India restricts sale of off-patent TB medicines to government channels to combat drug resistance

“The drug should be used as per Standards of TB Care in India (STCI) guidelines with the conditional access through the National TB Elimination Programme only," the apex drug regulator said in a letter to all states and Union Territories. 

The Drugs Controller General of India (DCGI) emphasised that the labels of all such TB drugs and their packaging should carry a warning in a box with a red background, stating: "For the use in National TB Elimination Programme only."

It said these medicines are critical drugs that are reserved for the treatment of Multi-Drug-Resistant TB infection. Availability of such drugs in the open market through retail outlets may lead to indiscriminate use and development of resistance, causing treatment failure. 

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The regulator asked the states and UTs to amend the conditions of all licences already granted to manufacture such drugs and incorporate the clause on their restricted usage. It also sought action-taken reports from them.

The DGCI directive pertains to drugs such as Bedaquiline (100 mg and 20 mg), Delamanid (50 mg and 25 mg), Pretomanid (100 mg), and Rifapentine (150 mg and 300 mg), said an official with knowledge of the matter.

Patents for Bedaquiline and Delamanid expired last year, leading to their widespread manufacture by several pharmaceutical companies and their subsequent open availability in private drug stores.

The Central TB Division had raised concerns about the easy availability of these TB drugs in October last year and sought the DCGI’s intervention to regulate their sale.

Latent TB infection

The drugs are vital components of the combination therapy for latent TB infection, when an infected person has no symptoms and cannot spread the disease to others, and Multi-Drug-Resistant Tuberculosis (MDR-TB). Rifapentine and a fixed dose combination of Rifapentine and Isoniazid have been approved for the treatment of latent TB infection.

Last year, India rolled out a six-month MDR-TB regimen called BPaL (Bedaquiline, Pretomanid and Linezolid), which has a very high success rate and treatment outcome. These medicines are provided free to patients in both government and private healthcare set-ups.

TB medicines are approved for import/manufacturing by the Central Drugs Standard Control Organisation in consultation with the Subject Expert Committee and experts from the Central TB Division at the ministry of health and family welfare.

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“The matter was discussed last week during the Drugs Consultative Committee meeting chaired by the DCGI," the person said. “These drugs will primarily be distributed through government channels under the National TB Elimination Programme to hospitals and TB treatment centres, allowing for detailed tracking of manufacturers and patients."

Elimination campaign

Last month, Prime Minister Narendra Modi chaired a high-level meeting on the National TB Elimination Programme and called for strategies to be scaled up to meet India’s commitment to eliminate TB.

At a recent 100-Day TB elimination campaign, over almost 720,000 TB cases were detected across the country, including 285,000 asymptomatic cases, highlighting the challenge and the importance of controlled drug access.

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TB is a contagious disease caused by a bacterium called Mycobacterium tuberculosis. It mainly affects the lungs. It can also affect other parts of the body such as the brain, the kidneys, or the spine.

India reported 2.6 million TB cases last year. Despite the challenges, India has made significant strides in its fight against TB.

The WHO Global TB Report 2024 indicates an 18% reduction in TB incidence and a 21% decline in TB mortality from 2015 to 2023, double the global pace. With an 85% treatment coverage, India is steadily nearing its TB elimination target.

Queries sent to the health ministry spokesperson and the DCGI’s office were unanswered.