Technical Committee recommends CDSCO to approve import, marketing of Sanofi TB drug with clinical trial waiver

New Delhi: Apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has been recommended by the Techincal Committee to granted permission to Sanofi (India) Pvt Ltd to import and market Refapentine film-coated tablet 150mg (PRIFTIN) in the country without conducting a clinical trial of the said formulation.

The decision comes after detailed deliberation of the recommendation submitted by the Subject Experts Committee (SEC) in this regard. A year ago, the SEC Committee (Antimicrobial & Antiviral) functional under CDSCO examined Sanofi's proposal in its meeting. The firm presented their proposal along with non-clinical & clinical data generated outside India in support of drug for the treatment of latent TB infection with a request for a local clinical trial waiver.

The committee noted that India aims to eliminate TB by 2025. Treatment of LTBI is an important component for the elimination of TB in India. The Rifapentine is included in the WHO Essential Medicines List. The drug is reported to have an advantage of once weekly regimen for 3 months for treatment of LTBI.

After careful examination, the committee considered that there is an unmet need of this drug for the treatment of LTBI and recommended that in public interest permission to import & market the drug should be granted with a local clinical trial waiver for the treatment of LTBI. However, the nod for the drug is subject to certain conditions which read;

• This drug should be available only through the National TB control program in the treatment of LTBI.


• Phase IV clinical trial shall be conducted by the firm through the programme, for which protocol should be developed in consultation with the programme expert & submitted to CDSCO for review through SEC.

The matter was referred to Technical Committee for further deliberation, whether based on the justification submitted by the firm and recommendation of SEC permission to manufacture and market Refapentine film-coated tablet 150mg can be given to the firm with a clinical trial waiver.

The Technical Committee after detailed deliberation agreed with the recommendation of the Subject Expert Committee (Antimicrobial & Antiviral) and recommended for grant of permission to import and market the drug in the country with a local clinical trial waiver subject to the same conditions as recommended by the SEC.

The drug, Refapentine film-coated tablet is sold under the brand name Priftin and is indicated for the treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis in adults and children 2 years and older who are at high risk of progression to tuberculosis disease (Including those in close contact with active tuberculosis patient, recent conversion to positive tuberculin skin test, HIV infected patients or those with pulmonary fibrosis on radiograph). Refapentine is Active TB should be ruled out before imitating treatment for latent TB infection

It is reported that the Refapentine( Priftin) was approved by USFDA for LTBI indication in 2014. Later it is also approved in Taiwan, Hongkong and Phillippines.

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