Law Updates

The Ministry of Chemicals and Fertilizers has announced the cancellation of three Quality Control Orders under the Bureau of Indian Standards Act, 2016. The government has rescinded the earlier orders related to Acrylonitrile, Maleic Anhydride, and Styrene (Vinyl Benzene). These Quality Control Orders, first issued in April 2022, are now withdrawn with immediate effect.

The decision aims to simplify chemical regulations and improve industry compliance. The move follows consultations with the Bureau of Indian Standards and reflects a step toward reducing regulatory burden on manufacturers and traders. By withdrawing these orders, the government ensures that the production, import, and trade of these key industrial chemicals remain smooth and uninterrupted.

This update marks an important policy shift in India’s chemical sector, supporting ease of doing business while maintaining public safety through other existing regulatory measures. The notifications were published in the Gazette of India on 24th October 2025.

The Central Government has issued the Mineral (Auction) Third Amendment Rules, 2025 under section 13 of the Mines and Minerals (Development and Regulation) Act, 1957. The amendment introduces significant updates to the Mineral (Auction) Rules, 2015, focusing on simplifying mineral sales, lease management, and compliance alignment.

Under the revised rules, captive mine leaseholders can now sell minerals produced from their mines after meeting specified conditions, replacing the earlier restriction that capped market sales at 50 % of total production. The amendment also ensures that newly found minerals within a lease area may be included in the mining lease in accordance with section 15B, thereby improving procedural clarity.

Additional modifications across rules 10, 16, and 18 insert cross-references to “section 15B and the rules” to harmonize legal provisions. Furthermore, rule 21 prohibits the inclusion of atomic minerals, meeting the notified threshold value, within leases meant for non-atomic minerals. These reforms aim to streamline mineral governance, boost transparency, and ensure responsible resource utilization.

The Ministry of Consumer Affairs has issued the Legal Metrology (Packaged Commodities) Amendment Rules, 2025, to align packaging and labelling norms for medical devices with the Medical Devices Rules, 2017. The amendment states that packages containing medical devices must follow the Medical Devices Rules for all declarations, such as product details, numerals, and letter size on labels. It also clarifies that any relaxation under rule 33 of the original Legal Metrology Rules will not apply to medical devices governed by the 2017 Rules.

This change ensures consistency between packaging standards and medical device regulations, strengthening consumer transparency and compliance. By linking Legal Metrology norms with the Medical Devices Rules, the government aims to avoid duplication and confusion in labelling standards. The notification came into force upon its publication in the official gazette, marking an important step toward harmonized regulatory practices in India’s packaging and medical device sectors, improving clarity and accuracy in consumer information.

The Legal Metrology (Government Approved Test Centre) Amendment Rules, 2025 (hereinafter “Amendment Rules”) update the Legal Metrology (Government Approved Test Centre) Rules, 2013 under the Legal Metrology Act, 2009. They redefine that weights and measures listed in the First Schedule must undergo verification by a recognised test centre or a legal-metrology officer. The recognition process for centres now mandates submission of an application to the Joint Secretary in the Department of Consumer Affairs, and introduces a new inspection step by both Central and State legal-metrology officers. Government-controlled reference-standard laboratories and National Test House labs are explicitly deemed approved centres. Verification certificates must now be issued individually per instrument, and centres may operate within their district, or state if authorised. A revised fee structure is introduced: for example, an application for approval attracts Rs 2 lakh per instrument, payable also at renewal. These changes aim to bolster the reliability and transparency of measurement verification nationwide.

The Central Government has officially revoked several Quality Control Orders related to fatty acids, citing public interest and following consultations with the Bureau of Indian Standards (BIS). These orders, originally issued in April 2022 under the Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals, included notifications for Lauric Acid, Acid Oil, Palm Fatty Acids, Rice Bran Fatty Acids, Coconut Fatty Acids, and Hydrogenated Rice Bran Fatty Acids.

Each order, published in the Gazette of India under S.O. numbers 1961(E) to 1967(E), has been rescinded immediately, reflecting a significant regulatory update in the quality control framework for these chemicals. The government exercised powers under Section 16 of the Bureau of Indian Standards Act, 2016, to take this step.

This move is expected to streamline compliance requirements for manufacturers and suppliers, ensuring that outdated or redundant notifications no longer affect operations. The decision highlights the government’s commitment to maintaining relevant and efficient standards in the chemicals and petrochemicals sector while protecting public interest.

The Central Drugs Standard Control Organisation (CDSCO) has released a detailed draft guidance on regulatory requirements for medical device software under the Medical Devices Rules (MDR), 2017. The document, dated October 21, 2025, clarifies the scope, classification, technical documentation, and quality management requirements for both domestic and overseas manufacturers.

The guidance distinguishes between Software in a Medical Device (SiMD), which is integrated with hardware, and Software as a Medical Device (SaMD), which operates independently for medical purposes. Risk classification follows MDR-2017 provisions, with SiMD aligned to the hardware’s risk and SaMD classified based on its role in healthcare decisions, ranging from Class A to Class D.

The draft outlines regulatory pathways, clinical investigation requirements, and licensing procedures. Manufacturers must maintain a comprehensive Quality Management System (QMS) and submit detailed technical documentation, including risk management reports and system architecture. Post-market surveillance, adverse event reporting, and corrective actions are mandatory, ensuring patient safety and software reliability. Stakeholders can submit comments within 30 days.