Subject Expert committee of CDSCO recommends for grant of permission to import and market Delamanid Dispersible Tablets 25mg against pulmonary multi drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants.
Delamanid is a dihydro-nitroimidazooxazole derivative. It acts by inhibiting the synthesis of mycobacterial cell wall components, methoxy mycolic acid and ketomycolic acid. Delamanid is a pro-drug which gets activated by the enzyme deazaflavin dependent nitroreductase (Rv3547). A reactive intermediate metabolite, formed between delamanid and desnitro-imidazooxazole derivative, is considered to play a vital role in the inhibition of mycolic acid production.
In 2014, Delamanid was approved for medical use in Europe, Japan, and South Korea. It is on the World Health Organization (WHO) 's List of Essential Medicines. As of 2016 the Stop TB Partnership had an agreement to get the medication in more than 100 countries.
In August 2022 meetings of SEC, Mylan presented the proposal for import and marketing of Delamanid Dispersible Tablets 25 mg for the indication for use as part of an appropriate combination regimen for pulmonary MDR-TB in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability before the committee.
After detailed deliberation, the committee recommended that the proposal should be re-deliberated in the next meeting along with the Pediatrician and TB expert.
The next meeting was organised on 27th september 2022, where the committee recommended for grant of permission to import and marketing of Delamanid Dispersible Tablets 25mg for proposed indication.
Tuberculosis infects 316 Indians per 1 lakh which is way above the 193 predicted by WHO in 2019, according to the National TB Prevalence Survey 2019-2021, unveiled on March 24, 2022 by government of India.
