Law Updates

Subject

Summary: The Central Government has issued draft rules to amend the Drugs Rules, 1945, under the authority of the Drugs and Cosmetics Act, 1940. The proposal has been released after consultation with the Drugs Technical Advisory Board and is currently open for public comments. According to the draft notification published by the Ministry of Health and Family Welfare, the amendment targets Schedule F, Part XII-C, Para G of the Drugs Rules, 1945. The government has proposed to remove the provision that requires final pharmaceutical products to be tested for HIV-I antibodies, HIV-II antibodies, Hepatitis B surface antigen, and Hepatitis C virus antibodies. The draft rule specifically states that the sentence mandating these viral testing requirements will be omitted from the regulation. This proposed change forms part of the government’s ongoing efforts to update and streamline pharmaceutical regulatory provisions. Stakeholders, pharmaceutical companies, and industry experts may submit objections or suggestions within 30 days from the date the Gazette of India notification is made available to the public. After reviewing the feedback, the government will finalize the amendment and announce the effective date through the Official Gazette.

Subject

Summary: The Directorate General of Foreign Trade (DGFT), under the powers of the Foreign Trade Policy 2023, has extended the deadline for filing Annual RoDTEP Returns (ARR) for the Financial Year 2023-24. Exporters can now submit their ARR until 31st March 2026 by paying a composition fee of Rs 15,000. Non-filing beyond this date may lead to actions under para 4.94 of the Handbook of Procedures 2023, including denial of RoDTEP benefits and scrolling out of scrips. This extension focuses on enhancing the ease of doing business and export promotion, giving exporters additional time to comply. Exporters are encouraged to complete filings within the extended period to avoid penalties and safeguard their RoDTEP entitlements.

Subject

Summary: The Directorate General of Foreign Trade ( DGFT ) has issued Notification S.O. 577(E) amending the import policy for ITC (HS) Code 71141920, covering articles of platinum under Chapter 71 of ITC (HS) 2022. Exercising powers under Sections 3 and 5 of the Foreign Trade (Development & Regulation) Act, 1992, read with the Foreign Trade Policy, 2023, the Central Government has revised the import status of these goods with immediate effect. Earlier classified as “Free”, the import of platinum articles has now been shifted to the “Restricted” category. A new Policy Condition No. 6 has been introduced in Chapter 71 to regulate such imports. However, specific exemptions are provided. Imports will continue to be treated as “Free” in cases of the re-import of Indian-origin platinum articles that were sent abroad for exhibitions or export promotion tours, rejected, returned, or unsold goods, and goods re-imported for repair. This amendment reflects DGFT’s intent to strengthen import controls on precious metals while allowing legitimate trade-linked re-imports. The notification has been issued with the approval of the Minister of Commerce & Industry.

Subject

Summary: The Directorate General of Foreign Trade ( DGFT ), under the Ministry of Commerce and Industry, has issued a Notification dated 5 February 2026, introducing significant changes to the import policy governing umbrellas and sun umbrellas classified under Chapter 66 of ITC (HS) 2022.  Under this amendment, the import policy for finished umbrellas falling under HS Code 66019100 (umbrellas with telescopic shaft) and HS Code 66019900 (other umbrellas) has been revised from Free to Restricted. This change reflects the government’s intent to regulate low-value imports and protect domestic manufacturers from price undercutting due to cheaper foreign products. However, the notification provides an important relaxation. Imports of umbrellas under the above HS codes will continue to be treated as “Free” if the CIF value is Rs. 100 or more per piece. This effectively introduces a Minimum Import Price (MIP) threshold, ensuring that only higher-value imports enter the Indian market without restriction. Further, the DGFT has clarified that the MIP condition will not apply to imports made by Advance Authorisation holders, Export Oriented Units (EOUs), and Special Economic Zone (SEZ) units, provided that such imported umbrellas are not sold in the Domestic Tariff Area (DTA). This exemption supports export-oriented manufacturing and maintains the competitiveness of Indian exporters.

Subject

Summary: The Central Government has notified the Plant Quarantine (Regulation of Import into India) (Second Amendment) Order, 2026, exercising powers under Section 3(1) of the Destructive Insects and Pests Act, 1914. The amendment comes into force from the date of publication in the Official Gazette and updates Schedule VI of the Plant Quarantine Order, 2003. A key change has been introduced at S. No. 687, concerning Mitragyna speciosa (Kratom Leaves). The existing import entries have been renumbered, and a new category has been added. The amendment now permits the import of dried Mitragyna speciosa leaves for processing, with Uganda specified as the country of origin. Notably, no additional declarations are required to be included in the Phytosanitary Certificate for this category. However, strict special import conditions apply. The consignment must be free from soil, quarantine weed seeds, and other plant debris, ensuring biosecurity compliance. This update provides clarity for importers, strengthens plant quarantine controls, and aligns regulated imports with India’s plant health and trade compliance framework.

Subject

Summary: The Directorate General of Foreign Trade ( DGFT ), through Notification S.O. 429(E), has amended the import policy under ITC (HS) 2022, Schedule-I, in line with the Foreign Trade Policy (FTP) 2023. The amendment applies to Penicillin G-Potassium (ITC HS 29411010), 6-APA (29411050), and Amoxicillin Trihydrate (29411030) falling under Chapter 29. As per the revised policy, imports of these pharmaceutical intermediates are now classified as “Restricted” if the CIF value falls below prescribed thresholds Rs 2,216/kg for Penicillin G, Rs 3,405/kg for 6-APA, and Rs 2,733/kg for Amoxicillin. The restriction is effective immediately and will remain in force for one year from the date of notification. However, the DGFT has provided specific exemptions. The restriction does not apply to 100% Export Oriented Units (EOUs), SEZ units, or imports under the Advance Authorisation Scheme, subject to the condition that such imported inputs are not diverted to the Domestic Tariff Area (DTA). This move aims to protect domestic API manufacturers, address undervalued imports, and strengthen India’s pharmaceutical supply chain.