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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.

The Ministry of Health and Family Welfare has placed Pregabalin under Schedule H1 of the Drugs Rules, 1945, amid concerns over its rising misuse for sedative, euphoric, and dissociative effects, particularly among youth. The move seeks to strengthen regulatory control by restricting over-the-counter access and ensuring sale only against valid prescriptions with stricter monitoring and record-keeping requirements.
Source: shortlink.uk/1vI8d

India’s Madras High Court ruled that a mother need not undergo DNA testing to donate a kidney to her son when official records establish their biological relationship. The court set aside the transplant approval rejection and directed authorities to permit the donation immediately. This humanitarian interpretation reinforces that documentation standards should prioritise life saving procedures over rigid procedural requirements, potentially influencing future authorization committee decisions on donor recipient relationships.
Source: shortlink.uk/1vI8z

India’s central food authority is moving towards a centralised food surveillance system deploying third party agencies for sample collection, centralised laboratory testing, and digital alerts for faster regulatory action. The framework requires 50% of samples from organised supply chains. The shift signals a technology driven overhaul of food safety governance, raising compliance and traceability expectations for manufacturers, retailers, and supply chain operators.
Source: shortlink.uk/1vI8l

4. Global pharmaceutical companies are increasingly shifting high-value clinical research, regulatory, pharmacovigilance, and innovation-led functions to India as the country evolves from a low-cost outsourcing destination into a strategic global research and development hub. The shift could accelerate investments in clinical research infrastructure, advanced therapies, AI-enabled drug development, and specialised talent while strengthening India’s competitiveness as a global life sciences and biotech hub.
Source: shortlink.uk/1qk9u

5. The Competition Commission of India (CCI) has rejected allegations of monopoly and excessive pricing against 12 private hospitals in Delhi, ruling that higher prices alone do not prove abuse of dominance. The regulator found hospitals operated within competition norms, allowed external procurement, and charged within MRP, dismissing decade-long complaints.
Source: shortlink.uk/1vI8q

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 Department of Consumer Affairs has clarified that customary units such as inches, feet, yards and square feet may be used only as supplementary declarations alongside standard SI units under the Legal Metrology framework. The clarification aims to ensure uniformity in trade practices while preventing misleading or ambiguous quantity declarations for consumers.
Source: shortlink.uk/1vwL3

2. FSSAI plans to centralize food surveillance by separating sampling from enforcement, reducing state officers’ discretionary powers. Neutral agencies will collect samples, with results uploaded to a national database for quick alerts. This aims to enhance transparency, consistency, and consumer safety while ensuring enforcement remains with state authorities.
Source: shortlink.uk/1vwJ8

3. The Supreme Court has directed Delhi authorities to urgently frame a Standard Operating Procedure (SOP) ensuring private hospitals built on concessional government land provide free treatment to Economically Weaker Section (EWS) patients, addressing widespread non-compliance with the mandate of reserving 10% inpatient beds and 25% outpatient services.
Source: shortlink.uk/1q97l

4. The CDSCO has directed state and Union Territory drug regulators to closely monitor surrogate advertising and promotional activities related to prescription GLP-1 drugs used to treat obesity and metabolic disorders. The regulator has cautioned against indirect promotional practices, including disease-awareness campaigns and digital outreach, that could influence public demand for prescription-only medicines. The move signals intensified regulatory scrutiny of marketing, distribution, and promotion, and may also lead to stricter compliance expectations for pharmaceutical companies, digital platforms, wellness clinics, and marketers involved.
Source: shortlink.uk/1q96J

5. The Indian Council of Medical Research (“ICMR”) has introduced a single-window approval mechanism for medical research studies, replacing the earlier fragmented process requiring approvals from multiple ethics committees and institutions. The framework is intended to streamline ethics clearances, reduce procedural delays, and accelerate approvals for multicentric and collaborative research projects.
The development is significant for India’s clinical research ecosystem as it is expected to improve regulatory efficiency, transparency, and coordination in study approvals.
Source: shortlink.uk/1q96K

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 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

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 (CDSCO) reportedly flagged 35 drugs manufactured in Telangana as Not of Standard Quality (NSQ), including painkillers, antacids and antibiotics. These medicines, failed quality or labelling standards, resulting in regulatory and manufacturing oversight gaps. Affected batches are reportedly recalled, and show-cause notices are issued.
Source: h7.cl/1oCiU

2. The Indian Pharmacopoeia Commission (IPC) has entered into three strategic Memoranda of Understanding (MoUs) with the Goa State Pharmacy Council (GSPC), Quality Council of India (QCI), and HLL Infra Tech Services Limited. These collaborations aim to strengthen pharmacovigilance systems, enhance professional competencies, and promote uniform standards for medicine quality and patient safety across India.
Source: h7.cl/1oCj1

3. India and United States has agreed under an interim trade framework to address long-standing barriers for US medical devices, eliminate restrictive import licensing procedures, and review adoption of US or international standards within six months to boost market access. The move is part of broader efforts to improve MedTech trade and bilateral economic cooperation
Source: h7.cl/1jzb3

4. Delhi High Court disposed of a trademark infringement suit after parties reached an amicable settlement. The defendant acknowledged superior trademark rights of the plaintiff in trademark “Blue Heaven”, agreed to permanent injunction, withdrew trademark applications, paid damages and costs, removed online listings, and enabled refund of court fees as ordered.
Source: h7.cl/1oCj9

