Law Updates

The Government of India has introduced a new Risk Classification Module on the CDSCO Online System for Medical Devices. This update simplifies the approval process and makes it easier to classify medical devices that are not listed in the CDSCO published classification list. The module became active on 27 November 2025 under the Medical Device Rules, 2017. Any applicant can now submit device details through the CDSCO medical device portal to get the correct risk category for the product. This new system supports faster regulatory review, improves compliance, and helps ensure the safe use of medical devices across the country. The change also supports better transparency and smoother processing of applications for medical device risk classification.

The Hand Tools (Quality Control) Order, 2025 sets new rules to improve the safety and quality of hand tools sold in India. The Ministry of Commerce and Industry issued this order under the Bureau of Indian Standards Act, 2016. The order will start on 1 October 2026 and will apply to several common hand tools like pipe wrenches, open-jaw spanners, ring spanners, pliers, and adjustable wrenches. Each tool must follow the matching Indian Standard and carry the BIS Standard Mark under a licence issued by the Bureau of Indian Standards.

The order lists important standards such as IS 4003 (Part 1 and 2) for pipe wrenches, IS 2028 for open-jaw spanners, IS 2029 for ring spanners, IS 6149 for adjustable wrenches, and IS 3650 for cutting pliers. Large industries must follow the rules from October 2026, while small enterprises get time till 1 January 2027, and micro enterprises get time till 1 April 2027. This phased start supports smaller units so they can upgrade their systems without pressure.

The order does not apply to items made for export. Manufacturers can also import up to 200 units of hand tools each year for research and development without BIS certification, but these items must be scrapped later and cannot be sold.

The Bureau of Indian Standards will act as the main authority to certify and enforce these rules. Any violation of this order will lead to punishment under the BIS Act, 2016. The new framework aims to raise product quality, create safer tools, and strengthen consumer trust across the country.

The Central Government has issued the Fertiliser (Inorganic, Organic or Mixed) Control Twelfth Amendment Order, 2025, introducing key regulatory changes under the Essential Commodities Act, 1955. A significant inclusion is the recognition of Organic Carbon Enhancers produced from Compressed Biogas plants, now covered under Schedule VIII with defined quality standards. Inspectors are sanctioned to draw and document samples of these enhancers following new procedures, with analysis mandated at designated Regional Centres or approved laboratories.

Amendments to clauses 28, 29, 29AB, 29D, and 30 update sampling, testing, and compliance requirements for Organic Carbon Enhancers alongside organic fertilisers and non-edible de-oiled cakes. Schedule I receives numerous additions, including specifications for NBPT-coated urea, new NPK grades, revised micronutrient and fortified fertiliser norms, and updated tolerance limits for customised, liquid, fortified, and beneficial fertilisers. Liquid fertiliser standards now include Potassium Acetate and Liquid Potassium Carbonate. Forms J, K, and L-1 are revised to incorporate Organic Carbon Enhancers and related substances to ensure uniform documentation.

The Directorate General of Foreign Trade (DGFT) has issued an important amendment to the Handbook of Procedures (HBP) 2023 under Paras 4.87(a) and 4.88. This update expands the list of airports that can handle personal carriage of gems and jewellery parcels for both export and import. Earlier, this facility was available through major airports such as Delhi, Mumbai, Kolkata, Chennai, Kochi, Coimbatore, Bangalore, Hyderabad, and Jaipur. The new amendment now includes Ahmedabad Airport in this list.

Under the revised Para 4.87(a), foreign-bound passengers can carry gems and jewellery export parcels from all EOU, SEZ, and DTA units through the approved airports, including Ahmedabad. Customs will handle the procedure for personal carriage, and export payments will continue through normal banking channels.

Para 4.88 has also been updated to allow import of gems and jewellery parcels by Indian importers or foreign nationals through Ahmedabad Airport. The process will follow the same steps as regular air freight. The parcels must be brought to Customs for inspection and release, and clearance will take place under the normal customs procedure.

The main effect of this public notice is the official inclusion of Ahmedabad Airport as an authorised point for personal carriage of gems and jewellery parcels for both import and export. This change supports smoother trade, faster movement of high-value goods, and easier access for exporters and importers operating in western India.

The Ministry of Chemicals and Fertilizers issued an important update on 28 November 2025. The Central Government cancelled several Chemical Quality Control Orders under the BIS Act 2016. The decision came after consulting the Bureau of Indian Standards (BIS). The cancellation started immediately in the public interest.

These withdrawn orders were first issued in 2021 to control the quality of important industrial chemicals. The chemicals included p-Xylene, Toluene, Methyl Acrylate, Ethyl Acrylate, Vinyl Acetate Monomer, Ethylene Dichloride, and Vinyl Chloride Monomer. These chemicals are used in petrochemicals, plastics, paints, and the pharmaceutical industries. Each earlier order required manufacturers and importers to follow specific BIS standards.

This move aims to support smooth industrial operations and avoid compliance burdens for businesses. It may also help with faster supply chain movement and reduce production delays. The decision highlights that chemical regulations may change depending on industrial needs and public interest.

The BIS Act remains the main law for ensuring product quality in India. Any new orders or standards may come again in the future, as per national requirements

On 28 November 2025, the Food Safety and Standards Authority of India (FSSAI) issued an order directing immediate enforcement action against the illegal use of Auramine, an industrial dye, in food products. The order specifically targets roasted Chana and similar items where Auramine has been reportedly used to improve colour.

Auramine is a synthetic dye not permitted under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Its presence renders any food product unsafe under Section 3(1)(zz)(v) of the Food Safety and Standards Act, 2006.

FSSAI has instructed Commissioners of Food Safety in all States and Union Territories, along with Central Licensing Authorities, to conduct inspections, sampling, and testing of vulnerable products. Actions must cover manufacturing, processing, storage, distribution, transportation, and sale across organized, unorganized, and e-commerce sectors. Defaulting Food Business Operators (FBOs) will face appropriate action.

A combined report of actions taken must be submitted within 15 days. FSSAI has also provided a list of four NABL-accredited laboratories for Auramine testing in cereal and cereal products.