India – Indian regulators waive clinical trials for drugs approved elsewhere

  • New drugs approved for use in EU, UK, Australia, Japan and US will be automatically allowed in India, provided clinical trials included Indian patients
  • The move is expected to reduce the time taken by pharma firms to introduce drugs in India and prevent duplication of studies

New drugs approved for use in select developed markets will be automatically allowed in India if the global trials included Indian patients.

The new Drugs and Clinical Trials Rules, 2019, has done away with the formality of conducting local trials so that the drugs can be introduced in Indian markets sooner.

“The move is expected to reduce the time taken by the company to introduce the drug in India and prevent duplication of studies. For example, if a US-based company conducted clinical trials that also included Indian patients and the drug is marketed in the US, there will be no need for conducting local clinical trials to prove its efficacy in India, » a senior government official said, requesting anonymity…