Law Updates

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.

The Bureau of Indian Standards (BIS) has issued implementation guidelines for the revised IS 16242 (Part 1):2025 / IEC 62040-1:2017, which replaces IS 16242 (Part 1):2014 / IEC 62040-1:2008. The concurrent operation of both standards will continue only until 19 November 2025, after which the older version will be withdrawn.

All existing BIS licensees are required to ensure compliance with the revised standard before the deadline. They must submit complete test reports from BIS-recognized laboratories for lead models and provide an undertaking confirming conformity for all series models under their licence. Non-compliance beyond the deadline may lead to licence cancellation or model deletion.

For new applicants, processing under the old standard will be allowed only until the implementation date, with a declaration of commitment to adopt the revised version. After 19 November 2025, no licences will be granted under the old standard.

These revised guidelines aim to align India’s certification framework for UPS systems with international safety norms under IEC 62040-1:2017.

The Central Government has officially issued an amendment to the Air (Prevention and Control of Pollution) Act, 1981, specifically under the powers issued by the proviso to sub-section (1) of Section 21. This update was made in consultation with the Central Pollution Control Board (CPCB) and directly amends the existing notification published on November 12, 2024, by the Ministry of Environment, Forest, and Climate Change.

As per the latest revision, the earlier issued Schedule has been completely substituted with a new version. The revised Schedule aims to simplify environmental compliance and enhance regulatory clarity for industries and other stakeholders. These modifications are intended to boost the effectiveness of air quality management and align enforcement standards with current environmental needs.

This move marks a continued effort by the government to curb air pollution by updating statutory frameworks in line with expert recommendations and evolving environmental challenges.

The Directorate General of Foreign Trade (DGFT) has announced a key amendment to India’s import policy regarding areca nuts. As per the Notification, roasted areca nuts classified under ITC (HS) Code 20081991 will now face a strict import restriction. Specifically, any consignment of roasted areca nuts with a Cost, Insurance, and Freight (CIF) value of less than INR 351 per kilogram is now classified as “Prohibited” for import into India.

This amendment falls under the Foreign Trade (Development & Regulation) Act, 1992, and aligns with Paragraphs 1.02 and 2.01 of the Foreign Trade Policy (FTP) 2015-2020. The policy change also applies to ITC (HS) Code 08028090, updating the conditions under Schedule-I (Import Policy) of ITC (HS) 2022.

The decision, approved by the Commerce and Industry Minister, aims to regulate low-cost imports that may undermine domestic producers or bypass quality standards. Importers dealing in areca nut products should carefully assess CIF values and documentation to ensure compliance with the new regulation.