Notification for exemption of Povidone Iodine Throat Spray under Paragraph 32(iii) of the Drugs (Prices Control) Order 2013

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-27082026-275838 EXTRAORDINARY PART II-Section 3-Sub-section (ii) PUBLISHED BY AUTHORITY No. 4594] NEW DELHI, THURSDAY, AUGUST 27, 2026/BHADRA 5, 1948 MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 27th August, 2026 S.O. 4779(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 (Prices 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 G.S. Pharmbutor Private Limited, seeking exemption from the provisions of DPCO, 2013 under para 32(iii) of the said order in respect of the formulation "Povidone Iodine Throat Spray 0.45% w/v", which was duly approved by the Office of Central Drugs Standard Control Organisation (India) as a new drug under the Drugs and Cosmetics Act, 1940 and Rules thereunder. 4. And whereas the NPPA considered the recommendations of the Multidisciplinary Committee (MDC) in detail at its 150th meeting held on 25.08.2026 under DPCO, 2013 and approved that “Povidone Iodine Throat Spray 0.45% w/v” of M/s G.S. Pharmbutor Private Limited qualifies for the non-application of provisions of DPCO, 2013 under para 32(iii) of the said order for a period of 5 years from the date of its market approval in India. 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 G.S. Pharmbutor Private Limited is exempted from the provisions of DPCO, 2013 under para 32(iii) of the said order in respect of the formulation “Povidone Iodine Throat Spray 0.45% w/v" for a period of five years with effect from 17.12.2024, which is the date of grant of marketing approval by the Central Drugs Standard Control Organization. 6. M/s G.S. Pharmbutor Private Limited shall inform NPPA, the Price to Retailer (PTR) and Maximum Retail Price (MRP) fixed by the company in respect of the said formulation by issuing a price list in Form V under DPCO, 2013. 7. M/s G.S. Pharmbutor Private Limited shall also seek retail price approval for the formulation “Povidone Iodine Throat Spray 0.45% w/v", as applicable, three months before the expiry of the exemption granted under para 32(iii) of DPCO, 2013. [PN/282/150/2026/F / F. No. 8(150)/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.