New Delhi: The Narendra Modi government’s subject expert committee (SEC) has rejected Sun Pharmaceutical’s proposal to grant “emergency authorisation status” to its plant-based drug, AQCH, to treat Covid-19 patients.
Sun Pharmaceutical, the country’s largest drugmaker, had in June received permission from the Drugs Controller General of India (DCGI) to start clinical trials of AQCH, to see if it can treat Covid-19 patients.
Meant for the treatment of dengue, AQCH is still in the trial stage.
AQCH is derived from the tropical shrub Cocculus hirsutus, which is used across Asia for its medicinal properties. It was considered the first phytopharmaceutical drug (made from plants) approved by the DCGI for clinical trials as a potential treatment for Covid-19.
Sun Pharma had presented the results of the trial this month, with a request for emergency use authorisation, before the SEC, according to the minutes of a meeting held on 17-18 December. The minutes were uploaded on the Central Drugs Standard Control Organisation’s (CDSCO) website Tuesday.
The CDSCO is the health ministry arm that regulates quality of drugs and vaccines in the country.
“After the presentation of the re-analysed data, committee observed that the results of the study did not meet the efficacy criteria of primary end point,” the SEC concluded.
“Therefore the committee has not recommended for grant of approval of emergency use authorization at this stage,” read the minutes.
ThePrint has reached Sun Pharma via email for comments. This report will be updated if the company responds.
AQCH is being developed to treat dengue
According to a statement released by the company in June, clinical trials of the drug were supposed to be conducted across 12 centres and among 210 patients in the country.
“The treatment duration for patients will be 10 days. The results of the clinical trial are expected by October 2020,” the company had said.
It had also said “human safety study of AQCH” was complete and the drug was found to be safe at the recommended dose.
The Mumbai-based drugmaker has also been developing this phytochemical-based drug to treat dengue for the last four years in collaboration with the Department of Biotechnology International Centre for Genetic Engineering and Biotechnology (DBT-ICGEB) and the Council of Scientific and Industrial Research (CSIR).
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