India waives clinical trials for some drugs approved in select nations

The drugs that are already approved in the US, UK, Japan, Australia, Canada, and the European Union will not go through clinical trials for approval in India, the government said. 

An order issued Wednesday by drugs regulator Central Drugs Standard Control Organisation (CDSCO) said the government has authorized the exemption of local clinical trials for approval of new drugs ‘as per Rule 101’.

“As per Rule 101 of New Drugs and Clinical Trial Rules, 2019 the Central Licensing Authority, with approval of the Central Government, may specify by an order, the name of the countries from time to time 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 of the said rules,” the order signed by Dr. Rajeev Singh Raghuvanshi, the drugs controller general of India, said. 

The categories of drugs that have been exempted from trials are orphan drugs for rare diseases; gene and cellular therapy products; new drugs used in pandemic situations; new drugs used for special defense purposes; and new drugs having significant therapeutic advances over the current standard care. 

The decision would make drugs manufactured outside India more accessible and affordable in the Indian market. 

India had previously given such waivers only for drugs and medical devices that have got regulatory clearance in the US, UK, Australia, Canada, and Japan, The Economic Times reported.

Addition of the EU for the clinical trial waiver has been under consideration since 2018 when EU officials raised the issue, the report said. 

Anil Matai, director general, Organisation of Pharmaceutical Producers of India (OPPI), welcomed the waiver and said it would benefit domestic and foreign drug manufacturers.

“This strategic alignment is particularly crucial for accelerating access to innovative therapies to the patients in India,’’ he told The Hindu.