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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. Punjab’s Food and Drugs Administration (FDA) has cancelled a pharmaceutical manufacturer’s licence and ordered a nationwide product recall following findings that allegedly linked substandard oxytocin injections to maternal deaths. The action highlights increased scrutiny of GMP compliance and data integrity, signalling stricter enforcement where product quality deficiencies may endanger patient safety.
Source: shortlink.uk/1rjtj

2. Maharashtra’s FDA has uncovered a supply of falsely labelled “sterile” surgical gloves to government hospitals in Mumbai. The gloves were allegedly unsterilised due to company’s sterilization machine was malfunctioning, prompting raids and seizure of stock. The company responsible had attempted to recall the unsterilized surgical gloves before the raid with no success. Authorities are investigating licensing violations and whether proper recall procedures were followed.
Source: shortlink.uk/1rjtr

3. A U.S. federal court has allowed a proposed class-action lawsuit to proceed against a manufacturer of a children’s nutritional drink over allegations that its marketing and packaging misled consumers into believing the product was clinically proven to help children grow taller. The court held that product claims, combined with visual branding and advertising elements, could reasonably be interpreted by consumers as referring to height growth rather than general growth and development. The lawsuit alleges that consumers were misled regarding the product’s benefits, while the company maintains that its claims are scientifically supported and appropriately describe the product’s role in supporting children’s growth and development. The case will now proceed for further judicial consideration.
Source: shortlink.uk/1rjtH

4. India’s Directorate General of Foreign Trade has exempted Special Economic Zone (SEZ) units and developers from the applicability of conditions of Quality Control Orders (QCO) and Bureau of Indian Standards (BIS) rules. This exemption will be applicable on the permissible good imported like raw materials and capital goods which are authorized for SEZ operations. However, if these imported items or their resulting manufactured products are moved into the Domestic Tariff Area (DTA), they will be required to fully comply with all applicable QCO and BIS laws. Additionally, SEZ entities will have to submit a formal undertaking to the Development Commissioner at the time of import.
Source: shortlink.uk/1rjtg

5. The United States Food and Drug Administration is conducting a scientific safety review of mifepristone, the abortion pill, using existing drug safety systems. The review could influence future distribution requirements for the medicine. While the agency maintains that mifepristone is safe and effective when used as directed, abortion rights groups have criticized the review.
Source: shortlink.uk/1rjtT

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 Drug Controller General (DCGI) has reaffirmed that the revised Schedule M good manufacturing practice norms will be enforced as scheduled from January 1, 2026, with no further extensions even amid industry calls for delays. The rule applies to all drug makers and aims to elevate quality standards, though many MSMEs cite compliance challenges and potential business impacts.
Source: h7.cl/1h1Ta

2. The Department of Pharmaceuticals has extended the deadline for manufacturers to apply under the Production Linked Incentive (PLI) Scheme for domestic manufacturing of critical KSMs, drug intermediates, and APIs until 16 January 2026. Applications must be submitted online through the designated portal, and all previously issued terms and conditions in the earlier notice will continue to apply.
Source: h7.cl/1lXQo

3. A plea filed recently in India’s Supreme Court, reportedly, argues that the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 is outdated. It seeks recognition of AYUSH doctors as registered medical practitioners and calls for reforms to curb misleading drug advertisements while allowing truthful, evidence-based information.
Source: h7.cl/1lXPt

4. India is considering waiving customs duty on select pharmaceutical products manufactured in special economic zones and sold in the domestic market. The proposal aims to boost investment, strengthen domestic supply of critical medicines and vaccines, and support the pharmaceutical sector amid rising global trade pressures.
Source: h7.cl/1h1Ti

5. Australian health authorities had recently flagged concerns over counterfeit batches of anti-rabies vaccine circulating in India. The public sector manufacturer clarified that the issue pertained to a specific counterfeit batch identified in January 2025 which has since been removed from circulation. The company emphasized that genuine vaccines released through authorized channels remain safe.
Source: h7.cl/1lXPz

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 Ministry of Environment, Forest, and Climate Change (MoEF&CC) has introduced the Environment (Construction and Demolition) Waste Management Rules, 2025, effective from April 1, 2026. These Rules apply to construction, demolition, remodeling, renovation, and repair activities, with key provisions on Extended Producer Responsibility (EPR) and waste management plans.
Source: bit.ly/42AOQIu

2. India’s Central Drugs Standard Control Organization (CDSCO) has issued a Standard Operating Procedures (SOPs) to streamline the transfer of drugs manufactured in Special Economic Zones (SEZs) to domestic markets (Domestic Tariff Area) for sale and distribution. SEZ units are exempted from mandatory import and registration requirements, provided these drugs are not diverted for domestic sale and are used exclusively for export purposes.
Source: bit.ly/44ftUYL

3. Pune Municipal Corporation has issued notices to private hospitals instructing to not demand any advance deposit from patients seeking emergency medical care and to strictly follow the Bombay Nursing Home Registration Act, 1949, which forbids demanding any advance deposit from “emergency” patients.
Source: bit.ly/4j52xp2

4. A content creator agreed to remove part of a podcast after a company objected to a guest’s remarks about an antiseptic product. The guest’s claims were considered disparaging. The court-approved settlement also required related social media posts to be deleted to protect the product’s reputation.
Source: bit.ly/42sBOeV

5. A global agricultural company is helping Indian rice farmers adopt eco-friendly farming methods. These practices reduce harmful greenhouse gases. In return, the company will issue its first carbon credits, certified by Gold Standard, which environmentally conscious companies can purchase to offset their emissions.
Source: bit.ly/4iavSgm

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 and Family Welfare has developed ONDLS Portal for receiving applications from small and medium scale pharmaceutical manufacturers who wish to avail benefit of extension from requirement to comply with new Good Manufacturing Practices (GMP) under revised Schedule M. Such applications must be strictly submitted online before lapse of three months from February 11, 2025. Submission of hard copy applications will no longer be accepted.
Source: https://bit.ly/4iEFh0U

2. The Indian Ministry of Health is working with Bureau of Indian Standards (BIS) to develop a standardized invoice format for hospitals, nursing homes, clinics and diagnostic centers. Once notified, clinical establishments will have to follow a standard invoice format with detailed and transparent breakdown of charges incurred by patient.
Source: https://bit.ly/4c4CM5w

3. India’s Supreme Court has held that even in consumer contracts which contain arbitration clauses, a consumer has the right to decide whether to pursue arbitration or approach the consumer forum for resolution of consumer dispute. The Court further reiterated that consumer disputes are non-arbitrable unless the consumer voluntarily opts for arbitration.
Source: https://bit.ly/4c4CPOK

4. The Directorate General of Foreign Trade (DGFT) has decided to withdraw the Remission of Duties and Taxes on Exported Products (RoDTEP) Scheme benefits for exports arising from Advance Authorizations (AAs), Special Economic Zones (SEZs), and Export Oriented Units (EOUs).
RoDTEP Scheme helps pharmaceutical exporters to get refund on taxes and duties on export.
Source: https://bit.ly/4c43M59

5. The Food Safety and Drug Administration (FDA) of Karnataka has reportedly increased inspections to address the issue of adulteration of tea powders and spices.
The decision has been taken due to reports of addition of harmful substances in food products, with the goal of reducing health risks to the public.
Source: https://bit.ly/4cjrdrr