Law Updates

Subject

Summary: The Central Government has amended the import policy condition for Urea (Exim Code 31021010) under ITC (HS) 2022, Schedule I. Through Notification, issued under the Foreign Trade (Development and Regulation) Act, 1992, and aligned with the Foreign Trade Policy 2023, the State Trading Enterprise (STE) status of Indian Potash Limited (IPL) has been extended. As per the amendment, Indian Potash Limited will continue to handle the import of agricultural-grade Urea on the government account up to 31 March 2027. This extension ensures continuity in the existing import framework and avoids disruption in fertilizer supply. The import remains subject to Para 2.21 of FTP 2023, which governs imports through State Trading Enterprises. No other changes have been introduced, and all previous conditions prescribed under earlier notifications remain unchanged. This move provides regulatory clarity and strengthens the controlled import mechanism for Urea, ensuring timely availability for agricultural needs while maintaining policy consistency.

Subject

Summary: The Central Government has amended the export policy for wheat under ITC (HS) Codes 10011900 and 10019910 through Notification S.O. 1769(E), issued under the Foreign Trade (Development & Regulation) Act, 1992, and the Foreign Trade Policy, 2023. The export policy for wheat continues to remain “Prohibited.” However, a limited relaxation has been introduced. Export of up to 25 Lakh Metric Tonnes (LMT) of wheat is now permitted. The Directorate General of Foreign Trade (DGFT) will issue a separate Public Notice detailing the procedure, eligibility, and operational modalities for this permitted quantity. Importantly, the earlier condition under DGFT Notification No. 06/2015-2020 dated May 13, 2022, remains in force. Accordingly, wheat exports may also be allowed beyond the 25 LMT cap based on specific approvals granted by the Government of India to other countries, particularly to address food security requirements upon their request. This amendment reflects a calibrated approach, balancing domestic supply concerns with international obligations and strategic export commitments.

Subject

Summary: The Ministry of Chemicals and Fertilizers has notified revised ceiling prices for scheduled formulations under the Drugs (Prices Control) Order (DPCO), 2013, based on an annual Wholesale Price Index (WPI) increase of 0.64956% for 2025 over 2024. The revised prices will be effective from 01 April 2026 and apply to key medicines, including Acetyl Salicylic Acid, Calcium Carbonate, Dapsone, Rifampicin, Medroxy Progesterone Acetate, and condoms. Manufacturers selling above the notified ceiling price must reduce the Maximum Retail Price (MRP) in line with the revised limits, while those below may revise prices as per WPI provisions under Para 16(2). GST can be added only if actually payable. Manufacturers must submit price revisions in Form II within 15 days and issue updated price lists in Form V. Retailers are required to display price lists prominently. Quarterly reporting in Form-III and prior intimation for discontinuation in Form-IV are mandatory. Non-compliance with ceiling price provisions will lead to recovery of overcharged amounts with interest under DPCO, 2013, and the Essential Commodities Act, 1955.

Subject

Summary: The National Pharmaceutical Pricing Authority (NPPA), under the Department of Pharmaceuticals, has issued Order S.O. 1585(E) dated 25 March 2026, granting a key exemption under the Drugs (Prices Control) Order (DPCO), 2013. The exemption has been provided to M/s Intas Pharmaceuticals Limited for its patented “Clozapine Extended Release Capsules” in strengths ranging from 12.5 mg to 200 mg. This decision follows NPPA’s 144th meeting held on 24 March 2026, where it was confirmed that the formulation qualifies under Para 32(ii) of DPCO, 2013. The product is backed by an Indian patent (No. 437433, granted on 05 July 2023) for an extended-release pharmaceutical composition of Clozapine under the Patents Act, 1970. As per the order, the exemption from price control provisions will remain valid for five years from the date of commencement of commercial production or until patent expiry, whichever is earlier. Intas is required to notify NPPA of production timelines and pricing details through Form V. Post-exemption, compliance with ceiling price regulations or retail price approval will be mandatory.

Subject

Summary: The National Pharmaceutical Pricing Authority (NPPA), under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, has issued a notification revising the ceiling price of Coronary Stents. This update continues a series of price fixation orders issued since 2018 under the Drugs (Prices Control) Order (DPCO), 2013. The revision is based on the Wholesale Price Index (WPI) increase of 0.64956% for the year 2025 over 2024. Accordingly, the revised ceiling prices (exclusive of GST) will come into effect from 01 April 2026. Manufacturers and importers are permitted to adjust the Maximum Retail Price (MRP) where it is below the ceiling price, strictly in line with Paragraph 16(2) read with Paragraph 13(2) of DPCO, 2013. Further, GST can only be added if actually paid or payable. Retailers and dealers must display updated price lists prominently as per Para 24(4). Non-compliance with ceiling price norms will attract recovery of overcharged amounts along with interest under DPCO, 2013, and the Essential Commodities Act, 1955.

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.