Even as hectic preparations are going on in the office of the drug controller general of India (DCGI) to centralize the issuance of WHO-GMP certificate, the exporters are demanding to increase the validity of the WHO-GMP certificate and the Certificate of Pharmaceutical Products (COPP) from the existing two years to five years.

So far, since the WHO-GMP certificate was issued by the state licensing authorities (SLAs) after a joint inspection by the CDSCO (DCGI office) and state drug control department, there was not much delay in the process. With the DCGI proposing to centralize the issuance of WHO-GMP certificate, there is apprehension among the exporters that there will be avoidable delays in issuing the certificate. Their apprehension stems from the fact that the DCGI office does not have the infrastructure to dispose of the application for WHO-GMP certificates expeditiously.

The exporters' apprehensions in this regard are not out of place as hundreds of applications regarding blood banks, rDNA-based vaccines, biologicals and large volume parenterals are learnt to be pending in the DCGI office for years. The power to issue licenses for these are lying with the Central Licensing Authority (CLA).

Exporters, who are opposing the centralization of issuance of WHO-GMP certificate, said that there is need to increase the validity of these certificates to five years on the lines of manufacturing license. The exporters plead that if the validity is raised to five years, the industry can save a lot of time and energy wasted in every two years to get these certificates.

WHO-GMP certificate is issued to manufacturing plants and COPP is issued for individual products and both of these are issued by the SLAs for two years. WHO-GMP certificate is a basic document required by the exporters to export their products to the countries where there is no regulatory system of their own. While the US, European Union countries, Canada, Australia and other developed countries have their own regulatory system and they import the drugs from the plants inspected and approved by their own agencies like the US FDA, countries in Latin America, Africa, CIS countries and other developing countries accept WHO-GMP certificate as the proof of quality of the manufacturing plant and COPP as the quality of the product.