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The drugs pricing regulator is considering an application from G S Pharmbutor for exemption of its indigenously developed antiseptic formulation povidone iodine 0.5 % w/v nasal spray from the drug price control, under the Drugs (Prices Control) Order (DPCO), 2013 which exempts new drugs patented in the country from the pricing provisions.
The Multi-Disciplinary Committee (MDC) of Experts, which advises the National Pharmaceutical Pricing Authority (NPPA) on various drug pricing related matters, is considering such a request from the company. The NPPA has recently notified exemption of the company's indigenously developed povidone iodine throat spray 0.45% w/v from the drug price control for five years, from the date of its market approval in India.
The company applied for exemption of the drug from the provisions of DPCO, under Para 32(I) in respect of the new drug.
The Committee noted that povidone iodine 0.5% w/v nasal spray has been approved by the Central Drugs Standard Control Organisation (CDSCO) as a new drug and is covered by Indian patent. The Indian Patent is owned by New Delhi-based Modi-Mundi Pharma Pvt Ltd.
The MDC noted that the company has submitted an exclusive patent license agreement from the patentee and the manufacturing permission for the applied formulation.
However, the Committee did not receive inputs regarding the scope and validity of the patent claims from the patent office in its latest meeting held on September 28, since the representative of the Controller General of Patents, Designs & Trade Marks (CGPDTM) was not present in the meeting.
Under Para 32(i) of the DPCO, 2013, the provisions of the price control order is not applicable to a manufacturer producing a new drug patented under the Indian Patent Act, 1970 (39 of 1970), for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country. The provision shall apply only when a document showing approval of such new drugs from the Drugs Controller General (India) is produced before the Government.
G S Pharmbutor, an Umesh Modi Group company which specializes in in-license contract manufacturing across pharmaceuticals, nutrition, cosmetics, among others, submitted an application for exemption of the formulation from the pricing norms on September 2, 2026.
As reported, the NPPA has recently notified exemption of antiseptic povidone iodine throat spray 0.45 % w/v from the drug price control for five years, after its Multi-Disciplinary Committee (MDC) of Experts once again confirmed that the drug has been developed through indigenous research and development (R&D).
The exemption is valid for a period of five years with effect from December 17, 2024, which is the date of grant of marketing approval by the Central Drugs Standard Control Organisation (CDSCO), said a notification issued on August 27, 2026.
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