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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 National Pharmaceutical Pricing Authority has announced that all applications for retail price fixation of new drugs in Form I must be submitted through the dedicated online portal, Integrated Pharmaceutical Database Management System (IPDMS 2.0) from April 1, 2025. At present, Form I applications for the retail price fixation of new drugs are being submitted via email.
Source: bit.ly/4i4aKJw

2. India’s small retailers are facing challenges as quick-commerce giants are allegedly engaged in deep discounting  for the products sold through their platform. The All India Consumer Products Distributors Federation has urged the Competition Commission of India to investigate these discounting pricing practices.
Source: bit.ly/4ixzqtB

3. The Information Technology Industry Council (ITI) urges the government to delay children’s data processing rules under the Digital Personal Data Protection (DPDP) Rules, 2025, as global tech firms are facing operational challenges. They recommend aligning age verification with international standards.
Source: bit.ly/3QQV1l0

4. The Indian Council of Medical Research’s new guidelines exempt Ayush-approved medicines from additional safety evidence from animal studies or phase I/II human clinical trials in integrative research. However, non-codified traditional medicines must undergo full regulatory approval and adhere to applicable regulations.
Source: bit.ly/3QQWkAq

5. The Competition Commission of India (CCI) has ruled that a hospital’s intentional misleading of consumers, involving the misrepresentation of its surgeon’s qualifications and false advertising, does not raise any concerns under the provisions of the Competition Act 2002 and is outside CCI’s jurisdiction.
Source: bit.ly/3Fbvl05

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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.

1. Indian courts have recognized copyright protection granting a temporary injunction against Indian pharmaceutical companies for unauthorized use of drug dossier. This occurred in a lawsuit where a pharmaceutical company accused a Canadian company of breaching a licensing agreement, misappropriating trade secrets, and sharing drug dossiers with Indian companies.
Source: bit.ly/3XvnzV7

2. The Ministry of Health & Family Welfare has made registration for Clinical Research Organisations (CROs) mandatory, effective April 1, 2025. CROs can now register online through the SUGAM portal by submitting their applications along with the required documents.
Source: bit.ly/3F6DKBX

3. Punjab’s Food and Drugs Administration has implemented stringent reporting obligations on manufacturers, C&FAs, wholesalers, and retailers, requiring them to submit monthly sales and distribution reports on every 7th day of the month to the state’s drug control offices to monitor the movement of seven Schedule H and H1 drugs or formulations prone to misuse for intoxication.
Source: bit.ly/3QKofC5

4. India’s Supreme Court has urged state authorities to frame guidelines to prevent exploitation by private hospitals, ensuring patients are not compelled to purchase overpriced medicines and medical devices. The Court also recognized that private hospitals are essential to addressing healthcare gaps until infrastructure is improved.
Source: bit.ly/3QLU8tY

5. The Delhi government’s social welfare department has urged the health department to fast-track the establishment of dedicated wards for transgenders in all government hospitals and designate a hospital for sex reassignment surgeries, aiming to ensure rights, dignity, and healthcare access.
Source: bit.ly/4i4dkiN

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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

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. 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

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 Ministry of Environment, Forest and Climate Change has clarified the manner of labelling on battery, battery pack or equipment having battery or battery pack by notifying an amendment to the labelling requirements prescribed under the Battery Waste Management Rules, 2022. Now, labelling declarations can be made through QR Code or product information brochure.
Source: bit.ly/3XgF3Vc

2. Indian Government has reinforced its requirement for the electronic issuance of Certificates of Origin (CoO), cautioning exporters and agencies against using manually issued certificates. The Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce and Industry, has issued a Trade Notice reminding all stakeholders that any CoO issued outside the online eCoO 2.0 platform will be deemed to be invalid after the specified deadlines.
Source: bit.ly/43aT6PC
Source: bit.ly/3XjttZn

3. India’s Karnataka Government has requested the Union Health Ministry to implement a system for sharing alerts about drugs that fail quality tests. This initiative aims to tackle the issue of substandard injectable drugs that do not pass sterility tests.
Source: bit.ly/43dDjji

4. India’s Health Ministry has reportedly revoked the export NOCs and manufacturing licenses for exporting unapproved Tapentadol and Carisoprodol combination drugs to West Africa. Both drugs are individually approved in India, but their combination is not. Reportedly a shipment to Ghana is also under investigation.
Source: bit.ly/4hXNxc8

5. India’s Supreme Court has recently emphasized the need for establishing a mechanism to address complaints related to misleading medical advertisements and called for strict action to curb such deceptive ads. The Court also highlighted the importance of consumer protection and ensuring that advertisements in the medical field do not mislead.
Source: bit.ly/3D7kVxG

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 Foreign Trade regulator, the Directorate General of Foreign Trade (DGFT) has recently issued a Trade Notice, cautioning exporters to no longer accept physical copy Certificate of Origin, and to only accept electronically issued Certificates of Origin since the deadline for using physical copies has passed on 31st December 2024.
Source: bit.ly/439cxs0
Source: bit.ly/439ayEk

2. In light of a recent international report regarding the misuse of drug combinations in various countries in the African continent, India’s Ministry of Health and Family Welfare has rescinded the export license and No Objection Certificate (NoC) of a manufacturer of the said combinations.
Source: bit.ly/4353Mzp

3. India’s Supreme Court, in its recent order has expressed that the medical educational institution admission guidelines, which requires that “both hands [should be] intact” for a person suffering from a disability to gain admission to a medical educational institution, is violative of disability rights and has no basis under law.
Source: bit.ly/3QyRKH0

4. In a recent order, the High Court of Kerala has instructed the State Government to issue a circular to all Doctors in the state, requiring the preservation of foetus in case of a Medical Termination of Pregnancy of a minor, and require permission from the State Government for the destruction of said foetus.
Source: bit.ly/4bblB1L

5. The recent decision of the United State Government to terminate employment of several employees of the United States Food and Drug Administration (FDA) has the possibility to cause delay in obtaining approvals and licenses from the FDA by members of the Medical Device industry.
Source: bit.ly/4hRolDN