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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 Pollution Control Board (CPCB) has extended the deadline for registered Producers, Importers, Brand Owners (PIBOs) and Plastic Waste Processors (PWPs) for filing annual returns under the Plastic Waste Management Rules, 2016 until 31st January 2026. The previous deadline for filing of annual returns was November 30, 2025.
Source: h7.cl/1iapl

2. India’s Central Pollution Control Board (CPCB) has issued a notice clarifying implementation of Extended Producer Responsibility (EPR) guidelines for plastic packaging, permitting regulated inter-category certificate purchases only until FY 2025–26. Producers, importers, and brand owners will then be prohibited from cross-category adjustment of surplus EPR certificates and barred from using end-of-life certificates for recycling targets.
Source: h7.cl/1n9HG

3. The Union Health Minister has directed CDSCO and the Department of Pharmaceuticals to find a workable solution to industry concerns over revised Schedule M GMP norms. The revised guidelines necessitate structural and layout changes to facilities, setting up rigorous quality control systems, and training personnel. The Ministry is considering deadline extensions or relaxations following consultations with industry bodies, particularly for small and medium manufacturers facing compliance issues.
Source: h7.cl/1n9HM

4. The High Court of Allahabad has dismissed petitions by directors and officials of a major drug manufacturer challenging summons for alleged violations under the Drugs and Cosmetics Act after a test analysis found samples to be of substandard quality. The analysis found the presence of ethylene glycol in cough syrup, a toxic industrial chemical. The Court found the summons lawful, as the officials were responsible for the company’s business conduct.
Source: h7.cl/1n9HR

5. India’s Delhi High Court has upheld the rejection of a foreign drug manufacturer’s patent application for a nematode-based cancer detection method, ruling it a non-patentable diagnostic process under the Patents Act, 1970. The court said the invention performs essential diagnostic steps and cannot bypass exclusion by being labelled as screening or in-vitro testing.
Source: h7.cl/1iar0

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 and Medical Device Regulator, The Central Drugs Standard Control Organisation (CDSCO), has issued a public notice that it will reject applications if the queries to the applications are not responded within 90 days from the date of receipt of the query on its official application portal called SUGAM portal. A time-bound reminder and rejection mechanism for timely disposal of the pending applications has been introduced. Applications pending for two years will now be rejected after 30 days notice if no response is submitted.
Source: h7.cl/1i6LX

2. India’s Ministry of Commerce and Industry has extended the deadline for importers and manufacturers to obtain BIS certification for aluminium utensils and food and beverage cans covered under the Quality Control Order, 2026. The revised timelines are issued in a phase wise manner based on industry category, beginning from 1 October 2026.
Source: h7.cl/1i6L0

3. Several drug companies are cautious about a new fast approval program under the United States Food and Drug Administration. They fear quicker reviews may weaken scientific scrutiny, increase legal risk, and invite court challenges, even as others support faster access to important medicines for patients nationwide safely.
Source: h7.cl/1i6Lg

4. The Maharashtra Public Health Department has launched dedicated menopause clinics in Pune to provide specialised care for women’s physical and mental health needs. Weekly OPDs will be held every Wednesday at government hospitals, offering medical management, counselling, and lifestyle guidance. The initiative aims to address menopause-related health issues across urban and rural areas.
Source: h7.cl/1n5Uw

5. India’s Ministry of Agriculture and Farmers Welfare has announced that the Seed Act, 2026, to introduces a nationwide seed traceability through QR codes, mandate seed company registration, and impose penalties up to ₹30 lakh for substandard seeds, and safeguards the traditional seed systems and strengths transparency.
Source: h7.cl/1i6Lp

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 CDSCO has issued detailed FAQs to enhance public awareness regarding the Drugs and Cosmetics (Compounding of Offences) Rules, 2025. The FAQs clarify the procedure for compounding offences, the stage at which an application may be filed, and the information and documentation required to support such applications.
Source: shorturl.at/Mkg3L

2. India’s Central Drug Authority has notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025.
Stakeholders intending to apply for compounding of offences under these rules are required to submit the application in the prescribed format as a physical copy, along with an advance copy via email to raj[dot]shree64[at]cghs[dot]nic[dot]in, addressed to the Compounding Authority.
Source: h7.cl/1mrDG

3. India’s Delhi High Court directed the Central Health Ministry to respond by January 20, 2026 to a contempt plea alleging illegal operations of online health service aggregators. The petition claims these platforms violate the Clinical Establishments Act by functioning without mandatory registration, posing risks to public health and regulatory compliance.
Source: h7.cl/1hvu5

