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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 Central Drugs Standard Control Organization has cancelled the import registration of a cosmetic product after finding misleading drug-related claims on its website, which were inconsistent with the approved product labels, including claims relating to treatment of medical conditions.
Source: h7.cl/1hoPv

2. CDSCO has issued guidelines and SOPs under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, detailing eligibility, application process, authorities, and conditions for compounding certain regulatory offences, enabling settlement through monetary penalties and compliance measures instead of prosecution, supporting ease of doing business while maintaining regulatory oversight.
Source: h7.cl/1mlwh

3. The Food Safety and Standards Authority of India has notified that all amendments to food labelling and display regulations will come into force from 1 July of the year of notification. It has also revised the compliance timeline, extending the mandatory transition period for industry from 180 days to 365 days.
Source: h7.cl/1mlvZ

4. The Union Health Ministry is reportedly in discussions with state drug authorities to consider granting a six-month, case-by-case extension for pharmaceutical companies to comply with revised GMP requirements. The updated Schedule M introduces stricter manufacturing quality standards to align India’s drug production framework with global norms.
Source: h7.cl/1mlw4

5. India’s pharma regulator reportedly plans to introduce a dedicated wholesale licensing regime for bulk drugs, APIs and key starting materials. The move, along with a national supplier database, aims to improve traceability of imported materials and strengthen accountability and supply-chain oversight amid rising quality concerns.
Source: h7.cl/1hoPC

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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 Legal Metrology Division has clarified that the label declaration of “Manufactured by” is not required if the complete name and address of the brand owner is provided with the words “Marketed by” or “Brand Owner.” The declaration of manufacturer is a mandatory declaration under the Legal Metrology (Packaged Commodities) Rules, 2011.
Source: urli.info/1jgRA

2. The Department of Consumer Affairs, Legal Metrology Division, has clarified through the recently released Frequently Asked Questions that omission or obscuring of the maximum retail price is permissible on packages marked “Not for Retail Sale–For Institutional Customers Only” or “Evaluation Samples–Not for Sale”.
Source: urli.info/1jgRA

3. The Ministry of Agriculture and Farmers Welfare has issued draft Insecticides (Amendment) Rules, 2025, proposing to extend the compliance deadline for registration and related requirements under Insecticides Rules, 1971 from June 30, 2024 to June 30, 2026. Stakeholders may submit objections or suggestions within 30 days.
Source: urli.info/1jh3Q

4. The Gujarat High Court has held that healthcare services provided by private hospitals to in-patients are composite contracts, where the supply of medicines, implants, and consumables constitutes a “deemed sale” of goods embedded within the service, and hospitals are liable to pay VAT on the goods transferred during treatment as a works contract.
Source: urli.info/1eta4

5. India’s Delhi High Court directed Central Board of Indirect Taxes & Customs (CBIC) to frame a uniform policy on whether imports of products like “body massagers” or “sex toys” should be permitted or prohibited, noting inconsistent Customs practices. The Court said such decisions must follow national and contemporary standards, not the subjective discretion of individual officials.
Source: rb.gy/opp4oe

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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 has released guidance to identify spurious drugs under the Drugs Rules, 1945. Earlier, the rules mandated QR codes on all APIs from January 2023 and barcodes or QR codes on the top 300 drug brands from August 2023. The authority has now issued a process flow to verify drug authenticity.
Source : https://short-url.org/1gVQq

2. India’s Central Drug Regulator has allowed manufacturers to apply for Certificate of Pharmaceutical Product/World Health Organization – Good Manufacturing Practices (COPP/WHO-GMP) certificates while product license applications are under review by the State Licensing Authority. Final COPP/WHO-GMP certificate will be issued after product approval.
Source: https://short-url.org/1gVUB

3. India’s central government has proposed the Assistive Technology (Standards and Accessibility) Rules, 2025, requiring all assistive devices to meet Bureau of Indian Standards quality standards. The draft ensures transparent procurement, financial aid, repair support, and a toll-free helpline, with an online Assistive Technology Portal for device certification, supply tracking, and grievance redressal.
Source: https://short-url.org/1ceKb

