The WHO and the IUATLD have recommended fixed dose combination (FDC) tablets containing Rifampicin for TB treatment. However, due to variation in bioavailability of the Rifampicin and quality of Rifampicin in FDCs have prevented their large scale use resulting in lower production and higher prices beyond affordability in developing countries. In this paper, the authors estimate the potential size of the market for Rifampicin containing FDCs assuming that all the currently marketed Rifampicin will be sold in FDCs. The quantity of Rifampicin is estimated by the following equations : the quality of Rifampicin per treatment regimen multiplied by the number of TB cases treated in public and private sector. The future size of the market for FDCs will be influenced by trends in numbers of cases, the ratio of cases treated in the public v/s the private sector and the ratio of cases not treated at all. The future trends of the TB epidemic may be influenced by several factors such as implementation of control strategy, commitment of government for TB control and the impact of the HIV epidemic. Hence, the authors have decided to provide an estimate of the present market.

WHO collected the information on the use of FDCs in public sector through a questionnaire; 85 countries representing about 90% of the world’s TB cases responded to the WHO questionnaire. About 50% of the 85 countries use Rifampicin as FDCs in the public sector, however most of these are small countries. In the public sector, an estimated 23.8% of the total number of notified TB cases are treated with two or three drug FDCs. In the public sector it is estimated that the global amount of Rifampicin used yearly to treat 3.57 million TB cases is 123.7 metric tons, representing 78.9% million tablets of 150 mg Rifampicin or 34 g per TB case. In the private sector, it is estimated that 2.54 million TB cases are treated using 99.9 metric tons, representing 666.3 million tablets of 150 mg Rifampicin or 39 g per case. Thus, the potential global market for the four drug FDC tablet (R-150 mg, H-75 mg, PZA-400 mg and Emb-75 mg) is 305 million tablets per year, 105 and 200 million of which would be distributed in the public and private sectors respectively. The uncertainty of the estimate remains considerable, as shown by the 90% confidence intervals. In conclusion, the study demonstrated a large potential global market for FDCs that should encourage pharmaceutical manufacturers to produce WHO recommended dosages of FDCs at affordable prices. Current use of Rifampicin in the FDCs is only 25% of the total Rifampicin used in the world.

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.