Notification for exemption to M/s Intas Pharmaceuticals Limited under para 32(ii) of DPCO 2013 in respect of the formulations Clozapine Extended Release Capsules 12.5 mg / 25 mg / 50 mg / 100 mg / 200 mg

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-25032026-271289 EXTRAORDINARY PART II—Section 3—Sub-section (ii) PUBLISHED BY AUTHORITY No. 1520] NEW DELHI, WEDNESDAY, MARCH 25, 2026/CHAITRA 4, 1948 2202 GI/2026 MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 25th March, 2026 S.O. 1585(E).—Whereas the National Pharmaceutical Pricing Authority (NPPA) was established vide the Resolution of the Government of India in the Ministry of Chemicals and Fertilizers No. 33/7/97-PI.I dated 29th August, 1997, inter-alia, to fix prices and notify the changes therein, if any, of bulk drugs and formulations, monitor the prices of non-scheduled drugs and formulations and oversee the implementation of the provisions of the Drugs (Price Control) Order (DPCO). 2. And whereas the Ministry of Chemicals and Fertilizers vide S.O.1394 (E) dated the 30th May, 2013, in exercise of the powers conferred by Section 3 and 5 of Essential Commodities Act, 1955 has delegated the powers in respect of specified paras of the DPCO, 2013, including para 32 of the said order to be exercised by the NPPA on behalf of the Central Government. 3. And whereas an application was received from M/s Intas Pharmaceuticals Limited seeking exemption from the provisions of DPCO, 2013 under Para 32 (ii) and (iii) of the said order, in respect of the formulations "Clozapine Extended Release Capsules 12.5 mg / 25 mg / 50 mg / 100 mg / 200 mg”. Further, the Patent Office, Government of India has granted Patent to M/s Intas Pharmaceuticals Limited for an invention entitled “Extended Release pharmaceutical composition of Clozapine” in accordance with the provisions of the Patents Act, 1970 (Patent No. 437433 and date of Grant 05.07.2023). 4. And whereas the NPPA in its 144th meeting dated 24.03.2026 noted that M/s Intas Pharmaceuticals Limited meets the requirement of para 32(ii) of DPCO, 2013 and decided that exemption may be granted to M/s Intas Pharmaceuticals Limited under para 32(ii) of DPCO, 2013 for their formulations “Clozapine Extended Release Capsules 12.5 mg / 25 mg / 50 mg / 100 mg / 200 mg”. 5. Now, therefore, in exercise of the powers delegated under para 32 of the Drugs (Prices Control) Order, 2013 vide S.O.1394(E) dated 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, M/s Intas Pharmaceuticals Limited is exempted from the provisions of DPCO, 2013 under para 32(ii) of the said order in respect of the formulations “Clozapine Extended Release Capsules 12.5 mg / 25 mg / 50 mg / 100 mg / 200 mg" for a period of five years from the date of the commencement of commercial production in the country by the manufacturer or expiry of the Indian patent, whichever may be earlier. 6. M/s Intas Pharmaceuticals Limited shall inform NPPA the date of commercial production of the formulations "Clozapine Extended Release Capsules 12.5 mg / 25 mg / 50 mg / 100 mg / 200 mg” in the country and the Price to Retailer (PTR) and Maximum Retail Price fixed by the company in respect of above said formulations by issuing a price list in Form V under DPCO, 2013. 7. M/s Intas Pharmaceuticals Limited, shall after the expiry of period of exemption granted under para 32(ii) of DPCO, 2013, shall follow the notified ceiling price or seek retail price approval three months before the expiry of the exemption, as applicable, for the formulations “Clozapine Extended Release Capsules 12.5 mg / 25 mg / 50 mg / 100 mg / 200 mg. [PN/276/144/2026/F/F. No. 8(144)/2026/D.P./NPPA-Div.-II] BHIVA RAM YADAV, Assistant Director