The Central Drugs Standard Control Organisation (CDSCO) has launched audits of ongoing clinical trials by the expert teams to ensure that they meet the desired norms although the draft guidelines are still being finalized to streamline the sector.
The CDSCO is also planning to make sure that all CROs get registered from June this year, after notifying the guidelines which are waiting for final clearance from the DCC and the DTAB with a view to take appropriate safeguards in the trials, sources said.
The special teams comprising drug inspector, pharmacologist and clinical trials expert are carrying out the onsite inspections to make sure that norms were adhered to. During the course of audits, being held for the first time in the country, glaring deficiencies have been found with several sponsors, monitors and CROs in complying with the protocols. Action will be initiated once the guidelines are finalized, it is learnt.
The authorities are also planning to cancel or suspend the licence for trials due to the discrepancies while enforcing the guidelines sternly. Another measure being planned is to make registration of CROs mandatory so that all the relevant information such as target audience can be brought into public domain. The basic norms for running the CROs have been drafted already by an expert panel with inclusion of industry representatives, officials and NGOs.
The expert panel, set up by the DCGI, had already carried out surprise checks on trial sites and urged for mandatory registration of CROs. The draft guidelines to monitor and regulate the sector are also being framed and would be put into force very soon, sources said.
US FDA and experts from Health Canada, facilitated by the WHO, have been giving necessary training to the officials of the CDSCO. They had already held a couple of workshops and conducted on-site visits along with Indian officials to give hands-on training to the drug inspectors.
The Indian clinical research segment is currently valued at USD 200 million and growing at 84 per cent annum. It would be a USD 1-billion industry by 2010.