d) Health Economics
AU : Trebucq A
TI : Requirements for anti tuberculosis drug tender requests
SO : INT J TB & LUNG DIS 1999, 3 (Suppl), S358-S361
DT :  
AB :

As more and more institutions and experts advocate for the use of fixed-dose combinations (FDC) of anti-TB drugs, it is expected that the market will change dramatically in the next few years. Prices should go down, but quality must remain an essential goal for managers in charge of the procurement process. In this paper, general essential requirements for suppliers submitting for competitive bidding are reviewed, in particular the WHO certification scheme. The expiry of patents on older drugs, the diversification of production sites and liberalization of the international pharmaceuticals’ market has resulted in multi source generics. These are the only affordable and alternative drugs for low income countries. The main criteria while procuring drugs for the NTP should be price, quality and availability of anti-TB drugs. As in case of other drugs bids for anti-TB drugs should also take into account the specifications such as delay and reliability of delivery. The standard steps in the tender cycle are selection of suppliers to participate in the tender selection and issue of contracts to winning bidders, and monitoring of performance and product quality. The call for suppliers can be made through open tender, restricted tender and direct procurement from single supplier at the quoted price. There is an informal network between authorities, international organizations and NGOs to facilitate the selection of suppliers who qualify the requirements. For quality assurance for drugs, same regulations like Good Manufacturing Practices (GMP), Pharmaceutical product licence (PPL) and the WHO certification scheme have been introduced from 1963 onwards in many developed and developing countries. The WHO certification scheme is based on voluntary participation of countries that import and export drugs by way of three different certificates. (i) Statement of licensing : it attests that a PPL has been issued by the regulatory authorities of the exporting country for use by importing agents; (ii) Certificate of a pharmaceutical product issued by the competent national regulatory authorities of the exporting country; (iii) Batch certificate – the manufacturer issues this certificate for each individual batch of a pharmaceutical product. It is a mandatory requirement and is provided with the bidding documents. It attests the quality and expiry date of a specific batch and should include the specifications of the final product. The cost of FDCs are likely to go down and would become accessible for the programme. For the NTP, different combinations of specified formulations of three or four drug combinations are recommended and can be made available on the basis of making request for the type of combination and dosage for each product. A contract taking into account of all the details of the drugs and of the services (labeling, packaging, shelf life, expiry dates, bid bonds, shipment specification, penalties for default) need to be signed between the provider and purchaser. Quality control of FDCs is essential. Bio-availability studies must be conducted for rifampicin according to the protocol recommended by the IUALTD and the WHO, whereas for other components dissolution tests are significant. This should be made as condition before bidding or before supply. Management of competitive tenders is an important and difficult task. Low prices and high quality drugs must be the result of this process in order to procure good drugs for TB patients.