A procurement organisation has two levers to ensure that only quality drugs enter the system: (1) prequalification criteria to filter out unqualified suppliers and (2) external quality testing protocols.
But submitting prequalification applications to a number of online mortgage sites can be counterproductive.
One method to overcome this is to gain WHO prequalification and be eligible to sell products to international donors; a number of firms, already GMP qualified, were attempting to do this.
Its focus on innovation and quality to meet WHO prequalification standards led to a higher cost structure than its domestic competitors who did not meet these standards.
Two primary goals of the grant were to build a facility in line with WHO prequalification standards and to build technical capacity to produce ARVs.
Furthermore, because of the prominence of donor-financed tenders throughout Sub-Saharan Africa, the lack of WHO Prequalification would continue to be a limitation.
Two additional clinical studies (phase 3), a lot consistency study in India and a large safety study in Africa, were ongoing at the time of prequalification and submitted to regulatory authorities as part of the early postlicensure requirements.
The vaccination was intentionally conducted as a demonstration project in contradistinction to a vaccine trial to assess the feasibility of the use of the vaccine nationally because the OCV already had an extensive safety and efficacy record that had led to prequalification by WHO.
This initial focus on process and quality innovation may have delayed Shanvac-B's launch, but it allowed Shantha to become the first Indian firm to receive WHO prequalification, and opened the door to large international contracts [See Table 2].
The WHO-facilitated procedure used for licensure in India and to accelerate prequalification of the vaccine worked well to prequalify PsA-TT in a timely manner.
