Walking the talk on GCP
“If we are interested in exporting medicines, we have to also import the standards.” This statement from a senior official of the CDSCO at the recent FICCI Pharma Summit sums up the tough stance being taken today by India’s regulators, on maintaining standards at our drug manufacturing facilities as well as while conducting clinical trials and research.
But can we walk the talk? All branches of the pharmaceutical regulatory mechanism in India as well as the industry have been under fire in the last two years. While the US FDA’s warning letters and import bans put a question mark on India’s GMP norms, on the GCP side, a May 2012 report of the Parliamentary Standing Committee on Health revealed a nexus between a host of pharma companies, CROs, clinicians and hospitals involved in trials and the regulator, the Drug Controller General (India)’s office.
The DCGI has since launched into Operation Clean Up and 2013 saw many new regulations. Industry observers allege that many new regulations were knee jerk and poorly structured and as a result, difficult to implement due to the many grey areas. Our cover story (Clinical trials in India: Uncertainty lingers, page 22-26) presents some of the issues being faced by industry while trying to implement these notifications like the need for audio visual recording of the informed consent process. Registration followed by accreditation of ethics committees are good steps, but do we have the capabilities right now to roll this out? Sponsors and CROs in India are already shifting trials to other Asian nations, not willing to wait for change.
The heart of the matter is that different stakeholders have conflicting perceptions of what clinical research is and how patients can be protected. There are efforts to resolve these differences. Another story in the section (Clinical trials: Perception vs reality, page 27-28) offers a ringside glimpse of discussions between regulators and industry. More like a tug of war, the two sides may seem to be moving in circles and stuck in limbo, but plugging the loopholes is better than allowing rogue elements to exploit them as in the past.
While there seems to be genuine intent to move forward, there is a huge trust deficit… on all sides. But there seems to be a consensus: we need clinical research and trials, but they need to be better regulated. In other words, keep the baby, but replace the bathwater. With a judicious dose of tough regulations, clinical research and trials can both safeguard patient safety as well as revive revenues. The answer is not more rules, but stronger implementation.
Viveka Roychowdhury
Editor
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