Advanced patented medicines used to treat Drug Resistant Tuberculosis (DR-TB) are available to only about 1,000 patients out of the tens of thousands who need it, because the innovator-manufacturers are not ready to licence Indian drug-makers who can sell them at affordable prices.
Bedaquiline and Delaminid, the new-generation drugs, are recommended by the World Health Organisation (WHO) for DR-TB patients.
It is five years since Bedaquiline became available, but India has fewer than 1,000 patients on it. Only 81 patients have access to Delaminid, according to the Union Health Ministry.
“These numbers are terrifying. India does not seem to be mounting emergency measures to deal with the airborne disease,” said Prof. Jennifer Furin of Harvard Medical School, US, who has closely followed TB drug access in India.
Only donations
Nearly 1.3 lakh DR-TB patients need treatment but the Health Ministry has only 10,000 doses of Bedaquiline and 400 doses of Delaminid, obtained as ‘donations’ from Janssen (US) and Otsuka Pharmaceuticals (Japan), the respective manufacturers.
On September 19, 2017, a panel chaired by Dr. Soumya Swaminathan, then Director-General of the Indian Council of Medical Research and currently the Deputy Director-General of the World Health Organisation (WHO) recommended, among other steps, that the Health Ministry consider issuing a compulsory licence (CL) for the two TB drugs.
Dr. Swaminathan said recently that India should consider the CL option for the two drugs, if the country runs out of options.
“We need better access to new TB drugs. We need to think of some feasible strategies,” she said.
“One particular strategy would be to think about compulsory licensing. Before we get to that point, we need to have a dialogue with the companies about voluntary licensing. We have enough companies in India that can manufacture and market these drugs and cost can be brought down and at the same time, the innovator company will get their royalties. I would think the VL option should be the one to be really explored. We should keep CLs for when we run out of options,” she said.
A CL can be issued by the government, as provided for by the World Trade Organization’s trade-related intellectual property regime, in case of ‘extreme urgency’ and ‘national emergency,’ without waiting for voluntary licensing.
The Union Health Ministry told The Hindu that it had requested Janssen and Otsuka, to grant Voluntary Licenses (VL) to Indian manufacturers.
A VL would allow Indian companies to pay a royalty to the innovators and manufacture generic, affordable versions. The Hindu found that both companies turned down the Health Ministry’s request. While Janssen said it will increase its donations, Otsuka did not respond to a query. Otsuka has appointed Mylan India, subsidiary of US pharmaceutical company Mylan NV, as a distributor (not manufacturer).
Sanjiv Navangul, managing director, Janssen India said, “since 2012 we’ve donated approximately 1,000 courses of Bedaquiline in India through compassionate use and controlled access programmes, and since April 2017, we’ve supported the government’s move to expand treatment to 156 new sites across the country by donating an additional 10,000 treatment courses of Bedaquiline.”
A Janssen spokesperson said, Bedaquiline is manufactured in India and exported. This has, however, upset domestic TB patients, who would have to encounter rationing of medicines or face uncertainty after donations are phased out in 2019. “Only 1,000 Indians have access to this medicine. What do they plan to do after the donations run out? It is a violation of our human rights to deny us treatment that exists,” said Ketholelie Angami, an activist.
Active transmission
An estimated 1,300 Indians die due to TB everyday. India is home to the largest number of TB patients, with 2.8 million suffering from the airborne disease. Out of this, around 1,30,000 are the worst-affected as they have become resistant to known medicines. Effective drugs are needed to prevent spread of infection to families, co-workers and friends of patients.
The Health Ministry, however, has made little progress on Dr. Swaminathan’s recommendations over the last six months. The compulsory licensing committee has not met since 2014 and senior Ministry officials said they would not consider the ‘CL route,’ due to pressure from the US government. The Joint Secretary, Health Ministry, Sudhir Kumar, said the government was unable to issue a compulsory licence because “no company has come forward to apply for compulsory licence for the drugs before the competent authority.”
India exercised the CL option for the first time in 2012, and the Supreme Court upheld the manufacturer, Natco’s move to make a generic version of Bayer’s cancer drug Nexavar. The move cut the price of the drug by 97%, from ₹2.8 lakh to ₹8,800.
Since then, the United States Trade Representative has demanded that India protect patents of American pharmaceutical companies. D.G. Shah, Secretary-General, Indian Pharmaceutical Alliance (IPA), a lobby group of domestic drug makers said no generic company wanted to apply for a CL after the “harassment” that Natco faced since it sought a CL.
The Health Ministry did not comment on why it was not invoking the ‘government-use’ CL option, for which an application from a domestic company is not required.
In 2017, a teenage girl from Patna took the Centre to court over access to the two TB medicines and won. The victory has not significantly increased access to the medicines.
But with the option of compulsory licence ruled out, and the companies that manufacture Bedaquiline and Delaminid refusing to issue VLs, the price at which the drugs will be sold are to be decided in meetings between officials of the TB programme and pharmaceutical companies.
Health Ministry sources said Bedaquiline is likely to be priced at $900 for a six month course while Delaminid could cost each patient $1,700 for a six month course. Patients with drug resistant TB typically need a course of 18 months of both drugs, which means a cost of about ₹5.1 lakh per patient.
Andrew Hill, Professor of Molecular and Clinical Pharmacology at the University of Liverpool estimates that a generic version of Bedaquiline could be sold at $54 - $96 and Delaminid at $24 - $54 for a six month course if a generic company got a license.
