NPPA Exempts Povidone Iodine Throat Spray 0.45% from DPCO Provisions for 5 Years

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has granted G.S. Pharmbutor Private Limited a five-year exemption from the provisions of the Drugs (Prices Control) Order (DPCO), 2013, for Povidone Iodine Throat Spray 0.45 % W/V with effect from December 17,2024 the date of marketing approval granted by the Central Drugs Standard Control Organisation (CDSCO).

The decision was notified by the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, through S.O. 4779(E), dated August 27, 2026, after the pricing regulator considered the recommendations of its Multidisciplinary Committee (MDC) at its 150th meeting held on August 25, 2026. The Authority concluded that the formulation qualified for non-application of the provisions of DPCO, 2013 under paragraph 32(iii) for five years from the date of its market approval in India.

It further noted that the Ministry of Chemicals and Fertilizers, through S.O. 1394(E) dated May 30, 2013, and in exercise of powers conferred under Sections 3 and 5 of the Essential Commodities Act, 1955, had delegated to NPPA the Central Government's powers in respect of specified provisions of DPCO, 2013, including paragraph 32.

The matter arose after M/s G.S. Pharmbutor Private Limited submitted an application to NPPA seeking exemption from the provisions of DPCO, 2013 under paragraph 32(iii) for its formulation Povidone Iodine Throat Spray 0.45% w/v. According to the notification, the formulation had been duly approved as a new drug by the Office of the Central Drugs Standard Control Organisation (India) under the Drugs and Cosmetics Act, 1940 and the Rules made thereunder.

NPPA subsequently placed the matter before its 150th meeting on August 25, 2026, where it considered in detail the recommendations made by the Multidisciplinary Committee (MDC) under DPCO, 2013. Following its consideration, the Authority approved that G.S. Pharmbutor's Povidone Iodine Throat Spray 0.45% w/v qualified for exemption from application of the provisions of DPCO, 2013 under paragraph 32(iii) for a period of five years from the date of its market approval in India.

Acting on this decision and exercising the powers delegated under paragraph 32 of DPCO, 2013 through S.O. 1394(E) dated May 30, 2013, NPPA formally exempted M/s G.S. Pharmbutor Private Limited 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. The regulator specifically recorded that December 17, 2024 was the date on which CDSCO granted marketing approval for the formulation.

The exemption, however, is accompanied by specific requirements concerning the price fixed by the company. NPPA has directed G.S. Pharmbutor Private Limited to inform the Authority of the Price to Retailer (PTR) and Maximum Retail Price (MRP) fixed by the company for Povidone Iodine Throat Spray 0.45% w/v. This information has to be provided by issuing a price list in Form V under DPCO, 2013.

The company will also have to take action before the five-year exemption period comes to an end. NPPA has directed G.S. Pharmbutor Private Limited to seek retail price approval, as applicable, for Povidone Iodine Throat Spray 0.45% w/v three months before the expiry of the exemption granted under paragraph 32(iii) of DPCO, 2013.

Accordingly, the August 27 notification grants G.S. Pharmbutor's Povidone Iodine Throat Spray 0.45% w/v exemption from DPCO, 2013 for five years beginning from its CDSCO marketing approval date of December 17, 2024, while requiring the company to keep NPPA informed of the PTR and MRP through Form V and to seek retail-price approval, where applicable, three months before the exemption period expires.

To view the official notice, click the link below: