Even as the cases related to the issuance of Certificate of Pharmaceutical Products (CoPP) are pending in the Madras High Court, different state drug authorities in the country are resorting to different approaches in dealing with the CoPP applications ever since the DCGI order on CoPP was stayed by the court in October last year.
Prior to October last year, the convention was to conduct joint site inspections by the central and state drug authorities for issuing CoPP. But when it became a bone of contention between the two agencies following the circular of DCGI in September 9, 2009 and the court case thereafter, joint site inspections are being held only in very few states. Some state drug control administrations have formed their own separate committees to conduct the inspection.
For instance, in Andhra Pradesh the state drug control administration has formed a separate body comprising one drug inspector, an assistant director and one deputy director to conduct the plant inspections on the basis of applications they get from exporters, and the process is going on smoothly.
Sources in the CDSCO sub-zonal office in Hyderabad said that there is no communication between the CDSCO office and the state drug department after October last year. When asked whether any inspection was conducted jointly by his office and the state officials, A Chandrasekhar Rao, the assistant drugs controller said they had associated jointly only for one inspection in November last for which the application was received before October.
When contacted, the director general of Drug Control Administration of the state, R P Meena said, “Our officers are conducting the inspection of our own. We are following the order of Madras High Court. We have formed a committee with one Drug Inspector, assistant director and one deputy director.” When asked about the second circular issued by the DCGI asking the state and central authorities to maintain the status quo till a final verdict is come out from the Court, Meena said the DCGI had issued a circular centralizing CoPP release, but the Madras High Court had quashed it. “So we are conducting the inspections with our team for the benefit of the people,” Meena said while admitting that he has to obey the rules of the Court as he is an IPS officer.
While joint inspections are going on in some states like Tamil Nadu and Karnataka, in Uttarakhand the inspections are conducted by the state drug authorities alone. Uttarakhand drug controller DD Upreti said his office is not getting any officers from the CDSCO office for joint inspection despite a number of letters he sent to them asking to accompany for the inspection. At last the drugs controller has decided to send a representative from his office to the Ghaziabad CDSCO office requesting their association for continuing the previous system.
According to R M Sharma, drugs controller of Haryana, his office is conducting no inspection after October last year as he is not getting any application for CoPP. The Drugs Controller of Punjab, Bang Sing, said his office is following the conventional system of joint inspection. PN Saraswat, the Drugs Controller of Rajasthan said, in his state joint inspection is going on.
SK Roy Chowdhari, the director of Drugs Control Administration in West Bengal said they are now planning for joint inspection. After the issuance of DCGI’s order there was no inspection held. He said in Bengal there are only five companies that require this CoPP.
But the situation in Orissa was different Ranjan Kumar Hota, deputy drugs controller of the state said in his state joint inspection is continuing. Kerala Drugs Controller MP George said his staffs are not seeing the CDSCO staff while conducting the site inspection.
The DCGI’s circular was to centralize the issuance of CoPP on the ground that the certificates issued by states did not conform to the norms of WHO certification scheme. Afterwards, it became a tug of war between the state and central drug regulating agencies ending it for final decision in the court. The order of the Central Drug Administration was to come into effect from October 1, 2009.