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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

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TOP 5 HEALTH LAWS & POLICY UPADATES

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 of India has notified the Legal Metrology (Packaged Commodities) Second Amendment Rules, 2025, effective 1 February 2026. The amendment removes pan masala from an earlier exemption, mandating that all pan masala packages, regardless of size, must fully comply with the standard declaration requirements prescribed under the rules.
Source: h7.cl/1kzQU

2. Central Pollution Control Board has issued a notice allowing plastic packaging producers, importers, and brand owners facing a shortage of Cat II/III recycling certificates to use End-of-Life (EOL) certificates to meet their FY 2024–25 recycling obligations. Now, 1 ton of Cat II/III recycling obligation can be fulfilled using 1.5 tons of EOL certificates.
Source: h7.cl/1kzQI

3. The U.S. Food and Drug Administration (FDA) has issued draft guidance reducing or eliminating the requirement for non human primate toxicity testing for certain monoclonal-antibody therapies. This change may shorten preclinical timelines and lower costs, while promoting alternative safety evaluation methods.
Source: h7.cl/1fEU5

4. India’s drug regulator has been alerted that fake versions of widely used medicines may be circulating after Puducherry officials seized several suspected counterfeit samples. States and Union Territories have also been asked to maintain “strict vigil” on the movement of these batches of widely popular medicines.
Source: h7.cl/1kw0M

5. The Supreme Court has issued notice to the Union Government on a petition seeking a statutory framework for criminal prosecution in medical negligence cases. The plea highlights that no rules have been created despite the Jacob Mathew judgment in 2005 and urges independent, multi-stakeholder inquiry panels to ensure fair, unbiased investigations.
Source: h7.cl/1fETM

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 Central Pollution Control Board (CPCB) has issued a notice to producers, importers, and brand-owners (PIBOs) who have not filed their plastic packaging Extended Producer Responsibility (EPR) annual returns (AR) for FY 2024-25. The AR filing deadline was extended to November 30, 2025, and CPCB has warned that environmental compensation will be levied on non-complying entities.
Source: minilink.pro/1jAk4

2. The Indian government is reportedly set to impose a minimum import price (MIP) on about 10 critical pharmaceutical raw materials, targeting underpriced Chinese imports. The move aims to protect domestic API producers amid concerns over dumping and strategic dependence on China.
Source: minilink.pro/1jAki

3. A Munich court has reportedly held that an AI system unlawfully reproduced copyrighted lyrics from multiple songs, ruling that the model had memorized protected content during training. The court rejected arguments based on data-mining exemptions and user liability. This ruling sets an important precedent for copyright protection in AI-driven economy.
Source: minilink.pro/1jAkl

4. West Bengal has flagged off 110 self-sufficient Mobile Medical Units (MMUs), each equipped for 35 free clinical tests including blood tests and X-rays with doctors, nurses, and technicians onboard. The initiative, partly funded via MPLAD, targets healthcare delivery in remote, hilly, and tribal regions.
Source: minilink.pro/1jAkZ

5. Chief Executive Officer of Food Safety and Standards Authority of India has directed all the States/Union Territories to fast-track food-safety grievance redressal with fortnightly reviews and publish enforcement actions daily. He also directed mandatory NABL accreditation and optimal use of High-End Equipment in labs, emphasizing data-driven decisions, streamlined licensing, and stronger centralized surveillance for nationwide food-safety reliability.
Source: minilink.pro/1jAkx

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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. 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

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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 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

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Labelling requirements under Plastic Waste Management Rules, 2016

As per Plastic Waste Management Rules, 2016, until 1st July 2025, the mandatory declarations on the label of the plastic packaging material should be mentioned on each category of plastic packaging material or plastic packaging of the product. However, starting from 1st July 2025, the declarations can be made in one of the following ways. Please note that this requirement is not in addition to the existing requirements rather a relaxation to declare the mandatory declarations on the plastic packaging material.

Link to the amendment copy: bit.ly/41hEGun

  •  In a barcode or Quick Response (QR) code printed on the plastic packaging
  • In the product information brochure
  • Printed on each individual plastic packaging material
  • Printed on the plastic packaging with the unique number issued under any applicable law (awaiting more clarity from CPCB on this point)

Additionally, the manner of declaration must also be communicated to CPCB.

The labelling requirements required to be printed on plastic packaging material are described below:

  • Name of the importer/brand owner
  • EPR registration certificate number.
  • Thickness of flexible plastic packaging (e.g., plastic sachets, pouches, covers, and carry bags).
  • For recycled plastic packaging: Please declare “recycled having [—–specify percentage—–] of recycled plastic” along with a mark as shown below and conform to the Indian Standard: IS 14534: 2023 titled as “Plastics — Recovery and Recycling of Plastics Waste — Guidelines”

