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Date: 2026-03-25 Category: Extra Ordinary State: Union Government Country: India

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

Issued by Ministry of Chemicals and Fertilizers · Department of Pharmaceuticals

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Executive Summary & Key Takeaways

**Executive Summary** This order, issued by the National Pharmaceutical Pricing Authority (NPPA) on March 25, 2026, grants M/s Intas Pharmaceuticals Limited a pricing exemption for specific Clozapine formulations under the Drugs (Price Control) Order (DPCO), 2013. The exemption is valid for five years from the start of commercial production or until the expiry of the relevant Indian patent, whichever is earlier. Key requirements include mandatory reporting of production dates and price lists to the NPPA. **Key Points / Main Content** **Exemption Provisions** * **Granted Entity:** M/s Intas Pharmaceuticals Limited is exempted from the provisions of DPCO, 2013 under Para 32(ii). * **Applicable Products:** The exemption applies to "Clozapine Extended Release Capsules" in dosages of 12.5 mg, 25 mg, 50 mg, 100 mg, and 200 mg. * **Basis for Exemption:** The decision follows the grant of Indian Patent No. 437433 (dated July 5, 2023) for an "Extended Release pharmaceutical composition of Clozapine." * **Duration:** The exemption remains in effect for five years from the date of commencement of commercial production in India or until the Indian patent expires, whichever occurs first. **Reporting and Compliance** * **Production Notification:** The manufacturer must formally inform the NPPA of the exact date commercial production begins in the country. * **Pricing Submission:** The company is required to submit a price list in Form V under DPCO, 2013, specifying the Price to Retailer (PTR) and the Maximum Retail Price (MRP) fixed by the company. **Post-Exemption Requirements** * **Price Regulation:** Upon the expiry of the exemption period, the manufacturer must adhere to the notified ceiling prices. * **Approval Timeline:** The company must seek retail price approval or follow notified prices three months before the exemption period expires. **Impact Analysis** **M/s Intas Pharmaceuticals Limited** **Impact** The company is permitted to set its own prices for the specified Clozapine formulations without adhering to standard DPCO price caps for a period of up to five years. **Action Required** The company must notify the NPPA of the commercial production date and submit price lists via Form V. They must also apply for retail price approval or prepare to follow ceiling prices three months prior to the exemption's expiration. **National Pharmaceutical Pricing Authority (NPPA)** **Impact** The NPPA acts as the monitoring body for this exemption, transitioning from price fixation to oversight of the company’s self-regulated pricing and eventual re-entry into price control. **Action Required** The authority must record the commencement of commercial production and monitor the price lists submitted by the manufacturer to ensure compliance with the terms of the order.

