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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 RBI’s revised draft for the Foreign Exchange Management (Export and Import of Goods and Services) Regulations, 2025, mandates repatriation of unutilized advances if imports aren’t completed within the contract period. If outstanding advances exceed Rs 25 crore, future imports must be secured with an irrevocable standby letter of credit or an international bank guarantee.
Source: bit.ly/4jrYGCl

2. Major global pharma companies are reportedly setting up Global Capability Centres (GCCs) in India, driven by the country’s tech talent amid the global economic slowdown. Experts predict that India’s GCC sector will surpass $100 billion by 2030, with significant growth in the Life Sciences and Healthcare sector.
Source: bit.ly/4j1ZZYO

3. The Gujarat Food and Drug Administration has reportedly assured the Indian medical device manufacturers that the differential pricing order for cardiac stents, implemented under the Ayushman Bharat scheme, will be repealed. Under this scheme, stents approved by the US FDA are priced at Rs 25,000, while those approved by the Indian regulator are priced at Rs 12,000.
Source: bit.ly/42lIV8K

4. India’s Department of Animal Husbandry and Dairying (DAHD) has mandated that all poultry farms across the country must register with their respective state animal husbandry departments within a month. This initiative is part of the Centre’s strategy to enforce strict biosecurity measures in response to the ongoing H5N1 avian influenza outbreak affecting multiple states.
Source: bit.ly/4251YFL

5. The Supreme Court of India reportedly rejected a plea to ban children under 13 from social media which was filed over concerns about mental health and addiction. It stated the issue is a policy matter for the government, not the judiciary, and advised approaching relevant authorities or Parliament.
Source: bit.ly/4cqw7Tx

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 amended the definitions of micro, small, and medium enterprises (MSMEs) on March 21, raising investment and turnover limits.  This reclassification will move many medium-sized businesses to the small enterprise category, enabling access to benefits like public procurement, the GeM platform, and dispute resolution services.
Source: bit.ly/4iQlc7N

2. The Rajasthan High Court quashed a drug complaint, ruling that failing a dissolution test is a minor defect and not the ground for prosecution if the active pharmaceutical ingredient is within standard limits. The court held that slower dissolution doesn’t affect efficacy or make the drug spurious by itself.
Source: bit.ly/43DZJKO

3. The United States Food and Drug Administration (US FDA) has rejected in vitro studies conducted by an India-based contract research organization due to significant data integrity issues. Certain generics relying on bioequivalence data from the affected studies are marked with a “BX,” indicating insufficient evidence for therapeutic equivalence, thereby impacting their market status and sale.
Source: bit.ly/3FPn9mB

4. The Association of Indian Medical Device Industry (AiMED) has reportedly criticized Gujarat Government’s new pricing for drug-eluting stents, which sets USFDA-approved stents at double the price of domestic-approved ones. The association urged the state to reverse the decision, noting that such price disparities are not observed globally.
Source: bit.ly/4hXrfWM

5. According to a fact sheet issued by the White House after the US President’s announcement, pharmaceutical products are not yet subject to reciprocal taxes, providing relief to Indian pharmaceutical companies that earn significant revenues from exports to the United States.
Source: bit.ly/3YdSJAy

 

 

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 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

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 Department of Pharmaceuticals (DoP) has invited applications for R&D funding in six key areas- (1) New Chemical Entity, New Biological Entity and Phyto-pharmaceuticals (2) Complex generics and Biosimilars (3) Precision medicine (Targeted innovative therapeutics) (4) Medical devices (5) Orphan Drugs and (6) Drug development for AMR funding upto INR 100 Cr (1000   illion) is available.
Source: bit.ly/41AvbXF
Source: bit.ly/4bJLVQU

  1. The Indian government is reportedly considering lowering tariffs on imports of US medical devices to ease trade tensions. Such a policy decision would run counter to India’s Make in India policy and preference to procure medical devices manufactured in India for government hospitals.
    Source: bit.ly/41zI3x8
  1. The UK Government is reportedly proposing to raise the Statutory Scheme payment rate for newer branded medicines from 15.5% to 32.2%. The ‘payment rate’ is the revenue that pharma companies refund to government from sales of branded medicines to the National Health Service (NHS)
    Source: bit.ly/3DSk30j
  1. France has become the second European country, after Denmark, to ban per- and polyfluoroalkyl substances (PFAS) in certain products, including cosmetics, textiles, and ski wax addressing concerns over health and environment. The production, import, export, and sale of PFAS-containing goods will be prohibited in France from  January 2026
    Source: bit.ly/420sUVI
  1. The European Commission has proposed a bill to reduce the European Union’s dependence on India and other countries for antibiotics and other essential medicines by requiring Member States to procure medicines on parameters other than price, in order to incentivize domestic manufacturing. The bill, called Critical Medicines Act, is under consideration.
    Source: bit.ly/4ii2whc
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 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

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 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

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

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

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 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 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