  • The acronyms PET (Polyethylene terephthalate), HDPE (High-density polyethylene), V (Vinyl/PVC), LDPE (Low-density polyethylene), PP (Polypropylene), PS (Polystyrene), and “Other” mentioned above refers to all other resins and multi-materials like ABS, PPO, PC, PBT, etc.
  • For compostable plastic packaging: Please declare “compostable only under industrial composting” and comply with IS/ISO 17088:2021, titled “Specifications for Compostable Plastics.”
  • For biodegradable plastic packaging: Please declare “Biodegradable in [— specify number of days —] only in the [— specify recipient environment, e.g., soil, landfill, water, etc. —].”
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 Pollution Control Board (CPCB) has clarified that producers of plastic packaging in the micro & small category do not have to EPR fulfill obligations with effect from Financial Year 2023-24. However, they will have to file annual returns for the financial year 2023-24.
Source: bit.ly/3JqZRBH

2. India’s Directorate General of Trade Remedies (DGTR) has initiated an anti-dumping probe into Vietnamese imports of calcium carbonate filler masterbatch to determine how these imports affect the nation’s domestic industry. The medical sector uses this product for pouches, blister packaging, and individual-wrap containers. The DGTR will examine market patterns, injury claims, alleged dumping tactics and anti-dumping measures necessary to shield local manufacturers from unfair competition.
Source: bit.ly/3AF2Vtc

3. India’s Ministry of AYUSH has notified the Drugs (Fifth Amendment) Rules, 2024, which revise licensing procedures for homoeopathic medicines. The requirement for renewing manufacturing and loan licenses has been removed, making it valid in perpetuity subject to submission of self declaration.
Source: bit.ly/3YT6BBc

4. The State Drug Controller of Tamil Nadu has reportedly clarified that there is no legal provision for issuing separate licenses for pharmaceutical marketing companies or marketers. Pharmaceutical marketers and other stakeholders have been advocating for an amendment to the Drugs and Cosmetics Act (D&C Act) to include a provision for granting separate licenses for pharmaceutical marketers.
Source: bit.ly/3CbsZNh

5. In an effort to reduce exaggerated health claims made by supplement manufacturers about illness treatment or risk reduction, the government panel have proposed to transfer power from the Food Safety and Standards Authority of India (FSSAI) to a drugs regulator. The expert group was initially formed to examine how to handle the challenges that overlap between drugs and nutraceuticals.
Source: bit.ly/3YSrjRG

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TOP 5 HEALTH LAWS AND POLICY UPDATES

The new criminal code, Bharatiya Nyaya Sanhita (BNS) has replaced the Indian Penal Code (IPC) and introduced stricter penalties for medical negligence. Registered Medical Practitioners can now face up to two years in jail and fines for medical negligence. The new law will apply from July 1, 2024.
Source: bit.ly/3RXnx5t

The Central Pollution Control Board (CPCB) has extended the last date of filing of annual returns by the registered producers, importers, brand owners (PIBOs) and plastic waste processors for FY 2022-24 and FY 2023-24 respectively till September 2024. The earlier timeline to file the annual returns were June 30, 2024 and April 30, 2024 respectively.
Source: bit.ly/3XQtxAY

In an effort to decrease reliance on imports and to promote domestic production of medical devices, the Department of Pharmaceuticals (DoP) reportedly intends to launch a new program that will provide shared facilities for medical device parks or clusters that are formed with the exclusive financial assistance of the state governments.
Source: bit.ly/3xU6b2u

The Enforcement Directorate (ED) is investigating an alleged nationwide network of contraband dealers and has placed several pharmaceutical companies under scrutiny who are engaged in the production of drugs and opioids as a measure to prevent the creation of illicit distribution networks through fraudulent sale and supply bills.
Source: bit.ly/3VNzoEw

The United States Food and Drug Administration (USFDA) has published a draft guidance that removes the requirement of undertaking switching studies for applicants undertaking an approval for treating Biosimilars as interchangeable. The USFDA has now made switching studies optional for biosimilar approvals. Hence, persons applying for approval for Biosimilars may now use computer modelling based on the current acceptable analytical technologies to demonstrate the Biosimilars as interchangeable.
Source: bit.ly/4eQUudy

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TOP 5 HEALTH LAWS AND POLICY UPDATES

India’s Central Pollution Control Board has issued final warning to all Producers, Importers, Brand Owners and Plastic Waste Processors, to complete Extended Producer Responsibility (EPR) registration on dedicated EPR portal latest by June 30, 2024, or face punishment.
Source: bit.ly/4cgRsxK

India’s Health Ministry has published Guidelines for Ethical Use of Leftover De-identified/ Anonymous Samples for commercial purposes.
Source: bit.ly/3RIc0XE

The Committee on Energy and Commerce in Congress of the United States of America has sought reply from US Food and Drugs Administration (US FDA) about institutional weaknesses in US FDA’s foreign inspection program over variations in inspection outcomes from India and China.
Source: bit.ly/3RF3xEH

India’s Karnataka High Court has formed a sub-committee to draft rules for establishing Intellectual Property Division (IPD) in Karnataka High Court. IPD benches are established with specialised judges to cater to Intellectual Property Disputes.
Source: bit.ly/4bmOVR8

India’s Kerala High Court, in a recent case, has framed guidelines for prosecuting guardian of a minor, or the owner of a vehicle driven by a minor, for offences involving vehicle driven by the minor.
Source: bit.ly/3RHALDn