The issuance of the Certificate of Pharmaceutical Product (CoPP) has come to a virtual standstill in the country for the last more than a month as neither the SLAs (state drug authorities) nor the Central Drugs Standard Control Organisation (CDSCO) issues the certificate, which is the stamp of quality of a particular pharma product issued by the drug department for the purpose of exporting. While the CDSCO (DCGI office) has stopped issuing the CoPP in the wake of Madras High Court stay orders, the SLAs are also refusing to issue the CoPP on the plea that they have no written directive from the DCGI to issue it.
According to sources, the exporters are in a real dilemma as to whom to approach for the CoPP as neither the CDSCO offices nor the state drug authorities entertain their request for immediate issuance of the CoPP resulting in cancellation of orders. The exporters are concerned over the prospects of further delays in issuance of CoPP by the CDSCO and the resultant loss of business as exports are time bound and any delay will result in cancellations of the orders, which means loss of crores of rupees.
The situation was created by the DCGI office when it issued an order to the state drug controllers early this year under which the CoPP was to be issued by the CDSCO from October 1 this year after the auditing by the CDSCO officials. Till then, the CoPP was issued by the SLAs after a joint inspection by the CDSCO and state drug control department. The DCGI took this action of centralisation of CoPP in the wake of concerns expressed by the WHO on the lack of a single authority in issuing the CoPP in the entire country.
But, ever since the Madras High Court stayed the DCGI order, the CDSCO was legally handicapped to issue the CoPP otherwise it would result in contempt of court. When the exporters approach the SLAs, they also refuse to issue the CoPP on the plea that there is no fresh written directive from the DCGI to issue CoPP. “Though there is verbal directive, instead of the written directive from the DCGI, the SLAs are not issuing CoPP,” industry source said.
The industry is of the view that the system which was in vogue for several decades should have been allowed for some more time till a final verdict is given by the court. “The DCGI should have directed the SLAs to issue CoPP till the court delivers its verdict as that would have avoided unnecessary inconvenience to the exporters,” an industry leader said. He said that an industry association, representing hundreds of exporters, had also represented the DCGI in this regard. But, he did not take any action on that, he regretted.
Meanwhile, an immediate solution to the issue looks bleak as the Madras High Court has once again postponed the hearing in the case to December 7.