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 Health has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019, proposing to remove the provision dealing with the provisional registration of Ethics Committees. The designated authority will now directly grant final registration in Form CT-03 after scrutiny of Form CT-01, or reject with written reasons.
Source: h7.cl/1oifC

2. Bulk Drug Manufacturers Association of India has launched a marketing portal enabling Indian pharmaceutical companies to promote and source active pharmaceutical ingredients, intermediates, pallets, and contract development and manufacturing services, supporting both domestic and international markets through an integrated vendor management system with no cost registration for buyers.
Source: h7.cl/1oifJ

3. The Department of Pharmaceuticals has extended the deadline for submitting applications under the Common Facilities for Medical Device Clusters (CFMDC) sub-scheme to 15 February 2026. The scheme supports shared testing infrastructure for medical devices, including cardiac and orthopaedic implants, infusion pumps, imaging equipment, and Class B, C, and D IVDs.
Source: h7.cl/1jfLz

4. The Maharashtra government has issued a resolution by introducing a new fee structure at state-run hospitals from effective from January 16, 2026. ₹5 for OPD registration, ₹10/day for inpatient admission, and up to ₹40,000 for major surgeries like joint replacements. Diagnostic services, ICU care, and ambulance services also have updated charges. Implementation across hospitals is pending.
Source: h7.cl/1oiwW

5. The Indian Pharmacopoeia Commission is reportedly taking efforts to develop more biosimilar in alignment with governments Biopharma Shakti initiative. This move aims to align Indian quality standards with global benchmarks and strengthen the country’s biologics and biosimilars ecosystem.
Source: h7.cl/1jfLU

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 Government of India has in the Union Budget 2026–27, removed basic customs duty on 17 cancer drugs to reduce treatment costs. The move aims to ease the financial burden on patients, particularly for high-cost imported therapies, and improve access to essential cancer medicines across the country.
Source: h7.cl/1nZbu
#Drugs #Cancer #CustomDuty #Slashed #Budget2026

2. The Supreme Court of India has held that administering stem cell therapy for Autism Spectrum Disorder (ASD) outside an approved clinical trial setting is unethical and amounts to medical malpractice. The Court clarified that such therapy is not recognised as a sound and established medical practice due to the lack of scientific validation of safety and efficacy. The same is permissible only for an approved and monitored clinical trial with the intent to advance science.
Source: h7.cl/1nZbb

3. Maharashtra’s State Blood Transfusion Council has reportedly warned blood banks against collecting excess blood and transferring it to other states for profit. Violations, including commercial supply to plasma fractionation companies, may invite licence cancellation, as centres are directed to collect only patient-linked requirements to protect voluntary donation ethics.
Source: h7.cl/1iYh-

4. The Enforcement Directorate reportedly conducted searches at twenty six locations across multiple states as part of a probe into illegal international narcotics trafficking and money laundering. Investigations revealed a structured interstate drug network, leading to seizure of cash, narcotic substances, contraband, and incriminating documents indicating organised distribution and laundering activities.
Source: h7.cl/1nZbD

5. The Government of India has proposed amending the Drugs Rules, 1945 to designate Navi Mumbai International Airport (NMIA) as an authorised drug import entry point, making it a 12th approved airport, improving logistics and reducing congestion at existing ports. Stakeholders have been requested to submit comments withing 30 days.
Source: h7.cl/1nZbN

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. The Central Council for Research in Ayurvedic Sciences has launched SIDDHI 2.0, a national industry research interface platform, to accelerate scientifically validated Ayurvedic product development. The initiative brings together regulators, researchers, and manufacturers to promote quality, safety, regulatory compliance and global competitiveness of Ayurvedic pharmaceuticals.
Source: h7.cl/1fbDr

2. The Telangana Drugs Control Administration (DCA) has issued a circular requiring all licensed retail and wholesale pharmacies across the state to prominently display a QR code and toll-free number to report adverse drug reactions (ADRs). This step enforces compliance with Central Drugs Standard Control Organisation (CDSCO) guidelines, strengthening pharmacovigilance under the national Pharmacovigilance Programme of India (PvPI).
Source: h7.cl/1k1Ny

3. Karnataka Pharma Retailers & Distributors Organization (KPRDO) has reportedly urged the government to halt ten-minute medicine delivery services, warning that treating prescription drugs as fast-moving consumer goods violates drug safety laws. They argue that medicines require prescription verification and pharmacist oversight, and that instant access to antibiotics and addictive drugs could lead to misuse, antimicrobial resistance, and public-health risks.
Source: h7.cl/1fbDv

4. Public commenters are calling on the US Food and Drug Administration (FDA) to loosen clinical trial requirements, particularly for rare diseases and drug development. Commenters are urging the FDA to allow more flexible trial designs and reduced burden to accelerate access to therapies, especially for rare or underserved conditions like disseminated coccidioidomycosis.
Source: h7.cl/1k1NB

