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 National Pharmaceutical Pricing Authority (NPPA), exercising powers under paragraphs 5, 11, and 15 of the Drugs (Prices Control) Order, 2013, has notified the fixation of retail prices for specified new drug formulations. The prices, exclusive of Goods and Services Tax, apply to the formulations listed with defined strength, unit, manufacturer, and marketing company. Manufacturers of drugs classified as “new drugs” under DPCO 2013 must strictly adhere to the notified retail price. GST may be added only if it is actually paid or payable to the government. Retail prices for individual packs must be calculated as per paragraph 11 of DPCO 2013. Manufacturers are required to issue and submit price lists in Form V through the Integrated Pharmaceutical Database Management System and share copies with State Drug Controllers and dealers. Retailers and dealers must prominently display these price lists at their business premises. The applicability of the notified price is limited to manufacturers or marketers who have applied for price fixation or revision and fulfilled all statutory requirements, including valid licensing approvals. Non-compliance will attract recovery of overcharged amounts with interest under DPCO 2013 and the Essential Commodities Act, 1955. Prior price orders for the same formulations stand superseded.  

Subject

Summary: 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.

Subject

Summary: The Ministry of Chemicals and Fertilizers has issued an important update through the National Pharmaceutical Pricing Authority (NPPA). The ministry has extended the existing ceiling prices for orthopaedic knee implants used in knee replacement procedures. These prices were originally fixed in August 2017 to avoid sudden spikes in treatment costs and have been renewed several times based on public interest. The earlier extension was valid until 15 November 2025. With the latest order, the same ceiling prices will now continue until 15 November 2026, or until the government releases a new directive. This ensures consistent pricing for hospitals and manufacturers while providing financial safety to patients undergoing knee replacement surgery. All notes and conditions included in the original 2017 notification will stay active during this extended period. The decision highlights the ministry’s ongoing focus on transparency, fair pricing, and accessible healthcare for those who depend on crucial orthopaedic implants.