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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 Food Safety and Standards Authority of India (FSSAI) has issued an advisory directing food businesses to stop using “100%” claims on labels and promotional materials, citing them as misleading and undefined under current regulations. The move aims to protect consumers from deceptive marketing practices.
Source: bit.ly/3FidCVc

2. India’s Central Drugs Standard Control Organisation (CDSCO) has released guidelines for safe disposal of expired and unused medicines. It mandates flushing 17 high-risk drugs like fentanyl and diazepam to prevent harm. The guidance urges states to establish Drug Take Back programs under biomedical waste rules to curb misuse, environmental risks, and promote responsible pharmaceutical waste management.
Source: bit.ly/4jqNO70

3. The Bureau of Indian Standards has issued Amendment on 22 May, 2025 to IS 17349:2020, the medical textile standard for shoe covers. The revised standard enhances quality and safety. The old standard will remain in force till November 21, 2025.
Source: bit.ly/4dDEuf3

4. The International Council for Harmonisation (ICH) has released new guidelines to aid in developing medicines for pregnant populations. These guidelines emphasize the need for robust clinical data to assess drug safety and efficacy during pregnancy. Additionally, they provide updated recommendations for presenting quality information in the Common Technical Document (CTD).
Source: bit.ly/43jxTmn

5. The European Medicines Agency (EMA) is promoting faster global timelines for post-approval changes (PACs) through regulatory reliance, allowing non-EU countries to use EMA’s assessments. This reduces duplication, speeds up approvals, and improves patient access. Companies must clearly communicate PAC submissions and inform EMA when sharing data with other regulators to ensure smooth coordination.
Source: bit.ly/4jv8rzh

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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 Drugs Standard Control Organization clarified that labelling, overprinting, or stickering is strictly permitted for imported drugs. These activities require a valid manufacturing license, appropriate facilities, and adherence to labelling norms. Original labels must remain visible to maintain regulatory transparency and ensure clear identification of modifications and responsibilities.
Source: bit.ly/4kjfBYw

2. The Himachal Pradesh High Court held that vicarious liability for supplying substandard drugs requires proof that an individual was responsible for the company’s operations. Without such evidence, partners cannot be held liable, and only the company itself can be prosecuted for manufacturing or selling defective drugs.
Source: bit.ly/3Hfap9o

3. India’s Ministry of Health has released draft Drugs Rules proposing mandatory testing for bacterial endotoxins or pyrogens in injectable drugs. The rules require drug sales to be supervised by a competent person, with timely reporting of any changes. Exemptions apply to non-antimicrobial drugs used in food and beverage manufacturing. Feedback from stakeholders invited by June 30, 2025.
Source: bit.ly/4jomruw

4. West Bengal’s Drugs Control Administration mandates wholesalers and retailers to verify QR codes on top-selling brands and ensure purchases through authorized channels, aiming to curb counterfeit drug circulation.
Source: bit.ly/4krbkCj

5. The Bureau of Indian Standards (BIS) seized products worth ₹90 lakh from a Bengaluru warehouse for allegedly using the ISI mark without authorization, raising concerns for compliance in product sourcing and labelling across industries.
Source: bit.ly/4jppfr4

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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 Pollution Control Board (CPCB) has extended the deadline for filing E-Waste EPR returns till June 30, 2025, and mandates audits for all registered entities to strengthen rule compliance and traceability.
Source: bit.ly/4k8KbE8

2. Food Safety and Standards Authority of India has proposed reforms to ease food license renewals, including fixed renewal dates (Jan 15, Apr 15, Jul 15, Oct 15), 10-year validity for Trade/Retail businesses, and a 3-year minimum for registrations. These aim to standardize compliance, reduce admin burdens, enable bulk renewals. Stakeholders have been invited to submit feedback by 30th June, 2025.
Source: bit.ly/3SBuv09

