs Consultative Committee (DCC) has approved amendments to Forms 27D/27DA and 28D/28DA under the Drugs Rules, 1945, enabling manufacturers to apply for licenses to produce stem cell-derived, gene therapy, xenograft, and modified-release products via both state and central authorities.
Source: bit.ly/3Ii5o0f

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. Medical device companies have raised concerns over Uniform Code for Marketing Practices for Medical Devices (UCMPMD) and have approached the Department of Pharmaceuticals, citing overreach and operational challenges, particularly in the context of a DGHS advisory that restricted medical representative’s interactions with HCPs in government hospitals.
Source: bit.ly/3InfXiu

2. India’s Central Drugs Standard Control Organisation (CDSCO) is working on making drugs/medicine packaging more readable. The move aims to improve visibility of key details like expiry dates and dosages, addressing concerns over hard-to-read glossy labels. Proposed measures include clearer print standards and digital aids such as voice-enabled QR codes and Braille cards to enhance accessibility and consumer safety.
Source: bit.ly/46oMIpA

3. India’s Drugs Consultative Committee (DCC) has agreed to amend the Drugs Rules, 1945, to include Good Distribution Practices (GDP) guidelines for pharmaceutical products as a separate schedule. The decision follows detailed deliberations and stakeholder consultations to align with revised WHO guidelines.
Source: bit.ly/4lxABuC

4. The U.S. FDA is reportedly planning to revise the labeling for all extended-release stimulants prescribed for attention-deficit hyperactivity disorder (ADHD), requiring inclusion of a “limitation of use” section with a statement on higher rates of adverse reactions in children younger than six years.
Source: bit.ly/4l2REoA

5. The European Commission has amended its regulation to allow electronic instructions for use (eIFUs) for all medical devices intended for professional use, not just high-risk ones. Paper instructions are still required if the device could also be used by patients. eIFUs must be linked in Eudamed (the European medical device database).
Source: bit.ly/4lcdMx1

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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 in Kerala has reportedly stated that there is no objection to display discount on flex board of retail drug stores. However, all retail drug stores are required to display a price list of medicines which will allow consumer to evaluate which drugs are available at a discount and make informed choices.
Source: bit.ly/4ctkgT3

2. As per India’s Central Food Regulator, the claim of 100% fruit juice on packaging of juices which are reconstituted from fruit concentrate, or which are not reconstituted but to which water has been added, is misleading and therefore prohibited. Any pre-printed packaging material which contains the misleading claim should be utilized by the Food Business Operators (FBOs) before 31st December 2024. Fruit juices manufactured before 31st December 2024 but which carry the misleading claim on the package will be permitted to be sold in the market until their expiry.
Source: bit.ly/4fV2gDN

3. A trademark infringement suit filed by a U.S. fast-food burger chain has been decided in favor of a Pune-based burger joint on the grounds of prior use and honest use in India.
Source: bit.ly/4dGZLmY

4. Indian medical gloves manufacturers have raised strong objection with Indian government about ongoing import of chlorinated gloves into India despite there being a ban on its use by healthcare facilities.
Source: bit.ly/3AyqQdG

5. 12% of all spices tested between May and July have reportedly failed to meet quality standards.
Source: bit.ly/3AwNV0b