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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 Tamil Nadu Online Gaming Authority has introduced regulations making Know Your Customer (KYC) mandatory for players before they can engage in online real-money gaming. This ensures age verification, promotes responsible gaming, and aims to curb gaming disorder, recognized by the WHO in ICD-11.
Source: bit.ly/3XMtzsq

2. An E-commerce giant in India has introduced a new pricing policy that enables sellers to set a ‘bank settlement value, while the platform controls the final listing price after fees and discounts. Sellers express concerns that this could violate FDI norms, promote anti-competitive pricing, and disrupt pricing parity across platforms.
Source: bit.ly/3FpxrcM

3. The Canadian government has proposed regulating caffeine as a supplemental ingredient, requiring cautionary labels on products with high caffeine content to prevent excessive intake and ensuring that caffeine-containing products are clearly labelled, “Do not [eat/drink] on the same day as any other source of caffeine.”
Source: bit.ly/4bQzRx5

4. The Canadian government is set to regulate harmful ‘forever chemicals’ (PFAS) found in everyday products to address growing concerns about human health and the environment. The anticipated new regulations will restrict per- and polyfluoroalkyl substances (PFAS) in a range of everyday items, including cosmetics, clothing, and food packaging.
Source: bit.ly/3DKQhKM

5. The European Commission aims to reduce reliance on Asian countries for essential drugs, including antibiotics, through the draft Critical Medicines Act. The upcoming law seeks to promote fair pricing for European generic drugmakers, ensure stable and reliable supply chains within the EU, and strengthen public health protection and security.
Source: bit.ly/422yzvy

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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 District Consumer Court in Jaipur has issued legal notices to certain Indian film actors for making misleading claims in a pan masala advertisement and misrepresenting the product. The petition seeks action against the actors for misleading consumers with false claims.
Source: bit.ly/3XH8gbQ

2. India’s top music labels have filed a suit against an AI company on grounds that AI Company has used copyrighted music and sound recordings to train its AI models without authorization. The outcome of the suit will bring clarity on the legality of use of copyrighted material by AI companies to train AI.
Source: bit.ly/4ilUqnz

3. Indian rubber glove manufacturers have raised concerns over the import and stockpiling of low-quality, non-medical gloves by importers in anticipation of potential notification of Medical and Surgical Gloves (Quality Control) Order (QCO). After QCO, only BIS certified gloves for medical use will be permitted to be sold in India.
Source: bit.ly/3Dna2YV

4. The former CEO of a leading U.S. diagnostic company has reportedly pleaded guilty to charges over defective lead-testing devices that posed a public health risk. The company had failed to inform US Food and Drug Administration about inability of its product to meet the claims made on the label and was prosecuted for marketing misbranded products.
Source: bit.ly/41Dod3X

5. India’s National Pharmaceutical Pricing Authority (NPPA) will reportedly consider additional data sources, including IPDMS, web sources, and market surveys, to set ceiling prices for scheduled formulations. This decision comes in wake of concerns about the limited coverage of Pharmatrac, particularly regarding hospital supply products.
Source: bit.ly/41Doh3H

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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 Bombay High Court is set to decide whether donuts and cakes should be classified under restaurant services or as separate bakery products under the Goods and Services Tax (GST) framework. The former attracts a 5% GST, while the latter could be taxed up to 18%. This decision has the potential to impact the broader food service and bakery industries, as this classification may lead to higher prices for the end consumers.
Source: bit.ly/4hdF4Aj
Source: bit.ly/3F4Nw7H

2. India’s Gujarat High Court has directed enforcement of noise pollution control rules, and to frame a policy for tackling noise pollution. This direction is pursuant to alleged non-implementation of Supreme Court’s existing ruling and a notification issued by the Gujarat Pollution Control Board for noise pollution.
Source: bit.ly/4iiEcv8

3. India’s Kerala High Court has ruled that adoption by step-parent cannot be permitted unless the biological parent of the child gives consent for adoption. The court emphasized that in child custody cases, adoption without consent can have serious repercussions like denial of custody to biological parent.
Source: bit.ly/3QMfbww

