Updated on 10 January 2013
The Supreme Court orders and the subsequent debate over clinical trials in India have only dampened the operations in the CRO space in India through indirect repercussions felt by the industry in the form of delays. In 2011, 12 drug advisory committees were set up to review new drug applications in different areas of specialization such as neurology and cardiology, that were supposed to respond with their comments within six weeks of receiving the applications. It was decided that their comments would be discussed at joint meetings and approvals will be granted subject to their responses. Industry sources say no such committee meetings have been held in the last three months. Some are slated to start this month. Such delays will only make it difficult for small and mid-sized CROs to survive and operate in the coming years.
"It has become difficult to get clarity on clinical trial approvals for not just drug companies but also academic and research institutes. Delays have become commonplace. What the industry needs now is a change in the mindset, when it comes to approving sites or specific studies," says Dr Arun Bhatt, an industry veteran and president, ClinInvent Research.
However, no one can deny the existing lacunae in the structure that allow for malpractices in clinical trials to occur. Several measures are being suggested to curb incidences such as those reported in Madhya Pradesh a year ago. Ms Suneela Thatte suggests a national list of non-compliant sites can be made public. Other initiatives for publicly blacklisting errant organizations could go a long way in restoring public faith, which has of late taken a severe beating.
For now, Dr Bopanna says they will wait and watch. "Since the court order is only asking for CROs to abide by the given guidelines, the ISCR will not initiate any response."
Experts from the industry cite the need for a strong and robust industry, once more domestic pharma companies mature and start developing drugs in this decade. For this, the organized clinical trials industry needs to take an active initiative to differentiate itself from unauthorized entities and co-operate with the country's drug regulator to adhere to the judiciary's requirements. Greater dialogue with more accountability is the need of the hour.