WHO launches plan for cheaper TB drugs
Why in news
The World Health Organisation (WHO), on Tuesday, invited pharmaceutical companies around the world to submit proposals to manufacture affordable versions of newer medicines for treatment of drug resistant tuberculosis.
- A WHO spokesman said the aim was to replicate the success of addressing the HIV epidemic. Competition among Indian drug producers had then brought down the price of HIV medicines by 99% from $15,000 per patient per year to less than a dollar a day.
- WHO has now requested drug makers to submit an Expression of Interest (EoI) for Bedaquiline and Delaminid, two new-generation drugs, recommended for drug resistant-TB. Under WHO norms, drugs submitted upon such requests and complying with its standards are included in a list for procurement by the UN and other organisations.
- India has nearly 1.3 lakh DR-TB patients, the most in the world, but the Health Ministry gets only 10,000 doses of Bedaquiline and 400 doses of Delaminid. The medicines are obtained as donations from Janssen (US) and Otsuka Pharmaceuticals (Japan), the respective manufacturers.
- “One of the aims of pre qualification is to ensure that a greater number of manufacturers are supplying quality medicines, which in turn means a more competitive market and more affordable prices. We have seen this with HIV, where the pre-qualification of many predominantly Indian manufactured products brought the price down of many anti-retrovirals. Inclusion within the scope of PQ has also incentivised the development of fixed dose combinations, which have yielded much better results for patients,” said Daniela Bagozzi, Communication Manager, WHO.
- In the case of HIV, one company, Cipla, came up with a ‘AIDS cocktail’ combination of Stavudine, Lamivudine and Nevirapine, enabling effective treatment. Cheaper drugs to treat HIV became possible at the time as the Indian Patents Act did not provide for product patents on pharmaceutical products, until required by the Trade Related Intellectual Property Rights (TRIPS) framework of the World Trade Organization (WTO). India became TRIPS compliant with pharma product patents in 2005.
- The whole world looks to India to provide access to affordable drugs because of our capabilities. With WHO’s backing, we will be able to accelerate introduction of generics,
- Inclusion of the two new drugs, Bedaquiline and Delaminid, in the pre-qualification call is being interpreted by aid agency Médecins Sans Frontières (MSF) as WHO’s backing for generics.
Tuberculosis in India
- India continues to have the highest number of tuberculosis (TB) cases in the world, the Global TB Report 2017 released by World Health Organization (WHO) on Monday revealed.
- In 2016, there were an estimated 10.4 million new TB cases worldwide. Seven countries accounted for 64% of the total burden, with India having the maximum number of TB patients, followed by Indonesia, China, Philippines, Pakistan, Nigeria and South Africa, the report said.
- According to the report, in India, an estimated 27.9 lakh patients were suffering from TB in 2016 and up to 4.23 lakh patients were estimated to have died during the year.
- According to the report, Multidrug-resistant TB (MDR-TB) remains a public health crisis and a health security threat. WHO estimates that worldwide, there were 600,000 new TB cases with resistance to rifampicin—the most effective first-line drug, of which 490,000 had MDR-TB. Almost half of these cases were in India, China and the Russian Federation.
- The report highlighted that underreporting and underdiagnosis of TB cases continue to be a challenge, especially in countries with large unregulated private sectors and weak health systems, including India.
- “Of the estimated 10.4 million new cases, only 6.3 million were detected and officially notified in 2016, leaving a gap of 4.1 million. India, Indonesia and Nigeria accounted for almost half of this global gap,” the report stated.
- “Only one in five MDR-TB cases was started on treatment. India and China accounted for 39% of the global gap. Treatment success remains low, at 54% globally,” the report said.
- Though the Indian government has made several announcements to eliminate TB by 2025, the WHO report showed that up to 27.9 lakh patients were estimated to be infected in the country in 2016. The infection burden in China, a more populous country, is one third of India at 8.95 lakh.
- Out of the 27.9 lakh estimated patients, only 1,938,158 TB cases were notified in the public and private sector in India, which means over 8.5 lakh cases were missing the treatment options.
- The report said TB care and prevention investments in low- and middle-income countries fall almost $2.3 billion short of the $9.2 billion needed in 2017. In addition, at least an extra $ 1.2 billion per year is required to accelerate the development of new vaccines, diagnostics, and medicines.