4. India’s Bombay High Court has described drug addiction as a “quasi-pandemic” and has called for the implementation of a model first information report (FIR) issued by the Bureau of Police Research to address the issue of procedural irregularities and to standardize the investigations in Narcotic Drugs and Psychotropic Substances Act (NDPS Act) cases.
Source: bit.ly/4ij5guo

5. Medical tourism in India is reportedly set to receive increased investment. Further, telemedicine facilities are set to be introduced at all Primary Health Centers (PHCs), making healthcare more accessible, especially in rural areas.
Source: bit.ly/3QLT5dz

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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.

India’s Central Food Regulator (FSSAI) has published draft of the certificate required to be procured by importer of vegan food, from regulatory authority of exporting authority, in order to import vegan food into India. Objections may be submitted by 30th April 2025.
Source: bit.ly/4hbimbQ

2. Karnataka State Government is reportedly working on a Not of Standard Quality (NSQ) drug recall policy. In addition to recall, if a batch of medicines is found spurious or NSQ, the manufacturing and distribution license may get suspended until corrective actions are taken.
Source: bit.ly/4ioKGc0

3. India’s Environment Ministry (MoEFCC) has issued an SOP which clarifies that white-category industries can be exempted from obtaining consent to establish (CTE) only when they submit a self-declaration of compliance with applicable environmental laws. White category industries are least polluting industries.
Source: bit.ly/43mS433

4. India’s Central Pollution Control Board (CPCB) has discovered major non-compliances during audit of plastic packaging waste recyclers such as the absence of production capacity relative to Extended Producer Responsibility (EPR) certificates issued and the absence of GST invoices for sales transactions. Brand owners should not buy EPR certificates from such recyclers.
Source: bit.ly/43fNDXY

5. India’s Supreme Court has clarified that for an activity to be construed as “manufacturing” process requiring license under Factories Act 1948, the activity need not transform goods or necessarily produce an entirely new product that is commercially recognized as different.
Source: bit.ly/43fNQdI

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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. Various State Pharmacy Councils are reportedly planning to issue notices to pharmacists who work in medical shops that advertise discounts through physical discount boards, warning them that working in such shops is unethical and illegal, and may result in cancellation of registration.
Source: bit.ly/4h0LByd

2. India’s Supreme Court has stayed the Kerala High Court order which had directed Central Government to continue to support a patient suffering from rare disease, even after the medical expense of the patient crossed the Rs. 50 lakh limit imposed by The National Policy for Rare Diseases.
Source: bit.ly/41B8zHE

3. Beverage manufacturers will have to use rigid plastic packaging such as PET bottles that contain at least 30% recycled plastic content. India’s Ministry of Environment had introduced this requirement as part of Extended Producer Responsibility (EPR) for plastic producers.
Source: bit.ly/4hVwTts

4. State Drug Controllers are reportedly finding it difficult to prosecute drug manufacturers based in other states who manufacture substandard drugs because information required for prosecution is not readily made available by State Licensing Authority of State in which the manufacturer is located.
Source: bit.ly/4h5WvTj

5. India’s Central Drug Regulator (CDSCO) is reportedly planning to simplify Export No Objection Certificate (NOC) issued for unapproved drugs, by removing buyer and quantity-specific limitations, based on the exporting company’s export history. This may improve regulatory efficiency and ease manpower strain.
Source: bit.ly/3F3Tdm6

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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 Madras High Court has refused to pass interim order staying the controversial gaming law in Tamil Nadu, which prohibits minors under 18 years from playing games and generally imposes restrictions on gaming between 12 am and 5 pm.
Source: bit.ly/43hwJYX

2. Andhra Pradesh’s Director of Medical Education has instructed government medical colleges and hospitals to ensure doctors prescribe drugs using generic names. The ethical guidelines applicable to doctors mandate prescription in generic names, and brand name may be used in addition.
Source: bit.ly/43nG6WS

