Law Updates

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.

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.