Law Updates

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Each order, published in the Gazette of India under S.O. numbers 1961(E) to 1967(E), has been rescinded immediately, reflecting a significant regulatory update in the quality control framework for these chemicals.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This move is expected to streamline compliance requirements for manufacturers and suppliers, ensuring that outdated or redundant notifications no longer affect operations.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The Central Drugs Standard Control Organisation (CDSCO) has released a detailed draft guidance on regulatory requirements for medical device software under the Medical Devices Rules (MDR), 2017.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.

The Central Drugs Standard Control Organisation (CDSCO) has launched a Digital Monitoring System through its Online National Drug Licensing System (ONDLS) portal to strengthen oversight of high-risk pharmaceutical solvents. This initiative, communicated via a letter dated October 22, 2025, responds to recent safety concerns, including the detection of Diethylene Glycol (DEG) in cough syrups, which posed major public health risks.

Following a high-level meeting chaired by the Union Health Secretary on October 5, 2025, the CDSCO has authorized strict compliance for solvent manufacturers. All manufacturers must now obtain or register their licenses on the ONDLS portal, with existing licensees submitting their current data through the “Old Licence Management” section. Additionally, batch-wise details, including quantity produced, Certificate of Analysis (CoA), and buyer information, must be uploaded.

State and UT Drug Controllers are directed to ensure no high-risk solvent batch reaches the market without adherence to these requirements. The updated ONDLS portal is fully operational to secure the pharmaceutical supply chain and protect product quality.

The Government has introduced the Telecom Cyber Security Amendment Rules 2025 to strengthen the protection of telecom identifiers and digital services. A new kind of entity, called a Telecommunication Identifier User Entity (TIUE), is now formally brought under supervision. TIUEs include any organisation that uses mobile numbers or other telecom identifiers to identify customers, deliver services, or perform verification.

A central Mobile Number Validation (MNV) platform will be set up so that TIUEs, government agencies, or licence-holders can verify whether a telecom identifier submitted by a user matches the database of a licensed telecom operator. The MNV platform will collect requests, route them to licence-holders or authorised entities, and share responses. A small fee will apply per validation request.

The rules also introduce enhanced controls on device identifiers: manufacturers and importers must not assign IMEI numbers already in use, a national database will list tampered or restricted IMEIs, and used device sellers must check this list before resale.

The Government gains stronger supervisory powers: it can demand data from licence-holders and TIUEs on identifiers, suspend or permanently block identifiers without prior notice if the public interest demands it, and direct affected entities accordingly.

This regulatory update aims to ensure that telecom identifiers are not misused for fraud, impersonation, or unauthorised access. The new rules apply to telecom operators, digital platforms, and service providers that use mobile numbers for onboarding. Implementation will require integration with the MNV platform, data-handling safeguards, and compliance systems. The amendment reflects a shift toward trusted digital identity and stronger cybersecurity in India's telecom ecosystem.

The Ministry of Chemicals and Fertilizers has issued the Polypropylene (PP) Materials for Moulding and Extrusion (Quality Control) Second Amendment Order, 2025. The amendment updates the earlier 2024 PP Quality Control Order. The key change sets the new enforcement date as 24th April 2026.

This amendment ensures that all polypropylene materials used for moulding and extrusion comply with updated BIS standards. Manufacturers and industries using PP materials must follow the revised quality and safety norms from the new effective date. The government emphasizes public safety and industry standardization through this amendment.

The order strengthens the regulation of polypropylene in manufacturing processes, aiming for consistent quality in finished products. This update is crucial for the plastics industry, promoting safer and higher-quality PP products in India.