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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 constituted a committee to develop a policy governing refurbished medical devices. The committee will examine the scope of refurbished medical devices, methodology to evaluate the safety, performance, and remaining useful life of refurbished medical devices & suggest guidance for waste disposal of such refurbished devices.
Source: h7.cl/1o8qd

2. Indian government has announced a tax holiday until 2047 for foreign companies that provide cloud services globally using data centres located in India. Further, there will be no risk of foreign firms’ global income being taxed in India solely because they use Indian data centres. This move is aimed at attracting long-term investment into India’s digital infrastructure.
Source: h7.cl/1o8qp

3. Indian Government has released first national evidence-based lung cancer treatment and palliation guidelines. It offers 15 recommendations to standardise diagnosis, treatment and palliative care, improve early detection, reduce treatment disparities and ensure consistent, patient-centred care across the country.
Source: h7.cl/1o8qA

4. India’s Ministry of Consumer Affairs issued show-cause notices to major edible oil companies for violating the amended Vegetable Oils Products, Production and Availability (VOPPA) Order, 2025. Companies failed to submit monthly production data and register on official portals. Authorities have warned that continued non-compliance could lead to inspections and confiscation under the Essential Commodities Act, 1955.
Source: h7.cl/1o8qN

5. The United States Food and Drug Administration has launched the PreCheck pilot program to strengthen domestic pharmaceutical manufacturing. The initiative offers early regulatory engagement for new manufacturing facilities, improving predictability, streamlining facility assessments and accelerating readiness to supply medicines for the United States market.
Source: h7.cl/1o8qS

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) has launched a new online Risk Classification Module for medical devices, excluding IVDs. Effective 27 November 2025, applicants can seek classification for devices not listed in CDSCO’s published list via the portal, simplifying regulatory approvals for Medical Devices.
Source: h7.cl/1kNrH

2. Indian Council of Medical Research (ICMR) and India’s Central Drug authority CDSCO (IVD Division) has jointly developed the MedTech Mitra IVD Innovators Handbook to guide developers through clinical validation. It outlines key milestones, regulatory and ethical expectations, and evidence requirements, helping innovators plan effectively and generate strong clinical data to support the safety and efficacy of their diagnostic products.
Source: h7.cl/1kNrK

3. Rajya Sabha members urged the government to ban misleading surrogate ads promoting tobacco and liquor, citing rising cancer and heart disease cases. During debate on the Central Excise (Amendment) Bill, 2025, they sought stricter controls, awareness campaigns and higher taxes to curb tobacco use and protect public health.
Source: h7.cl/1fVMQ

4. The Delhi High Court has declined to grant injunctive relief against an Semaglutide manufacturer, thereby permitting the manufacture and export of semaglutide to jurisdictions where no valid patent protection subsists. The Court clarified that while export to non-patent markets is permissible, the sale or distribution of the drug within India remains prohibited until expiry of the relevant patent.
Source: h7.cl/1kNrT

5. The Indian government has introduced the Health Security se National Security Cess Bill, 2025, proposing a new cess on the installed machinery or processes used for the manufacture of goods such as pan masala, with scope to include other products in future. The cess will apply across all production methods, machine-based, manual, or hybrid.
Source: h7.cl/1kNrW

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TOP 5 HEALTH LAWS & POLICY UPADATES

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 issued a new SOP for using spent acetic acid from 7ADCA and paracetamol manufacturing to produce Pigment Yellow 12. The guideline lays out strict rules for storage, handling, emissions control, wastewater treatment, and record-keeping to ensure the safe and compliant utilization of hazardous waste.
Source: h7.cl/1fJVZ

2. The Parliamentary Standing Committee on Chemicals and Fertilisers has reported steep disparities between stockist and retail prices of several non-scheduled drugs, with trade margins reaching 600–1,100%. It has urged the NPPA and Department of Pharmaceuticals to review trade-margin practices and strengthen pricing transparency across the supply chain.
Source: h7.cl/1fJW7

3. The Department of Telecommunications (DoT) has reportedly directed messaging platforms to implement SIM-binding, linking user accounts to the SIM used during registration. Under this mandate, web-based sessions of messaging platforms will automatically log users out every six hours and require re-authentication.
Source: h7.cl/1kBdb

4. Pune Municipal Corporation has reportedly issued guidelines urging residents to avoid over-the-counter (OTC) antibiotics to combat rising antimicrobial resistance (AMR), aligning with Union government directives. Residents must use antibiotics only with prescriptions and complete full courses, especially during winter.
Source: h7.cl/1kBdk

5. The government of China will reportedly begin charging a 13 % value added tax on condoms and other contraceptives from January, ending a decades-long exemption. The move aims to encourage higher birth rates, but critics warn it could increase unprotected sex and fail to address high child-rearing costs.
Source: h7.cl/1fJWy

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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 Drugs Consultative Committee (DCC) has approved a proposal to delete the exemption under Entry 13 of Schedule K for cough syrups. The move follows recent incidents involving deaths linked to contaminated cough syrups.
Source: h7.cl/1ft5I

