In a significant move, the Central Drugs Standard Control Organisation (CDSCO) on Wednesday that it has waived off local clinical trials for certain categories of new drugs that have already been approved in the United States, United Kingdom, Japan, Australia, Canada and the European Union.
According to the circular, as seen by Financial Express.com, Clinical trial waivers will also be considered for new drugs for rare diseases, drugs used in pandemic situations or for special defence purposes, new drugs having significant advances over the existing standard of care and gene and cellular therapy products that are approved in these developed markets.
Reportedly, the decision has been taken to fast-track the availability of new drugs and medical devices in the country. According to the circular, the waiver has been granted under Rule 101 of the New Drugs and Clinical Trials Rules, 2019.
Meanwhile, Anil Matai, Director General, Organisation of Pharmaceutical Producers of India (OPPI) welcomed the move and said that it will benefit both domestic and foreign drug manufacturers.
“We welcome the Government of India’s decision to notify the list of countries under Rule 101 of the New Drugs and Clinical Trial Rules, 2019 that would, subject to other conditions, enable waiver of the requirements of local clinical trials for several drugs if already approved in well-regulated markets, including the USA, UK, Japan, Australia, Canada, and the EU. This progressive move will significantly benefit both domestic and foreign drug manufacturers by expediting the approval process and facilitating faster access to essential medications for Indian patients,” Matai told Financial Express.com.
OPPI has been advocating for this notification, recognizing its potential to transform both, the pharmaceuticals, and the healthcare landscape in India, he said.
“The inclusion of specific categories like orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, those for special defense purposes and new drugs with significant therapeutic advance over the current standard care would address critical and unmet medical needs. This strategic alignment is particularly crucial for accelerating access to innovative therapies to the patients in India,” he emphasised.
However, while this is a commendable beginning, we believe that extending these waivers to a broader range of therapeutic categories will further enhance access to cutting-edge treatments, he pointed out.
“We urge Government of India to consider additional therapeutic areas where similar waivers could significantly impact patient access. Moreover, it is pertinent to understand how the criterion for ‘new drugs having significant therapeutic advance over the current standard care’ is defined and implemented. This could set a precedent for recognizing and adopting breakthrough therapies that offer superior clinical benefits,” Matai told Financial Express.com.
OPPI and its member companies remain committed to collaborating with the government to ensure that Indian patients benefit from the latest advancements in medicine as swiftly as possible, maintaining a balance between safety, efficacy, and expedited access, he said.
“This development marks a significant step forward in our ongoing efforts to align India’s regulatory framework with global standards, ultimately benefiting the healthcare ecosystem and the patients we serve,” he added.