3. The Drugs Controller General of India (DCGI) has revoked import registrations of several cosmetic products containing salicylic acid concentrations exceeding the prescribed limit, in violation of the Cosmetics Rules, 2020.
Source: bit.ly/4kyzz1e

4. India’s Kerala High Court rules that prescribing medicines and tests over the phone doesn’t constitute gross negligence, reinforcing protections for doctors against unwarranted criminal liability.
Source: bit.ly/4dybNQy

5. India’s Central Drugs Standard Control Organisation (CDSCO) has identified numerous MSME pharmaceutical firms in India producing substandard drugs, with April data revealing about 60 samples failing quality standards. Affected products include eye drops, anaesthetics, and supplements.
Source: bit.ly/4jirNHr

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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 Punjab & Haryana High Court mandates state government to notify rules under Mental Healthcare Act, 2017 within 60 days, addressing a 7-year delay that hampers effective implementation and delivery of mental health services.
Source: bit.ly/4k3CEpU

2. India’s Central Drugs Standard Control Organisation (CDSCO) has issued a guidance document outlining the procedure for obtaining a Free Sale Certificate (FSC) for licensed medical devices in India. It simplifies the regulatory process for submitting an application and obtaining the FSC from the Central Licensing Authority.
Source: bit.ly/3FbKQW9

3. Food Safety and Standards Authority of India (FSSAI) mandates that FBOs with expired licenses or registrations in FY 2024–2025 must submit a Closure Report via the FoSCoS portal. The report must confirm no ongoing business or provide details of a new license. Reasons for non-renewal must be stated to ensure transparency and traceability in licensing.
Source: bit.ly/3Se67kQ

4. India’s Department for Promotion of Industry and Internal Trade (DPIIT) has extended the implementation of the Quality Control Order (QCO) for household and commercial electrical appliances to March 19, 2026. The update includes relaxations for Micro, Small and Medium Enterprises, R&D and export units, supporting quality and ease of business.
Source: bit.ly/4ksMTEb

5. The Drugs Control Department of Kerala has taken an action against a private hospital for illegally stocking and selling Physician’s sample medicines at inflated prices, highlighting that sample medicines can neither be stocked nor sold by hospitals.
Source: bit.ly/3FieSaJ

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 Standard Control Organization (CDSCO) is in the process of initiating license withdrawal procedures for unapproved fixed-dose combinations (FDCs) of antibiotics. This action follows the failure of state drug licensing authorities to submit critical data. The move is aimed at curbing irrational antibiotic use and combating antimicrobial resistance.
Source: bit.ly/4j6zhxs

2. India’s government plans to mandate QR codes on vaccines, antimicrobials, narcotics, and cancer drugs to enhance traceability and combat counterfeiting. The move also includes adding excipient details on labels for certain medicines, aiming to improve drug authenticity, safety, and public health protection across the supply chain.
Source: bit.ly/4jflqFa

3. An Indian industry group has urged the government to scrap the mandatory testing of cough syrups at government-approved laboratories before export. The group argues that this costly process delays shipments and places a heavy burden on small manufacturers. The requirement was introduced following reports linking India-made syrups to fatalities in Gambia.
Source: bit.ly/437zHNO

4. The United States Food and Drug Administration (US FDA) has issued a warning to an Indian drug manufacturer for significant violations of Current Good Manufacturing Practices (CGMP) at its production facility. The violations include unsanitary conditions, inadequate equipment cleaning, poor documentation, and unverified raw material, raising serious global concerns about product quality, safety, and regulatory compliance.
Source: bit.ly/4mjGJIg

5. The EU’s Scientific Committee on Consumer Safety (SCCS) has concluded that butylparaben at 0.14% is unsafe for children aged 0.5–10 years when used in multiple cosmetic products. However, it is considered safe in single-use dermal and oral products, excluding body lotions.
Source: bit.ly/3H8EmYu

