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.