The pharmaceutical industry in Gujarat is upset over the way the drug authorities are rejecting their renewal application for WHO-GMP certificate. The authorities are denying WHO-GMP certification to even such plants which have been holding the certificate for the last several years, if not decades. More than 20 applications for renewal of WHO-GMP certificate have been rejected by the authorities in the state during the last some months, it is learnt.
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. It 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. With the rejection of their application for WHO-GMP certificate, several manufacturers in the state are not able to export their products.
Sources said that several of these plants were holding the WHO-GMP certificate for the last several years and have been exporting their products to unregulated and semi-regulated markets like Latin America, Africa, CIS countries and other developing countries. But, during the last some months, most of the plants were denied WHO-GMP certification on flimsy grounds. "The inspectors insist for so many compliances which are not even specified in the WHO-GMP. If we have to comply with all of them, at least Rs 40-50 lakh is required which is very difficult during this time of recession. When we ask for the checklist, they simply do not listen," a manufacturer said.
Surprisingly, the CDSCO office has even rejected some of the application papers on the plea that the papers are not WHO-compliant. They reject the papers saying that there are discrepancies in the application papers, sources said.
The harried manufacturers say that all this is happening in a state which is one of the best regulated states in the country along with Maharashtra and Tamil Nadu. While the drug manufacturing plants in Madhya Pradesh, Rajasthan and others are getting WHO-GMP certificate, manufacturers in Gujarat, known for its quality of medicines and the regulatory set-up, are denied this quality certificate, an industry leader said.