A CDSCO (Central Drugs Standard Control Organization) panel has instructed Mankind Pharma to conduct a Phase I clinical trial for Sintilimab Injection in India before proceeding to Phase III trials. Sintilimab is a recombinant humanized monoclonal antibody used for the treatment of certain types of cancer. The decision was made after reviewing the company’s proposal to conduct a Phase III trial for the drug.
Mankind Pharma had submitted a proposal to the CDSCO to conduct a Phase III trial for Sintilimab Injection, which is already approved in China for the treatment of relapsed or refractory classical Hodgkin’s lymphoma. However, the CDSCO panel noted that the company had not conducted any clinical trials for the drug in India and had only submitted data from trials conducted in China.
The panel expressed concerns that the pharmacokinetic and pharmacodynamic data generated from Chinese patients may not be applicable to the Indian population due to differences in genetics, diet, and lifestyle. Therefore, the panel directed Mankind Pharma to conduct a Phase I trial in India to generate data on the safety, tolerability, and pharmacokinetics of the drug in the Indian population.
The Phase I trial will involve a small group of healthy volunteers and will be designed to assess the safety and tolerability of the drug. The trial will also generate data on the pharmacokinetics of the drug, including its absorption, distribution, metabolism, and excretion.
The CDSCO panel’s decision is in line with the regulatory requirements for the approval of new drugs in India, which mandate that clinical trials be conducted in the country to generate data on the safety and efficacy of the drug in the Indian population. The decision also reflects the regulator’s emphasis on ensuring that new drugs are safe and effective for Indian patients before they are approved for marketing.
Mankind Pharma will now have to conduct the Phase I trial and submit the data to the CDSCO before proceeding to the Phase III trial. The company had planned to launch the drug in India by the end of 2023, but the delay in conducting the Phase I trial may push back the launch timeline. The development is significant as it highlights the importance of conducting clinical trials in India to generate data on the safety and efficacy of new drugs in the Indian population.