Johnson & Johnson and Mylan have proposed measures expected to make their multi-drug resistant tuberculosis medicines available in India at lower rates to ensure patients continue to get access to them after free supplies to the country are stopped, people familiar with the matter said.
J&J has offered to provide one course of the drug bedaquiline for free if the government buys four courses at $900 (Rs 58,400) each, two people aware of the matter told ET.
A single course of bedaquiline consists of 188 tablets and lasts a patient six months and each course is sold at $900 in markets like South Africa, one person said on condition of anonymity. In the US, bedaquiline is priced at $30,000 (Rs 19.45 lakh) for one course, the person added.
Mylan is considering a ‘Make in India’ option for its TB drug delamanid to lower the price when donations run out, according to people close to the development.
“The government is currently in talks with Johnson & Johnson and Mylan,” a senior official said, referring to procurement prices of bedaquiline and delamanid. The official declined to specify the options discussed, said negotiations are going on and the government has not made a final decision on the matter.
The talks coincide with increasing calls from health activists for India to grant compulsory licences for delamanid and bedaquiline so that domestic companies can make generic versions of the potentially life-saving drugs at much cheaper rates. Compulsory licensing allows authorities to grant permits to make, use, sell or import a product under patent without permission of the patent owner provided certain procedures and conditions are fulfilled.
As of now, 10,000 courses of bedaquiline have been promised to India for free through the US Agency for International Development, of which 3,500 courses have been donated and 1,000 used, one person said.
A detailed questionnaire and follow-up email sent to J&J about its negotiations were unanswered by press time on Wednesday. J&J is said to be in early-stage talks to grant a voluntary licence to Macleods Pharmaceuticals to manufacture a generic version of bedaquiline, ET reported on Tuesday.
Mylan officials approached the health ministry last week proposing to manufacture delamanid in India, said two persons familiar with the development. Delamanid is priced between $1,500-2,000 in different markets, according to one of the persons.
“Mylan has shown a keen interest and there is a discussion to manufacture delamanid locally,” said the second person requesting anonymity.
Mylan holds an exclusive licence to supply delamanid to India and South Africa for patients with pulmonary MDR TB. Japan’s Otsuka Pharmaceuticals developed the drug.
“Mylan is dedicated to creating treatment access for patients across India in multiple therapeutic and life-threatening disease segments, and is committed to manufacturing medicines for the treatment of tuberculosis,” a Mylan spokesperson told ET.
India is expected to receive 400 courses of delamanid for free. The government is expected to administer delamanid to patients across 21 sites as soon as the donations come in, said a senior government official requesting anonymity. Access to bedaquiline is being expanded to 147 sites from 21 sites now, the official added.
Bedaquline and delamanid are considered the last line of defence in the fight against TB and are administered by the government to patients in a controlled manner so that resistance to these drugs is not developed, said the official.
India had an estimated 1.3 lakh MDR TB patients in 2015, according to the government’s TB India annual status report of 2017.
On Tuesday, Prime Minister Narendra Modi reiterated India's goal to eliminate TB by 2025, five years ahead of the global target.