Context: Drugmaker Natco Pharma has received emergency use approval for Baricitinib tablets
More in the News:
- Baricitinib, in combination with Remdesivir, is used for treatment of COVID-19 positive patients.
- The company mentioned seeking a compulsory license based on emergency use and in light of the grave and serious public health emergency across India due to the pandemic.
More about Emergency Use Approval
- In India till 2019 there was no such use provision, it was provided in 2019 as ‘Accelerated Approval Process’ in grave situations like the Covid-19 pandemic.
- This approval is given to drugs or vaccines still in the clinical trial development, but have proved its meaningful therapeutic benefits in the early phases of trials.
- Approved drugs or vaccines are used to treat the life threatening conditions only, not for normal use.
- Such approvals are valid for 1 year only.
- Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India who grants such licenses.
Source: The Hindu