There is a need to better understand the extent of the utilisation of Rifampicin in the market, particularly in Fixed-Dose Combinations (FDC). The objective of the study was to review the Indian market of anti-TB drugs, as this is the largest single market in the world of this therapeutic class where about 50% of global consumption of Rifampicin takes place. The study was designed to review and analyse the sales data proffered by the Indian market audit. Estimated data relating to public sector product usage were utilised in order to obtain a more complete scenario.

There are 3 Indian Rifampicin fermentation plants with a total capacity of about 340 metric tons, supplying to the demand of local market and export activities. It is estimated that there was a total consumption of 250-275 metric tons of Rifampicin in 1998. Other raw materials for the formulation of anti-TB drugs such as Isoniazid, Pyrazinamide and Ethambutol are also produced in India for local consumption as also for export. FDCs were particularly produced in India with sales of about US$139 million in 1998 (public sector - $60 million – HMR/India estimate), private sector - $70 million.

Sales for Lupin Laboratories represents 41% of the private market followed by Novartis with a market share of 10%. Rifampicin + INH FDC group is the largest of all anti-TB drug sub groups. Exactly 50% of this market sub-group are represented by the sales of two leading double FDC brand names worth US$25.8 million. Triple FDC (Rifampicin + INH + Pyrazinamide) sales of US$10.4 million are characterised by a large variety of different dosage ratios for the 3 drugs and market leader has the market share of 14%. Two quadruple FDCs sales in India are limited and the AKT FD brand has 87% of this sub-group for the time being. Both the public and private sectors of anti-TB drugs are likely to grow in the future in volume and value and the Indian pharmaceutical industry is very active in the export of raw materials.

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.