|
The Multi-Disciplinary Committee (MDC) of Experts, which advices the National Pharmaceutical Pricing Authority (NPPA) on various drug pricing related matters, has once again recommended exemption of antiseptic povidone iodine throat spray 0.45 % w/v from the drug price control for a fixed period, after cross checking that the drug has been developed through indigenous research and development (R&D).
While the Committee has in an earlier meeting recommended exemption of the drug from the drug pricing order under Para 32(iii) of the Drugs Prices Control Order (DPCO), 2013 based on an application by G S Pharmbutor Pvt Ltd, the NPPA decided to defer the final decision and decided for further examination.
The NPPA sought evidence from the manufacturer on indigenous R&D for the product, and the company immediately submitted a comprehensive set of documents to substantiate its claim.
The data submitted include recognition from the Department of Scientific and Industrial Research (DSIR) since the product was developed in a DSIR-approved lab, details of its in-house R&D infrastructure and equipment, records of DSIR filings demonstrating the product's development over time, extensive formulation, analytical, packaging, process validation and stability development documents, Central Drugs Standard Control Organisation's (CDSCO) new drug approval supported by phase III clinical trial data, and details of the R&D team involved.
"The Committee observed that these documents establish that the product was conceived, developed, validated, and brought to market through the company's indigenous research and development efforts carried out at DSIR-recognized R&D facility," said MDC in its latest meeting.
With this, the Committee reiterated its earlier recommendation to grant exemption to the company for the product, under Para 32(iii) of the Drugs Prices Control Order (DPCO), 2013, for a period of five years from the date of its market approval in India.
Under Para 32(iii) of the DPCO, 2013, the provisions of the price control order are not applicable to a manufacturer producing a new drug involving a new delivery system developed through indigenous research and development for a period of five years from the date of its market approval in India, provided that the provisions of the paragraph shall apply only when a document showing approval of such new drugs from the central drug regulator 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 April 30, 2025, and the MDC has considered it in multiple meetings.
The MDC, in its 75th meeting held on February 11, 2026 wherein it was noted that the other products available in the market are not approved by CDSCO, therefore their quality, safety, efficacy cannot be established and they cannot be compared with the product which has been approved by CDSCO following due process based on clinical trial conducted by the company.
The Committee also noted that the applied formulation is a new drug involving novel delivery systems developed in a lab approved by DSIR for indigenous R&D. With this observation, it recommended to grant exemption under Para 32(iii) of DPCO, 2013 to the company for the particular formulation for a period of five years from the date of its market approval in India.
The Authority meeting held following this discussed the recommendation and decided to defer the matter for further examination.
Povidone iodine throat spray 0.45 % w/v is a targeted antiseptic to address sore throats, mouth ulcers, and mucosal infections.
|