Experts welcome waiver of clinical trials approved in select countries

New Delhi [India], August 8 : Experts welcomed the Indian government's decision to waive clinical trials for drugs that have already been approved in select countries to accelerate the availability of new and innovative medicines in India, and reduce the time and cost associated with conducting clinical trials.
According to Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance, "IPA welcomes the move to waive clinical trials for several drugs that have already received approval in major Western markets. This will facilitate faster access to medicines. Furthermore, this is a step towards regulatory simplification for better patient care."
Raj Prakash Vyas, President of Corporate Affairs, Cadila Pharmaceuticals Limited, said the waiver of clinical trials for new drugs is a "visionary step".
India has waived clinical trial requirements for new drugs with significant therapeutic advances that have been approved in the US, UK, Japan, Australia, Canada, or the EU. The Central Drugs Standard Control Organisation (CDSCO) stated that this move aims to speed up drug availability, especially for rare diseases, pandemics, and special defence needs.
"We welcome the recent order issued by the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, which specifies countries whose drug approvals can be recognised for faster clearance in India," said Vyas.
"This landmark decision is a significant step forward in expediting the availability of life-saving medications to Indian patients suffering from the identified categories of diseases," he added.
"The move is expected to significantly reduce the drug development cycle time in India, enhance affordability, and improve patient access to critical therapies. By aligning regulatory standards with those of leading global drug regulators, India is poised to emerge as a more attractive destination for pharmaceutical research and development," said Vyas.
"Drug regulation in countries like the US and UK is robust and our government has also accepted this. The step taken by the government will reduce the cost involved in clinical trials and time for drugs which will benefit patients," said Rajeev Juneja, Managing director of Mankind Pharma.
"This new rule and regulation will decrease the waiting period for use of these critical life-saving drugs in Indian patients in various life-threatening conditions. These developed countries already have a very robust system of checking various drugs in phases 1, 2, and 3, and then only they clear it for clinical use in patients," said Dr Anup Kumar, Head Unit, Department Urology Robotics, and Renal Transplant.
The centre waived local clinical trials of several drugs in India. According to official sources, medicines already approved by other regulatory authorities like the US, UK and EU that are not immediately available in 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 authorisation in India," said official sources.
Now, it has been decided based on the patient requirements that certain countries, like the USA, UK, Japan, Australia, Canada and 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, used for special defence purposes and 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 further informed that the decision will help reduce the costs of public procurement of the Indian govt 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.