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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 Council of Medical Research and India’ central drug authority “CDSCO” have released draft standard protocols for evaluating In-Vitro Diagnostic kits for Influenza, SARS-CoV-2, RSV, Malaria, Dengue, Nipah, and other pathogens. Pharma and diagnostics stakeholders can submit comments by 25 August 2025, after which revisions will be minimal before final adoption.
Source: short-link.me/1b0iM

2. India’s Supreme Court has disposed of a plea challenging misleading AYUSH medicine ads and vacated its stay on the omission of a rule which had removed the requirement for state-level pre-approval of Ayurvedic, Siddha, and Unani drug advertisements. With the rule deleted, companies can advertise without state clearance.
Source: short-link.me/16ALo

3. The All India Organisation of Chemists and Druggists has urged the government to ban ultra fast ten minute delivery of high risk prescription medications by quick commerce platforms, citing threats to public health, rising drug misuse, ghost prescriptions, and a disregard for established regulatory safeguards.
Source: short-link.me/1b0iY

4. India’s Health Ministry has launched SHRESTH Index to benchmark and strengthen state drug regulatory systems. The data-driven framework will guide improvements in infrastructure, manpower, digitization, inspections, and grievance redressal. Upcoming measures include expanding the Not of Standard Quality (NSQ) Dashboard to all states as well.
Source: short-link.me/1b0j6

5. India’s public health organisations call for mandatory front of pack warning labels on food items high in fats, sugar, and salt, replacing Indian Nutrition Rating (or Health Star Rating) system. They cite rising diet related deaths and rapid ultra processed food growth.
Source: short-link.me/16ALH

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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

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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 amended the Cosmetics Rules, 2020 introducing clearer expiry labelling, redefining terms, updating recordkeeping norms, and empowering authorities to suspend or cancel licences. Notable changes include labelling for exports, new batch record rules, and designation of the Central Cosmetics Laboratory.
Source: short-link.me/1aoFG

2. In order to enhance ease of doing business, India’s central drug authority (CDSCO) has streamlined the process of issuance of Dual Use NOC through Sugam Portal for importing bulk drugs for non-medicinal use. Further to reduce the compliance burden, CDSCO has initiated issue of 1 year NOC, subject to prescribed conditions for such drugs. The new online Dual use system will be effective from 31st August 2025.
Source: short-link.me/1aoEr

3. The Food Safety and Standards Authority of India (FSSAI) has mandated all food business operators such as restaurants, cafes, dhabas and cloud kitchens to display their licence or registration along with a QR code linking to the Food Safety Connect app. This helps consumers access details, lodge complaints and provide feedback, promoting transparency and accountability.
Source: short-link.me/1aoOH

4. The Indian government enacted the Vegetable Oil Products, Production and Availability (VOPPA) Regulation Order, 2025, replacing the 2011 framework. It mandates mandatory registration for all vegetable oil producers, monthly online reporting of production, stocks, sales, and pricing, and grants authorities inspection and enforcement powers to boost market transparency and curb hoarding.
Source: short-link.me/1aoEM

5. Karnataka’s Health & Family Welfare Department has filed 29 legal cases under the Drugs & Cosmetics Act, and has served show-cause notices to 231 pharmacies for dispensing prescription drugs without prescriptions; simultaneously, authorities have flagged food vendors using synthetic colors and have issued warnings.
Source: short-link.me/1aoEW

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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 Health Ministry has approved adding the HPV vaccine to the Universal Immunisation Programme, targeting girls aged 9–14. This aligns with the June 2022 NTAGI recommendation and is supported by ongoing frontline healthcare worker training and rollout planning.
Source: shorturl.at/3e0T0

2. Meghalaya announced plans to introduce legislation requiring mandatory HIV/AIDS testing prior to marriage. The government is drafting a cabinet note and engaging district stakeholders to advance a mission mode HIV control policy.
Source: tinyurl.com/yfhymxdx

3. The India-UK Free Trade Agreement, signed on July 24, 2025, excludes patent term extensions and data exclusivity, safeguarding India’s generic drug industry. However, experts warn it restricts compulsory licensing by promoting voluntary licences and “adequate remuneration” clauses, and that this could undermine India’s ability to supply affordable medicines to developing countries.
Source: tinyurl.com/3wm9wwz9

4. The All-India Organisation of Chemists and Druggists (AIOCD), representing over 12 lakh chemists nationwide has reportedly urged the Drug Controller General of India to take urgent action, alleging that State Licensing Authorities are failing to stop illegal e pharmacies misusing draft notifications leading to unregulated online medicine sales and posing risks to public health.
Source: tinyurl.com/39b9a44n

5. Nathealth urged Niti Aayog to simplify healthcare regulations through a digital single-window system, highlighting burdensome compliance from 10–12 ministries. A white paper identified 85 regulatory challenges, calling for harmonisation across states to boost efficiency, innovation, and patient-focused care in hospitals, diagnostics, and medtech.
Source: tinyurl.com/5582rp5n

