Intas Pharma Secures 5-Year NPPA Price Control Exemption for Patented Clozapine ER Capsules

New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA) has granted a five-year exemption from price control provisions under the Drugs (Prices Control) Order, 2013 (DPCO) to Intas Pharmaceuticals Limited for its patented formulations "Clozapine Extended Release Capsules 12.5 mg/25 mg /50 mg /100 mg /200 mg" from the date of commencement of commercial production in the country by the manufacturer or expiry of the Indian patent, whichever may be earlier.

Further, the notice stated that Intas Pharmaceuticals Limited shall inform NPPA of 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 the said formulations by issuing a price list in Form V under DPCO, 2013.

This came after an application was received from 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 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).

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).

Further, the Ministry of Chemicals and Fertilizers, vide S.O.1394 (E) dated 30th May, 2013, in exercise of the powers conferred by Sections 3 and 5 of the Essential Commodities Act, 1955, has delegated powers under specified provisions of the DPCO, 2013, including para 32, to be exercised by the NPPA on behalf of the Central Government.

In addition, the notice highlighted that the NPPA, in its 144th meeting held on 24.03.2026, observed that M/s Intas Pharmaceuticals Limited meets the requirements of para 32(ii) of DPCO, 2013 and that the formulations are covered under a granted patent.

Accordingly, the Authority decided that exemption may be granted to M/s Intas Pharmaceuticals Limited under para 32(ii) of DPCO, 2013 for the formulations “Clozapine Extended Release Capsules 12.5 mg / 25 mg / 50 mg / 100 mg / 200 mg”.

In line with the above, the notice added,

"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."

In addition, the notice stated that Intas Pharmaceuticals Limited shall, after the expiry of the 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.

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/2026/03/31/87471a042b62714d4b65ceb516a3deee-338610.pdf