Ending more than two months of stalemate over the issuance of certificate of pharmaceutical product (CoPP) in the country, the DCGI has directed the state licensing authorities (SLAs) asking them to revert to the old practice and issue the CoPP till the Madras High Court delivers its verdicts on the issue.

Meanwhile, an early legal solution to the issue appears unlikely as the Madras High Court has once again posted the case on CoPP for December 21 for hearing. The case came up for hearing on December 9 for the fifth time.

The DCGI's decision to issue a directive in this regard comes in the midst of widespread resentment among the industry over the virtual stalemate in issuing the CoPP in several states in the country ever since the Madras High Court stay orders in October this year. Earlier this year, the DCGI had issued an order to the SLAs under which the CoPP was to be issued by the CDSCO (DCGI office) 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.

Though the DCGI wanted to centralise issuance of CoPP in the country, as was desired by WHO which had some time back expressed concerns on lack of a single authority in issuing CoPP in the entire country, the DCGI's apple-cart was spoilt by the court interference, which had granted four stay orders, three by Madras High Court and one by Karnataka High Court.

As the issue lingered on due to the court interference, the exporters were in a dilemma as to whom to approach for the CoPP as neither the CDSCO offices nor the SLAs in several states entertained their request for immediate issuance of the CoPP resulting in cancellation of orders. The exporters were 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 would result in cancellations of the orders.

While the Madras High Court stay orders handicapped the CDSCO to issue the CoPP, SLAs in several states also refused to issue the CoPP on the plea that there is no fresh written directive from the DCGI to issue CoPP.

Now that the DCGI has directed the SLAs to issue CoPP till court verdict, there will be a semblance of normalcy on the issue.