Law Updates

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These withdrawn orders were first issued in 2021 to control the quality of important industrial chemicals.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.

The Food Safety and Standards Authority of India (FSSAI) has extended the date for enforcing new labelling rules for alcoholic beverages. These rules are part of the Food Safety and Standards (Alcoholic Beverages) First Amendment Regulations, 2025. Earlier, the rules were supposed to start on January 1, 2026. Now, the new enforcement date is 1st July, 2026.

The notification issued on June 20, 2025, introduced new standards for different alcoholic drinks such as mead (honey wine), craft beer, Indian liquors, wine-based beverages, and alcoholic ready-to-drink (RTD) products. It also included changes in labelling requirements for these products.

A stakeholder pointed out that alcoholic beverages must also follow State Excise Laws. In many states, label registration takes place at the beginning of the excise year, which usually starts on April 1st or July 1st. Changing labels in the middle of the excise year can create many practical problems. It may lead to business disruption, waste of already printed labels, and extra cost for printing and re-registering new labels.

After reviewing these concerns, FSSAI decided to grant more time to the industry. The extension has been issued under the powers given to FSSAI under Section 16(5) of the Food Safety and Standards Act.

The National Pharmaceutical Pricing Authority has issued a new price update under the Drugs Prices Control Order, 2013, acting through the Ministry of Chemicals and Fertilizers. The order fixes new retail prices for specific drug formulations submitted by manufacturers and marketing companies through Form I. These prices are exclusive of GST, which can be added only when it is officially payable.

Manufacturers should calculate pack-wise prices as per paragraph 11 of DPCO 2013 and submit the revised price list in Form V through IPDMS. A copy must also be sent to the State Drug Controller and to dealers. Retailers and dealers are required to show the updated price list in a clearly visible area of their premises, ensuring transparent access for consumers.

The notification also supersedes any previous price orders for the same formulations. Non-compliance will need manufacturers or marketers to return the overcharged amount with interest under DPCO 2013 and the Essential Commodities Act, 1955. The update reinforces pricing discipline and regulatory oversight across the pharmaceutical supply chain.

On 01 October 2025 and 09 October 2025, CPCB issued drafts regarding clear directions for all air-polluting industries operating in NCR-Delhi. These directions mandate installation and connectivity of only verified Online Continuous Emission Monitoring Systems (OCEMS). 

The national verification agency, CSIR-NPL (Council of Scientific & Industrial Research – National Physical Laboratory), now runs an OCEMS certification scheme. To date, 21 OCEMS models have received CSIR-NPL verification. Only these certified models are permitted to connect to the CPCB server. 

Industries must install these certified OCEMS units before any connectivity approval. Regulatory authorities must ensure compliance for every listed industry in their jurisdiction. A list of certified models appears on the CPCB website and requires periodic checking since the list will update over time. 

Use of non-certified OCEMS is strictly prohibited. The move aims to standardize emission monitoring and secure reliable, real-time air quality data across NCR-Delhi. Immediate action by authorities will help enforce regulatory compliance and support cleaner air monitoring across all relevant industries.

The Central Drugs Standard Control Organization (CDSCO) has officially finalized the risk classification of medical devices used in interventional radiology and radiotherapy under the Medical Devices Rules, 2017. These classifications comply with the draft lists released on January 6, 2025.

The updated lists are included in Appendix A of the respective notifications and give a structured framework for defining regulatory requirements for manufacturing and import.

The CDSCO elucidates that the general intended use given for each device acts only as guidance, manufacturers may describe particular intended uses for their products. The notified classifications are active and may be revised from time to time under the Medical Devices Rules, 2017.

Each device is assigned to Class A, B, C, or D, which determines the applicable regulatory pathway to ensure safety, quality, and compliance for technologies used in radiological and therapeutic procedures.