Law Updates

The Ministry of Health and Family Welfare has released a draft notification proposing significant changes to Schedule H2 of the Drugs Rules, 1945. This amendment aims to include more medicines under a category that mandates strict prescription and monitoring protocols. The Drugs (Amendment) Rules, 2025, the draft has been issued under the Drugs and Cosmetics Act, 1940, and is open for public consultation.

The proposal introduces a new Table under Schedule H2, identifying specific therapeutic categories of drugs that are considered high-risk, critical, or vulnerable to misuse. These additions are meant to strengthen regulatory oversight and ensure safer use of potent medications.

Stakeholders, healthcare professionals, and the public have 30 days from the Gazette publication date (October 16, 2025) to submit feedback or objections. The Ministry will review all suggestions before finalizing the amendment.

This move underscores the government’s focus on public health and the responsible distribution of sensitive drug formulations through tighter legal controls.

The Central Government has issued the Sugarcane (Control) Amendment Order, 2025, under the Essential Commodities Act, 1955, updating the Sugarcane (Control) Order, 1966. A significant addition is Clause 6F, which lays out the framework for reinstating derecognised Industrial Entrepreneur Memorandums (IEMs).

Under the new rules, reinstatement will be reviewed on a case-by-case basis. Conditions include submission of fresh or additional bank guarantees INR 50 lakh per year for regularising expired periods or seeking extensions. A one-time relaxation is still applicable for the COVID-19 period (March 2020 - February 2022).

The reinstated IEM’s validity can be extended up to two years, not exceeding one year at a time, for completing the necessary steps. An additional extension of up to two more years is allowed strictly for starting commercial production. However, failure to meet deadlines will result in forfeiture of bank guarantees.

All reinstated IEMs must follow the minimum distance standards and adhere to other existing provisions, unless specified otherwise in the reinstatement order and after consultation with the State Government and the Ministry of Law and Justice.

The Bureau of Indian Standards (BIS), in accordance with Sub-rule (1) of Rule 15 of the BIS Rules, 2018, has officially informed the establishment of new Indian Standards. These newly known standards are listed in the second column of the accompanying schedule and come into effect from the dates mentioned in the third column.

Moreover, the notification gives information about any existing standards that will continue to remain valid alongside the new ones. These parallel standards are stated in the fourth column and will be valid until the dates mentioned in the fifth column, after which they will be officially withdrawn.

This move by the BIS aims to ensure a smooth transition and maintain regulatory clarity for manufacturers, service providers, and other stakeholders. The simultaneous operation of old and new standards allows businesses ample time to adapt their systems and comply with updated norms without disruption.

Stakeholders are advised to refer to the official schedule for detailed information on each standard and its effective or withdrawal date.

The Directorate General of Foreign Trade (DGFT) has amended import policy conditions for specific items under Chapters 70, 73, 84, and 85 of ITC (HS) 2022, Schedule I. These changes apply to items used in solar and wind energy projects. From 01.11.2025, certain products like tempered safety glass, towers, bearing housings, gears, electric motors, photovoltaic cells, and generators must be registered on the Renewable Energy Equipment Import Monitoring System (REEIMS) of the Ministry of New and Renewable Energy before import.

The REEIMS registration is mandatory for all imports via air, sea, or land routes. Applications must be submitted two days in advance for air cargo and five days for sea or land shipments. Registrations are valid for three months, free of charge, and can cover multiple consignments for a specific port. Importers must declare the intended end-use of products during registration.

This amendment ensures better monitoring of renewable energy equipment imports and aligns trade practices with India’s renewable energy goals. The revised import policy imposes specific conditions for HS Codes 70071900, 73082019, 84833000, 84834000, 85016420, 85016430, 85023100, 85030090, 85414200, and 85414300. Compliance with REEIMS registration is mandatory to clear customs and maintain smooth import operations.

The Directorate General of Foreign Trade (DGFT) has amended the import policy for Sulfadiazine API under Chapter 29 of ITC (HS), 2022, Schedule-I. The notification takes effect immediately under powers granted by the Foreign Trade (Development & Regulation) Act, 1992, and provisions of the Foreign Trade Policy (FTP) 2023.

Under the new rule, imports of Sulfadiazine API with a CIF value below Rs. 1,774 per kg are now classified as ‘Restricted’ until 30th September 2026. The Modified Import Policy (MIP) applies unless specific exemptions exist.

Exemptions cover Advance Authorization holders, Export Oriented Units (EOUs), and units in Special Economic Zones (SEZs), provided the API is not sold in the Domestic Tariff Area (DTA).

This amendment balances domestic supply control while supporting export-focused and SEZ operations. The notification has been issued with approval from the Minister of Commerce & Industry.

The Ministry of Commerce and Industry, through the Directorate General of Foreign Trade (DGFT), has issued a new notification updating the export policy for meat and meat products. Starting from 29th October 2025, all exports of chilled and frozen meat of bovine animals, including boneless meat and edible offal like tongues and livers, will require proof of remittance to the Meat Export Development Fund (MEDF) managed by APEDA.

This amendment ensures that exporters contribute to the development of the meat industry in India while complying with regulatory norms. The specific HS Codes affected are 02013000, 02023000, 02061000, 02062100, 02062200, and 02062900. Exports of these goods will be permitted only after submission of MEDF remittance proof.

The update provides a transition period for exporters to comply with the new conditions. This step strengthens India’s meat export framework, promotes industry growth, and aligns with international trade standards. Exporters must follow these rules to avoid shipment delays or regulatory penalties.