Tuberculosis (TB) is one of the diseases which India is fighting hard to ensure that millions of people are not affected every year. The emergence of drug-resistant TB is one of the greatest conundrums nowadays. This is when the standard drugs fail to do wonders since the TB germs become more robust. The government is working out new regulations to prevent the deterioration of this issue. These regulations will complicate the process of individuals purchasing essential TB drugs such as Bedaquiline and Delamanid at the open market in an unchecked manner.
Let’s understand why this step is important and how it will help the country in fighting TB.
Why is India planning to restrict TB medicines in the open market?
TB is a serious disease that mostly affects the lungs. When TB patients don’t take their medicines properly, the germs inside their body become stronger. This type of TB is called drug-resistant TB.
Medicines like Bedaquiline and Delamanid are special drugs. They are given to patients when other TB medicines fail. Earlier, these medicines were protected by a patent, so they were not easily available. But now, after the patent expired, more companies can make these medicines. This means they can be found easily in the market.
While this sounds good, it also increases the risk of misuse. People might buy these medicines without a doctor’s advice or may not take them properly. If this happens, the TB germs can become even more powerful, and the medicines will stop working.
What is the government planning to do?
To stop the misuse of these TB medicines, India’s Drugs Consultative Committee (DCC) has suggested some strong steps:
✅ Special license rules: Companies that want to sell these TB medicines will have to follow national TB treatment rules.
✅ Controlled access: The medicines will mostly be available through the National TB Elimination Programme (NTEP).
✅ Warning labels on packs: Every pack of these TB medicines will have a label that clearly says — for use only under NTEP.
These steps will make sure that only those patients who really need these medicines get them, and only through proper channels.
How will this help India’s fight against TB?
By restricting the free sale of these medicines, India will be able to:
✔ Make sure that patients follow the right treatment plan.
✔ Reduce the risk of germs becoming stronger (drug-resistant TB).
✔ Track who is getting the medicines and how they are being used.
✔ Support the national plan to make India free from TB in the coming years.
What does this mean for pharma companies?
This plan will also change the way pharmaceutical companies work. Especially for a monopoly medicine company in India, this could mean working more closely with the government. Such companies, who are given special rights to sell medicines in a particular area, will have to ensure that they follow all the new rules.
Also, companies that are into pharma contract manufacturing will see new opportunities. These companies make medicines for other brands. They will have to make sure that the TB medicines they produce meet all the government’s quality and safety standards.
This is also a chance for these companies to build trust by supporting the government’s goal to eliminate TB.
The role of the National TB Elimination Programme (NTEP)
The NTEP is the main government programme that works to control and stop TB in India. Under this new plan, the NTEP will have a big role. It will make sure that:
➡ The medicines are given only to patients who really need them.
➡ Patients take the medicines properly and complete the full course.
➡ There is no misuse or overuse of these powerful TB medicines.
Conclusion
Pharma companies, whether they are monopoly medicine companies in India or pharma contract manufacturing companies, will need to align with these rules and play their part in protecting public health.
By working together — the government, pharma industry, and healthcare workers — we can move closer to a TB-free India.