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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 Central Pollution Control Board (CPCB) has extended the deadline for registered Producers, Importers, Brand Owners (PIBOs) and Plastic Waste Processors (PWPs) for filing annual returns under the Plastic Waste Management Rules, 2016 until 31st January 2026. The previous deadline for filing of annual returns was November 30, 2025.
Source: h7.cl/1iapl

2. India’s Central Pollution Control Board (CPCB) has issued a notice clarifying implementation of Extended Producer Responsibility (EPR) guidelines for plastic packaging, permitting regulated inter-category certificate purchases only until FY 2025–26. Producers, importers, and brand owners will then be prohibited from cross-category adjustment of surplus EPR certificates and barred from using end-of-life certificates for recycling targets.
Source: h7.cl/1n9HG

3. The Union Health Minister has directed CDSCO and the Department of Pharmaceuticals to find a workable solution to industry concerns over revised Schedule M GMP norms. The revised guidelines necessitate structural and layout changes to facilities, setting up rigorous quality control systems, and training personnel. The Ministry is considering deadline extensions or relaxations following consultations with industry bodies, particularly for small and medium manufacturers facing compliance issues.
Source: h7.cl/1n9HM

4. The High Court of Allahabad has dismissed petitions by directors and officials of a major drug manufacturer challenging summons for alleged violations under the Drugs and Cosmetics Act after a test analysis found samples to be of substandard quality. The analysis found the presence of ethylene glycol in cough syrup, a toxic industrial chemical. The Court found the summons lawful, as the officials were responsible for the company’s business conduct.
Source: h7.cl/1n9HR

5. India’s Delhi High Court has upheld the rejection of a foreign drug manufacturer’s patent application for a nematode-based cancer detection method, ruling it a non-patentable diagnostic process under the Patents Act, 1970. The court said the invention performs essential diagnostic steps and cannot bypass exclusion by being labelled as screening or in-vitro testing.
Source: h7.cl/1iar0

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 Health Ministry has approved adding the HPV vaccine to the Universal Immunisation Programme, targeting girls aged 9–14. This aligns with the June 2022 NTAGI recommendation and is supported by ongoing frontline healthcare worker training and rollout planning.
Source: shorturl.at/3e0T0

2. Meghalaya announced plans to introduce legislation requiring mandatory HIV/AIDS testing prior to marriage. The government is drafting a cabinet note and engaging district stakeholders to advance a mission mode HIV control policy.
Source: tinyurl.com/yfhymxdx

3. The India-UK Free Trade Agreement, signed on July 24, 2025, excludes patent term extensions and data exclusivity, safeguarding India’s generic drug industry. However, experts warn it restricts compulsory licensing by promoting voluntary licences and “adequate remuneration” clauses, and that this could undermine India’s ability to supply affordable medicines to developing countries.
Source: tinyurl.com/3wm9wwz9

4. The All-India Organisation of Chemists and Druggists (AIOCD), representing over 12 lakh chemists nationwide has reportedly urged the Drug Controller General of India to take urgent action, alleging that State Licensing Authorities are failing to stop illegal e pharmacies misusing draft notifications leading to unregulated online medicine sales and posing risks to public health.
Source: tinyurl.com/39b9a44n

5. Nathealth urged Niti Aayog to simplify healthcare regulations through a digital single-window system, highlighting burdensome compliance from 10–12 ministries. A white paper identified 85 regulatory challenges, calling for harmonisation across states to boost efficiency, innovation, and patient-focused care in hospitals, diagnostics, and medtech.
Source: tinyurl.com/5582rp5n

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s Consumer Affairs Ministry’s is proposing to amend labelling and packaging regulations for pre-packaged goods. Currently, certain large packages, like those exceeding 25 kilograms or liters, are exempt from displaying crucial information. This includes details like the maximum retail price (MRP), the date by which the product should ideally be consumed (best before date), who manufactured it, and where it came from (country of origin). Other exempt categories include cement, fertilizer, agricultural produce in 50 kg bags, and products destined for industrial or institutional use. The proposed amendment aims to close this loophole and ensure all these bulk packages are labelled clearly and consistently, just like retail products.
The proposed amendments are open for public consultation till 29th July 2024.
Source: bit.ly/4cZPiCG

2. Maharashtra state in India has reportedly announced a ban on sale of energy drinks with high caffeine content within 500-meter radius of schools. This directive aims to safeguard student health.
Source: bit.ly/467rxGj

3. India’s Karnataka Medical Council (“KMC”) has issued a show cause notice to a dermatologist alleging violation of Code of Medical Ethics, 2002 for advertising drugs/medicines on social media. The action on the part of KMC comes after it received a complaint from Indian Association of Dermatologist, Venerologists and Leprologists.
Source: bit.ly/3zLuAYY

4. India’s drugmakers are pushing the government to loosen price controls. They propose exempting all medicines under ₹5 and extending the exemption for patented drugs (currently 5 years) to 10 years. This comes amid rising costs for ingredients, prompting them to request a reduction in GST on these materials. The industry argues stricter controls stifle research and development.
Source: bit.ly/3S7oqIF

5. Indian Supreme Court has rejected Doctor’s plea for improved security, which is filed by a Delhi Medical Association. The apex court was hearing the DMA’s petition which also sought directions to the authorities to ensure adequate security at hospitals and medical centres to prevent attacks on doctors and healthcare workers by patients’ relatives and others. The Apex Court stated that currently laws exist to deal with such instances.
Source: bit.ly/3Ln9Fh9

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.

Corporate hospitals may soon have to comply with advertisement norms applicable to doctors

India’s National Medical Commission (NMC), which regulates the conduct of medical practitioners (doctors), has endorsed the position that all hospitals should comply with the same standards of ethics as are applicable to doctors under the NMC Registered Medical Practitioner (Professional Conduct) Regulations, 2023. The operation of 2023 Regulations is currently under suspension.
Source: bit.ly/3vpJ7aV

High Court imposes damages of 244 crores in Standard Essential Patents case

India’s Delhi High Court has reportedly imposed damages amounting to INR 244 Crores on an Indian smartphone manufacturer. The Court found smartphone manufacturer guilty of infringing seven patents on 2G, EDGE, and 3G technology granted to a global telecom company. The order is expected to be out soon.
Source: bit.ly/3TxOXyI

Drug Manufacturers will have to upload all product details on Government portal soon

The Drugs Consultative Committee (DCC), a committee comprising State-level Drug Regulators, has recommended that the Central Drugs Regulator, Central Drugs Standard Control Organization (CDSCO), should set a deadline for manufacturers of drugs to upload list of drugs manufactured on an online portal called SUGAM.
Source: bit.ly/3TxP0uo

Ban on trade of ferocious dog breeds has been stayed in various States in India

India’s Kerala High Court, Karnataka High Court and Kolkata High Court has stayed a controversial circular of the Central Government which prohibited import, trading and selling of 23 breeds of dogs identified as ferocious in the circular. The circular also mandated sterilization of dogs from further breeding as pets. The circular has been challenged on the ground that it is unscientific, not based on evidence and has been issued without consultation with relevant stakeholders.
Source: bit.ly/3TVZcyi

European Medicines Agency urges sponsors of clinical trials to register on new portal before January 2025 deadline

The European Medicines Agency (EMA) has strongly advised sponsors of clinical trials that have been approved before 31 January 2023 to submit application to move the clinical trials to the new Clinical Trials Information System (CTIS) as soon as possible, considering it will take EMA up to three months to review and authorize the application. As of now, only 20% of clinical trials have been moved to the new platform.
Source: bit.ly/3TZRzHl