No clinical trial for drugs approved in select nations
- The Central government has decided to waive the requirement for clinical trials in India if the drugs are approved in the United States, United Kingdom, Japan, Australia, Canada, and European Union.
Highlights:
- According to an order issued recently by India’s drug regulatory agency, Central Drugs Standard Control Organisation (CDSCO), the Central Government has authorised the exemption of local clinical trials for approval of new drugs, ‘as per Rule 101’.
- The Central Government has specified a set of five categories for new drugs that will be considered for the Indian market.
- Drugs including vaccines that fall in the category orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, new drugs used for special defence purposes, and new drugs having significant therapeutic advances over the current standard care.
- order has been a long standing demand of the pharmaceutical companies and health experts who have been advocating for enhanced drug accessibility for patients and for research.
- This move will significantly benefit both domestic and foreign drug manufacturers by expediting the approval process and facilitating faster access to essential medications for Indian patients.
Prelims Takeaway
- CDSCO
- Clinical trials