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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 Directorate General of Foreign Trade (DGFT), has extended the Annual Remission of Duties and Taxes on Exported Products (RoDTEP) Returns filing deadline for FY 2023-24 from November 30, 2025 to March 31, 2026, with a ₹15,000 composition fee. Missing the extended deadline may lead to denial of RoDTEP benefits or scrip cancellations.
Source: h7.cl/1p1E2

2. The National Pharmaceuticals Pricing Authority (NPPA) has directed manufacturers and marketing companies to revise the Maximum Retail Prices (MRP) of 17 life-saving cancer drugs following their exemption from Customs Duty. Downward change in Duties/taxes should be passed on to consumers at the retail level, Form V must be submitted along with issue of to dealers and NPPA.
Source: h7.cl/1jXJ8

3. The Tea Board of India has issued updated guidelines for tea warehouse licence applications and renewals. The specifications that a warehouse must meet have been specified in the guidelines. Modifications of warehouse license is allowed only for floor area changes, and renewals can be auto-processed. Non-submission of requisite documents may lead to rejection without fee refund.
Source: h7.cl/1p1DR

4. Indian Council of Medical Research (ICMR) has reportedly directed that clinical trials in India focus on local genetics, diets, and lifestyles rather than rely on Western research. The move addresses rising lifestyle diseases and aims to produce more relevant evidence. Multicentre trials with government funding will study therapies suited for Indian patients, potentially improving effectiveness and access.
Source: h7.cl/1p1Ef

5. The Department of Pharmaceuticals has reportedly invited stakeholder comments on the amended list of 354 medical devices exempted from restrictions on global tender enquiries. The exemption, valid until March 31, 2027, allows public procurement agencies to source these devices internationally, subject to review of adequate domestic manufacturing capacity.
Source: h7.cl/1jXJk

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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 NPPA’s Multi-Disciplinary Committee (MDC) flagged a typographical error in major pharmaceutical drug manufacturing company’s IPDMS Form I, reporting retail price of tablet as ₹13 per tablet instead of ₹91, leading to incorrect pricing. MDC has cautioned the manufacturer to avoid such negligence to prevent procedural delays.
Source: short-link.me/1aSCE

2. The Indian government has reportedly clarified that there is no official classification of drugs as “life-saving drugs.” However, to ensure affordability and accessibility, 930 formulations listed in the National List of Essential Medicines (NLEM) are under price control, leading to significant price reductions and improved patient access.
Source: short-link.me/16tjO

3. The Chhattisgarh High Court, in a recent interim order, has permitted Bachelor of Pharmacy (B.Pharm) graduates to apply for Pharmacist (Grade-II) posts under the National Health Mission (NHM). The court deemed the NHM’s exclusion of degree holders as arbitrary, a violation of Articles 14 and 16 of the Constitution.
Source: short-link.me/1aSCL

4. Indian pharmaceutical exports specifically generics and biosimilars -are currently exempt from the U.S. tariffs, underscoring their indispensable role in ensuring affordable, high-quality medicines for U.S. consumers. With about 40% of generics and 15% of biosimilars in the U.S. supplied by India, Pharmexcil has reportedly urged sustained collaboration to preserve stable, resilient pharmaceutical supply chains.
Source: short-link.me/1aSCW

5. United States Food and Drug Administration experts recommended dropping the “black box” warning on estrogen-based menopause therapies, especially low dose vaginal estrogen arguing the label has deterred women from effective treatment. They cited updated evidence showing benefits in reducing heart attack and bone fracture risk. In India, doctors are optimistic this move will boost confidence in hormone therapy, which remains underused despite its potential benefits for millions of postmenopausal women.
Source: short-link.me/1aSCZ

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 (NPPA) has directed all manufacturers, importers, and marketers of non-scheduled drugs and medical devices to cap MRP increases at 10% over the preceding 12 months. Violation of this directive, issued under the Drugs Price Control Order 2013, will invite penal action under relevant laws.
Source: bit.ly/3GIUvEu

2. The Food Safety and Standards Authority of India (FSSAI) had issued a notification mandating 100% inspection of all packaged drinking water units in Hyderabad and across state of Maharashtra, deploying RAFT kits and mobile labs. The move classifies bottled water as “high-risk,” requiring annual or bi-annual audits, tighter quality checks to ensure product safety, and enforce immediate corrective actions through intensified inspections and enhanced stakeholder awareness.
Source: bit.ly/4o0HYwZ

