WHO to promote second line anti-TB drugs production

Jayashree Padmini - New Delhi

The anti-TB drugs market is set to witness some action in the near future with the World Health Organization (WHO) proposing more programmes to promote second line drugs production. A growing market estimated to touch $450 million by 2010 is set to uncover opportunities to the Indian anti-TB drug manufacturers.

The WHO is charting multiple strategies to rope in drug manufacturers for production of second line anti-TB medicines.

The WHO—boosted by the additional support offered by donor organisations—plans at least four projects in India in the next eighteen months.

Speaking to Express Pharma Pulse, Dr Ernesto Jaramillo, who is spearheading the anti-TB programme at WHO Geneva, said, ‘‘The market for second line anti-TB drugs, which is growing exponentially, is estimated to touch $450 million by 2010. Currently, the global market for this category stands at around $six million. Donors like the World Bank and the Global Fund have pegged up financial support for the fight against TB and this is an encouraging opportunity for drug manufacturers, especially the Indian industry.’’

The WHO is planning a meeting with manufacturers in the South East Asian region in August this year and this is likely to be held in India. The meeting will focus on making the drug industry in the region aware of the benefits of WHO Green Light Committee and will encourage companies to go for WHO pre-qualification.

The WHO also believes that with its proven manufacturing capability the Indian pharmaceutical industry would stand to benefit in capturing a major share of the emerging market in second line anti-TB drugs. The drugs in this list include kanamycin, capreomycin, cyclosterine, ethionamide and ofloxacin.

The combination therapy using these drugs is very crucial in checking MDR TB, says Dr Jaramillo. The treatment will take around two years and the success rate observed in countries like Russia, Philippines and Peru is around 80 per cent, which is quite encouraging. The second line therapy is yet to come in government supported programmes in India but is available through private hospitals.

However, the WHO is working towards bringing second line therapy through public funded programmes to the masses, utilising the additional funds it would receive from its donors. This is said to trigger the growth of the market for these drugs, thus opening up newer avenues for Indian manufacturers.

The WHO tender market for *****DOTS regime of drugs at $500 million may remain stagnant, while the DOTS Plus market witnesses phenomenal growth over the next couple of years. Compared to the six months regime of DOTS, the second line therapy takes a longer period of two years indicating a sustained market over longer tenure.

The domestic anti-TB drugs major, Lupin, owns a dedicated facility for production of DOTS drugs like ethambutol, rifampicin and pyrazinamide and the company has been targeting to corner ****Rs 200 crore per annum from export of these drugs alone.

The shift in WHO policy to strengthen second line therapy could be another bonanza for companies like the Lupin. Dr Jaramillo said that in the next 10 years, no new drugs are expected to come into the market and the therapy using second line drugs to fight the multidrug-resistant TB (MDR-TB) is catching momentum globally.

The size of the market in terms of the number of patients would cross one million and the drugs market is now strengthened by the WHO supported programmes, he added.

To enhance access of drugs for MDR-TB, the WHO has set up the Green Light Committee mechanism and the key functions of the committee are procurement of drugs, quality assurance and technical review.

It is the task of the Green Light Committee to review applications from potential DOTS-Plus pilot projects and to determine whether or not they are in compliance with the guidelines for establishing DOTS-Plus pilot projects for the management of MDR-TB.

— jayashreep@expressindia.com