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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. India’s Ministry of Health has issued draft amendments to the New Drugs & Clinical Trials Rules, 2019 introducing a framework for filing of post-approval changes in new drugs. Manufacturers of new drugs may have to take prior approval from the authorities for major and moderate quality changes while minor quality changes might be implemented without prior approval and changes which might have a minimal effect can be implemented with annual submission by 1st quarter of every calendar year to the authorities.
Source: h7.cl/1odSN

2. The Delhi High Court upheld the conviction of a sweet manufacturing unit for discharging untreated effluents into public sewers leading to the Yamuna River. However, citing the 2024 amendment to the Water Act, which replaces imprisonment with monetary penalties, the court set aside the jail term and imposed an ten lakh rupees penalty, underscoring strict environmental compliance.
Source: h7.cl/1jbwq

3. The National Biodiversity Authority has launched a digital portal for electronic issuance of Certificates of Origin for cultivated medicinal plants, enabling access and benefit sharing exemptions. The initiative operationalises the amended Biological Diversity framework, offering a single window online process for traditional medicine, seed and research sectors.
Source: h7.cl/1odSP

4. The Government has amended the Plant Quarantine Order to permit the import of dried Mitragyna speciosa (Kratom) leaves from Uganda for processing, subject to a phytosanitary certificate confirming the consignment is free from soil, quarantine weed seeds, and other plant debris.
Source: h7.cl/1jbwX

5. The Karnataka High Court has stayed a penalty imposed by the Central Consumer Protection Authority on an e-commerce platform for allowing the sale of walkie-talkies without mandatory licensing disclosures. The E-commerce platform had argued that its liability is limited owing to it being a mere intermediary.
Source: h7.cl/1jbx0

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 Food Safety and Standards Authority of India has issued draft amendments to the Food Business Licensing Regulations mandating food manufacturers to keep daily production and raw-material records and to follow FIFO/FEFO storage norms. Retailers and non-manufacturers are exempt. The move strengthens traceability, inventory control, and food safety compliance. Public comments are invited within 30 days of Gazette publication.
Source: h7.cl/1iFOX

2. Madras High Court has ruled that the word “Vapo” is a descriptive and generic term derived from “vapour” and cannot be claimed exclusively by any party, rejecting petitions seeking cancellation of trademarks for “Vaporin” products. The Court held that the rival marks and trade dress are distinct and unlikely to cause consumer confusion.
Source: h7.cl/1nG6S

3. India’s Central Government has amended Uniform Consent Guidelines under the Air and Water Acts to simplify industrial approvals and cut delays. Key changes include consolidated consents covering multiple environmental laws, faster timelines for red-category industries, and Consent to Operate remaining valid until cancelled. Inspections, audits, and cancellation powers remain to ensure environmental compliance.
Source: h7.cl/1iFAP

4. The India–EU free trade agreement is set to eliminate duties on about 90% of European medical devices imported into India, reducing tariffs that earlier went up to 27%. The agreement is expected to lower costs and improve access to advanced technologies, Indian manufacturers are seeking regulatory alignment and mutual recognition to overcome non-tariff barriers.
Source: h7.cl/1iFAU

5. The India–EU Free Trade Agreement is expected to expand opportunities for Indian traditional medicine in Europe. In EU countries where no specific regulations exist, AYUSH practitioners will be allowed to offer services based on their Indian qualifications. The agreement also provides long-term certainty for setting up AYUSH wellness centres and clinics across EU member states.
Source: h7.cl/1iFAX

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 FSSAI has issued an advisory urging Food Business Operators (“FBOs”) to ensure compliance with the Hon’ble Supreme Court’s decision in IMA & Anr vs Union of India & Ors to curb misleading advertisements.  As per the advisory, FBOs must generate and upload a self-certificate on the Ministry of Information & Broadcasting’s Broadcast Seva portal before telecasting or publishing any advertisement. (Copy of advisory attached).
Source: bit.ly/3AFzkQy

2.  The World Health Organization’s (“WHO”) Intergovernmental Negotiating Body (“INB”) Ambassador has reportedly informed that the pandemic agreement will not be adopted at the special World Health Assembly (“WHA”) next month, as countries need more time to conclude complex negotiations, including those on the proposed Pathogens Access and Benefit Sharing (“PABS”) system.
Source: bit.ly/3As8uLP

3. A response to a Right to Information (RTI) application seeking the status of Draft Drugs and Magic Remedies (Objectionable Advertisements) (Amendment) Bill, 2020 (“DMR(OA) (Amendment) Bill”) has revealed that it is still pending. The amendments were intended to enable stricter action against misleading advertisements, as well as to widen the scope of the Drugs and Magic Remedies (Objectionable Advertisements) Act by introducing 24 diseases and disorders. The DMR(OA) (Amendment) Bill has been pending with the Ministry of Health and Family Welfare, since 2020.
Source: bit.ly/3Obgtjf

4. The Delhi High Court has granted an ex-parte interim injunction restraining AquaKind Labs LLP from using the suffix “KIND” in their trade name “Aquakind” and ruling in favor of Mankind Pharma. This ruling was based on the reasoning that AquaKind Labs’ name was deceptively similar to the registered trademark “MANKIND”, potentially causing confusion in the pharmaceutical market and to the consumers.
Source: bit.ly/4hIoXMw

5. The Ministry of Environment, Forest and Climate Change has published the Water (Prevention and Control of Pollution) (Manner of Holding Inquiry and Imposition of Penalty) Rules, 2024, outlining procedures for holding inquiries and imposing penalties under section 45B of the Water (Prevention and Control of Pollution) Act (“Water Act”). The Rules will come into force upon the publication in the Official Gazette.  (Copy of rules attached.)
Source: bit.ly/3UONcyC