3. The Health Ministry has linked the Kayakalp scheme with National Quality Assurance Standards certification. Hospitals must apply for state level NQAS certification within three months of receiving Kayakalp results to get incentives, ensuring a direct shift from cleanliness efforts to comprehensive healthcare quality and patient safety.
Source: bit.ly/4lJv0Sr

4. India’s Union Health Ministry has clarified that states and UTs bear primary responsibility for implementing passive euthanasia and living wills within hospital protocols and, must establish ethical safeguards as per Supreme Court guidelines. States are also tasked with training healthcare professionals to respect patients’ end of life choices and simplify advance directive procedures
Source: bit.ly/44TTG3q

5. Uttar Pradesh Health Department is reportedly set to digitally deliver medical test reports directly to patients’ mobile phones, via WhatsApp, SMS, and the Personal Health Record portal. The system aims to connects district and community health center hospital management information systems with Laboratory information systems under the Ayushman Bharat Digital Mission.
Source: bit.ly/3TWuvZa

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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 National Pharmaceutical Pricing Authority (NPPA) plans to consult subject matter experts to determine a separate pricing structure for cementless knee implants, aiming to ensure affordability and accessibility for patients requiring these advanced medical devices.
Source: bit.ly/43XywRM

2. The Indian Pharmaceutical Alliance (IPA) has expressed opposition to the government’s recent directive limiting the entry of medical representatives into Central government hospitals, arguing that such restrictions could hinder the dissemination of critical medical information to healthcare professionals.
Source: bit.ly/4kDnNCZ

3. The Ministry of Electronics and Information Technology (MeitY) is considering the discontinuation of the bundled consent mechanism, proposing stricter regulations to enhance data privacy and security standards in digital platforms.
Source: bit.ly/4kE8qdH

4. India has asserted its stance on protecting pharmaceutical innovations, countering recent patent infringement allegations from Switzerland, and emphasizing the country’s commitment to safeguarding public health interests.
Source: bit.ly/4n66Lzd

5. The U.S. Department of Agriculture is set to introduce new dietary guidelines for schools, aiming to reduce added sugars and sodium in meals, promote plant-based options, and support local agriculture, thereby enhancing student health and nutrition.
Source: bit.ly/3Hzzv2P

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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 Delhi government has directed state-run hospitals to procure medicines and consumables exclusively through the Central Procurement Agency (CPA), aiming to streamline procurement and reduce costs, as earlier methods through direct purchases or via the cart feature on the Government e-Marketplace (GeM) portal often resulted in inflated pricing.
Source: bit.ly/4krkAX0

2. Central Pollution Control Board (CPCB) has reportedly initiated action against pan masala brands in Delhi for using plastic sachets to pack and store tobacco and pan masala. Companies may face fines unless they switch to eco-friendly packaging alternatives, per CPCB directives.
Source: bit.ly/4kJM7CW

3. Public health and consumer organisations are reportedly urging the government to add mandatory warning labels on the front of packaged food products that are high in salt, sugar, and fat. They want the Health Star Rating system to be scrapped, saying it misleads people and protects food companies.
Source: bit.ly/3ZjbNOu

4. The Delhi Pollution Control Committee (DPCC) has issued a Standard Operating Procedure (SOP) to streamline the imposition and recovery of environmental compensation from violators of environmental norms. The SOP mandates timely issuance of show cause notices within five days of inspection, a 15-day response window for violators, and follow-up actions within 30 days.
Source: bit.ly/3ZjTVmx

5. India’s Health Ministry is reportedly expanding Schedule H under the Drugs Rules, 1945, raising the number of prescription-only drugs from 536 to over 700. This includes remdesivir, dexamethasone, favipiravir, ivermectin, and mebrofenin etc. The move aims to curb antimicrobial resistance by restricting OTC sales, covering drug classes like cardiovascular, neurological, respiratory, anesthetic, immunological, NSAIDs, and sterile formulations
Source: bit.ly/3ZKZACb

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

 

 

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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. The Ministry of AYUSH has proposed an amendment to the First Schedule of the Drugs and Cosmetics Act, 1940, expanding the list of authoritative books for Ayurveda, Siddha, and Unani Tibb drugs. The updated list now includes more vernacular books with details such as the author’s name and language. These drugs must be manufactured according to the formulae described in the books listed in the First Schedule, as defined by the Act.
Source: bit.ly/40UqMhL