3. India’s Department of Pharmaceuticals (DoP) has established a technical committee to devise strategies aimed at enhancing supply chain resilience and reducing reliance on China for pharmaceutical products. This initiative, part of the Indo-Pacific Economic Framework, aims to strengthen key industries like healthcare and chemicals.
Source: bit.ly/43aZ1UZ

4. India’s Central Food Regulator (FSSAI) will reportedly release new Maximum Residue Level (MRL) values for 98 spices, up from the current values for 18 spices. A SOP guidance to fix MRL for pesticides is expected to be published soon as well.
Source: bit.ly/4h19LZl
Source: bit.ly/41luW2f

5. Delhi High Court has remarked that the government should put in place a legal framework to tackle “e-infringement” of trademarks in e-commerce. Since multiple parties are involved in e-commerce, it is difficult to determine who is responsible for infringement.
Source: bit.ly/4hX8TpY

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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 Drugs Regulator (CDSCO) has clarified that modified or sustained-release form of a drug including gastro-resistant tablets/capsules, delayed-release tablets/capsules, or novel drug delivery systems will be regulated as ‘new drug’. New drugs must undergo clinical trials for obtaining manufacturing license
Source: bit.ly/41znUZe

2. India’s Central Licensing Authority (CLA) has directed manufacturers of unapproved fixed dose combination drugs to apply for permission to conduct Phase IV study / active post marketing surveillance within three months
Failure may result in cancellation of manufacturing license.
Source: bit.ly/3Xmpjjr

3. India’s Central Food Regulator (FSSAI) has reminded all food businesses that any post approval change in license information such as name of nominee, product category, expansion has to be communicated before such change takes place. Failure may result in cancellation of license.
Source: bit.ly/41AjyRq

4. India’s product standard setting body (BIS) has amended the Baby Diapers Standard 17509:2021. The amendment clarifies that actual dimensions of the diapers can vary based on the manufacturer’s design choices, with the diaper’s design being subject to the agreement between the buyer and seller.
Source: bit.ly/41znT7C

5. Clinical trial sponsors can add clinical trial sites and change the principal investigator (PI) by applying on SUGAM Portal.
The application for change of PI is deemed approved on application, and for addition of site within 30 days of application.
Source: bit.ly/41wrvHo

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 Allahabad High Court recently ruled that a Food Business Operator cannot be held liable for ingredients purchased in sealed packets from a licensed manufacturer with a proper invoice, even if they are found to be unsafe. The court clarified that liability for unsafe products rests with the manufacturer or distributor.
Source: bit.ly/4hAlyip

2. India’s Department of Consumer Affairs has issued a draft Legal Metrology (Packaged Commodities) Amendment Rules, 2025 thereby relaxing the requirement to make labelling declarations at one place on the principal display panel (PDP) for the packages containing medical devices. Currently, all declarations are required to be made at one place on the PDP. The draft is open for public comments till 12th March 2025.
Source: bit.ly/40UsX4R

3. India’s Intellectual Property (IP) Office has issued a draft Guidelines for processing patent applications related to AYUSH systems, including Ayurveda, Yoga, Unani, Siddha, and Homeopathy. The guidelines aim to provide clarity to the filing and processing patent applications of Ayush systems and related inventions. Stakeholders are invited to provide feedback by February 28, 2025.
Source: bit.ly/3WZjWXa

4. India’s National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling prices of antibiotics Azithromycin and Amoxicillin-Clavulanic Acid under the Drugs (Prices Control) Order (DPCO), 2013. The revisions account for a 0.00551% impact from the Wholesale Price Index (WPI) for 2024.
Source:  bit.ly/3EBV7u4

5. Jammu and Kashmir’s Health Department had issued clear directives to ensure compliance with the prescription guidelines. However, doctors in government hospital have continued to disregard these guidelines thereby imposing a significant financial burden on the patients. Under these guidelines, doctors are required to write prescriptions in legible capital letters along with their name, designation and signatures.
Source: bit.ly/40YI1yl

