NPPA Issues Rs 52.75 Crore Demand Notice to Akums Drugs Subsidiary, Hetero, Abaris Over Lanol Injection

Original source summary

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has issued a demand notice totalling Rs 527468193 to Hetero Healthcare Limited, Pure and Cure Healthcare Private Limited and Abaris Healthcare Private Limited over alleged pricing violations concerning "Lanol 1000 mg injection", 100 mL. The demand comprises recovery of the alleged overcharged amount, a penalty equal to 100% of that amount, and interest. It relates to batches manufactured between December 2017 and August 2024. Pure and Cure Healthcare Private Limited, also referred to as Pure & Cure, is a wholly-owned subsidiary of Akums. In its disclosure dated October 15, 2026, Akums informed the National Stock Exchange of India Limited and BSE Limited that the subsidiary had received the NPPA demand notice dated October 13, 2026. The NPPA functions under the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India. Also Read:NPPA Approves Discontinuation of 20 Scheduled Formulations Including Grisovin FP, Doncept in FY26 According to the filing, Pure & Cure manufactured the formulation for its client, Hetero Healthcare Limited. The notice alleges that Hetero Healthcare fixed the product’s maximum retail price (MRP) above the prescribed limits under the applicable provisions of the Drugs (Prices Control) Order, 2013, or DPCO, 2013. The disclosure identifies Hetero Healthcare Limited as the marketer, and Abaris Healthcare Private Limited and Pure & Cure as manufacturers, among the three parties named in the demand notice. Annexure-A to the filing further states that the notice concerns the manufacture or marketing of the new drug/formulation “Lanol 1000 mg injection”, 100 mL, without obtaining prior price approval from the Government of India. The annexure describes the applicable requirement as being under “Section 15” of the DPCO, 2013. The total financial impact disclosed for the parties is broken down as follows: Component Amount Details Overcharged amount ₹18,94,80,64

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