4. The Food Safety and Standards Authority of India has kept the spice enforcement drive (whole & powder) in abeyance until further orders. All state food safety commissioners and regional directors have been instructed not to initiate any action under the earlier directive until further instructions.
Source:
https://short-url.org/1ceKS
https://short-url.org/1gVSp

5. The US Food and Drug Administration (FDA) is seeking public input on evaluating AI-enabled medical devices, including generative AI tools. The aim is to enhance patient outcomes, public health, and accelerate medical innovation, while regulating these advanced technologies
Source: https://short-url.org/1ceLs

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 has issued the first amendment to Food Products Standards & Food Additives Regulations, introducing norms for meat sausages, dehydrated tarragon, changes in packaged drinking water specifications, and revisions to food colour and additive rules. The regulations take effect from 1 February 2026.
Source: bit.ly/44C2uMH

2. The Supreme Court of India has recently ruled that stem cell banking including enrolment, collection, processing, and storage of umbilical cord blood qualifies as a healthcare service. It held that such services support preventive and therapeutic care, and are therefore exempt from service tax.
Source: bit.ly/3Ixa7eK

3. India’s Central Drug Authority (CDSCO) has released a guidance document outlining the process for manufacturers to obtain a No Objection Certificate (NOC) for exporting unapproved or approved new drugs. Key updates include mandatory online applications, one-time registration valid for a year, detailed reconciliation and a 7-day NOC issuance timeline.
Source: bit.ly/4kLR6CO

4. India’s Women & Child Development Ministry has issued an advisory to states urging them to curb edible oil usage amid rising obesity and non communicable diseases. It also reiterates previous guidance to limit added salt, sugar, and synthetic additives in Anganwadi nutrition provisions.
Source: bit.ly/4m37IH3

5. In India–EU trade negotiations, the EU seeks substantial tariff reductions on medical devices, automobiles, wine, spirits, meat, poultry, and stronger IP protections. Automotive and med tech duties currently up to 10% are in focus. India is pushing for reciprocity, including non tariff barrier reductions under phased FTA talks.
Source: bit.ly/4lZN8Hu

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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. Directorate General of Foreign Trade (DGFT)Trade Connect ePlatform has reportedly expanded the ‘Source from India’ portal to include all pharma Status Holder exporters with valid IECs. This upgrade enhances global discoverability, boosts buyer-supplier connectivity, and further promotes India’s position as a key player in global pharmaceutical trade.
Source: bit.ly/3Ts7gWt

2. The global pharma market is reportedly shifting toward specialty drugs like biologics and oncology therapies. India, while leading in generics, is investing heavily in biosimilars, innovation, and digital health—strengthening its dual role in high-volume supply and cutting-edge pharmaceutical R&D.
Source: bit.ly/4n6JKvN

3. Association of Southeast Asian Nations (ASEAN) has issued new harmonised guidance for medical device classification and borderline products. The update refines risk categories (A–D), defines ambiguous products, and promotes faster regulatory approvals, supporting pharma-medtech innovators in expanding across the Southeast Asian market.
Source 1 : bit.ly/43P2g4t
Source 2 : bit.ly/3HKZ8xN

4. The Confederation of Indian Alcoholic Beverage Companies has reportedly expressed their concern Maharashtra’s government to revisit its decision to raise excise duty on Indian-made foreign liquor(IMFL), country liquor, and imports by up to 50–85%. Industry leaders warns this could trigger a surge in illicit trade, harm legal sales, and reduce long-term state revenues despite short-term ₹14,000 crore projections.
Source: bit.ly/4jQJ3UN

5. The U.S. Food and Drug Administration (FDA) has finalized guidance to streamline the pre-submission facility correspondence (PFC) process for priority abbreviated new drug applications (ANDAs). By submitting complete and accurate facility information at least 60 days before ANDA submission, applicants can qualify for an expedited 8-month review timeline.
Source: bit.ly/4jRpNq0

