| A clinical trial • It is a systematic study conducted to generate data on the clinical and pharmacological profile, including pharmacodynamics, pharmacokinetics, and potential adverse effects of a new drug in humans. • It is the only method to establish the safety and efficacy of a drug before it is introduced to the market for human use. • Clinical trials are preceded by animal studies, where efficacy, side effects, and estimated dosage are first observed. |
- The Union government has decided to waive the requirement for local clinical trials for drugs manufactured outside India if they are approved in the U.S., U.K., Japan, Australia, Canada, or the European Union.
- This move is aimed at making these drugs more accessible and affordable in the Indian market.
- The waiver applies to five categories of new drugs:
- Those for rare diseases (Orphan drug)
- Gene and cellular therapy products
- Drugs used in pandemic situations
- Drugs for special defence purposes
- Drugs with significant therapeutic advances over current standards of care.
- The government has stated that the list of eligible countries may be updated as needed.
- This decision is authorized under Rule 101 of the New Drugs and Clinical Trial Rules, 2019.
Dig Deeper: Read about the new changes introduced by New Drugs and Clinical Trials Rules in 2019.
