The just released guidelines on Certificate of Pharmaceutical Products (CoPP) do not provide much time to pharma exporters to understand and gear up to comply with these norms. The CoPP implementation, which takes effect from October 1, calls for more submissions by the industry.

Although the industry received a circular dated September 1, 2009 from the Karnataka drugs control department calling to seek approvals for exports from October 1, the guidelines have come in from the DCGI only on September 24. "With hardly six days left for the CoPP implementation, we feel the DCGI should have made efforts to consult the industry before going ahead. Karnataka accounts for 8 per cent of the total exports. Global orders are critical and every international customer is valuable. We cannot afford to waste a single day in abiding to the COPP rules", Anjan K Roy, president, Karnataka Drugs and Pharmaceutical Manufacturers Association and managing director, RL Fine Chem told Pharmabiz.

With no more joint inspections for export audit, there is also confusion for the industry about the issuing authority for export related documents like the Free Sale Certificate and Performance Certificate which is sourced from the State drugs control authority, he added.

Though the guidelines have come in late, some clarity has emerged about the CoPP. The rules call for additional submissions like Master Document and Quality Manual etc. In fact, these are presented to the regulator by the industry while seeking WHO GMP certification. Now, these-submissions will create duplication of work. Going by the delay in the releasing the guidelines, DCGI should have extended the CoPP implementation to November 1 as the industry needs time to understand the requirements to properly adhere to the rules, said Kaushik Desai, member, executive committee, Indian Pharmaceutical Association (IPA) and CEO, Global Pharmatech.

According to Sunil Attavar, joint secretary, Karnataka Drugs and Pharmaceutical Manufacturers Association and managing director, Group Pharma, commenting on CoPP guidelines is difficult at this stage as it is not easy to say how it will impact the industry. However, Karnataka units have largely adhered to stringent international audits and this too is as good as a global inspection.

Currently CoPP is issued in Karnataka, but with the CDSCO office yet to be operational in the State, for the time being companies will have to seek clearances from Chennai which will again become a logistics issue and a concern for delay, said Desai.