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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. Kerala Deputy Drugs Controller (Ayurveda) has issued a stern warning to a prominent Ayurvedic drug manufacturer, for violating Rule 170 of the Drugs and Cosmetics Rules, 1945. This rule mandates that manufacturers obtain prior approval from state licensing authorities before advertising their products, aiming to prevent misleading promotions of AYUSH drugs.
Source: bit.ly/3H0LSoi

2. The All India Organization of Chemists & Druggists has cautioned against the Centre’s plan to expand the over-the-counter (OTC) drug list, warning that unsupervised use of routine medicines could pose serious health risks and lead to misuse without expert medical guidance.
Source: bit.ly/3H2vB2n

3. Small scale pharma companies have opposed CDSCO’s new export NOC rules, calling them burdensome for them. They warn of losing export markets to competing countries and seek an extension for Schedule M compliance and a tribunal to resolve regulatory disputes efficiently.
Source: bit.ly/3GZoac9

4. Experts have reportedly identified certain fixed-dose combinations (FDCs) in personal care products such as aloe vera, jojoba oil, and orange oil, as irrational and potentially harmful, recommending their prohibition to safeguard public health.
Source: bit.ly/3SGKh9N

5. The U.S. Food and Drug Administration (FDA) is reportedly initiating action to remove from the market unapproved concentrated fluoride drugs for infants and toddlers, citing concerns over microbiome disruption, thyroid issues, weight gain, and possible IQ decline.
Source: bit.ly/4doJeVr

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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 The Indian Supreme Court has ruled that individuals convicted of food adulteration offences under the now-repealed Prevention of Food Adulteration Act cannot be granted probation. The Court clarified that the law in force at the time mandated strict punishment for such offences, and the bar on probation remains valid under the current Food Safety and Standards Act, 2006.
Source: bit.ly/3SD2x3R

2. India’s Chhattisgarh High Court has invalidated tender clauses by the Chhattisgarh Medical Services Corporation Limited that permanently barred previously blacklisted companies from bidding, even after their blacklisting period had ended. The Court emphasized that such conditions are arbitrary and violate principles of fairness in public procurement.
Source: bit.ly/45aP0Ik

3. India’s Jharkhand High Court ruled that selling goods at concessional rates alone does not amount to a sham transaction. The Court quashed notices issued for alleged discrepancies, stating that comparing sale prices to market rates is not sufficient grounds to question the authenticity of the transactions.
Source: bit.ly/4kfrgqE

4. The Indian government has invited fresh applications under the Performance-Linked Incentive (PLI) scheme to boost domestic production of bulk drugs. The focus is on 11 key product categories, including Active Pharmaceutical Ingredients (APIs), Key Starting Materials (KSMs), and intermediates. The initiative aims to reduce reliance on imports, particularly from China.
Source: bit.ly/42Zm6ti

5. A leading beverage company will revise its recycling labels following a greenwashing complaint by the European Consumer Organisation (BEUC). The updated labels will clarify that only the bottle body contains 100% recycled plastic, exclude caps and labels, and remove green imagery and the phrase “Recycle Me Again” to avoid misleading consumer.
Source: bit.ly/4khtF4V

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 Supreme Court has ruled that volume-based discounts are lawful and do not constitute discriminatory pricing, for such discounts to be considered discriminatory they must be applied unequally to similarly situated buyers in comparable transactions.
Source: bit.ly/4mghWEN

2. India’s Supreme Court has issued a notice to the central government on a petition seeking to make it mandatory for hospitals and clinical establishments to display service rates and charge fees within limits set by the Centre, in consultation with state governments. The Court noted that the failure to enforce this requirement stems from the government’s failure to specify the service charge limits which potentially impacts citizens’ fundamental right to healthcare.
Source: bit.ly/4jXJ75U

3. The High Court of Jammu & Kashmir and Ladakh has upheld a government advisory requiring retail and wholesale pharmacies to install CCTV cameras and adopt computerized billing systems. This measure aims to curb the sale of prohibited drugs and enhance transparency in pharmaceutical operations.
Source: bit.ly/4mgjrCV

4. In a proposed Free Trade Agreement with the UK, India has reportedly decided to reduce import duties on medical devices under the Production-Linked Incentive (PLI) scheme starting only from the sixth year. This phased approach aligns consumer needs with the Make in India programme, aiming to protect domestic manufacturers while gradually opening market access for UK exporters.
Source: bit.ly/4mlyPy8

