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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 Delhi High Court has allowed an Indian drugmaker to manufacture the lifesaving spinal muscular atrophy drug Risdiplam and rejected a global pharmaceutical company’s injunction plea. The Court emphasized that public interest and affordable access to life-saving treatments outweigh corporate monopoly and profits.
Source: bit.ly/4c5xRB8

2. India’s Ministry of Health and Family Welfare has released National Guidelines on Medical Oxygen Management and launched a capacity-building program at AIIMS Delhi to improve oxygen supply. It aims to train 200 experts and help hospitals use oxygen efficiently by reducing waste and enhancing patient care.
Source: bit.ly/43wfF1t

3. Online gaming companies are challenging Tamil Nadu’s night-time ban on online rummy, arguing it’s an indirect prohibition. They also oppose mandatory Aadhaar verification, asserting there are alternative methods for player identity. The Madras High Court adjourned the case for further hearing.
Source: bit.ly/3Y9k8DE 

4. President of USA reportedly has plans to impose a 25% or higher tariff on imported pharmaceuticals in USA which could increase costs for Indian drug exports, potentially reducing their competitiveness in the U.S. market.
Source: bit.ly/42lBv6I

5. Indian Council of Medical Research (ICMR), in collaboration with AIIMS has utilized drones to transport corneas for transplantation, reducing delivery time significantly. This advancement enhances efficiency in healthcare logistics, helping bridge the gap between donor sites and recipients while ensuring timely medical interventions.
Source: bit.ly/3FJQ8rP

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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 (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

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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 Ministry of Health and Family Welfare has developed ONDLS Portal for receiving applications from small and medium scale pharmaceutical manufacturers who wish to avail benefit of extension from requirement to comply with new Good Manufacturing Practices (GMP) under revised Schedule M. Such applications must be strictly submitted online before lapse of three months from February 11, 2025. Submission of hard copy applications will no longer be accepted.
Source: https://bit.ly/4iEFh0U

2. The Indian Ministry of Health is working with Bureau of Indian Standards (BIS) to develop a standardized invoice format for hospitals, nursing homes, clinics and diagnostic centers. Once notified, clinical establishments will have to follow a standard invoice format with detailed and transparent breakdown of charges incurred by patient.
Source: https://bit.ly/4c4CM5w

3. India’s Supreme Court has held that even in consumer contracts which contain arbitration clauses, a consumer has the right to decide whether to pursue arbitration or approach the consumer forum for resolution of consumer dispute. The Court further reiterated that consumer disputes are non-arbitrable unless the consumer voluntarily opts for arbitration.
Source: https://bit.ly/4c4CPOK

4. The Directorate General of Foreign Trade (DGFT) has decided to withdraw the Remission of Duties and Taxes on Exported Products (RoDTEP) Scheme benefits for exports arising from Advance Authorizations (AAs), Special Economic Zones (SEZs), and Export Oriented Units (EOUs).
RoDTEP Scheme helps pharmaceutical exporters to get refund on taxes and duties on export.
Source: https://bit.ly/4c43M59

5. The Food Safety and Drug Administration (FDA) of Karnataka has reportedly increased inspections to address the issue of adulteration of tea powders and spices.
The decision has been taken due to reports of addition of harmful substances in food products, with the goal of reducing health risks to the public.
Source: https://bit.ly/4cjrdrr

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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 Consumer Disputes Redressal Commission (NCDRC) absolved a major Super Specialty Hospital from charges of medical negligence, and stated that the absence of specific specialists doesn’t imply improper treatment or breach of medical duty when a patient is under the care of a multi-disciplinary ICU team.
Source: bit.ly/4kGd0sh

2. The Karnataka government has reportedly proposed the establishment of a special court to handle cases related to the supply of fake and spurious drugs. This proposal aims to tackle drug-related frauds, speed up trials, reduce delays and impose stricter penalties on offenders.
Source: bit.ly/4bPYme3

3. As of March 12, 2025, the National Pharmaceutical Pricing Authority (NPPA) has fixed ceiling prices for 928 scheduled formulations and retail prices for over 3,200 new drugs, reducing average prices by approximately 17% leading to estimated annual savings of about ₹3,788 crore for patients.
Source: bit.ly/4bRQF7a

