Launching new drugs in India takes up to a four-year delay compared to the US or the European Union, primarily due to complex clinical trial regulations, the lobby of foreign drugmakers told India’s apex drug regulator, News18 has learnt.
On November 24, the Drug Controller General of India (DCGI) invited domestic and foreign players to discuss the challenges around global clinical trials.
The Organisation of Pharmaceutical Producers of India (OPPI), the lobby representing top pharma giants in India, including Novartis, Roche, Astra Zeneca, Sanofi, Merck and others, told DCGI in its presentation that there is a lack of ecosystem supporting innovation.
The presentation, accessed by News18, said “regulatory capacity building is not in line with newer advances in clinical research”.
Be it for oncology, rare diseases, or other innovations, OPPI said there is delayed access to innovative medicines for Indian patients and global organizations are hesitant to include India in phase III studies. It has urged the regulatory agency to create a “predictable regulatory pathway and no ambiguity”.
The meeting was also attended by the Indian Society of Clinical Research (ISCR), an association of clinical research professionals. ISCR highlighted several points, including the need to take another look into the requirement for ‘Clinical Trial Insurance’ which is presently a mandate to run a clinical trial in India.
Launch Timelines Can be Shortened: OPPI
According to the lobby’s presentation, the timelines can easily be squeezed into less than two years if India participates in global trials.
“Less than two years’ lag from the first launch in the US or European Union versus India if India participates in global clinical…,” the presentation said. It said that it can be further shortened if overall review timelines can be reduced to 12 months or review is done parallel to the US and EU.
“Delayed access to innovation and significant lag in the launch of new assets vs the United States and European Union,” the presentation said.
Similar Delays for Vaccine Trials and Approvals
OPPI claimed that it takes almost 7-9 months for the start of vaccine studies in India from the date of submission of clinical trial application since all vaccine investigational products need to be batch released by Central Drugs Laboratory in Himachal Pradesh’s Kasauli.
It highlighted that the issuance of a No Objection Certificate takes four to six months followed by testing of investigational vaccine by CDL Kasauli which takes an additional two to three months.
The lobby said that it negatively impacts India’s ability to participate in global vaccine trials especially where there is a short enrolment period and competitive recruitment strategy.
What Are the Challenges?
According to the presentation by ISCR, accessed by News18, country-specific protocol amendments requested by the Subject Expert Committee (SEC) – the panel which approves trials and new drugs in India – can be blamed for delays in the approval of the study and in some cases inability to participate in the global program.
It also said that the “SEC’s new requirement imposed for the inclusion of 50 per cent of government sites and 50 per cent of patients from government sites” is difficult to meet.
“Negative impact on the approval process and/or study start-up in India since some of these conditions are difficult to meet,” the presentation said.
According to OPPI, there are multiple queries on global clinical trial applications that take approximately over two months post-submission.
They highlighted the delay in inclusion in the SEC along with the delay in issuance of approval post-SEC recommendation for approval.
“Lengthy approval timelines leave very little time for Indian sites to meaningfully contribute to global clinical trial (GCT) recruitment or inability to participate in the study.”
It said that “participation of Indian sites in GCT limited or cancelled due to lengthy and unpredictable approval timelines”.
OPPI has recommended to permit parallel testing of the investigational vaccine at CDL Kasauli while clinical trial Application (CTA) is under review. It also suggested separate test licences to import limited doses of the investigational vaccine for testing only should be issued within 15 days of submission of the application and test licence application.
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