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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 Consumer Protection Authority (CCPA) has issued notices to popular e-commerce platforms for selling walkie-talkies without mandatory disclosures such as operating frequencies, licensing requirements, or Equipment Type Approval. This violates the E-commerce Rules and misleads consumers into believing these wireless devices can be freely operated without regulatory clearance.
Source: bit.ly/42RYUx2

2. The Government of India has directed the Department of Pharmaceuticals, along with the National Health Systems Resource Centre (NHSRC), to identify essential drugs, enhance their availability, and implement price controls to ensure affordability aiming to mitigate combat-related health risks during the ongoing conflict.
Source: bit.ly/4jQwcm9

3. Music companies are taking legal action against influencers for using copyrighted songs commercially in paid social media posts without proper permission or licenses. According to a popular social media platform policy, licensed music is allowed only for personal, non-commercial use and not for branded content.
Source: bit.ly/3GOLxoK

4. US President is reportedly set to bring an executive order that seeks to cut prescription drug prices by using global benchmarks and bringing in “most favored nation” pricing into play. The U.S. will match the lowest price paid by any nation, potentially impacting Indian exporters’ profit margins.
Source: bit.ly/43kJiBk

5. India and the UK have finalized a free trade agreement, where India has agreed to reduce import duties on the British products, including Scotch whisky, gin, and cars. However, India is protecting its farmers and local producers by maintaining duties on sensitive agricultural items like dairy, apples, cheese, and oats.
Source: bit.ly/3GK4bOG

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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 Medical Commission (NMC) has reportedly not initiated any action against 30 doctors involved in a pharma freebies case. An RTI response reveals that the Department of Pharmaceuticals has not directed action, despite earlier findings of violations by the pharmaceutical company sponsoring lavish trips.
Source: bit.ly/44xs6e4

2. The Indian Pharmacopoeia Commission (IPC) has announced changes to certain monograph titles and synonyms in the upcoming Indian Pharmacopoeia (IP) 2026 which is effective from July 2026. Manufacturers have been advised to assess the impact on existing products and start taking necessary steps to update the label.
Source: bit.ly/4dtuq8p

3. India’s Ministry of Health has reportedly raised concerns that only a small fraction of small and medium-sized pharmaceutical companies have applied to the government for an extension of the timeline to comply with the Revised Good Manufacturing Practices (GMP) under Schedule M and to submit their facility upgradation plans. With the 12th May 2025 deadline approaching, state health secretaries have been asked to coordinate with local manufacturers and ensure timely compliance.
Source: bit.ly/4ka44u3

4. The Government of Odisha has reportedly announced plans to draft a state-wide mental health policy, including early intervention frameworks and counselling centres, to address rising mental health issues particularly among vulnerable groups such as youth and the elderly
Source: bit.ly/44peMIy

5. The European Medicines Agency (EMA) has officially recognized suicidal thoughts as a potential side effect of a medication commonly used to treat male pattern baldness. While the EMA maintains that the benefits of the drug continue to outweigh the risks, it has mandated that all 1 mg packages include a patient card highlighting these risks.
Source: bit.ly/3SgZLBr

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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 Drug Regulator has issued guidance for obtaining NOCs to manufacture for export of approved/unapproved new drugs. It sets a 7-day timeline for NOC issuance, allows limited reuse of un-exported stock within specified residual shelf lives, and mandates quantity-specific NOCs for NDPS/banned drugs.
Source: bit.ly/4iQ5g4z

2. India’s Bombay High Court has issued notice to central drug regulator CDSCO’s response to a petition filed by a cancer research organization for rejection to initiate Phase I human trials of its homegrown cancer immunotherapy vaccine which has not been tested on animals.
Source: bit.ly/3ESEcUD

3. Patient groups, health organizations and patent experts in India have reportedly urged the Indian government to oppose TRIPS-plus provisions in Free Trade Agreements (FTA) with the US, UK, and EU, citing risks to affordable medicine access and self reliant domestic pharma industry.
Source: bit.ly/3EYEFEG