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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 Environment, Forest and Climate Change has notified the Environment Protection (Management of Contaminated Sites) Rules, 2025 to identify, assess, and remediate contaminated sites across India. The rules mandate state pollution boards to coordinate sampling, remediation, cost recovery, and risk-based action plans using a centralized online portal for monitoring and enforcement.
Source: bit.ly/3IMIeiU

2. The National Medical Commission released formal guidelines on the ethical conduct and broadcasting of live surgeries. Key provisions include mandatory explicit patient consent, anonymisation protocols, supervision by ethics boards, clear educational intent, and strict limits on commercial elements. The notice responds to Supreme Court scrutiny and aims to safeguard patient welfare in live surgical demonstrations.
Source: bit.ly/3IOGaqH
Source: bit.ly/45lJceG

3. India’s Drug Controller General has mandated state regulators to instruct manufacturers to closely monitor NDMA levels in ranitidine API and finished formulations, reduce shelf life, and implement risk-based controls. This follows a DTAB recommendation for a broader expert review and an ICMR safety study amid carcinogen concerns.
Source: bit.ly/4of1dTy
Source: bit.ly/3IPcABh

4. Delhi Drug Control Department has issued directive addressed to pharmacies to install CCTV cameras by July 31, 2025, to curb the sale of over-the-counter dual-use drugs without a valid prescription. Pharmacists across Delhi are voicing financial and procedural concerns over the government’s advisory.
Source: bit.ly/4mdEgOD

5. Delhi High Court directed the Centre to establish clear and enforceable guidelines for the collection and transport of medical samples. In response, the government has formed expert panels that have finalized draft standards, which are now under legal review and expected to be officially notified within three months.
Source: bit.ly/41freYK

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 authority has launched a new CT 04 application module on its SUGAM online portal, streamlining the issuance of import licences for cell & gene therapeutic products to simplify and accelerate regulatory compliance and imports.
Source: bit.ly/3TGuNmR

2. A Central Drugs Consultative Committee panel has noted consumer complaints over unreadable expiry dates, tiny fonts, glossy packaging, and generic-brand confusion on medicinal products. It recommends forming a DCGI-led sub committee including a packaging expert to overhaul labelling norms and evaluate regulatory requirements for packaging suppliers under Drugs Rules, 1945.
Source: bit.ly/3IpVF8h

3. Food Safety and Standards Authority of India (FSSAI) has recently directed licensing authorities to audit annual returns filed by food business operators on the FoSCoS platform. Authorities have been directed to flag inconsistencies, permit revisions via updated portal features, and enforce penalties for false declarations.
Source: bit.ly/4lpGH0p

4. The Central Board of Indirect Taxes and Customs has mandated that customs officers verify the registration of plastic raw material importers on the Centralized Extended Producer Responsibility (EPR) Portal before clearing consignments. This directive aligns with the Plastic Waste Management (Amendment) Rules, 2024.
Source: bit.ly/3TYREu9

5. The Government of India has reportedly planned to transfer the National Health Claims Exchange (Insurance claims platform) from the health ministry to the finance ministry under Insurance Regulatory and Development Authority’s oversight to combat inflated hospital bills for insured patients.
Source: bit.ly/40hID2M

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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 Department of Pharmaceuticals has extended the application deadline for Round V of its Production-Linked Incentive (PLI) scheme to 21 June 2025, giving pharma companies additional time to apply. Applications can only be made online through the given link in the circular.
Source: bit.ly/4kn1e4J

2. The Delhi High Court has barred a leading Ayurvedic manufacturer from airing advertisements claiming superiority of its Chyawanprash, ruling that freedom of commercial speech doesn’t justify misleading claims for regulated drugs. It has further emphasized stricter scrutiny on drug-related marketing to prevent false efficacy claims and consumer deception.
Source: bit.ly/4kqs63F

3. The Madras High Court has clarified that importing Ayurvedic drugs into India does not require an import license, provided the products conform to the standards set for domestically manufactured equivalents. This precedent emphasizes regulatory alignment with Indian pharmacopoeia standards and could facilitate smoother market entry for Ayurvedic importers while ensuring consistent quality.
Source: bit.ly/4lgEXH2

4. The National Pharmaceutical Pricing Authority (NPPA) will change its official website from nppaindia.nic.in to nppa.gov.in effective 15 July 2025. The new domain will host all notifications, pricing orders, data systems, and circulars. Stakeholders are advised to update their records and bookmarks to ensure uninterrupted access to NPPA services during the transition phase. The old domain will temporarily redirect users.
Source: bit.ly/44AXWF9

5. The National Pharmaceutical Pricing Authority (NPPA) has issued an Order thereby fixing the ceiling prices for I.V. fluids (non-glass with special features). Now the product I.V. fluids (non-glass with special features) cannot be sold beyond the fixed prices.
Source: bit.ly/44gE4rR