2. The Ministry of AYUSH has proposed an amendment to update the list of poisonous substances in Ayurveda, Siddha, Sowa-Rigpa, and Unani systems under Schedule E(I) of the Drugs Rules, 1945. The draft amendment has been published for public awareness, with a 30-day period for objections or suggestions. The amendment categorizes the poisonous substances by their botanical names and includes the drugs in the respective systems of medicine that are prepared using these substances.
Source: bit.ly/3QdJ6NP

3. India’s drug pricing regulator has directed all retailers and dealers, including online pharmacies, to display the current price list of medicines on their websites. This move aims to empower consumers and ensure they are not overpaying for their medications.
Source: bit.ly/41bnhEY

4. India’s Odisha Registered Pharmacists Association (ORPhA) has expressed disagreement to government’s classification of pharmacists as paramedics, despite the Pharmacy Council of India (PCI) stating they are independent healthcare professionals. The association has urged the health minister to take steps to avoid the classification, highlighting that pharmacists are specialized healthcare professionals who play a vital role in patient care through their expertise in areas like pharmaceutical sciences, pharmacology, and medication therapy management.
Source: bit.ly/3EtSniq

5. India’s central government has imposed a ban on the export of raw human hair valued at less than $65 per kilogram, as per a notification issued by the Directorate General of Foreign Trade (DGFT). The notification stated that the export policy for raw human hair has been changed from “restricted” to “prohibited.” However, exports will still be permitted without restrictions if the Free on Board (FOB) value is $65 or more per kilogram.
Source: bit.ly/4gBVKAU

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 drug regulator (CDSCO) has called for urgent input from the pharmaceutical industry on regulatory challenges and opportunities for innovation. Stakeholders in the pharmaceutical industry, including companies, researchers, and healthcare providers, are invited to share obstacles to drug approval, difficulties in meeting compliance requirements, and barriers to entering new markets and are encouraged to reach out to CDSCO through its official communication channels.
Source: bit.ly/3PNEUnW

2. The National Medical Commission (NMC) has proposed a draft regulation that grants a one-year senior residency exemption to doctors with foreign postgraduate medical qualifications from five English-speaking countries (United Kingdom, United States of America, Canada, Australia, and New Zealand) to join medical colleges as faculty.
Source: bit.ly/4hlIQZn

3. The Union Cabinet approved the continuation of the National Health Mission (NHM) for another five years, until 2030, which was scheduled to end in 2025. This decision comes after the NHM achieved significant milestones in the past decade, improving healthcare access and quality in India.
Source: bit.ly/4h2YEzV

4. The National Pharmaceutical Pricing Authority (NPPA) has asked pharmaceutical companies and marketing companies of Iohexol, a diagnostic agent to submit price and market data. This action follows a directive from the Department of Pharmaceuticals (DoP) to review the drug’s pricing.
Source: bit.ly/4h9DqR4

5. The U.S. Food and Drug Administration (FDA) has approved a nasal spray as a monotherapy for the treatment of adults with treatment-resistant depression. This marks a significant advancement in mental health treatment, as the nasal spray is the first and only medication approved for this purpose.
Source: bit.ly/40G1bdv

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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 leading pharmaceutical association reportedly has urged the Indian government to implement a predictable drug pricing policy by refraining from using Para 19 of the Drug Pricing Control Order, which gives power to the Government to cap prices of non-essential drugs and medical devices in public interest without advance notice.
Source: bit.ly/4dw7a8j

2. The National Consumer Disputes Redressal Commission (NCDRC) has held that doctors who have qualification of M.B.B.S, M.D. (medicine) are sufficiently qualified to treat ICU patients without requiring additional specialized intensive care training since no such training has been prescribed by National Medical Commission.
Source: bit.ly/3Yts4kh

3. Australia has approved the medical use of MDMA (Methylene Dioxy Methyl Amphetamine) and psilocybin for treating PTSD and depression. The drugs will be available under strict regulations, with treatments costing between A$15,000 and A$30,000, and with no current insurance coverage.
Source: bit.ly/46CttHg

4. India’s Central Food regulator, (FSSAI) has reintroduced restriction on re-using cooking oil that has developed total polar compounds (TPC) of more than 25% by adding fresh oil. Any cooking oil that has 25% or more content of TPC is not permitted to be used.
Source: bit.ly/4d8pvIT

5. India’s Department of Consumer Affairs has extended the last date for receiving public comments on the proposed amendment of rule 3 of the Legal Metrology (Packaged Commodity) Rules, 2011 to 30th August 2024. The proposed amendment aims to close loopholes and ensure that all bulk packages are labelled clearly and consistently, just like retail products.
Source: bit.ly/4dgRE0n