4. India’s Delhi High Court to examine the scope of Customs jurisdiction under the Prohibition of Electronic Cigarettes Act, 2019, following the seizure of “empty atomizer devices” which are not claimed to be licensed medical devices. Currently, the definition of electronic cigarette exempts products licensed under the Drugs and Cosmetics Act, 1940.
Source: bit.ly/4iIVRwb

5. The Food Safety and Standards Authority of India (FSSAI) has reportedly set an expert panel for reviewing the regulations for baby food, specifically focusing on prescribed limit of sugar in packaged food products for babies. This follows a report revealing Nestlé adds sugar to Indian baby food but not in high income countries.
Source: bit.ly/4hwdxdv

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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 Competition Commission of India (CCI) has reportedly raided offices of big advertisement and broadcasting firms as well as industry associations, on suspicion of fixing ad rates and undertaking price collusion. It is uncommon for CCI to raid industry associations, indicating possibility of cartelization.
The raid may affect advertisement by top brands.
Source: bit.ly/4iYMx7r

2. Pharmaceutical exporters have raised concerns about requirement to submit legal undertaking from API manufacturers in order to secure Export NOC from the Central Drug Regulator (CDSCO), on grounds that the APIs are procured from traders and not manufacturers, and manufacturers won’t readily agree to give legal undertaking. A new Export NOC system was introduced in March 2025 to expedite issuance of export NOC
Source: bit.ly/4iZDqTY

3. Representatives of leading cosmetics brands are reportedly demanding a separate law for regulation of cosmetics. The demand stems from the fact that cosmetics are regulated together with drugs under the current law i.e. Drugs and Cosmetics Act, 1940, because of which cosmetics are under system of significant licensing and inspection. The industry expects the law to require post-market notification as opposed to pre-market licensing.
Source: bit.ly/3DSCT7B

4. Google has recently announced a new health care update to its Search platform called the “What People Suggest” Feature, currently available only in the US. This new feature allows individuals with specific health conditions to compare their experiences with others. It utilizes artificial intelligence to collate online feedback from patients sharing similar diagnoses, enabling users to find insights on managing their conditions.
Source: bit.ly/421sKgK

5. The West Bengal Drug Control Administration is reportedly taking steps to closely monitoring discount pharmacies in order to eliminate counterfeit drugs. As part of the drive, inspectors will verifying purchase sources, inspect medicines, and enforce strict measures to ensure drug quality and public safety.
Source: bit.ly/4hIBxKk

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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. A medical device company has received compensation calculated at 25% of sales generated by a counterfeiting entity. The Court opined that 25% was a conservative profit margin for awarding damages. The Court has additionally awarded exemplary damages to punish the counterfeiting entity.
Source: bit.ly/4kHWYhn

2. The Indian Pharmaceutical Alliance (IPA) has reportedly questioned the authenticity of an US study linking India-made generic medicines to higher rates of serious adverse events (SAEs) calling the claims unfounded. IPA highlighted that Indian manufacturing facilities undergo stringent inspections by regulators like the FDA, and lower costs are due to production efficiencies, not compromised quality.
Source: bit.ly/4kEqkx8

3. The Indian government is reportedly considering exemption of health and life insurance premiums from the current 18% GST. The GST Council has sought input from the Insurance Regulatory and Development Authority of India (IRDAI), with the industry advocating for a reduction to 12% instead of a complete exemption or lower rate (5%), to be able to claim Input Tax Credit (ITC) on taxes paid for business operations.
Source: bit.ly/3Fu3dFx

4. India’s Health Ministry has reportedly directed the Drug Controller General of India (DCGI) to focusing on eliminating poor-quality medicines, supporting small pharma manufacturers (MSMEs), and refining medical device regulations. The move is aimed at enhancing global trust in Indian medical products and exports.
Source: bit.ly/3DHeK3J

5. The Director General of Foreign Trade (DGFT) has invited comments on proposed changes to export policy for Special Chemicals, Organisms, Materials, Equipment and Technologies (SCOMET), which seek to fast-track grant of approval. SCOMET goods typically face strict export controls.
Source: bit.ly/3Fr2Uva

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 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