5. A major US retail chain has recalled several bottles of saline nasal spray after US Food and Drug Administration (FDA) tests detected contamination with Pseudomonas lactis. The Class II recall covers two production lots with 2027 expiry dates. While the risk is considered medically reversible, regulators advise consumers to stop using the affected batches immediately.
Source: h7.cl/1k1NE

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 issued a clarification stating that only Indian-issued manufacturing, import, and sale licenses from the Central or State Licensing Authorities as applicable are mandatory for all medical devices in India. Procurement agencies and hospitals must require these licenses in technical bids. Any foreign certifications may be added but cannot replace mandatory Indian approval.
Source: h7.cl/1jTDc

2. India’s pharmaceutical industry is reportedly upgrading quality systems, regulatory alignment and scientific rigour as the Central Drugs Standard Control Organization (CDSCO) as tightens requirements for bioavailability and bioequivalence of oral drugs. Post-approval changes now require stronger data, dissolution studies, and risk-based evaluation. The move aligns India with global regulatory expectations and aims to enhance drug reliability, consistency, and overall patient safety.
Source: h7.cl/1jTDs

3. MNC drugmakers are urging CDSCO to grant 10-year regulatory data exclusivity for novel drugs, arguing it will protect first-mover clinical trial data, boost innovation, and attract R&D investment. This follows CDSCO’s sought industry feedback on rules that require the first applicant to conduct clinical trials and bioequivalence studies, while the subsequent filers could skip the trials.
Source: h7.cl/1jTDC

4. Raids by the Kerala Drugs Control Department in Kozhikode, Thrissur and Thiruvananthapuram revealed that discount pharmacies are stocking a wide array of counterfeit and poor-quality medicines, facilitated by weak inspection and unregulated distribution networks. Stakeholders are now urging Central Drugs Standard Control Organization (CDSCO) intervention.
Source: h7.cl/1jTDY

5. The National Accreditation Board for Testing and Calibration Laboratories has issued a guidance document to strengthen quality at medical laboratory sample collection centres, outlining requirements, hygiene and transport protocols, temperature control measures, and strict oversight to ensure integrity and reliability of patient test results across all facilities.
Source: h7.cl/1jTEn

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 has amended the New Drugs and Clinical Trials Rules, 2019, permitting bioavailability or bioequivalence (BA/BE) studies in human subjects for export purposes for certain drugs approved in India or any one of the regulated markets (USA, EU, Japan, Australia, Canada, UK) through submission of an online application as notification and its acknowledgement by the Central Licensing Authority, subject to certain conditions. The conditions are mainly ethics committee approval, record-keeping, and minimum sample size.
Source: urli.info/1iRyM

2. India’s Health Ministry has issued the draft amendments to Schedule K of the Drugs Rules, 1945. Liquid antiseptics are now categorized separately for household and hospital use, with distinct labelling and licensing conditions to ensure proper manufacturing, packaging, and sale compliance by licensed manufacturers and wholesalers.
Source: urli.info/1e4F-

3. Indian Food Authority (FSSAI) has issued an advisory to all Designated Officers, Food Safety Officers, and Enforcement Teams to ensure proper disposal of seized, rejected, and expired food, including packaging, through approved methods like incineration, sanitary landfilling, or composting. Disposals must be supervised, video-recorded, and certified by authorised food safety officials.
Source: urli.info/1iRz4

4. Indian medical devices regulator (CDSCO) has issued an updated list of about 1,700 Indian Standards (IS) under the BIS Medical Equipment and Hospital Planning (MHD) division, covering around 20 categories including surgical, diagnostic, orthopaedic, dental, and hospital-planning equipment. All medical devices manufactured, imported, and marketed in India must mandatorily conform to BIS standards for regulatory and quality compliance.
Source: urli.info/1iRz9

5. India’s Health Ministry has proposed amending Schedule H2 of the Drugs Rules, 1945, which contains a category of medicines that are mandated to carry a barcode or QR code on their label, to expand it with a new “Table 2” listing key therapeutic categories vaccines, antimicrobials, narcotic and psychotropic drugs, and anticancer drugs. Stakeholders can submit comments within 30 days.
Source: urli.info/1iRzg

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 Ministry of Environment, Forest and Climate Change has issued the draft Plastic Rules to mandate the use of recycled plastic in plastic packaging from FY 2025-26. Category-wise targets are specified, and CPCB may allow exemptions in cases involving statutory or technical constraints along with a three-year carry-forward for shortfalls in initial compliance. Stakeholders can submit objections to the draft within 60 days.
Source: bit.ly/4e0zhxV

