NPPA Issues Rs 52.75 Crore Demand Notice to Akums Drugs Subsidiary, Hetero, Abaris Over Lanol Injection
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.
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 | ₹18,94,80,649 | Relates to batches manufactured from December 2017 to August 2024 |
| Penalty | ₹18,94,80,649 | Equal to 100% of the overcharged amount |
| Interest | ₹14,85,06,895 | Calculated up to October 30, 2026 |
| Total demand | ₹52,74,68,193 | Combined amount disclosed for the parties named in the notice |
Akums stated that the primary responsibility for responding to the notice rests with Hetero Healthcare Limited, as the marketer of the product.
Explaining its contractual arrangements, Akums said that, in the ordinary course of business, the company and its subsidiaries enter into supply agreements with marketing entities containing a clause that places sole liability on the marketing entity for violations of DPCO provisions.
According to the company, these clauses also cover any penalty, fine, interest or other amount specified by a regulatory or statutory authority where a discrepancy is found in the MRP of the supplied medicine.
The company reported that the demand notice was received on October 15, 2026, at 11:05 a.m. IST. The same receipt details were included in Annexure-A.
Akums submitted the intimation under Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015. The accompanying annexure furnished details under Regulation 30 read with Clause 20 of Para A of Part A of Schedule III of those regulations.
