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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 Ministry of Health and Family Welfare has published a draft amendment to the Medical Devices Rules, 2017, proposing changes to labelling requirements for non-sterile and non-measuring medical devices, along with other regulatory updates. Stakeholders’ comments are invited within 30 days of publication of the draft Rules.
Source: h7.cl/1ghFK

2. India’s Bureau of Indian Standards has notified IS 19493:2025 on hospital bill formats, effective 8 December 2025. The standard specifies mandatory and optional billing elements for hospitals, nursing homes, diagnostic centres, and outpatient clinics, aiming to ensure uniformity, transparency, prevent overcharging, and improve clarity for patients and insurers nationwide.
Source: h7.cl/1ghFQ

3. The Supreme Court of India has issued notices to the Centre and all states on a PIL seeking to declare cancer a notifiable disease nationwide. The move aims to ensure uniform reporting, strengthen surveillance, and improve early detection and patient care through a centralized digital registry amid fragmented state-level data.
Source: h7.cl/1ghG2

4. A pharmaceutical innovator has appealed a Delhi High Court order permitting an Indian manufacturer to produce and export semaglutide to markets where patent protection has lapsed. The court declined interim relief, allowing exports to continue.
Source: h7.cl/1lb5k

5. The Ministry of Information and Broadcasting stated that the Information Technology Rules 2021 safeguard free speech while curbing fake and misleading digital content. Publishers of news must follow a Code of Ethics, intermediaries must prevent false information, and a grievance mechanism and fact checking by Press Information Bureau ensure accountability nationally.
Source: h7.cl/1ghGa

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