Otsuka, Mylan, & Government: A deal that will only fuel the superbug

Plan A was local production of delamanid. Plan B could be using the donated drugs to stall the superbug spread. If both fail, India needs to act on plan C

Over 100,000 people are infected with drug resistant tuberculosis in India. The most resistant cases need access to either one or both —bedaquiline and delamanid

The government has not tried to license these life-saving drugs to ensure production and affordability. Instead, it has accepted donation only to be used in six government funded centers across the whole country

Donated, 10,600 courses of bedaquiline and 400 courses of delamanid are not nearly enough to meet current and future needs of these drugs

The government has moved at a glacial pace in even using these drugs. Only about 600 patients have had access to bedaquiline till date. Is donation the best way to ensure drug availability?

Well, it’s too late tonight

To drag the past out into the light

We’re one, but we’re not the same

We get to carry each other, carry each other

— One, U2

The Irish rock band U2 committed the proceeds from its hit number ‘One’ to AIDS research over two decades ago. The song was intended to shame pharmaceutical giants; to make them provide HIV drugs to those who could not afford them in the developing world. If it was a virus then, it’s bacteria now. The song can offer direction to the Indian TB programme which is battling a superbug, too. Only if the Indian government listens, carefully.

The hopes of those carrying drug-resistant tuberculosis (DR-TB) bacteria in India were pinned on the decisions taken in the offices of the national TB programme, Indian Council of Medical Research (ICMR) and Drug Controller General (DCGI) over the last one month in Delhi. On 2 August, India became the first developing country to register Tokyo-based Otsuka Pharmaceutical’s wonder drug—delamanid. It is one of the two new drugs developed for TB in nearly 50 years. The drug did make it to India, but eight years after it was granted patent and after registering in the European Union, Japan, Republic of Korea, Hong Kong, and Turkey. But better late than never.

This approval is a win for the Indian patient. For now, at least. Delamanid, marketed under the brand name Deltyba, is one of the two drugs that can treat the most desperate cases of DR TB. Its presence is already high as India carries the highest burden of TB anywhere in the world. Delamanid is recommended by the World Health Organisation for all persons with multi drug resistant TB (MDR-TB) who are at high risk of treatment failure, and this could be as many as 70% of persons living with MDR-TB, says Jennifer Furin, a professor of Global Health and Social Medicine at Harvard Medical School. There is no doubt that delamanid could prick the expanding bubble of DR-TB in India, but that is not why Otsuka has entered India.

The Japanese major, that was until a month ago patiently capturing the Western market, had made it clear that if the drug will cross the ocean, it will be on its terms. On 24 August, Otsuka announced a deal with the US-based generic pharma Mylan which has a large presence in India. The terms are: Mylan will only ‘help deliver’ the drug, not manufacture it; and the government of India will accept a donation of the drug, not sell it.

Donation is better than no donation

Otsuka has claimed that because it does not have a commercial presence in the developing world, it has not been able to make delamanid available, unlike bedaquiline.

AUTHOR

Ruhi Kandhari

Ruhi writes on the impact of healthcare policies, trends in the healthcare sector and developments on the implementation of Electronic Health Records in India. She has an M. Sc. in Development Studies from the London School of Economics.

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