Key Entities Referenced

National Pharmaceutical Pricing Authority (NPPA): The regulatory body under the Ministry of Chemicals and Fertilizers responsible for fixing and monitoring drug prices and implementing the DPCO. Drugs (Price Control) Order (DPCO), 2013: The primary regulatory framework under which drug price exemptions are granted, specifically referenced for its Para 32 provisions. M/s Intas Pharmaceuticals Limited: The pharmaceutical entity granted a five-year exemption from price control for its patented Clozapine Extended Release formulations. Essential Commodities Act, 1955: The parent legislation that empowers the central government and NPPA to regulate the prices of essential drugs. Patents Act, 1970: The law under which the pharmaceutical composition of Clozapine was patented, serving as a key legal basis for the granted exemption.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-25032026-271289 CG-DxLx-xEG-I2D5H0x3x2x0 26-271289 xxxGIDExxx असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (ii) PART II—Section 3—Sub-section (ii) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 1520] नई दिल्ली, बधु वार, मार् च25, 2026/र्त्रै 4, 1948 13, 1947 26/पौष 17, 1947 No. 1520] NEW DELHI, WEDNESDAY, MARCH 25, 2026/CHAITRA 4, 1948 ss, 1947 /PAUSHA 17, 1947 रसायन और उर्रव क मत्रं ालय (औषध वर्भाग) (राष्ट्रीय औषध मल्ू य वनधारव ण प्रावधकरण) आदेश नई दिल्ली, 25 मार्च, 2026 का.आ. 1585(अ).—जबकक भारत सरकार के रसायन और उर्वरक मंत्रालय के किनांक 29 अगस्त, 1997 के संकल्प स.ं 33/7/97-पी आई–I द्वारा राष्ट्रीय औषध मूल्य वनधारव ण प्रावधकरण (एनपीपीए) की स्थापना, अन्य बातों के साथ- साथ थोक औषवधयों तथा वर्वनर्मववतयों के मल्ू य वनधावररत करन े और उनम ें पररर्तवन यकि कोई हो, को अवधसूवित करने, अवनयंवत्रत औषवधयों और वर्वनर्मववतयों के मल्ू यों पर नजर रखने और औषध (मूल्य वनयंत्रण) आिेश (डीपीसीओ) के प्रार्धानों का कायवन्र्यन करन े के वलए, की गई थी। 2. और जबकक, रसायन और उर्वरक मंत्रालय न ेका.आ. 1394(अ) किनांक 30 मई, 2013 द्वारा आर्श्यक र्स्तु अवधवनयम, 1955 की धारा 3 तथा 5 के अतं गवत प्रित्त शवियों का प्रयोग करते हुए डीपीसीओ, 2013 के वनर्िवष्ट पैरा के संबंध म ें उि आिेश के परै ा 32 सवहत शवियां राष्ट्रीय औषध मल्ू य वनधावरण प्रावधकरण को केंद्र सरकार की ओर स े प्रयोग करन े हते ु प्रत्यायोवजत की ह।ैं 3. और जबकक, मैससव इंटास फामावस्यूरटकल्स वलवमटेड स ेप्राप्त आर्ेिन द्वारा डीपीसीओ, 2013 के प्रार्धानों स ेछूट के वलए, पैराग्राफ 32(ii) और (iii) के अतं गवत उि आिेश म ें फॉमलुव ेशन “क्लोजापाइन एक्सटेंडडे ररलीज कैप्सूल्स 12.5 वम.ग्रा. / 25 वम.ग्रा. / 50 वम.ग्रा. / 100 वम.ग्रा. / 200 वम.ग्रा.” के संबंध म ें ह।ै इसके अवतररि, भारत सरकार के पेटेंट कायावलय द्वारा मैससव इंटास फामावस्यूरटकल्स वलवमटेड को “एक्सटेंडडे ररलीज फामावस्यूरटकल कंपोजीशन ऑफ क्लोजापाइन” शीषवक स े 2202 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] आवर्ष्कार हते ुपेटेंट अवधवनयम, 1970 के प्रार्धानों के अनुसार (पेटेंट संख्या 437433 तथा अनिु ान की वतवथ 05.07.2023) पेटेंट प्रिान ककया गया ह।ै 4. और जबकक, राष्ट्रीय औषध मूल्य वनधावरण प्रावधकरण न े अपनी 144र्ीं बैठक किनांक 24.03.2026 म ें यह अर्लोकन ककया कक मैसस व इंटास फामावस्यरू टकल्स वलवमटेड डीपीसीओ, 2013 के पैरा 32(ii) की आर्श्यकताओं को पूरा करता ह ैतथा यह वनणवय वलया कक उि फॉमुवलेशन “क्लोजापाइन एक्सटेंडडे ररलीज कैप्सूल्स 12.5 वम.ग्रा. / 25 वम.ग्रा. / 50 वम.ग्रा. / 100 वम.ग्रा. / 200 वम.ग्रा.” के वलए मैससव इंटास फामावस्यूरटकल्स वलवमटेड को डीपीसीओ, 2013 के पैरा 32(ii) के अतं गतव छूट प्रिान की जा सकती ह।ै 5. अब इसवलए का.आ. 1394(अ), किनांक 30 मई, 2013 को रसायन एर् ं उर्वरक मंत्रालय, भारत सरकार द्वारा जारी औषध (मूल्य वनयंत्रण) आिशे , 2013 के पैरा 32 के अंतगवत प्रित्त शवियों का प्रयोग करत ेहुए, मैसस वइंटास फामावस्यूरटकल्स वलवमटेड को उि आिेश के पैरा 32(ii) के अतं गतव डीपीसीओ, 2013 के प्रार्धानों स ेउि फॉमलुव ेशन “क्लोजापाइन एक्सटेंडडे ररलीज कैप्सूल्स 12.5 वम.ग्रा. / 25 वम.ग्रा. / 50 वम.ग्रा. / 100 वम.ग्रा. / 200 वम.ग्रा.” के संबंध म,ें िशे म ें वनमावता द्वारा इसके र्ावणवययक उत्पािन के प्रारंभ की वतवथ स ेपााँि र्ष वकी अर्वध के वलए या भारतीय पेटेंट की समावप्त, जो भी पहल ेहो, छूट प्रिान की जाती ह।ै 6. मैसस व इंटास फामावस्यूरटकल्स वलवमटेड उि फॉमुवलेशन “क्लोजापाइन एक्सटेंडडे ररलीज कैप्सूल्स 12.5 वम.ग्रा. / 25 वम.ग्रा. / 50 वम.ग्रा. / 100 वम.ग्रा. / 200 वम.ग्रा.” के िशे में र्ावणवययक उत्पािन की वतवथ तथा उि फॉमुवलशे न के संबंध म ें कंपनी द्वारा वनधावररत खुिरा वर्क्रेता को कीमत (पीटीआर) तथा अवधकतम खुिरा मल्ू य (एमआरपी) की जानकारी डीपीसीओ, 2013 के अतं गतव प्रपत्र V म ेंमल्ू य सूिी जारी करके एनपीपीए को सूवित करेगा। 7. मैससव इंटास फामावस्यूरटकल्स वलवमटेड, डीपीसीओ, 2013 के परै ा 32(ii) के अंतगवत प्रिान की गई छूट की अर्वध समाप्त होने के उपरांत, उि फॉमुवलेशन “क्लोजापाइन एक्सटेंडडे ररलीज कैप्सूल्स 12.5 वम.ग्रा. / 25 वम.ग्रा. / 50 वम.ग्रा. / 100 वम.ग्रा. / 200 वम.ग्रा.” के वलए अवधसूवित अवधकतम मल्ू य का पालन करेगा अथर्ा छूट की समावप्त स े तीन माह पूर्व, यकि लाग ू हो, खुिरा मल्ू य अनुमोिन प्राप्त करेगा। [का.सं./276/144/2026/एफ़/फा.सं. 8(144)/2026/डीपी/एनपीपीए-जडवी-II] भीवा राम यािव, सहायक जनििे क 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”.[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3 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 Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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