Notification/Circular No.: S.O. 4779(E) dated August 27, 2026
Applicable Act/Rule: Drugs (Prices Control) Order, 2013
Applicable Section/Rule: Paragraph 32(iii)
Effective Date: December 17, 2024
The National Pharmaceutical Pricing Authority (NPPA) considered an application from M/s G.S. Pharmbutor Private Limited seeking exemption from the provisions of the Drugs (Prices Control) Order, 2013 in respect of the formulation “Povidone Iodine Throat Spray 0.45% w/v”. The formulation was approved by the Office of Central Drugs Standard Control Organisation (India) as a new drug under the Drugs and Cosmetics Act, 1940 and the rules made thereunder. At its 150th meeting held on August 25, 2026, NPPA considered the recommendations of the Multidisciplinary Committee and approved the non-application of the provisions of DPCO, 2013 under paragraph 32(iii) for five years from the date of market approval in India.
M/s G.S. Pharmbutor Private Limited is exempted from the provisions of DPCO, 2013 under paragraph 32(iii) in respect of “Povidone Iodine Throat Spray 0.45% w/v” for five years with effect from December 17, 2024, being the date of grant of marketing approval by the Central Drugs Standard Control Organisation. The company shall inform NPPA of the Price to Retailer (PTR) and Maximum Retail Price (MRP) fixed by it for the formulation by issuing a price list in Form V under DPCO, 2013. The company shall also seek retail price approval for the formulation, as applicable, three months before expiry of the exemption granted under paragraph 32(iii) of DPCO, 2013.
Disclaimer: The information contained in this Article is intended solely for personal non-commercial use of the user who accepts full responsibility of its use. The information in the article is general in nature and should not be considered to be legal, tax, accounting, consulting or any other professional advice. We make no representation or warranty of any kind, express or implied regarding the accuracy, adequacy, reliability or completeness of any information on our page/article.