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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 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 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

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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 the Draft Food Safety and Standards (Alcoholic Beverages) Amendment Regulations, 2025, proposing tighter standards for special wine. The draft introduces a 0.3% sugar tolerance for “Brut” sparkling wine, removes “special wine used,” and makes standard-drink labelling mandatory. A format for public comments has been shared, and feedback is open until 3rd January 2026.
Source 1: urli.info/1jcbJ
Source 2: urli.info/1eoEY

2. The Central Drugs Standard Control Organisation (CDSCO) has reportedly instructed state drug controllers to immediately initiate inspections under the revised Schedule M for the manufacturing units that have not applied for extensions. For manufacturing units that have applied for extensions, the effective date for revised Schedule M implementation is January 1, 2026. The directive follows recent safety lapses, including the fatal cough-syrup incident.
Source: urli.info/1eoDR

3. The Goa Directorate of Food and Drugs Administration (DFDA) has directed all retail pharmacies to display QR codes to facilitate reporting of adverse drug reactions (ADRs) through the Indian Pharmacopoeia Commission’s ADR Monitoring System. QR codes must be prominently displayed to enable consumers and healthcare professionals to report ADRs.
Source: urli.info/1jcb0

4. The Indian Pharmacopoeia Commission, in partnership with NITI Aayog and the Central Tuberculosis Division, will reportedly develop new monographs for the anti-tuberculosis medicines delamanid, pretomanid and the rifapentine-isoniazid fixed-dose combination to enhance quality standards, support rational use and strengthen adverse-drug-reaction reporting.
Source: urli.info/1jcaF

5. The Food Safety and Standards Authority of India (FSSAI) has issued an advisory clarifying stating that honey samples exceeding the permissible 80 mg/kg limit for Hydroxymethylfurfural (HMF) shall be classified as “Substandard”, not “Unsafe.” The clarification follows the Scientific Panel’s view that current research is insufficient to determine health risks from higher HMF levels.
Source: urli.info/1eoD4

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. The District Consumer Disputes Redressal Commission (DCDRC) in Kochi has ordered a hospital and its doctor to pay ₹5 lakh in compensation after treating a patient for COVID-19 despite her RT-PCR test returning negative. The court found that the hospital failed to inform the patient of her negative status and administered unnecessary COVID-related treatments, causing significant mental and physical distress.
Source: bit.ly/40oTuIN

2. India’s drug regulator, CDSCO has identified 41 drug samples as ‘Not of Standard Quality’ (NSQ) following tests conducted in November, with an additional 70 samples flagged by state laboratories. Two samples were also found to be spurious, linked to unauthorized manufacturers. The Union Health Ministry has initiated investigations and emphasized that the identification of NSQ drugs is part of routine surveillance to enhance the quality of medicines available in the market.
Source: bit.ly/3PgINRZ

3. A pathologist in Maharashtra has been suspended and removed from the Medical Register by the Maharashtra Medical Council for three years for allowing a laboratory to use its signature while operating with an expired license.
Source: bit.ly/4fCsw4C

4. Homeopathic practitioners in Maharashtra are now permitted to prescribe allopathic medicines, provided they have completed a certified course in modern pharmacology, as per a new clarification from the Maharashtra Food and Drug Administration (FDA). However, the action has been criticized by the Indian Medical Association (IMA) as “mixopathy,” as it raises concerns about patient safety and the integrity of medical practice.
Source: bit.ly/41SZsCy

5. The Indian Medical Association (IMA) has launched the IMA AMR Smart Hospital Project, an initiative aimed at combating Antimicrobial Resistance (AMR) through advanced Antimicrobial Stewardship (AMS) and Infection Prevention and Control (IPC) practices. This certification program, the first of its kind globally, seeks to promote best practices in antimicrobial usage across hospitals and enhance patient safety.
Source: bit.ly/3DBawdC

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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 Pharmaceutical Pricing Authority (NPPA) has directed drug manufacturers to reduce the maximum retail price (MRP) of three crucial cancer drugs i.e., Trastuzumab Deruxtecan, Osimertinib, and Durvalumab. This is in line with reduction of customs duty and GST rates on these medications.
Source: bit.ly/4fBQ3Dd

2. Delhi High Court has granted a permanent injunction against a pharma company which had imitated the design and presentation of a drug manufactured by another pharma company. This ruling highlights the requirement for pharma companies to ensure a distinctive packaging to avoid copyright Infringement claims.
Source: bit.ly/40AprhH

3. The All India Organization of Chemists and Druggists (AIOCD) has urged the Drug Controller General of India (DCGI) to restrict a partnership between a rapid delivery platform and an e-pharmacy, citing concerns over regulatory and quality compliance issues that could potentially jeopardize patient safety.
Source: bit.ly/4fDJEqS

4. The Himachal Pradesh High Court has directed the state government to implement a QR code system to assess the quality of medicines in the state. This QR code will provide consumers with key information about the medicine, including production and expiry dates, unit details, batch numbers, and component specifics in order to enhance consumer awareness and transparency in medicine quality.
Source: bit.ly/3YE20Bw