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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 Food authority (FSSAI) has extended the validity of No Objection Certificates (NOCs) granted to imported alcoholic beverages bottled at origin or in bulk with over 10% alcohol content and with no expiry date to 365 days. If consignments remain in Customs premises beyond this period, re-validation can be done through visual inspection upon payment of a prescribed fee.
Source: bit.ly/44Lgsvu

2. India’s Drugs Consultative Committee (DCC) has reportedly proposed enabling the licensing of Bedaquiline, Delamanid, Pretomanid, and Rifapentine only through India’s National Tuberculosis Elimination Programme (NTEP), with strict label warnings. This move aims to prevent misuse, preserve drug effectiveness, and combat rising cases of drug resistant tuberculosis.
Source: bit.ly/4km2dC7

3. The National for Allied and Healthcare Professions (NCAHP) has recommended replacing the term “Paramedical” with “Allied and Healthcare” across all government and institutional communications (verbal, written or electronic). States, UTs, and relevant bodies must implement and enforce this updated terminology in all official usage.
Source: bit.ly/4ltTcYA

4. A popular U.S. snack brand will remove “100% natural” claims from its packaging after lawsuits highlighted trace herbicide residues in its ingredients. Although levels were within legal limits, consumer groups argued the label was misleading.
Source: bit.ly/3TlDeE4

5. The U.S. Food and Drug Administration (FDA) has issued warning letters to four entities, including an Indian drug manufacturer, citing violations such as non-compliance to clinical trial protocol, insanitary conditions, contamination risks, and inadequate donor screening. The FDA has directed them to implement corrective actions to ensure compliance and safeguard product quality.
Source: bit.ly/44aoWw8
Source: bit.ly/45S8eD4
Source: bit.ly/4nqNn01
Source: bit.ly/45Sv11E

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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 West Bengal Legislative Assembly has passed a new Bill which is an amendment to the Clinical Establishments Act, 2017. The new Bill empowers the State to regulate treatment costs in private clinics, enforce fixed and package rates, streamline licensing, and mandate electronic medical records to ensure consumer protection and transparency.
Source: bit.ly/4k87Cg8

2. India’s Consumer Affairs Ministry has reportedly directed edible oil manufacturers and importers to reduce retail prices in order to pass the benefits of the recent import duty cuts to consumers. Although the new rates are in effect, supply chain delays may postpone noticeable price reduction until late June.
Source: bit.ly/3I5h5Hm

3. Federation of Indian Pharmacist Organizations (FIPO) has urged the Union Health Ministry to reject Drug Technical Advisory Board’s draft permitting sale of 16 OTC drugs (like paracetamol, clotrimazole) through unlicensed outlets without pharmacist oversight, citing risk to public safety.
Source: bit.ly/4kNtMoO

4. The 20 Nifty Pharma firms held a record ₹48,913 cr in cash as of March 31, doubling FY20 levels, and added over ₹10,200 cr in FY25. The cash reserves are aimed at funding M&A, expanding into complex therapy areas to transition into higher-margin, innovation-driven sectors.
Source: bit.ly/4kRGMdg

5. The U.S. FDA has launched a pilot program to accelerate drug reviews for companies aligned with national health priorities, such as pandemic readiness and essential drug supply. Selected firms will benefit from enhanced FDA engagement and early submissions, expediting approvals without compromising safety standards.
Source: bit.ly/3HQPWrH

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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 Central government has reportedly exempted imported pharmaceutical high-density polyethylene (HDPE) medical-grade plastic from mandatory quality certification under Bureau of Indian Standards regulations to facilitate the production of syringes and IV cannulas and a steady supply of essential products in the healthcare sector.
Source: bit.ly/4ldtUOp

2. The Department of Pharmaceuticals (DoP) has reportedly declined to reveal the names of 30 doctors who accepted ₹1.91 crore worth of foreign trips from major pharmaceutical company. Citing privacy concerns, the DoP resisted disclosing details despite National Medical Commission (NMC) being asked to act. The decision has sparked criticism over transparency and ethical accountability in healthcare.
Source: bit.ly/3G400gp

3. The Karnataka State Pollution Control Board (KSPCB) has clarified that Biomass Briquette/Pellet manufacturing plants do not fall under the scope of the EIA Notification, 2006, which governs environmental impact assessments for specified projects.
Source: bit.ly/4n20u7l

4. The government of India is reportedly tightening oversight of online pharmacies offering rapid deliveries amid concerns over unverified prescriptions, safety, and compliance. A regulatory review is underway to enhance consumer protection and control the proliferation of unregulated digital pharma services.
Source: bit.ly/3G1nDpZ

5. India’s Uttarakhand High Court has quashed a case against a leading Ayurvedic drug manufacturer and its founders over alleged misleading medical advertisements claiming to cure conditions such as diabetes and high cholesterol. The Court cited lack of specific evidence or expert reports to support the allegation that the claims were misleading.
Source: bit.ly/3HZK8vW