2. The Drugs Consultative Committee (DCC) has observed gaps in monitoring drug marketers’ responsibility for product quality, safety, and efficacy, as their details are often unavailable for regulatory communication. To enhance accountability, the DCC has recommended amending the Drugs Rules, 1945 to mandate a licensing framework for all drug marketers.
Source: h7.cl/1kjPG

3. India is reportedly planning to introduce a Quality Control Order (QCO) requiring Bureau of Indian Standards compliance for food-processing machinery, aiming to curb unsafe imports, especially from China. The measure seeks to improve equipment reliability, ensure food-grade materials, strengthen domestic manufacturing, and minimise disruption for smaller processors across the industry.
Source: h7.cl/1ft5T

4. The government will reportedly introduce a Bill in the Lok Sabha seeking a new “health & national security” cess to replace the expiring GST compensation cess on cigarettes, pan masala, gutkha and other tobacco products. The aim is to keep overall tax incidence unchanged, sustaining high indirect-tax levels on “sin goods” while tying levy proceeds to public-health and national-security objectives.
Source: h7.cl/1kjPJ

5. The Food Safety and Standards Authority of India (FSSAI) has directed all state and central food-safety authorities to conduct inspections, sampling and testing of roasted chana and similar products following complaints that the banned industrial dye Auramine, which is not permitted under food-safety rules, was being illegally used for colouring. The order mandates action across manufacturing, storage, distribution and e-commerce channels and requires a consolidated compliance report to be submitted within 15 days.
Source: h7.cl/1kjQl

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 mandated manufacturers of pharmaceuticals to comply with strict testing of raw materials and excipients of every batch and each batch of final product and maintaining records. During inspections, State and UT Drug Controllers will inspect the licensee’s batch release records, ensure there is a robust vendor qualification system, and confirm that raw materials are sourced only from approved vendors.
Source: https://short-url.org/1csET

2. Central Drugs Standard Control Organization (CDSCO) has launched a 100-day awareness campaign on the Goods and Services Tax reduction on medicines and medical devices. Chemists and druggists associations are directed to encourage their members to display awareness posters at pharmacies. Compilation of photographs of the activities undertaken are to be submitted to CDSCO’s headquarter.
Source: https://short-url.org/1csHq

3. The Department of Consumer Affairs has granted three-month permit to leading FMCG, personal care, and medical device firms to use preprinted packaging despite labelling errors. Corrections such as unit sale price, company name, or customer care information must be declared using stamping, stickers, or online printing.
Source: https://short-url.org/1csCZ

4. India has notified its first binding Green House Gas (GHG) emission intensity targets for aluminium, cement, chlor-alkali, and pulp & paper sectors under the GHG Emission Intensity Target Rules, 2025. Industries must reduce emissions per output unit, trade carbon credits, and face penalties for non-compliance, boosting market-driven decarbonization.
Source: https://short-url.org/1habB

5. India’s Central Drug Regulator, CDSCO, has issued a notice inviting stakeholder comments to address disparities in new drug approvals. While the first applicant must conduct full local clinical trials and bioequivalence studies, subsequent applicants gain approval based solely on chemical, pharmaceutical, and bioequivalence data. This creates inequality in regulatory burden and costs. CDSCO seeks feedback by November 7, 2025, to develop fairer drug approval policies.
Source: https://short-url.org/1csDm

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 Ministry of Environment, Forest and Climate Change has extended the deadline for filing annual returns by Producers, Importers, and Brand Owners (PIBOs) of plastic packaging for 2024–2025 until November 30, 2025.
Source: short-url.org/1bS0C

2. The Delhi High Court, while deciding a trademark dispute, ordered customs at Mundra port to inspect containers suspected to contain dental-hygiene products which are allegedly packaged in deceptively similar manner to a leading brand’s red blue trade dress. The court found a prima facie likelihood of dilution of goodwill but withheld injunctive relief until confirmation from customs.
Source: short-url.org/1gxoM

3. Pursuant to over 3,000 complaints concerning the non-passage of tax cuts or “dark patterns” in discounting and price presentation, the government has reportedly summoned top e-commerce firms for hiking the prices or not reducing prices after recent GST reduction, even after September 22, 2025. It is scrutinising over 50 product categories and expects visible consumer price relief during the festive season.
Source: short-url.org/1bS2N

4. The Government of India has extended the RoDTEP (Remission of Duties and Taxes on Exported Products) scheme beyond September 30, 2025, until March 31, 2026. This scheme refunds hidden duties and taxes to exporters. It covers DTA (Domestic Tariff Area) units, Advance Authorisation holders, SEZ units, and EOUs at existing rates within the approved budget.
Source: short-url.org/1bS1c

5. The Delhi High Court has quashed an FIR against a manufacturer of medicines and injections that “may cause serious harm to the patient.” The Court held that only Drug Inspectors can prosecute offences under the Drugs and Cosmetics Act. Police registration of such FIRs was deemed beyond jurisdiction.
Source: short-url.org/1bS1W

