India waives local clinical trials of new drugs: Official sources

New Delhi [India], August 8 (ANI): The centre waived local clinical trials of several drugs in India. According to the official sources, the medicines already approved by other regulatory authorities like the US, UK and EU and are not immediately available for India are not required to conduct local trials in India.

“At present, several medicines already approved by other regulatory authorities like the US, UK and EU are not immediately available for Indian patients because of certain regulatory requirements under the Drugs and Cosmetics Act and rules made thereunder. These include the requirement of conducting a local clinical trial and generating safety and efficacy data locally before marketing authorization in India,” said official sources

The decision has been taken by the government delay in launching the drugs.

Now, it has been decided based on the patient’s requirements that certain countries like the USA, UK, Japan, Australia, Canada and the EU based on certain conditions can supply drugs to India without local trials under rule 101.

Drugs like orphan 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.

“The latest medicines to treat diseases like cancers, rare diseases like SMA and DMA, and autoimmune conditions will become available expeditiously in India,” said official sources

However, official sources also informed further that the decision will be helpful in reducing the costs of public procurement of the Indian government and state governments also under various schemes like CGHS and Ayushman Bharat.

“The costs of pharmaceutical firms in conducting local clinical trials will be reduced therefore passing on these savings to patients,” sources said further

However final phase four clinical trials for the drugs will be mandatory.