4. The Delhi government will declare human rabies a notifiable disease, requiring mandatory reporting of all suspected, probable and confirmed cases by government and private healthcare facilities. The move aims to strengthen disease surveillance, enable timely intervention, and support the capital’s goal of eliminating rabies-related human deaths.
Source: h7.cl/1hvts

5. A major infant nutrition manufacturer has initiated a large-scale recall of select infant formula products across multiple countries after detecting a potential toxin contamination linked to a supplier ingredient. No illnesses have been reported. The company is strengthening supply chains, activating alternate suppliers, and increasing production to ensure uninterrupted availability.
Source: h7.cl/1msn9

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. Government hospitals in Delhi will now use a different coloured bedsheet each day of the week (white, pink, green, purple, blue, light-grey, peach) under a new rotation system. The measure aims to enforce daily linen change, boost hygiene standards and reduce hospital-acquired infections.
Source: shorturl.at/kzVxx

2. The Department of Pharmaceuticals has invited applications under the Production Linked Incentive Scheme (PLI) for domestic manufacturing of Meropenem and Ritonavir. Eligible manufacturers can apply online from 27 November to 26 December 2025. The scheme specifies minimum annual production capacities and limits the number of applicants for each product.
Source: shorturl.at/DNuCk

3. The Kerala High Court has upheld the Kerala Clinical Establishments Act, requiring hospitals to display all service details and rates at reception areas and on their websites. Hospitals must also provide grievance-redressal information and cannot deny emergency care for lack of advance payment.
Source: shorturl.at/Cm1AZ

4. The Drugs Consultative Committee has urged nationwide uniformity in enforcing drug standards, highlighting delays, inadequate infrastructure, and low conviction rates. It recommended that the Union Government direct states to strengthen laboratories, manpower, and regulatory capacity under the State Health Regulatory Excellence Index to ensure consistent national drug quality.
Source: shorturl.at/ARjaQ

5. The Patents (Amendment) Rules, 2025 establish a fully digital system for investigating IP contraventions, issuing penalties, and processing appeals. New Forms 32 and 33 enable electronic filing of complaints and appeals, with strict timelines of 3 months for adjudication and 6 months for appeals, enhancing compliance certainty for industry innovators.
Source: h7.cl/1figr

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

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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 Drug Licensing authority has mandated to file all Post Approval Change (Form CT-06) applications for Cell and Gene Therapeutic Products exclusively through the SUGAM online portal after October 24 2025. Offline submissions will no longer be accepted thereafter.
Source: urli.info/1e0FX

2. The Indian Pharmacopoeia Commission has reportedly introduced 22 quality standards for blood and its components to ensure safe transfusions across India. These standards, to be included in the Indian Pharmacopoeia 2026, establish globally first comprehensive benchmarks ensuring quality, safety, and infection-free blood for patients nationwide.
Source: urli.info/1iNpx

3. The Ministry of Health and Family Welfare has issued draft amendments to the Drugs Rules, 1945, introducing provisions to debar applicants found submitting misleading, fake, or fabricated documents for licences or approvals. Offenders may face suspension for a defined period, with the right to appeal within 30 days. Stakeholder comments invited within 30 days of publication.
Source: urli.info/1e0Fx

4. The Delhi High Court held that a doctor accused of medical negligence can continue to earn a livelihood by working at other medical centres. The Court clarified that the restriction only bars the doctor from running their own centre and does not prevent them from practising their profession elsewhere.
Source: urli.info/1e0FN

5. A Consumer Dispute Redressal Forum in India has held that the absence of a pathologist’s physical signature on medical reports cannot alone justify the denial of an insurance claim. In a case where a policyholder’s claim was rejected due to a missing signature, the forum directed the insurer to reimburse the cost after finding no evidence of fraud.
Source: urli.info/1iNph

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 Pharmaceuticals has extended the application deadline for Round V of its Production-Linked Incentive (PLI) scheme to 21 June 2025, giving pharma companies additional time to apply. Applications can only be made online through the given link in the circular.
Source: bit.ly/4kn1e4J

2. The Delhi High Court has barred a leading Ayurvedic manufacturer from airing advertisements claiming superiority of its Chyawanprash, ruling that freedom of commercial speech doesn’t justify misleading claims for regulated drugs. It has further emphasized stricter scrutiny on drug-related marketing to prevent false efficacy claims and consumer deception.
Source: bit.ly/4kqs63F