5. Indian Council of Medical Research is reportedly rolling out an AI-based surveillance system under the National One Health Mission to detect zoonotic diseases early. By integrating human, animal, and environmental data, it will identify unusual patterns, provide real-time decision support, and help prevent local outbreaks from escalating into pandemics.
Source: h7.cl/1jzeb

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 food regulator, FSSAI, has reportedly initiated a nationwide surveillance drive to collect and test egg samples (branded and unbranded) for banned antibiotics like nitrofurans. Additionally, FSSAI is also scrutinising declarations such as ‘100% chemical-free’, ‘antibiotic-free’, ‘100% pure’, or ‘fresh’, checking compliance with permissible labelling declarations.
Source: h7.cl/1gl8j

2. India will host the Second World Health Organization Global Summit on Traditional Medicine in New Delhi from 17 to 19 December 2025, bringing global leaders together to strengthen science-based, ethical and sustainable integration of traditional medicine into national health systems and the global health policy framework.
Source: h7.cl/1leF9

3. India’s Parliamentary Standing Committee on Health & Family Welfare has reportedly called on the National Medical Commission (NMC) to issue clear guidelines to establish new medical colleges in states with fewer than 100 MBBS seats per million population, addressing uneven seat distribution, high costs, faculty shortages and access gaps in medical education.
Source: h7.cl/1gl9d

4. The Indian Council of Medical Research has reportedly funded a pan India clinical trial, Intermittent PARP Inhibitor Regimen in Ovarian Cancer, to evaluate intermittent dosing of the PARP inhibitor rucaparib in ovarian cancer, aiming to reduce treatment costs and side effects while maintaining clinical efficacy and improving patient access.
Source: h7.cl/1leFj

5. The Telangana Drugs Control Administration conducted a statewide inspection of retail medical shops and raided an unlicensed fertility centre, issuing notices to 180 outlets and seizing multiple medicines, reinforcing enforcement against illegal drug sales and violations of the Drugs and Cosmetics Act, and ensuring patient safety across the state.
Source: h7.cl/1gl8A

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

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 Food Safety and Standards Authority of India (FSSAI) has extended the provisional enrolment of 63 Non-Food Production (NFP) Units for collection used cooking oil from Food Business Operators (FBOs) until 31st July 2026. FSSAI may cancel enrolment for non-compliance of SOPs, order, guidelines or submission of false information or based on findings of inspections.
Source: bit.ly/45sysu7

2. The Ministry of Chemicals and Fertilizers has withdrawn the Quality Control Orders for Acetic Acid, Methanol, and Aniline, which were originally issued in 2019 and set to take effect from August 3, 2025. The immediate removal of mandatory BIS certification is expected to ease sourcing and compliance for the pharmaceutical sector.
Source: bit.ly/4kYKjpl

3. The Ministry of Environment, Forest & Climate Change has notified an Amendment to the Environment Protection Rules, 2025, introducing stricter emission and effluent standards for pesticide manufacturing units. New limits on pollutants such as COD, BOD, heavy metals, HCl, benzene, and methanol will enforce tighter pollution control compliance effective immediately.
Source: bit.ly/4odOlNx

4. A recent Indian Council of Medical Research (ICMR) study reveals that just 28.5 % of cancer patients in India receive radiotherapy, while the ideal rate should be around 58.4 %. India currently has 794 radiotherapy machines, but needs between 1,585 and 2,545 to meet demand. The council recommended urgent expansion.
Source: bit.ly/46sqsv3

5. Bihar’s Health Minister has inaugurated a state-level Anti-Fraud Unit Dashboard to monitor claims under Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana and the Chief Minister Jan Arogya Yojana to curb fraudulent hospital billing and establish a robust framework for transparency, accountability, and monitoring.
Source: bit.ly/3TTo5tQ

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 Health Ministry plans to discontinue the doorstep delivery of certain medicines that were permitted during the COVID-19 pandemic to prevent misuse by online platforms currently offering doorstep medicine delivery services. The earlier provision allowed licensed retailers of Drugs to deliver medicines on the doorstep based on original prescriptions during the pandemic.
Source: bit.ly/4izvgkG

2. India’s Health Ministry is considering a proposal to include the name of the person responsible (authorised person) for batch release in all drug manufacturing licenses. This aims to enhance accountability, as batch release ensures the safety and quality of medicines.
Source: bit.ly/4izvgkG

3. The Bureau of Indian Standards (BIS) has recently raided a facility supplying sanitary pads without the mandatory ISI mark and seized around 30,000 pads in Hyderabad. As per the Quality Control Order, BIS certification for sanitary pads is compulsory, and violations are strictly punishable.
Source: bit.ly/3S2bIdM

4. The Indian Council of Medical Research has recommended banning the drug ‘Nimesulide’ for individuals under 18 and above 60, and in all formulations above 100 mg due to risks of liver damage and gastrointestinal issues. ICMR also advises a black box warning on labels and cautions against use in women trying to conceive.
Source: bit.ly/42pwQ3Q
Source: bit.ly/4izvgkG

5. Indian government has defined ‘proof of origin’ for trade to enhance ease of doing business and prevent misuse of trade pacts. Importers must submit a certificate of origin to claim duty concessions under Free Trade Agreements (FTAs). The move aims to simplify procedures and ensure transparency.
Source: bit.ly/42rED11

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