With the state licensing authorities adopting different procedures to issue the Certificate of Pharmaceutical Products (CoPP) after the DCGI ordered status quo in the wake of stay orders on the centralisation move, the DCGI will shortly put up the list of units given the certificates after due procedures like joint inspections between the state and CDSCO officials.
The move is likely to create problems for many companies especially the small and medium sector firms as the exports of pharma products with CoPP issued by the state drug controllers without joint inspection will be stopped at the port offices.
The issue of different states resorting to different procedures came up at a meeting between the industry and the DCGI recently. It was pointed out that some States like Andhra Pradesh were issuing CoPP without joint inspection with the CDSCO officials which was the required norm. Hence the DCGI office has decided to publish the list of units which were given the certificates after joint inspections, sources said.
After the DCGI order to centralise the issuing of CoPP was stayed in the High Courts, the DCGI has issued circular to maintain status quo leaving the task of issuing CoPP with the SLPs. The usual practice earlier was to conduct site inspections jointly by the State and CDSCO officials. However, in the wake of the case and stay orders, some States have formed separate panels with the state officials alone to carry out the inspections.
The industry associations have already expressed apprehensions about the move to hand over the list of units to the port officers.