3. The Madras High Court has clarified that importing Ayurvedic drugs into India does not require an import license, provided the products conform to the standards set for domestically manufactured equivalents. This precedent emphasizes regulatory alignment with Indian pharmacopoeia standards and could facilitate smoother market entry for Ayurvedic importers while ensuring consistent quality.
Source: bit.ly/4lgEXH2

4. The National Pharmaceutical Pricing Authority (NPPA) will change its official website from nppaindia.nic.in to nppa.gov.in effective 15 July 2025. The new domain will host all notifications, pricing orders, data systems, and circulars. Stakeholders are advised to update their records and bookmarks to ensure uninterrupted access to NPPA services during the transition phase. The old domain will temporarily redirect users.
Source: bit.ly/44AXWF9

5. The National Pharmaceutical Pricing Authority (NPPA) has issued an Order thereby fixing the ceiling prices for I.V. fluids (non-glass with special features). Now the product I.V. fluids (non-glass with special features) cannot be sold beyond the fixed prices.
Source: bit.ly/44gE4rR

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 notified that the application process for issuance of permission for import of additional variant of approved cosmetics into the country, will henceforth be conducted through additional module which will be activated on the SUGAM portal from the 22nd February 2025.
Source: bit.ly/3CQu6m2

2. The National Chemists’ Association has sought a meeting with India’s drug price regulator the National Pharmaceutical Pricing Authority (NPPA) to highlight concerns that the obligation on chemists to publicly display the prices of all drugs being sold, may be a very heavy burden for the industry.
Source: bit.ly/3QfYFor

3. The Pune Municipal Corporation (PMC) has issued show-cause notices to 97 private nursing homes and hospitals for violations of the Bombay Nursing Home Registration Act and Maharashtra Nursing Home Registration Rules. Key breaches include non-compliance with fire safety regulations, lack of patient complaint mechanisms, inadequate staffing, and failure to meet other legal standards like displaying contact information and maintaining proper treatment tariffs.
Source: bit.ly/41bya9P

4. In a recently published guideline, the United States Food and Drug Administration has expanded the applicability of Predetermined Change Control Plans (PCCPs) scheme, now requiring manufacturers to notify any post-market changes made to devices, which operate using Artificial Intelligence and not just those devices that use Machine Learning.
Source: bit.ly/4aZ3D2i

5. A Federal Court in the United States has recently dismissed the petition of a prominent drug manufacturer claiming “unfair business practices” by a pharmacy selling compounded versions of a patented drug, on the ground that the pharmacy has ceased to market and sell the compounded version of the drug.
Source: bit.ly/4aYtVSa

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

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 Pharmacopoeia Commission (IPC) and India’s Central Drug Authority (CDSCO) have released Version 2.0 of the “Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products” wherein they have extended the timelines to report non-serious adverse events within 90 calendar days from the previous proposed timelines of 30 days.
Source: bit.ly/4dctGCs

2. Drugs Consultative Committee (DCC), which advises the Central and State Governments on uniform implementation of drug laws in India, has reportedly advised all the State Licensing Authorities (SLA) to ensure that all applications are exclusively received and processed through the Online National Drugs License System (ONDLS) portal only.
Source: bit.ly/4ejO8Tr

3. The Federal Court of Australia has heavily penalized and ordered one of the leading manufacturers and suppliers of medical devices for unlawfully supplying Infuse Bone Graft Kit without LT Cage. The Australian Register of Therapeutic Goods (ARTG) prevents the supply of Infuse Bone Graft Kit without LT Cage.
Source: bit.ly/3XChUMd
Source: bit.ly/4dlv5H1

4. The World Health Organization (WHO) has released guidance on best practices for clinical trials to improve the design, conduct, and oversight of clinical trials in countries of all income levels. The guidance provides recommendations to the national health authorities, regulatory authorities, funders, and others on how to facilitate clinical trials to generate evidence on health interventions in addition to practical concerns.
Source: bit.ly/47Fc0hI
Source: bit.ly/4ezzQxN

5. India’s Central Drug Licensing Authority has reportedly introduced new guidelines to lower the frequency of drug testing for imports from nations like the US, Australia, Japan, Canada, and the European Union, to one sample from every two years’ worth of consignments or one sample out of every 20 consecutive consignments, whichever occurs first provided the drug samples maintain a clean record with no quality failures in the last five years.
Source: bit.ly/3Bgacjo