Medicines approved in select countries no longer need clinical trials in India

New Delhi: The Union Health Ministry has decided to do away with the current regulatory practice of clinical trials for imported medicines, if the manufacturers receive approvals in the USA, UK, Japan, Australia, Canada and the European Union (EU) for their new drugs.

Such a move, the officials say, will help in quick introduction of patented drugs in the Indian market, as one of the exempted categories is “new drugs having significant therapeutic advance over the current standard care.”

Other exempted categories are: (1) orphan drugs for rare diseases (2) gene and cellular therapy products (3) new drugs used in pandemic situations and (4) new drugs for special defence purposes.

In none of the five categories, the companies will have to carry out the mandatory trials that typically take a couple of years.

The policy change was made after modifying one of the provisions (Rule 101) of the New Drugs and Clinical Trial Rules, 2019.

Officials said the policy decision will open up the gate for expeditious entry of some of the latest medicines against cancers, rare diseases like Spinal Muscular Atrophy (SMA) and Duchenne Muscular Dystrophy (DMA), and autoimmune conditions, as against earlier delays of five to 20 years.

“Removing the clinical trial requirement for entry can hasten the process of new drugs and vaccines reaching the Indian market. The liability of the company, however, remains. We are only doing away with bridge studies (needed for medicines approved by other regulatory agencies),” said an official.

Once a company applies for a waiver, it will be left to the Central Drug Standards Control Organisation (CDSCO) to decide whether the Drugs Controller General of India (DCGI) will accord an approval or the application needs to be scrutinised by a Subject Expert Committee (SEC).

“The SEC will mostly not ask for any local studies, but in rare cases if the SEC feels the need for local data, it will have to give a justification on why a study is needed in India,” he said, noting that the waiver norms were only for medicines manufactured and sold in six nations with strict regulatory agencies.