AP DCA has proposed a set of recommendations to DCGI, which may help the department to have a role in monitoring and regulating bioequivalence (BE) studies and clinical trials conducted in the state.
The move, prompted by the recent GVK issue, is expected to equip the department with necessary information and help the department to handle similar situations better in future, sources from DCA said.
The recommendations of AP DCA include: 1) Registration of Contract Research Organisations (CROs) should be made mandatory. 2) CDSCO to inform/update AP DCA on bio-equivalence (BE) studies and clinical trials conducted by various companies in the state. 3) Inspection by AP DCA at centres where BE studies and clinical trials are conducted to be made mandatory 4) Companies conducting studies in the state to inform or update AP DCA before starting the studies and after the studies are carried out. And 5) CDSCO's Regional Office at Hyderabad can be made as nodal agency which can coordinate with AP DCA in matters relating to conduct of BE studies and human clinical trials.
AP DCA is hopeful that DCGI will take necessary steps, sources said.
It is significant to note that DCGI has been concerned on bringing reforms in the clinical development activity. A year ago, the office of the Drugs Controller General of India (DCGI) collected suggestions from all sections of drug industry including industry associations like IDMA, OPPI and BDMA, trade associations like AIOCD and several consumer organisations towards evolving fresh regulatory guidelines on Schedule Y requirements, before proposing the amendments.