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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. India’s Finance Ministry has amended the Narcotic Drugs and Psychotropic Substances Rules, 1985 to replace Form 4A and revise Form 5, tightening procedures for import and export of narcotic drugs. The new rules mandate stricter documentation, separate accounting, monthly returns, transport permits, export-only restrictions, and compulsory surrender of unused morphine, codeine, thebaine and their salts to government facilities.
Source: h7.cl/1l0Dd

2. The Finance Ministry has authorized 15 pharma companies to import morphine, codeine, thebaine and their salts solely for producing export-bound formulations under strict conditions including use within 180 days, limits on waste, and surrender of unused material. The order is valid until December 31, 2027, with import certificates valid for 180 days.
Source: h7.cl/1g7yD

3. The Delhi High Court recorded an undertaking that a major Indian pharmaceutical company will not sell its semaglutide-based drug in India until March 20, 2026 when the secondary patent on the medicine is set to expire of another pharma company, while permitting it to manufacture and export the product to markets where no patent rights exist. The company’s assurance was noted by the court amid ongoing patent disputes, with similar relief previously granted to another domestic manufacturer in related proceedings.
Source: h7.cl/1g7xa

4. The Consumer Protection (Amendment) Bill, 2025, proposes to expand the definition of unfair trade practices to include nondisclosure of key terms and dynamic pricing, algorithmic manipulation of consumer behaviour, and the use of complex barriers that impede cancellations, returns, or opting out of services, thereby strengthening India’s legal framework against dark patterns.
Source: h7.cl/1l0Ca

5. India will reportedly invite the World Health Organization to audit and rate its drug regulatory system, aiming to strengthen quality oversight and restore global confidence in its pharmaceutical sector. The initiative follows recent safety concerns and seeks to align national processes with international regulatory maturity standards.
Source: h7.cl/1l0Ce

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. A multinational pharmaceutical company has approached the Delhi High Court to restrain the domestic pharma giant from launching its generic version of semaglutide, a widely prescribed drug for diabetes and weight loss. This is the second suit by the plaintiff innovator against local firms wanting to launch copies of the drug
Source: h7.cl/1g6X3

2. Department for Promotion of Industry and Internal Trade (DPIIT) has issued a draft framework mandating blanket licence for legally accessible content for AI-training, but deferring royalty payments until commercialisation. The plan sets up a centralised royalty-collection mechanism, replacing “zero-price licence” proposals.
Source: h7.cl/1g6X7

3. The Delhi High Court has temporarily barred a local supplier from using a mark found deceptively similar to a well-known ayurvedic brand, holding that the adoption appeared misleading and capable of confusing consumers. The Court restrained manufacture, sale, promotion, and any creation of third-party rights during the proceedings.
Source: h7.cl/1l00x

4. The Drug Consultative Committee has noted that some State Licensing Authorities (SLA) are issuing manufacturing licenses for new drugs without prior written approval from the Central Licensing Authority (CLA), as required under The New Drugs and Clinical Trials Rules, 2019. Members unanimously agreed that SLAs must obtain CLA approval before granting any such manufacturing permission.
Source: h7.cl/1g6Xk

5. The United States Food and Drug Administration has reportedly finalized guidance on promotional labeling and advertising for biologics and biosimilars, outlining standards to ensure accurate and non-misleading communications. The document clarifies expectations for data presentation, comparative claims, and identification of products, with specific caution against comparisons that imply reduced safety or effectiveness.
Source: h7.cl/1l00M

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 Drugs Standard Control Organization (CDSCO) has launched a new online Risk Classification Module for medical devices, excluding IVDs. Effective 27 November 2025, applicants can seek classification for devices not listed in CDSCO’s published list via the portal, simplifying regulatory approvals for Medical Devices.
Source: h7.cl/1kNrH

2. Indian Council of Medical Research (ICMR) and India’s Central Drug authority CDSCO (IVD Division) has jointly developed the MedTech Mitra IVD Innovators Handbook to guide developers through clinical validation. It outlines key milestones, regulatory and ethical expectations, and evidence requirements, helping innovators plan effectively and generate strong clinical data to support the safety and efficacy of their diagnostic products.
Source: h7.cl/1kNrK

3. Rajya Sabha members urged the government to ban misleading surrogate ads promoting tobacco and liquor, citing rising cancer and heart disease cases. During debate on the Central Excise (Amendment) Bill, 2025, they sought stricter controls, awareness campaigns and higher taxes to curb tobacco use and protect public health.
Source: h7.cl/1fVMQ

4. The Delhi High Court has declined to grant injunctive relief against an Semaglutide manufacturer, thereby permitting the manufacture and export of semaglutide to jurisdictions where no valid patent protection subsists. The Court clarified that while export to non-patent markets is permissible, the sale or distribution of the drug within India remains prohibited until expiry of the relevant patent.
Source: h7.cl/1kNrT

5. The Indian government has introduced the Health Security se National Security Cess Bill, 2025, proposing a new cess on the installed machinery or processes used for the manufacture of goods such as pan masala, with scope to include other products in future. The cess will apply across all production methods, machine-based, manual, or hybrid.
Source: h7.cl/1kNrW