World Health Organization (WHO) has invited pharmaceutical companies around the world to submit proposals to manufacture affordable versions of newer medicines for treatment of drug resistant tuberculosis (DR-TB). It has now requested drug makers to submit Expression of Interest (EoI) for Bedaquiline and Delaminid, two new-generation drugs, recommended for DR-TB. The aim of this proposal is to replicate success of addressing HIV epidemic. Under WHO norms, drugs submitted upon such requests and complying with its standards will be included in list for procurement by UN and other organisations.
India has nearly 1.3 lakh DR-TB patients, most in the world. Currently Health Ministry gets only 10,000 doses of Bedaquiline and 400 doses of Delaminid. These medicines are obtained as donations from Janssen (US) and Otsuka Pharmaceuticals (Japan), their respective manufacturers.
EoI considered by WHO for two drugs will be key compounds to address challenges of DR-TB. It will encourage generic competition to start finding ways to make these medicines available in countries where they are not yet registered. It will also allow generics manufacturers interested in producing these two drugs and currently facing technical challenges. The pre-qualification will ensure greater numbers of manufacturers are supplying quality medicines, which, in turn, means a more competitive market and more affordable prices.