5. UK government is set to launch ‘World-First’ Genomics-Led pandemic warning system. The system will utilize the technology to flag and monitor potential outbreaks of bacterial or viral diseases.
Source: bit.ly/4fBdyw6

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 notified the New Drugs and Clinical Trials (Amendment) Rules, 2024 which will take effect from1st April, 2025.These amended rules outlines the requirements for registration of the Clinical Research Organizations.
Source:  https://bit.ly/4ddpX81

2. India’s Central Food Regulator (FSSAI), has issued a show cause notice to a Tamil Nadu-based company that supplied ghee for making laddoos (prasadam) at the Tirupati Balaji temple, following the detection of animal fat in the laddoos. The company is required to respond to the charges by 23rd September, 2024, failing which appropriate action will be taken against them.
Source: https://bit.ly/3BheNln

3. The Government of India is reportedly planning to adopt a risk-based approach for monitoring the quality of imported consignments of medical devices at ports. This will involve random sampling of consignments of medical devices and testing of entire cargoes in case of critical diagnostic kits.
Source: https://bit.ly/3BhePtv

4. India’s central health regulator has declared five samples of drugs to be spurious based on the physical comparison and analytical tests done by the manufacturers and on the reports from State Licensing Authorities. The actual manufacturers, as claimed on the labels, have stated that they are not the actual manufacturers of these drugs and the drugs are spurious.
Source: https://bit.ly/3XTfUjP

5. India’s Directorate General of Foreign Trade (DGFT) has amended Chapter 5 of the Handbook of Procedures (HBP) 2023 under the Export Promotion Capital Goods (EPCG) Scheme. The EPCG Scheme, which allows pharma industry to import capital goods duty-free for producing quality goods and services to boost exports, has been updated to streamline its reporting requirements. The amendment eliminates the previous requirement for annual reporting of Export Obligation (EO) fulfilment and has been replaced with a periodic reporting system.
Source: https://bit.ly/4dkMUWC

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s drug regulator will implement the mandate of printing of QR codes to curb counterfeiting. The top-selling brands have reportedly said that they have already started integrated QR codes and bar codes for tracking and compliance checks.
Source: bit.ly/4d80PzG

2. Indian Health Ministry has issued draft rules under the Drugs and Cosmetics Act, 1940 relating to compounding of minor offences and violations. The draft rules establish a system for companies to settle minor violations of the Act, like manufacturing drugs without proper procedures, outside of court. Companies can apply to a designated compounding authority with relevant documents, and if approved, avoid prosecution. This aims to resolve issues efficiently without lengthy court cases, but serious offenses like selling adulterated drugs are not eligible for compounding.
Source: bit.ly/3zLSKlT

3. India’s Drug Control Officers collective proposal to Indian Government for changing the name of the Drugs and Cosmetics Act, 1940 to ‘Bharatiya Aushadhi awam Chikitsa Upakaran Adhiniyam’ has received mixed responses from the industry and various stakeholders. While some have reasoned that change of name of the Act is the need of the hour and should be done as early as possible, others have questioned the need and purpose of the exercise.
Source: bit.ly/4d9IsdV

4. India’s Pharmacy Regulator, the Pharmacy Council of India (“PCI”) has extended the deadline for submission of statutory documents till 31st July, 2024 by new institutions and existing institutions that have applied for introduction of new course. PCI stated that the documents should be submitted on its compliance portal only. No other mode other than the PCI Compliance portal will be entertained for submission of documents.
Source: bit.ly/3y0YeZE

5. Indian Health Minister stresses on India’s need for world class regulatory framework for Pharma and Medical Device Industry to ensure better quality of products. The Minister also stated the importance of transparency in India’s apex drug regulator the Central Drugs Standard Control Organisation (CDSCO). The Union Health Minister stated that it is important for CDSCO to be in continuous dialogue with the drugs and medical devices industry to understand their issues and support them to fulfill the quality expectations and standards of CDSCO.
Source: bit.ly/4d5XuBd

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Central Government is mulling including non-prescription Neutraceuticals currently regulated by the Central government food regulator the Food Safety Standards Authority of India, under the price control regime similar to Drug price regulation under the Drugs (Prices control) Order, 2013.
Source: bit.ly/4cRZVb7

2. The Supreme Court in continuation of prior orders issued acknowledging the concerns raised in a petition seeking to address the shortage of life saving Antiretroviral Drugs in the country, has granted the request of the petitioner to discuss the access of quality Antiretroviral Drugs to persons dealing with HIV.
Source: bit.ly/4cAATg9

3. The Central Government has issued a Draft Notification proposing amendment to the Drugs Rules, 1945, mainly intending to introduce restriction on advertising Drugs listed in Schedule G of the Rules.
Source: bit.ly/3Whm0Ke
Source: bit.ly/3VZZ0Or

4. Then United States Federal Trade Commission is set to take action against Drug supply middlemen and major pharmacy chains for use of anticompetitive tactics in negotiating Drug prices.
Source: bit.ly/3WgtAom

5. The World Health Organization has issued a new and updated list of pathogens, to reorient the prioritization in combating Antimicrobial Resistance.
Source: bit.ly/4czZdiw