[e-drug] WHO-Prequalification Rules and new manufacturers

E-DRUG: WHO-Prequalification Rules and new manufacturers
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My wishes to all the members of E-Drug!

WHO-Prequalification Project rules and regulations are not encouraging the New manufacturers to supply the vaccines.

I have gone through the procedure mentioned by the Department of vaccines and biologicals for vaccine purchase. In chapter 9 Production and distribution data, under 1st point clearly mentioned that the Manufacturer needs to show 3 years domestic/export distribution data.

I understood that it is not possible for someone who wants to start a new facility and supply the vaccines to UN agencies (one can only apply for pre-qualification after finishing 3 years production/sales).

On the other side, the availability of vaccines to UNICEF has dramatically decreased. (UNICEF is the largest buyer of vaccines for the poorest countries)

I want to know is there any chance to supply vaccine to UN agencies immediately after getting clearance certificate from national authority of the country orign to distribute/sale the vaccine to UN agencies.

I am also interested to know whether there is any difference between these regulations for children's vaccines (DPT, TT, Polio etc) and other vaccines like Rabies and Hepatitis-B to apply for WHO Pre qualification?

I am looking forward to receive opinions from forum members and experts

Thanks in advance

Sincerely

Reddy Nandan
Reg Affairs
India.
trnr_reg@hotmail.com