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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 Supreme Court of India has warned States and Union Territories of initiating contempt proceedings for failing to take action against misleading advertisements. It emphasized that authorities must ensure strict enforcement of laws to prevent such advertisements. The Court’s remarks come in light of a petition filed by the Indian Medical Association against a leading Ayurveda product manufacturing company on grounds of misleading claims and advertisements.
Source: bit.ly/3C3w9D4

2. India’s Bombay High Court, in a recent ruling, emphasized that authorities must uphold basic human rights, particularly in medical negligence cases. It stated that failure to provide adequate healthcare can violate a patient’s right to life and dignity. The court called for greater accountability and stricter enforcement of healthcare standards.
Source: bit.ly/3DVQlqO

3. The Food Safety and Standards Authority of India (FSSAI) has issued an order on 3rd January, 2025, to promote ease of doing business. It has decided that any changes or amendments to the Food Safety Standards (Labelling and Display) Regulations 2020 will be enforced starting from 1st July each year. The enforcement date will always be 1st July, with a minimum of 180 days between the notification of amendments and their enforcement. This policy applies to both labelling regulation changes and other food safety standards related to labelling. This move is aimed at enhancing regulatory predictability for food business operators while also improving consumer knowledge and transparency.
Source: bit.ly/4h001PO

4. The Indian Prime Minister’s Office (PMO) has directed the Indian Health Ministry to take appropriate steps to label oxygen cylinders clearly, distinguishing between industrial oxygen and medical oxygen. This action follows lawmaker Ajeet Madhavrao Gopchade’s appeal, emphasizing the importance of such measures for patient safety.
Source: bit.ly/4ais9eB

5. The U.S Food and Drug Administration (US FDA) has banned the use of Red No. 3 dye in food items and oral drugs due to potential links to cancer. The decision follows concerns raised by studies suggesting that the high exposure of dye could be carcinogenic.
Source: bit.ly/42f7YvR

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 Supreme Court of India has ruled that only the Central Government can regulate, prohibit, or restrict the sale of drugs. The judgment clarifies that drug inspectors and regulatory authorities cannot impose such bans or unilaterally declare a medicinal product as prohibited without a central notification.
Source: bit.ly/3DTt3Su

2. The Food Safety and Standards Authority of India (FSSAI) has reiterated the compliance requirements for e-commerce Food Business Operators (FBOs). They warned against operating without a valid FSSAI license or registration and making unsupported claims online. FBOs have been urged to adopt practices ensuring a minimum shelf life of 30% or 45 days before expiry at the time of delivery to the consumer, and to strictly adhere to food safety standards.
Source: bit.ly/3Z9lzmA

3. Indian Micro, Small, and Medium Enterprises (MSMEs) in the pharmaceutical sector are seeking a 3-year, condition-free extension for implementing Schedule M. They have cited financial constraints in upgrading their manufacturing sites to comply with Schedule M standards. In this context, they urge the Indian government to provide support in the form of financial and technical assistance to improve quality standards. The health ministry recently issued a draft notification proposing to extend the deadline for MSMEs to comply with revised Schedule M norms from 31st December 2024, to 31st December 2025.
Source: bit.ly/4fPf8u0

4. The National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling price of azithromycin 250 mg tablets to ₹11.67 per tablet, up from ₹11.65, following a review order by the Department of Pharmaceuticals (DoP). The review addressed Cipla Ltd.’s claim that its product, Azee 250 mg tablets, with a 2.3% market share, was omitted from the initial pricing calculation. The NPPA identified discrepancies in the Pharmatrac database and included Cipla’s product in the updated price.
Source: bit.ly/40kDNB8

5. Maharashtra police has arrested a man who was allegedly running an illegal call center that sold controlled medicines, like Viagra and Tramadol, to U.S. citizens. The accused used VOIP technology to impersonate a legitimate pharmaceutical representative. Authorities have seized several gadgets and accessories from the call centre and charged the individual under various laws, including the Information Technology Act and the Indian Telegraph Act.
Source: bit.ly/405X1Kw