September 1, 2009
Letter from DCGI Office:
A considered view has been taken that Certificate of Pharmaceutical Products(COPP) and Certificate of GMP under WHO Certification shall be taken over by theNational Regulatory Authority ie DCG (I) office.
The WHO has time and againexpressed concerns on the implementation of WHO Certification Scheme on the Qualityof Pharmaceutical Products Moving in International Commerce.The matter was discussed in the 40th meeting of DCC held at New Delhi on 29-06-2009 and the States were informed that this activity would henceforth be taken overby CSDCO in a period of 3 months and WHO informed accordingly.
Now, the directorate has decided to implement WHO Certification Scheme byCDSCO from 1s' October 2009 and COPPs will be issued by Offices of CDSCO afterinspection of manufacturing facilities by CDSCO regulatory officials.