4. A Recent vaccine trial faced criticism after children were offered financial incentives to participate, raising ethical concerns. The promotional material, shared via messaging apps, was based on unapproved drafts. The UK’s Prescription Medicines Code of Practice Authority (PMCPA) found that ethical standards were not upheld, and no internal investigation was conducted by the sponsor.
Source: bit.ly/4iTpxGq

5. The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has reportedly launched a strategic AI roadmap to enhance regulatory efficiency, data analysis, and decision-making, aligning with the EU AI Act and fostering innovation in pharmaceutical regulation.
Source: bit.ly/454woJZ

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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 Allahabad High Court recently ruled that insurance payouts must follow succession laws. It clarified that a nominee is not the actual heir but only holds the money on behalf of the legal heirs. So, the nominee cannot keep the insurance amount for themselves if there are rightful successors.
Source: bit.ly/4jMr2Yu

2. The Indian government has issued a Quality Control Order (QCO) mandating that all aluminum and aluminum alloy foil used for pharmaceutical packaging, along with other specified aluminum and aluminum alloy products to bear the Standard Mark under a license from the Bureau of Indian Standards. The order will take effect on 1st October 2025 and does not apply to products manufactured in India for export purposes.
Source:  bit.ly/3Sno9B4

3. India’s National Pharmaceutical Pricing Authority (NPPA) has fixed separate retail prices for new drug formulations manufactured by a pharmaceutical company. The company requested the separate pricing by highlighting the unique features of packaging like self-collapsibility and self-seal ability, not having air-vent and no chance of contamination during manufacture/ infusion/ admixing levels.
Source: bit.ly/4k7f3nR

4. The Government of India is reportedly planning to invoke the Essential Services Maintenance Act (ESMA) to prevent hoarding and ensure uninterrupted access to essential commodities. This move comes in response to potential supply chain disruptions and as part of anti-profiteering measures following Operation Sindoor.
Source: bit.ly/3GKcXvV

5. The United States government has issued an executive order aimed at boosting domestic pharmaceutical manufacturing. The order directs the Food and Drug Administration (FDA) to expedite the approval process for new domestic production facilities. Additionally, the government plans to impose tariffs on pharmaceutical imports to encourage domestic production and reduce reliance on foreign suppliers.
Source: bit.ly/3EVqyA8

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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. Drugs Technical Advisory Board (DTAB) has proposed to mandate the immediate suspension of licenses for drugs classified as Not of Standard Quality (NSQ) in the public interest. Such suspensions would remain in effect unless the concerned manufacturers submit a satisfactory Corrective and Preventive Action (CAPA) plan. The proposal also includes corresponding amendments to the Drugs Rules.
Source: bit.ly/3EFg5Zx

2. Drugs Technical Advisory Board (DTAB) has proposed to classify all antimicrobials as “New Drugs” under the New Drugs and Clinical Trials Rules, 2019. This move aims to facilitate stricter regulatory oversight in light of growing concerns over antimicrobial resistance.
Source: bit.ly/3EFg5Zx

3. Drugs Technical Advisory Board (DTAB) has proposed that manufacturers of medical devices with a valid manufacturing or loan license need not apply for a sterilization loan license. Instead, they can submit documentary evidence in support of proper sterilization when applying for a manufacturing license, provided the sterilization site’s license number is included on the device label.
Source: bit.ly/3EFg5Zx

4. Drugs Technical Advisory Board (DTAB) has proposed amendments to the Medical Devices Rules, 2017, to include clear definitions for “registration certificate” and “registration certificate holder.”  This change aims to provide better regulatory clarity in the medical device industry.
Source: bit.ly/3EFg5Zx

5. The Indian Government is finalizing revised biosimilar guidelines to align with global standards. The updated ‘Guidelines on Similar Biologics’ focus on stricter quality standards, reducing animal testing, and promoting in-vitro studies, while adhering to the 3R principles (Replace, Reduce, Refine). The aim is to streamline approvals and ensure patient safety.
Source: bit.ly/3GFiunq