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 Delhi High Court has recently ruled that businesses cannot justify failure to reduce prices after a GST rate cut by claiming to have increased the product quantity, especially when such changes are made without informing consumers. Continued non-compliance may lead to GST registration cancellation under anti-profiteering provisions.
Source: short-url.org/1gqnP

2. Central Drugs Standard Control Organization (CDSCO) has clarified that combi-packs of lyophilized injections with standard diluents (e.g., sterile water or saline) used for over four years will not be treated as new drugs, allowing State Licensing Authorities approval. Combi-packs with different diluents will still require CDSCO approval as new drugs.
Source: short-url.org/1gqnS

3. The Ministry of Labour and Employment has released draft Factories Workers Rules under the OSHW Code, 2020, inviting comments until 6th November 2025. The rules mandate safety, health, and welfare measures, including sanitation, ventilation, separate facilities, first-aid, nutrition, and emergency preparedness, with obligations varying by workforce size.
Source: short-url.org/1gqo1

4. Over the next five years, drugs worth $236 billion globally are slated to lose patent protection, paving the way for generic drugs and biosimilars. This “patent cliff” allows Indian pharma to capture market share, grow revenues, and lower drug costs for patients globally.
Source: short-url.org/1gqo6

5. Over the past five years, National Medical Commission (NMC) Ethics & Medical Registration Board has dismissed 162 appeals filed by patients/families alleging medical negligence. India’s Central Health Ministry has now reportedly begun a review of this, planning to consult with NMC to understand and address potential procedural bias.
Source: short-url.org/1bLfY

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. Central Board of Indirect Taxes and Customs (CBIC) has issued Notification revising GST rates effective September 22, 2025, after the 56th GST Council meeting. The GST rates for medical devices, drugs, food, beverages, and cosmetics have been notified.
Source: short-url.org/1f8PY

2. India’s Central Drugs Standard Control Organization (CDSCO) and Indian Council of Medical Research (ICMR) have issued a unified national protocols for evaluating in-vitro diagnostic kits for Chikungunya, Dengue, Zika and others. These guidelines set strict criteria on sensitivity, specificity, and quality, ensuring accurate diagnostics and strengthening regulatory oversight to improve access to quality-assured diagnostic kits in India.
Source: short-url.org/1f8Q4

3. The National Medical Commission has advised medical colleges to strengthen rabies case management via regular training, surveillance, and community outreach. Colleges must guarantee continuous supply of anti-rabies vaccine (ARV) and anti-rabies serum (ARS), maintain a register of animal bite exposure cases, and report suspected rabies cases through state nodal officers via IHIP under IDSP.
Source: short-url.org/1f8Qh

4. The Directorate General of Health Services is set to introduce new regulations establishing minimum standards for medical sample collection and transportation. These standards aim to ensure that blood, urine, and swab samples are handled by trained professionals and transported under proper conditions, including maintaining a cold chain, to prevent contamination and ensure accurate test results.
Source: short-url.org/1f8Qw

5. The Drugs Control Administration (DCA), Telangana suspended licences of 165 medical shops and permanently cancelled seven for retailing MTP kits without valid prescriptions or licensed supervision. 800+ inspections revealed violations including OTC sales of abortifacient drugs (mifepristone, misoprostol), lack of required records, and dispensing without qualified pharmacists.
Source: short-url.org/1f8QF

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 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 Delhi High Court to hear a Public Interest Litigation filed against major e-commerce platforms, accusing them of failing to make their apps accessible to people with disabilities, which constitutes a violation of fundamental rights. The plea also urged that return and refund processes be made more accessible for visually impaired users.
Source: bit.ly/4jK5X0b

2. India’s Kerala High Court has ruled that clubs and associations cannot be taxed for services or welfare schemes provided to their own members, calling it unconstitutional. These transactions involve only one entity, violating tax principle that a person cannot be taxed for “self-supply” of services.
Source: bit.ly/4isU4e4

3. The Indian Government reportedly plans to introduce Quality Control Orders for cosmetics to ensure product quality and curb imports of substandard items. However, industry leaders have raised concerns about overlapping regulations, as existing Cosmetic Rules, 2020 already align with the guidelines of Bureau of Indian Standards.
Source: bit.ly/4jm0PiZ

4. India has reportedly blocked imports of US dairy products like butter and cheese due to concerns over US cattle feeding practices involving animal-based proteins. India demands changes to these practices or adherence to its vegetarian certification norms. The issue could affect ongoing trade negotiations.
Source: bit.ly/3EoJveh

5. The Competition Commission of India (CCI) has reportedly ruled that leading food delivery platform’s platform fees, food prices, and delivery charges are not unfair or discriminatory. This decision came after a complaint was filed accusing the company of abusing its dominant position in the food delivery market.
Source: bit.ly/3S1JkZo