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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

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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 timelines for the filing of Extended Producer Responsibility (EPR) annul returns by producers of Battery waste and E-waste for the Financial Year (FY) 2023-2024 till 31st March 2025 and 31st January 2025 respectively. For E-waste the extension of timelines also applies to the filing of quarterly returns for the abovementioned FY.
Source: bit.ly/3WthHei
Source: bit.ly/4gcsPmW

2. India’s National Pharmaceutical Pricing Authority (NPPA) has issued an office memorandum (OM) requesting manufacturers and marketing companies of the scheduled formulations nicotine used for nicotine replacement therapy (NRT) to furnish the Price to Retailer (PTR) and Moving Annual Turnover (MAT) data, in value terms for October 2023, within 7 days from the issue of the OM. A format for submitting these details is also provided in the OM. This information is being sought to fix the ceiling prices of these formulations.
Source: bit.ly/4gnoEFb

3. India’s Central Drugs Standard Control Organization (CDSCO) has released a guidance document to support the development of rapid diagnostics for pathogen identification and Antimicrobial Susceptibility Testing (AST). The document offers guidance to innovators and developers on evaluating their tests and demonstrating their effectiveness.
Source: bit.ly/4heX8ue

4. The Kerala High Court (KHC) recently ruled that magic mushrooms are not classified as narcotic substances under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. After reviewing the legal status of psychedelic fungi, the honourable court concluded that since magic mushrooms are not specifically scheduled under Act, they are not subject to its restrictions.
Source: bit.ly/3CiZv0k

5. India’s Central Pollution Control Board (CPCB) has released draft guidelines for the Pharmaceutical Industry in India, which are currently classified as highly polluting. The guidelines outline criteria for the establishment of pharmaceutical units, including mandatory minimum distances from sensitive areas. Stakeholders and the public are invited to submit their comments and suggestions on the draft guidelines by February 5, 2025.
Source: bit.ly/4h1GC0Y

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 Rajasthan High Court (RHC) recently ruled that “a laboratory report can be countersigned only by a registered medical practitioner with a post-graduate qualification in pathology.” The court made this observation while hearing a petition that sought to restrict non-MBBS practitioners from signing medical laboratory reports.
Source: bit.ly/3WnKfWx

2. India’s Central Drugs Standard Control Organization (CDSCO) recently issued a letter to the Principal Commissioner of Customs, stating that the import of pre-owned, refurbished, or second-hand medical devices into the country is prohibited. CDSCO clarified that, as of now, there are no specific provisions in place for the regulation of such devices, and therefore, customs authorities have been directed to halt the importation of these items.
Source: bit.ly/3Ce6F5S

3. The Government of India has revised the Government of India (Allocation of Business) Rules, 1961, to designate the Department of Health Research (DHR) under the Ministry of Health and Family Welfare (MoHFW) as the authority responsible for Health Technology Assessment (HTA) matters. This change underscores DHR’s role, which already oversees Health Technology Assessment India (HTAIn), in evaluating the appropriateness and cost-effectiveness of both existing and new health technologies in the country as part of its “Research Governance” mandate.
Source: bit.ly/40hgGax

4. The Pharmacy Council of India (PCI) has updated the number of blocked pharmacists on its DIGI-PHARMed portal, increasing the list from 45,355 to 91,586. Affected pharmacists are required to re-register for re-verification. This action addresses issues with duplicate, invalid, or incorrect profiles on the platform, which supports pharmacy education by providing centralized services nationwide.
Source: bit.ly/42cCXc5

5. The World Health Organization has released a draft document to guide the adoption of continuous manufacturing (CM). This document covers finished products, as well as excipients and active pharmaceutical ingredients (APIs) produced through a CM process. The WHO is inviting feedback from stakeholders via its online platform, with comments due by 7 March 2025.
Source: bit.ly/42dNWSD

