Centralizing the issuance of Certificate of Pharmaceutical Products (CoPP) by the Drugs Control General of India (DCGI) from October 1, 2009 would result in extensive delays and would also be prone to manipulation and error, according to the pharma industry.

There will be hindrances, interruptions and setbacks if the onus of issuing the CoPP is in the hands of the central drug inspectors. Beginning from logistics involved in the submission of data to seeking approvals from Delhi in person and site inspections by the enforcement officers, the pharma industry is apprehensive and dissatisfied at the move.

Further, the industry is unable to comprehend the need for central issuance of CoPP when the state drug licensing authority had been efficiently carrying out the operations. The DCGI has also not shared the details of the WHO order calling to centralize the CoPP issue when transparency and accountability are insisted.

There has been no survey carried out to ascertain the positive and negative impact of this move. Export of pharma products calls for rigorous and painstaking efforts in submission of data and plant inspections. In the wake of the global economic slowdown, the pharma industry's efforts are towards payment recovery and to tap new markets. Single point issue is a major disadvantage and an imprudent move which will upset the applecart, stated sources.

Referring to the CoPP implementation order from the Central Drugs Standard Control Organization (CDSCO), industry sources said it was not clear about certain aspects. One is the required timelines for issuance of the certification and the other was the need to seek CoPP in October itself for facilities which already have a WHO-GMP certificate valid for two years.

Although the intention of the DCGI was good, its implementation was difficult. Going by the shortfall of inspectors at the DCGI office, there could also be occasions where the inspectorate team might not be able to visit each of these facilities to audit plants. In such cases, the onus of convincing the enforcement officers in charge of CoPP will now be on the manufacturers and in all likelihood there would be room for unethical practices, stated sources.

Karnataka drugs controller Dr BR Jagashetty is of the opinion that issuance of Certificate of Pharmaceutical Products (CoPP) should be either with the Drugs Control General of India or respective state drug controllers.

This is because CoPP is an audit of international importance as it is issued to companies to export in the global markets. There should be stringent inspections and extensive scrutiny of audit reports. Therefore inspectors of senior rank should be involved in conducting the audits and providing the certification, he added.