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Exporters Stipulate to Enhance  Validity of WHO GMP Certificate from 2 To 3 Years

The pharmaceutical exporters have demanded to enhance the validity period of World Health Organization - Good Manufacturing Practices (WHO GMP) certificate from 2 years to 3 years from the date of final inspection and recommendation to licensing authority as the exporters hardly get one year time for registration since the time needed for Certificate of Pharmaceutical Product (CoPP) and inclusion of new products takes more than six months.

The registration of product in every country takes minimum 16 to 18 months including countries in Africa and Asia. Hence by the time registration documents are processed and come under evaluation by respective drug authority, the CoPPs get expired. In such cases, the exporters are again forced to obtain new CoPP legalization which takes more time, additional expenses and delay in registration.

Also, most of the regulatory authorities are not accepting the CoPP with less than 6 months validity. Hence practically with the present two years' validity of GMP the exporters are able to use it only for 18 months. Currently, the validity of WHO GMP certification is given for 2 years only. All the importing countries irrespective of size now takes minimum 2 years for product registration hence CoPP validity is always a big problem and hurdle since by the time registration is on verge of completion CoPP gets expired so for a fresh CoPP it takes at least 2 to 3 months time which further delays registration period.

The exporters have therefore suggested that WHO GMP certificate should be issued for 3 years from the date of final inspection and recommendation to licensing authority. Every Indian manufacturer requires grant of WHO GMP certificate registration in order to export their pharmaceutical preparations to different countries. CoPP is granted after joint inspections of the manufacturing facilities by CDSCO officials and the state regulatory authorities. The validity of this CoPP is for 2 years only. Re-inspection is required to get the new CoPP, but many a times re-inspection is not possible in time due to various constraints and hence an extension of CoPP is sought.

Regulatory authorities in most countries do not accept CoPP with remaining validity of only 6 months. This means that CoPP is effectively valid only for 18 months. An extension of 6 months is given, but only after the completion of 2 years validity which is of no significant value and the registration process gets held up. The product registration offered by all countries is valid for 5 years. The drug manufacturing license in India is also valid for 5 years. Hence it was urged that the validity period of CoPP may also be 5 years or at least 3 years. This will help to expedite the registration of products and will help boost the nation’s pharmaceutical exports.



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