NPPA Grants DPCO Exemption to Intas for Patented Clozapine ER Capsules

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.