5. The U.S. government’s order to align domestic drug prices with global rates may impact Indian pharmaceutical firms, many of which rely heavily on U.S. revenues. Though primarily targeting Big Pharma, the move could subject Indian generic manufacturers to pricing pressure, potentially disrupting their business models and profitability.
Source: bit.ly/4dkH0Xt

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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 Central Drugs Standard Control Organization has lifted the suspension on an eye drop for presbyopia and approved its phase IV clinical trial but by restricting false media publicity. The suspension was imposed for violating marketing norms by promoting the product as a replacement for reading glasses.
Source: bit.ly/4cXhGpW

2. Indian food regulator, FSSAI, has released a consultation paper proposing clear labelling norms for synthetic paneer, including terms like “non-dairy” or “contains no milk” on packaging and restaurant menus. Stakeholders are invited to submit their comments within 60 days.
Source: bit.ly/42w1ZBl

3. The Central Consumer Protection Authority has taken suo-moto action against five restaurants for violating guidelines and failing to refund mandatory service charges. Acting on consumer complaints, the authority issued notices, reinforcing that service charges must be voluntary and cannot be added to bills without consent.
Source: bit.ly/43coUTK

4. The Belgian Competition Authority has fined three pharmaceutical companies for entering into anti-competitive agreements with pharmacies to secure preferential shelf placement for their products. The authority found that such practices distorted fair competition and limited consumer choice in the over-the-counter (OTC) medicine market.
Source: bit.ly/4cTwLc6

5. India and the United States are set to begin in-person sectoral trade negotiations in late May, with a goal to finalize the first phase of a Bilateral Trade Agreement (BTA) by fall 2025. The talks will address key areas, including tariffs, services, and supply chains, with sectors such as pharmaceuticals and medical devices likely to be part of the broader discussions.
Source: bit.ly/42XoMXe

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 Drugs Technical Advisory Board is reportedly reviewing a proposal to limit the sale of over-the-counter drugs. Only 27 essential medicines, including painkillers, antacids, and oral contraceptives, may be allowed without a prescription, with strict controls on dosage and pack size.
Source: bit.ly/4jqjkD0

2. Delhi High Court has upheld the Government’s move to restrict the sale of an anti-cold drug without warning labels against use in children below 4 years after April 15, 2025. For earlier batches, companies must publish notices in two national newspapers, which won’t count as advertisements or violations of license conditions.
Source: bit.ly/3SaUOK0

3. India’s drug regulator has reportedly approved eye drops aimed at controlling myopia progression in children. This pediatric formulation, the first of its kind to be approved in India, has successfully completed Phase III trials and will be available as a prescription drug.
Source: bit.ly/444JxCp

4. A group of doctors with disabilities has urged the World Health Organisation to include sunscreen in its Essential Medicines List, citing its importance for people with albinism who are highly susceptible to UV radiation. They argued that sunscreen is a vital medical need and not a cosmetic.
Source: bit.ly/44KmxJ9

5. The U.S. FDA reportedly plans to phase out several synthetic food dyes linked to health concerns like attention deficit hyperactivity disorder (ADHD) and obesity. Two dyes will be banned soon, with six more to be removed by 2026, and new natural color additives will be approved.
Source: bit.ly/3EFTFXQ

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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 Rajasthan High Court has ruled that retesting or resampling of Narcotic and Psychotropic drugs should not be a routine and must be allowed in exceptional circumstances. Applications must be made within 15 days of receiving the test report from Forensic Science Laboratory.
Source: bit.ly/4lDwRZu

2. The Supreme Court of India has ruled that dealing with substances listed in the Schedule of the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, even if not listed in Schedule I of the NDPS Rules, is still an offence.
Source: bit.ly/4jGg0TY

3. A preliminary inquiry reportedly revealed that eight doctors and an associate professor at a Ahmedabad Municipal Corporation (AMC) college conducted unauthorized drug trials on patients with 50+ pharma companies since 2021. Payments were deposited into the doctor’s personal accounts. AMC has suspended the staff involved.
Source: bit.ly/4jGg1Y2

4. The Central Board of Indirect Taxes and Customs has issued instructions to the officers processing GST registration to request only specified documents and avoid raising notices for minor issues. The move is intended to minimize delays and improve ease of doing business.
Source: bit.ly/4jglvJf

5. The Patna High Court has upheld Rule 6 of the Bihar Pharmacist Cadre Rules, 2014, stating that a D. Pharm is mandatory for pharmacist posts in the Bihar Health Department, even for candidates holding higher qualifications like B. Pharm or M. Pharm.
Source: bit.ly/3RteFnB

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 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