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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 central licensing authority, CDSCO has issued an alert on the theft of Lantus® SoloStar® insulin (Batch No. 5F0347B) belonging to Sanofi India during transit in Odisha. As the product requires cold-chain storage at 2–8°C, quality risks exist. CDSCO has issued an advisory to healthcare professionals, patients and regulators.
Source: short-url.org/1qgYH

2. India’s central drug regulator reportedly circulated a proposal from the Ministry of Cooperation that would allow Primary Agricultural Credit Societies (PACS) to operate Jan Aushadhi Kendras without registered pharmacists through restricted drug licences, aiming to expand access in underserved areas. The pharmacist community has raised serious concerns, arguing this move could weaken professional standards and patient safety.
Source: short-url.org/1qgYM

3. The Food Safety and Standards Authority of India has issued draft amendments to the Food Products Standards and Food Additives Regulations, 2011 proposing several changes. Stakeholders may submit objections or suggestions within sixty days from publication of the notification. The authority will consider all representations before finalising the proposed regulatory amendments.
Source: short-url.org/1qgYz

4. A court has granted interim relief in a trademark dispute involving the shape of a toilet cleaner bottle. It held that product shape can receive trademark protection even after design registration expires. Observing strong similarity between competing bottles, the court restrained sale of the allegedly infringing product pending further proceedings.
Source: short-url.org/1qgZN

5. The Madras High Court has stayed a single judge’s observation declaring the term “Vapo” as public property in a trademark dispute concerning vapour-based medicinal rubs. The Division Bench held that the finding requires further examination, while allowing continued use of the contested registered mark pending adjudication of the appeals.
Source: short-url.org/1l8DX

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 National Pharmaceutical Pricing Authority (NPPA) has approved the upward increase of (+) 1.74028% in the Wholesale Price Index (WPI) for all scheduled formulations. Importers and manufacturers of scheduled drugs and medical devices may increase the Maximum Retail Price (MRP) based on this WPI without prior approval from the government.
Source : bit.ly/3DWXVC8
Source : bit.ly/42jXgUs

2. The Central Board of Direct Taxes has raised the threshold of safe harbour provisions for Service Providers who provide R&D services relating to generic pharmaceutical drugs, from INR 200 crore to INR 300 crore.
Safe harbour provisions protect group companies who undertake international related party transactions from transfer pricing scrutiny.
Source: bit.ly/3Rpk3YK

3. A leading beverage brand has moved to Delhi High Court against Food Safety and Standards Authority of India’s ban on using “100% Fruit Juice” claim on label and advertisements of reconstituted fruit juices. The court denied an interim stay and set next hearing on April 1, 2025.
Source: bit.ly/3DUIZnX

4. The Supreme Court of India has ordered all states to set up a grievance redressal mechanism for misleading advertisements of medicines and cures within two months. It has directed all the authorities to take quick action, file cases if needed, and raise public awareness. The central government is also directed to finalize the complaint dashboard within three months.
Source: bit.ly/3FKNjXq

5. European Union has reportedly proposed to update the cosmetic ingredient glossary in Regulation (EC) No 1223/2009, replacing Commission Implementing Decision. This aims to standardize ingredient labeling and improve ingredient identification. The proposal, announced on March 13, 2025, is expected to be approved by second quarter of 2025.
Source: bit.ly/4c60PRH

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 drug price control authority, the National Pharmaceutical Pricing Authority (NPPA) has issued an Office Memorandum instructing drug manufacturers to revise the prices of the drugs on which customs duty has been reduced.
Source: bit.ly/4gNNEVW

2. The Materiovigilance Programme of India’s Ministry of Health and Family Welfare has published an updated Draft Adverse Event Reporting Form for In-Vitro Medical Devices seeking public comment. The last date for receiving public comment is 5th March 2025.
Source: bit.ly/3Qn7kW2

3. In its recent meeting, the Drugs Consultative Committee (DCC), a policy advisory committee to India’s drug regulator, has raised the proposal to include Anti-microbial drugs in the definition of “New Drug” under the New Drugs and Clinical Trial (Rules), 2019 in an attempt to heighten the oversight of antimicrobial drugs.
Source: bit.ly/3QqZlao

4. India’s Union Ministry of Health and Family Welfare has revealed plans to include the human papillomavirus (HPV) vaccine in the national immunization program this year. During the recent Budget session of Parliament, Minister of State for Health stated that the details for its implementation are currently being worked out.
Source: bit.ly/4hH6dMR

5. Representatives of the Pharmaceutical industry in the United States are set to meet with the new administration in a bid to revise price-control regulations, and the United States government’s right to negotiate Drug Prices with pharmaceutical companies.
Source: bit.ly/4i5UEP4

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 government has extended the deadline for small and medium pharmaceutical companies to comply with the revised Good Manufacturing Practices (GMP) under Schedule M of the Drugs and Cosmetics Act. The revised deadline is December 31, 2025, while the earlier deadline was January 1, 2025. This extension aims to assist smaller manufacturers in upgrading their facilities to meet stringent regulatory requirements.
Source: bit.ly/4a4HaAo

2. The Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR) have released draft standard evaluation protocols for licensing in-vitro diagnostics (IVDs) under the Medical Devices Rules, 2017. These protocols aim to ensure quality and performance evaluation of IVDs, establishing uniformity in testing across various diagnostic kits. Stakeholders are invited to provide their feedback on the draft by February 15, 2025.
Source: bit.ly/40kTlWt

3. The Ministry of Electronics and Information Technology (MeitY) has released the draft Digital Personal Data Protection Rules, 2025, inviting public feedback until February 18, 2025. These rules aim to operationalize the Digital Personal Data Protection Act, 2023, which was enacted to enhance the framework for protecting digital personal data in India. The draft includes provisions for data localization, compliance requirements for significant data fiduciaries, timelines for storing data and ensuring that personal data is processed responsibly.
Source: bit.ly/3C63oFx

4. The Ministry of Commerce and Industry has launched the Open Network for Digital Commerce (ONDC) initiative to democratize digital commerce in India by fostering open networks for the exchange of goods and services. This initiative focuses on inclusivity, enabling small and medium enterprises (MSMEs) to access digital marketplaces while promoting innovation through open protocols. By creating a level playing field, ONDC seeks to reduce the dominance of large e-commerce platforms and enhance competition among sellers.
Source: bit.ly/4gHo1al

5. The Telangana Medical Council has issued a show-cause notice to a Hyderabad-based hospital for allegedly collaborating with unqualified practitioners and promoting fake doctors. This action follows the hospital’s involvement in sponsoring the medical program and advertising the same on social media, where unqualified individuals were reportedly encouraged. The hospital has been given a 10-day deadline to respond; failure to do so may result in punitive actions under the National Medical Commission (NMC) Act and other regulations.
Source: bit.ly/3BWAQhM