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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 Jharkhand High Court has quashed criminal proceedings against an MBBS doctor charged under Section 304A of the Indian Penal Code for causing death by negligence, following a patient’s death after gallbladder surgery at his clinic. The allegations included medical negligence and violations under the Scheduled Castes and Scheduled Tribes (Prevention of Atrocities) Act. The court found no evidence of malicious intent or negligence on the doctor’s part, leading to the dismissal of the charges.
Source: bit.ly/4jiLOzc

2. India’s Central Pollution Control Board (CPCB) has released guidelines for the transportation and storage of used oil under the Extended Producer Responsibility (EPR) framework, effective from April 1, 2024. These guidelines outline the roles and responsibilities of collection agents, who are tasked with safely collecting, storing, and transporting used oil while adhering to environmental regulations. The framework aims to ensure proper management of hazardous waste and facilitate a more sustainable approach to oil recycling.
Source: bit.ly/3DTNDSR

3. India’s Central Pollution Control Board (CPCB) has released a methodology for conducting a gap analysis on biomedical waste management, aimed at improving compliance with existing regulations. This initiative is part of the CPCB’s ongoing efforts to ensure better environmental and public health outcomes related to the disposal of hazardous waste.
Source: bit.ly/4fYFBFq
Source: bit.ly/3PyGXfq

4. The U.S. Food and Drug Administration has released updated guidance regarding the notification process for manufacturers concerning permanent discontinuances or interruptions in the manufacturing of medical devices, as mandated by Section 506J of the FD&C Act. This guidance aims to prevent or mitigate shortages of critical medical devices during public health emergencies by requiring timely notifications from manufacturers about potential supply disruptions. The document also includes a list of devices that fall under this requirement and outlines the necessary information that must be provided.
Source: bit.ly/4hh2XqP

5. The U.S. Food and Drug Administration has released draft guidance proposing major changes to the accelerated approval pathway for drugs. These changes aim to strengthen the evidence and procedures required for quickly approving new medications, ensuring they deliver real clinical benefits while maintaining safety and effectiveness. The updates reflect the FDA’s commitment to improving the approval process for important therapies and addressing concerns about how these drugs perform once they reach the market.
Source: bit.ly/4hf9N09

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), in its 45th meeting, decided that the amendment to the Food Safety and Standards (Labelling and Display) Regulations, 2020, will be enforceable from 1st July 2025. This is subject to the condition that at least 180 days have passed from the date of notification of the amendment. Additionally, in cases of emergency, a separate decision may be taken regarding enforcement.
Source: bit.ly/3BPK9jH

2. The Supreme Court of India recently ruled that while courts have the authority to order the seizure of vehicles pending trial under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act), there is no provision in the Act that prohibits the return of seized vehicles. The Court emphasized that owners of such vehicles should be given an opportunity to be heard regarding the restoration of possession, particularly if they had no knowledge of the transport of narcotic or psychotropic substances,
Source: bit.ly/3DNibWg

3. The Rajasthan High Court, in a matter seeking to quash a petition against pathologists at a hospital accused of falsifying reports based on signature irregularities, held that cases of medical negligence must be subjected to a higher degree of scrutiny. The court further stated that mere irregularities in documents do not constitute falsification.
Source: bit.ly/3C2O64y

4. India’s Directorate General of Foreign Trade (DGFT) has issued a public notice regarding procedure for exporting certified organic products from the country. The new procedure requires that all ‘organic products’ intended for export should carry a Transaction Certificate issued by a National Accredited Body under the National Program for Organic Production (NPOP) and should be labelled in accordance with the NPOP. A revised NPOP will come into force from 5th July 2025
Source: bit.ly/4j48uD1

5. The US Food and Drug Administration has issued a finalized guidelines under the Advanced Manufacturing Technologies Designation Program, whereby manufacturers are able to obtain designation of the manufacturing process which may either reduce development time of drug or maintain supply of life-supporting, life-sustaining or critical drug.
Source: bit.ly/4j3H3Jr