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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. 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

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 Pollution Control Board (CPCB) has notified the establishment of a National Control Room (NCR) to coordinate and monitor nationwide enforcement of the ban on identified single-use plastic items. The NCR will support clarity, compliance tracking, stakeholder guidance, state control room reporting, inspections and awareness campaigns.
Source: h7.cl/1lmmL

2. The National Medical Commission has directed medical colleges to establish committees to monitor prescription practices, emphasising clear and legible handwriting and the use of generic drug names. The directive aims to strengthen patient safety, promote rational prescribing, and integrate these practices into medical education nationwide.
Source: h7.cl/1lmm6

3. Food Safety and Standards Authority of India has reportedly directed all states and Union Territories to launch a nationwide enforcement drive against adulteration and misbranding of milk, paneer and khoya. The move follows repeated detections and aims to protect public health through strict inspections and penalties across country.
Source: h7.cl/1gsAC

4. More than 60% of registered small and medium pharmaceutical units in India reportedly risk shutting down by December 2025 due to non-compliance with revised GMP (Schedule M) quality standards. Industry stakeholders warn of potential medicine shortages, job losses, and export disruptions if compliance challenges are not addressed promptly.
Source: h7.cl/1gsAd

5. The EU’s Medical Device Coordination Group has issued new guidance clarifying criteria for qualifying breakthrough medical and IVD devices under MDR/IVDR. It defines key criteria such as significant clinical benefit, unmet medical need, and innovation level, aiming to harmonize interpretation across authorities and support early regulatory engagement without lowering safety or evidence requirements.
Source: h7.cl/1lmli

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 Government has issued the Legal Metrology (General) Third Amendment Rules, 2025 to regulate non-invasive automated sphygmomanometers and their accessories. The rules specify standards for measurement accuracy, safety, and labelling to ensure reliability in blood pressure monitoring at the arm, wrist, or thigh.
Source: tinyurl.com/d6ftzhv7

2. The Maharashtra Medical Council (MMC) has transitioned its “Know Your Doctor” QR based KYD platform from voluntary to mandatory for all MBBS practitioners in the state. Doctors must prominently display their unique QR code in clinics, allowing patients to verify credentials instantly.
Source: tinyurl.com/mrx234ds

3. India’s Supreme Court reserved its order in cases involving couples who froze embryos before the Surrogacy Act, 2021. Now over the statutory age limit, they seek exemption from restrictions. Petitioners argue retroactive application is unfair. The decision may set a precedent for application of reproductive laws prospectively or retroactively.
Source: tinyurl.com/49tkfp5r

4. The Drug Controller General of India will soon direct states and Union territories to identify pharmaceutical companies not following Good Manufacturing Practices, especially Micro, Small and Medium Enterprises. This action follows global concerns over drug safety and aims to raise India’s pharmaceutical quality to international standards.
Source: tinyurl.com/wpnc2vjy

5. The National Health Authority has unveiled comprehensive Hospital Empanelment & Management (HEM) Guidelines to ensure consistent service quality across AB PMJAY facilities. Key updates include introduction of HEM 2.0 with stringent physical verifications, geo-tagged photo submissions, and mandatory periodic reviews for private hospitals.
Source: tinyurl.com/2s3k863r

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 National Medical Commission (NMC) has reportedly not initiated any action against 30 doctors involved in a pharma freebies case. An RTI response reveals that the Department of Pharmaceuticals has not directed action, despite earlier findings of violations by the pharmaceutical company sponsoring lavish trips.
Source: bit.ly/44xs6e4

2. The Indian Pharmacopoeia Commission (IPC) has announced changes to certain monograph titles and synonyms in the upcoming Indian Pharmacopoeia (IP) 2026 which is effective from July 2026. Manufacturers have been advised to assess the impact on existing products and start taking necessary steps to update the label.
Source: bit.ly/4dtuq8p

3. India’s Ministry of Health has reportedly raised concerns that only a small fraction of small and medium-sized pharmaceutical companies have applied to the government for an extension of the timeline to comply with the Revised Good Manufacturing Practices (GMP) under Schedule M and to submit their facility upgradation plans. With the 12th May 2025 deadline approaching, state health secretaries have been asked to coordinate with local manufacturers and ensure timely compliance.
Source: bit.ly/4ka44u3

4. The Government of Odisha has reportedly announced plans to draft a state-wide mental health policy, including early intervention frameworks and counselling centres, to address rising mental health issues particularly among vulnerable groups such as youth and the elderly
Source: bit.ly/44peMIy

5. The European Medicines Agency (EMA) has officially recognized suicidal thoughts as a potential side effect of a medication commonly used to treat male pattern baldness. While the EMA maintains that the benefits of the drug continue to outweigh the risks, it has mandated that all 1 mg packages include a patient card highlighting these risks.
Source: bit.ly/3SgZLBr

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. Indian pharmaceutical manufacturers will have to prove compliance with revised Good Manufacturing Practices at the time of renewal of manufacturing license, as per media reports.
Source: bit.ly/3MAGjg9

2. A woman who has filed for divorce should be treated as a divorced woman for the purposes of medical termination of pregnancy, and therefore will have the right to terminate her pregnancy: High Court
Source: bit.ly/4fNDhT7

3. The Multidisciplinary Committee of Experts (MDC), which advises the National Pharmaceutical Pricing Authority (NPPA), will invite an officer not below the rank of Deputy Controller of Patents and Designs, to evaluate eligibility for exemption of patented drug from application of price control law.
Source: bit.ly/46Ya8jY

4. A new scheme to boost domestic medical device industry in India is under works and will reportedly be launched in a month.
Source: bit.ly/4fUqrSU

5. A new portal for reporting adverse events of drugs, vaccines and medical devices has been launched by Indian Pharmacopoeia Commission. The adverse event may be reported by consumers and medical practitioners.
Source: bit.ly/4dxeUXY