NPPA Expert Committee Seeks More Evidence on Povidone Iodine Throat Spray's Indigenous Development
New Delhi: The Multidisciplinary Committee (MDC) has sought additional documentary evidence from G.S. Pharmbutor Private Limited to substantiate its claim that Povidone Iodine Throat Spray 0.45% w/v was developed through indigenous research and development while examining the company's application for exemption from price control under Paragraph 32(iii) of the Drugs (Prices Control) Order (DPCO) 2013.
The decision was taken during the 78th meeting of the Multidisciplinary Committee of Experts held on 24.06.2026 where the Authority deliberated on application for exemption of the 'New Drug' Povidone Iodine Throat Spray 0.45% w/v under Paragraph 32(iii) of the Drugs (Prices Control) Order 2013.
The Committee recalled that the matter was deliberated in the 75th MDC meeting held on 11.02.2026, wherein it was noted that the other products available in the market are not approved by CDSCO; therefore, their quality, safety, and efficacy cannot be established, and they cannot be compared with the product which has been approved by CDSCO following due process based on clinical trials conducted by the company.
The committee also noted that the applied formulation, Povidone Iodine Throat Spray 0.45% w/v, is a new drug involving a novel delivery system developed in a lab approved by DSIR for indigenous research and development. The Committee recommended granting exemption under Para 32(iii) of DPCO, 2013, to M/s G.S. Pharmbutor Private Limited for “Povidone Iodine Throat Spray 0.45% w/v” for a period of five years from the date of its market approval in India.
The Committee was informed that the matter was placed in 144th Authority meeting held on 24.03.2026 wherein it was decided to defer the matter for further examination in order to meet the requirement under Para 32(iii) of DPCO, 2013.
The committee, after detailed deliberations on the matter, observed that there are two important parameters to be fulfilled for exemption under para 32(iii) viz., new drug involving a new delivery system and indigenous research and development.
The company has submitted new drug permission from CDSCO granted for the first time for this product in support of new delivery system and also demonstrated their product before the Committee.
Further, with regard to indigenous research and development, the company has stated that the product has been developed in a lab approved by DSIR and submitted lab approval documents by DSIR.
The committee requires specific evidence that the product in question is in its true sense a product developed through indigenous research and development since this is the specific claim of the company for seeking exemption under Para 32(iii). Accordingly, the committee directed that the company may be asked to furnish documentary evidence substantiating their claim.