2. Active Pharmaceutical Ingredients (API) prices, which surged during the COVID-19 pandemic, are now declining, easing cost pressures on India’s pharmaceutical industry. As the sector relies heavily on imports from China, the drop in raw material costs is improving profit margins and providing much-needed relief to drug manufacturers.
Source: bit.ly/4dOkypE

3. The Ministry of Agriculture and Farmers Welfare has made amendment to Insecticides Rules, 1971 and introduced the new labelling requirement. Labels must follow new formats by pack size, include QR codes, safety warnings, and detailed info in Hindi and English. The said amendment comes into effect from June 3, 2025, with a phased compliance timeline for industry implementation.
Source: bit.ly/45hnclP

4. Indian Government has launched the ‘Ayush Nivesh Saarthi’ portal to attract global investment in traditional medicine. The platform offers a unified interface for investors, integrating policy frameworks, incentive schemes, and investment-ready projects. This initiative aims to position India as a global hub for traditional medicine and wellness
Source: bit.ly/45bCTe5

5. The European Medicines Agency (EMA) has published a draft guideline for public consultation, offering recommendations on including or retaining pregnant and breastfeeding individuals in clinical trials. The aim is to generate reliable clinical data to support informed, evidence-based treatment decisions for these populations.
Source: bit.ly/43xtYCH

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 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

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 Council of Medical Research-led national health consortium raises concern over rising adolescent obesity and recommends stricter advertising rules on high-fat, -salt, and -sugar (HFSS) foods. It also proposes a 32% health tax on sugar-sweetened beverages and 20-30% tax on other HFSS foods to curb obesity.
Source: bit.ly/42dvtUq

2. The Organization of Pharmaceutical Producers of India has raised concerns with the health ministry as foreign drugmakers face delays in launching essential drugs. Despite a provision for waivers on clinical trials for drugs approved in select countries, the Drug Controller General of India has not approved any.
Source: bit.ly/3RtXxhr

3. India’s National Centre for Disease Control (NCDC), operating under the Ministry of Health and Family Welfare (MoHFW), is reportedly preparing to launch a new digital portal designed to provide real-time tracking of rabies vaccine and anti-snake venom stocks. which are not easily accessible owing to manufacturing shortage. The portal will initially be rolled out as a pilot project in five states: Andhra Pradesh, Assam, Madhya Pradesh, Delhi, and Puducherry.
Source: bit.ly/3R186bH

4. The State Consumer Disputes Redressal Commission (SDRC) of Chandigarh, India has set aside an order against a plastic surgeon for medical negligence allegation for unsatisfactory results under a liposuction procedure. SDRC ruled that unsuccessful treatment does not amount to negligence unless there is clear proof of deviation from clinical standards.
Source: bit.ly/4hTidKv

5. Reimbursements to private hospitals under the Central Government Health Scheme (CGHS) reportedly increased significantly from 24% in 2019-20 to 60% in 2023-24, driven by a rise in beneficiaries. This surge has raised concerns about fraudulent billing, overcharging, and inadequate oversight of spending.
Source: bit.ly/4jdwjYn

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 Revised Schedule M of the Drugs Rules, 1945 which has come into force on the 28th December 2023, is now fully applicable to all manufacturers with turnover less than Rs. 250 Crores starting from 1st January 2025.
Source: bit.ly/4iZXAOt

2. India’s Central Drug Regulator has directed that the process to file applications for (1) addition of new Clinical Trial Site and (2) Change of Principal Investigator should henceforth be made online through the SUGAM Portal maintained by the regulator. An application for addition of clinical trial site is deemed approved if no objection received in 30 days of upload and an application for change of Principal investigator is deemed approved on the day of upload.
Source: bit.ly/4j1Kwbp

3. In order to curb instances of re-use and re-branding of expired food products by businesses India’s Central Food Regulator is now requiring all licensed Food Business Operators to upload the following data to the online portal on a quarterly basis once feature is activated:

a.  Quantity of food items rejected due to not meeting quality standards.
b. Quantity of expired food items returned by the business.
c. A detailed report of how the expired/ rejected food items were handled, including manner of disposal/ return/ destruction.

Provided that all licensed business should commence record-keeping in preparation of activation of upload feature on FoSCoS portal.
Source: bit.ly/3PjW8sP

4. The Delhi High Court recently held that a claim for medical negligence cannot be sustained on the basis that the patient had a certain expectation with respect to the quality of care, holding that no evidence was forthcoming that the Doctor’s conduct lead to harm to the patient.
Source: bit.ly/49YPn9m

5. The Foreign Contribution (Regulation) Rules, 2011 have been amended, permitting associations to carry-forward the unspent administrative expenses into the next financial year, provided that reason for carry-over needs to be mentioned in Form FC-4.
Source: bit.ly/4gOxvAo