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Trebucq A |
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Requirements for anti tuberculosis drug tender requests |
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INT J TB & LUNG DIS 1999, 3 (Suppl), S358-S361 |
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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.
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KEY WORDS: HEALTH ECONOMICS; FIXED DOSE COMBINATION;
DRUG TENDERS; BIOAVAILABILITY; FRANCE. |