Statistics recently put forward suggest that only 19 approvals were granted for clinical trials in India in 2013. This represents a 93% decline on 2012 numbers.
IHS Global Insight perspective | |
Significance | Figures suggest a 93% decline in clinical trial approvals in India in 2013 against 2012. In 2013, only 19 clinical trial applications received approval in India, against 262 in 2012. |
Implications | The low number of clinical trials can likely be attributed to tougher regulations for conducting clinical trials in the country and Indian Supreme Court rulings that handed control of clinical trials to the health secretary. |
Outlook | Many companies have already suggested that they have shifted clinical trial activities to other low-cost clinical trial destinations and it seems likely that increasing numbers of the remaining firms will follow suit. Aside from the clinical trial industry, the continued challenging clinical trials environment may impede access to the newest innovative drugs. |
The Pharma Letter has published statistics, cited in a Fierce CRO report, for clinical trial approvals in India in 2013 indicating that only 19 were started in the country last year. This represents a decline of 93% on 2012 numbers when 262 trials were approved. In 2010, 500 trials were approved.
The report suggests that a primary reason for the steep decline in clinical trials was the introduction of tougher regulations governing clinical trials. This regulation requires organisations conducting clinical trials in India to obtain trial protocol approval from pre-accredited ethics committees, register trials with regulators, and obtain good clinical practice (GCP) certification.
According to the source, the Indian government has shown an awareness of the declining rate of trials, but it believes that the industry may pick up again once companies conducting trials become more comfortable with regulations.
Outlook and implications
A serious factor limiting clinical trial approvals, not discussed by the source, may be rulings by the Indian Supreme Court. In January 2013, the Supreme Court handed the Indian health minister temporary control of clinical trial protocol approvals in the country (see India: 3 January 2013: Indian Supreme Court hands health secretary temporary control of clinical trials). In light of the political row and public anger that led to the court's ruling, the secretary showed an understandable reluctance to approve trials, with no clinical trials receiving approval, until 3 July to 31 August 2013, when 162 approvals were granted. This was despite 1,122 clinical trial applications being filed in the first six months of 2013. A further blow to the industry was dealt in October 2013 when the Supreme Court ruled that the Ministry of Health and Family Welfare (MoHFW) will be required to justify the clinical trial approvals it had made (see India: 1 October 2013: Indian clinical trial industry hit by Supreme Court's calls for MoH to justify trial approvals). It will also be required to justify a subsequent ruling, also in October, that required the MoHFW to re-examine nearly all of the trial applications it had granted (see India: 22 October 2013: India's Supreme Court orders MoHFW to re-examine clinical trial applications).
The latest statistics may go some way to demonstrating just how dramatically the once-booming Indian clinical trials industry has declined. Indeed, the Indian government has already received much criticism over this, with commentators suggesting in July 2013 that many companies had switched to other low-cost markets to conduct research (see Asia-Pacific - India: 5 July 2013: Increasing number of Indian pharma companies move operations to Southeast Asia). Given the long hiatus in trial approvals, it is possible that India may have permanently lost its reputation as a clinical trial destination.
Aside from the clinical trials industry, the continued hiatus may be affecting access to newer medicines. Novel medicines are commonly required to undergo Phase III clinical trials in India. However, with limited trial approvals, market entry of these newer products could potentially be delayed.
Furthermore, clinical trial challenges may be added to other concerns over matters such as the 2013 Drug Price Control Order, and the increasing threat of compulsory licences, to suggest increasingly hostile pharmaceutical market conditions in India. If India is to once again be regarded as an attractive destination to invest, the Indian government must find ways to strike a balance to bring patients greater access to the newest drugs safely, while maintaining favourable market conditions.