The drug controller general of India (DCGI)'s proposal to centralize the issuance of WHO-GMP certificate has raised sharp criticism from the pharmaceutical exporters in the country. Terming the proposal 'a suicidal policy', the exporters have said that it will prove to be a big stumbling block to the exporters as the DCGI office does not have the infrastructure to dispose of the application for WHO-GMP certificates expeditiously.

WHO-GMP certificate is issued for a period of two years and if the proposal to centralize the issuance of WHO-GMP certificate is accepted, the manufacturers have to approach DCGI office for renewal in every two years. Given the pace at which the DCGI office works due to lack of infrastructure, the manufacturers fear that it will put the exports in total disarray. "At a time when the country is looking to better the last year's pharma exports of $7.2 billion, such policies will adversely affect the export targets," an exporter of decades of standing said.

Expressing the suspicion that the MNCs are behind the DCGI's move, exporters said that the new policy will hit hard the small and medium enterprises the most as they market their products mostly in the semi-regulated markets like Latin American countries, African countries, CIS countries and other developing countries who only accept WHO-GMP certificate as the proof the quality of the manufacturing plants.

WHO-GMP certificate is a basic document which is required by all the exporters who wanted 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.

WHO-GMP certificate is issued to the manufacturing plants and it is issued by the state licensing authorities (SLAs) after a joint inspection by the CDSCO (DCGI office) and state drug control department. The proposal to discontinue the present system was discussed in the drugs consultative committee (DCC) meeting held on December 10. However, a final decision in this regard is still pending with the DCGI. As per the new proposal, only the DCGI office will be authorized to issue WHO-GMP certificates. The decision comes in the wake of WHO criticism that the WHO-GMP certificate is issued by the Indian authorities randomly.