Utter confusion and lack of coordination seem to prevail in the office of DCGI over the issuance of WHO-GMP certificates for the exporters. While DCGI Dr Surinder Singh categorically stated some days ago that there is no move to withdraw WHO-GMP certification or replacing it with certificate of pharmaceutical products (COPP), his North Zone office issued a circular asking the state drugs controllers of North Zone to withdraw the WHO-GMP Certificate issued by them.

In the letter issued to the North Zone drug controllers, deputy drugs controller, North Zone, Dr R Ramakrishna wrote: "It has been observed by this office that WHO-GMP Certificate has been issued to many firms by State Licensing & Controlling Authority. Copies of such certificates issued are enclosed for ready reference. It may please be noted that neither your office nor this office is having any authority to issue WHO GMP Certificate (which can only be issued by WHO, Geneva after pre-qualification assessment of the manufacturing site). As per WHO Certification Scheme, we are only authorized to issue COPP's for marketing in International Commerce. In view of above, you are hereby requested to withdraw all the above type of WHO-GMP Certificate issued in your state, if any, by your State Licensing Authority".

The letter is undated, but sources said it was issued on January 7 this year. Sources also said that in view of the letter, the North Zone state drug controllers are not issuing WHO-GMP Certificates to the manufacturers.

Incidentally, no such letter was issued by deputy drug controllers (DDCs) of other three zones in the country. Sources said that the other DDCs beat a hasty retreat and just stopped short of issuing such letters on oral instructions from the DCGI due to the hue and cry created by the industry over a news report stating that the DCGI office is going to withdraw the issuance of WHO-GMP Certificate.

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 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.