Some of the States are likely to oppose the recent move by the drug controller general of India (DCGI) to centralise the WHO-GMP certification process as it further takes away the powers of the state licensing authorities, besides making it tougher for the small scale units across the country.
Though the industry has in principle welcomed the move to do away with the WHO-GMP certification by making the Certificate of Pharmaceutical Products (COPP) mandatory, the industry associations have taken up the matter with the SLAs to write to the DCGI for a corrective step.
"Some of the state drug controllers have agreed to write to the DCGI on the matter as we have explained the hardships that will be faced by the small scale units. The states have no control over the COPP as it is issued by the CDSCO headquarters. It is not easy for us to go to the centre for certification each time," a senior industry leader disclosed, after interacting with a number of state drug controllers on the matter.
It was also pointed out that CDSCO was already short of manpower and it would delay the process further. "Even the zonal CDSCO offices cannot issue the certification. The WHO-GMP certification process was better as the inspection was done jointly by the Centre and the States and SLAs could issue the certification. Now those in the interior places also have to go to the Centre for the purpose. It is just to confuse the industry. What is the motive behind it?" he asked.
"Yes it obviously takes away our powers and we will have no more control over assessing the capability of a unit within our territory. We are thinking of taking it up with the DCGI," a drug controller, who did not want to be named, told Pharmabiz.
The pharma exporters, who are hit by the move, have already expressed their anguish over the move, terming it as stumbling block as many of the semi-regulated countries like Latin American, African and CIS countries insist on WHO-GMP.