The Drugs Controller General of India (DGCI) has permitted global pharmaceutical giant Mylan to sell its anti-tuberculosis (TB) drug in India, called pretomanid, making India the second country in the world to give regulatory approval to this drug. The DCGI has permitted the use and sale of the drug only under special circumstances under the National Tuberculosis Elimination Programme (NTEP), a nationwide campaign against TB.

Approval with combination of three drugs

Reportedly, pretomanid has been approved as part of a combination of three drugs. This combination includes the pretomanid with bedaquiline and linezolid, which is combined in the name BPAL. This drug combination is intended for adult TB patients who are required to take this medicine to treat lung problems or when the treatment is not tolerable, or the patient has developed drug resistance.

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After receiving approval from DCGI, Mylan will provide 400 treatment courses of its anti-TB drug as a donation. The company will provide these treatment courses absolutely free under the government’s NTEP campaign against TB. In addition, Mylan will also commercially provide the drug to NTEP at a previously announced price  of Rs 27,000 for a six-month treatment. Apart from this, Mylan will also manufacture the medicine for domestic and international supplies in India.

What is tuberculosis?

Tuberculosis or TB is an infectious disease that usually affects the lungs. It spreads from one person to another by air. TB bacteria can also make a healthy person sick while breathing, and is said to cause the second largest fatalities worldwide in terms of infectious diseases. Symptoms include cough, fatigue, and abnormal weight loss for more than three consecutive weeks. TB is usually cured with treatment, which includes a course of antibiotics. Experts say that it can take up to 6-9 months to treat TB. In some situations, it may take up to two years.

The fatality linked to tuberculosis can be gauged from the fact that hundreds of people die every day from the disease. The World Health Organization (WHO) reports indicate that TB is one of the world's deadliest infectious diseases. More than 4,000 people lose their lives every day, and another 30,000 cases are reported. According to a report by the National Health Portal of India, in the last decades, many important decisions have been taken regarding the prevention of TB. But even after this, the disease still remains one of the top ten causes responsible for deaths all over the world.

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Significantly, only a quarter of TB cases in the world are in India. According to reports, there are about 27 lakh cases of TB every year. Out of these, 1.30 lakh patients have drug-resistant problems. Apart from this, they also have to cope with complex and prolonged treatment, which is a problem in itself, and these treatments often do not produce good results either. In 2019, Mylan and the TB Alliance announced a global collaboration to provide pretomanid with two investigational drugs used in the treatment of TB to low and middle income countries. These drugs include BPAMZ (bedaquiline, pritonamid, moxifloxacin and pyrazinamide) in addition to BPAL.

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