New cutting-edge drugs from US, UK to now be quickly available to Indian patients

The countries from where such drugs can be made available directly in India include USA, UK, Japan, Canada and the European Union.

Hyderabad: In a groundbreaking development, Indian patients suffering from genetic disorders, cancer and rare or orphan diseases will have expedited access to cutting-edge drugs, including gene therapies and immunotherapy treatments, which are currently available in US and Europe, as the Indian drug regulatory authorities have waived-off the requirement to hold local clinical trials of such drugs in India.

The waiver means that innovative treatments, including mRNA-based drugs and vaccines developed in the United States, European Union, United Kingdom, Australia, Canada, and Japan, can be directly made available to Indian patients. This decision is expected to significantly improve treatment outcomes and reduce financial burdens for patients with these debilitating conditions.

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The Drugs and Controller General of India (DCGI) in a very recent order said ‘As per the rule 101 of New Drugs and Clinical Trial Rules, 2019, the Central Licensing Authority, with the approval of the Central Government, may specify the name of the countries, for considering waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V’.

The countries from where such drugs can be made available directly in India include USA, UK, Japan, Canada and the European Union. The categories of the new drug that will be made available in India including orphan drugs of rare disease, gene and cellular therapy products, new drugs used in pandemic situations, new drugs used in special defense purposes and those drugs having significant therapeutic advancement over the current standard care in India, the notice from the DCGI said.

The local clinical trial waiver for approval of a new drug, which is already approved in the five countries, can be considered if the drug is already approved and marketed in those countries. They also should not have major unexpected serious adverse events in their respective countries, the notice from the DCGI said.

The five countries including USA, UK, Canada and EU from where the newly developed drugs can be made available to Indian patients without local clinical trials are well known for their meticulous drug testing and tough regulations.

Some important points and categories of new drugs:

• Crucial and potentially life-saving drugs that are yet to be launched in India will be available soon

• No need to conduct spate clinical trials in India for already approved drugs in 5 countries

• The countries are USA, UK, Japan, Australia, Canada and EU

• Orphan drugs for rare diseases

• Gene and cellular therapy products

• New drugs used in pandemics

• New drugs having significant therapeutic advantage over current standard care