Johnson & Johnson’s global patent on bedaquiline, considered to be one of the most effective treatments available for tuberculosis, expired last month, paving the way for this life-saving drug to get cheaper across the world. Three Indian firms are already set to bring cheaper versions of the drug to the market soon. With J&J’s eight-year monopoly getting over on July 18, experts told ABP Live that the move would make the drug accessible and affordable in India, which is the largest contributor to global TB cases, as per the World Health Organization (WHO).
“It will be a boon not only for India but for most developing countries as India, known as the pharmacy of the world, provides 92 per cent of global anti-TB drugs supply. Multidrug-resistant TB treatment will become easier now than ever,” infectious diseases expert Dr Ishwar Gilada told ABP Live.
Dr Gilada said the cost of bedaquiline, the first drug for TB to be globally approved in 50 years, could be as less as 1 per cent of the present price.
“Once it is off patent, any pharmaceutical manufacturing company can make it. The cost can come down tremendously. One example is patented anti-HCV (hepatitis C virus) medicine, which was $1,000 per tablet. An 84-day course cost around $84,000. The generic versions are currently less than $250 for the full course — just 0.3% of patented medicine cost,” said Dr Gilada, who is also a governing council member of the International AIDS Society.
Bedaquiline, which has a high success rate in treating drug-resistant TB, was first introduced in the Indian market by J&J in 2015 at Rs 7 lakh for a vial. The prescribed six-month course currently costs around Rs 22,000. It is procured only through the government and then it is distributed through state-level TB programmes. In April, India scrapped an application by J&J to extend the patent on bedaquiline beyond July 2023.
Three Indian Firms To Bring Generic Versions Of Bedaquiline
Lupin, BDR Pharmaceuticals, and Macleods Pharmaceuticals are set to bring out generic versions of bedaquiline in the market soon, experts told ABP Live.
Confirming this, Dharmesh Shah, chairman and MD, BDR Pharmaceuticals, said the price of bedaquiline would be very competitive and affordable, and that the firm was in talks with the government to partner it in its TB elimination programme.
“We are just doing the final feasibility study and are evaluating the conditions and accordingly preparing ourselves to partner if necessary with the government or participate in a government tender to bring out the most cost-effective generic product in the market,” Shah told ABP Live.
With J&J’s monopoly on bedaquiline ending, Shah said generic pharma companies now have an opportunity to contribute towards the government’s vision to eliminate TB by 2025.
“The development will make cheaper generics available of equivalent quality as J&J. It will help to provide this medication to more and more patients suffering from multidrug-resistant TB,” he said.
Macleods Pharmaceuticals confirmed the development and said a generic version of bedaquiline would be available soon. A Lupin spokesperson said plans were afoot on developing the drug but refused to make any further comments.
An official from the Central TB Division of the Ministry of Health said bedaquiline was an essential drug to treat multidrug-resistant TB and they were working with all the stakeholders towards bringing an affordable version of it.
Resistance To Drug Big Concern
Dr KK Chopra, director, New Delhi Tuberculosis Centre, set up by the Centre, however, warned that unchecked consumption of bedaquiline might lead to bacteria developing resistance to the drug. That is why it was so far kept under the Centre’s conditional access programme, he said.
“Bedaquiline was developed more than 50 years after our last TB drug was made. Till date, we have kept this drug under the conditional access programme. This means the drug was not available in the open market. When it becomes available in the open market, then there are high chances of misuse,” Dr Chopra told ABP Live.
“Even if this drug is given in the private sector, there is no way to monitor how patients are taking it. Because, the private sector does not have any system of supervising the drug intake. Under the government programme, we were giving the drug to patients under supervision, so there was no misuse of the drug,” he added.
India’s TB Burden
India had made tuberculosis a “notifiable” disease in 2012. It means it is mandatory for states to report cases to government authorities.
According to the Global TB Report 2022, India accounts for 28 per cent of all cases in the world. In 2021, around 5.06 lakh people died due to TB.
In 2022, India reported 24.2 lakh cases or 172 cases per lakh population, as per the ‘India TB report 2023’.
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