Bangalore, May 17, 2010: Starting his TB-focused career in 1967, Dr Siddiqi joined the University of Maryland and developed BACTEC 460TB System and BACTEC MGIT 960 System. In 2000, he was appointed as BD Fellow, thus became one among the three scientists given the honor. Dr Salman H Siddiqi, BD Fellow who recently visited India to promote automation in TB diagnostics shares his views on various issues related to TB diagnosis.

How is the combat against tuberculosis in India and rest of the world?

The most crucial aspect in the control of TB in India is the need for rapid, accurate and cost-effective diagnosis. TB is no longer a poor man’s disease, it is capable of influencing the economy as it is diminishing the work force. However, it is a treatable disease, with the coordinated efforts of public and private bodies and by using effective and rapid diagnostic technology, we can significantly reduce the impact of TB.

TB is a leading killer of people with HIV — up to half the deaths of HIV/AIDS patients result from TB and a person with both diseases can be four times more likely to die during TB treatment than someone infected with TB alone. The emergence of multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), where patients cannot be treated with first-line drugs (or, in the case of XDR-TB, more expensive second-line drugs), further underscores the need for a new generation of TB drugs.

The existing treatment for TB is a cocktail of drugs that must be taken for 6–8 months. Often, one of the biggest challenges facing healthcare professionals is in ensuring that their patients finish the course of treatment.
Another growing challenge is the increasing number of people infected with TB who are also living with HIV. In 2008, 15 percent (1.4 million) of the 9.4 million new TB cases were in people with HIV. The recent findings suggest that the WHO spending on the diagnostics is around the 9.7 percent and maximum of 34.5 percent on drugs.

What are the latest technologies available for TB diagnosis?

Diagnosing tuberculosis has always been a challenge in terms of accuracy and reporting time. Tests developed more than 100 years ago are still considered as 'gold standards'. AFB smears, the oldest test, detects only 50 percent of the active TB cases yet it remains the mostly used test in the world.

Culture is considered as the gold standard method, however, solid culture media take almost 6-8 weeks for detection thereby resulting in loss of precious time and increasing the chances of transmission of the disease to other individuals. As compared to that, liquid culture systems (BD Bactec MGIT^TM 960) are much quicker and are able to provide results within 10-12 days. In fact liquid culture systems are the most comprehensive solution to TB diagnosis and have also been recommended by the WHO for adoption in resource constrained countries in 2007.

In addition, the sensitivity against the first line drugs has become a major concern among physicians treating TB. It is therefore critical to diagnose the drug susceptibility pattern of the patient effectively. The liquid culture systems are now standardized for both first and second line drug susceptibility testing.

What are the drawbacks in TB diagnosis in the developed and developing countries?

In the US, the diagnosis is very critical and part of high-end healthcare facilities provided by the government. Whereas in developing countries such as India and China, the situation is different. India and China together account for almost 50 percent of the global MDR-TB burden (WHO Global Report on TB, 2009).

China has the fund but they lack focus. India has enough money and now the government is gearing to develop laboratory capacity for diagnosis of MDR/ XDR–TB. However, the challenge is to build awareness among the masses so that they come forward for diagnosis.

What are the challenges and strategies followed by BD for India market?

The major problem with TB is that it spreads much faster than the diagnosis. In India, we have a good support system and it is important to collaborate with the government. The social structure in India is also a challenge and lack of awareness can become a hurdle for proper diagnosis of the disease. BD in India is working with both Foundation for Innovative New Diagnostics (FIND) and the National TB program (RNTCP) for developing laboratory capacity. The Government of India has plans to set up liquid culture facilities in 28 intermediate reference labs that will provide a significant boost to the government’s DOTS plus program.

What are your comments on the regulatory system in India?

The regulatory process of this country needs some changes in terms of approval time. Sometimes, it creates more delay. The segregation of diagnostics as a separate vertical within biotech industry, but different from biosuppliers, can help in reducing the cost of technology. There is a heavy duty on the import of diagnostic products. TB being a poor man's disease makes it difficult for them to afford the same. Therefore, the need of the hour is that life saving diagnostics should not be put in the same category as the other biosupplier items.

What are the major TB research initiatives happening in India?

Research in India is becoming more relevant with each passing day. It is taking off towards the new frontiers and one can see the initiatives being taken by the various public institutes in this regard. Moreover, the younger generation has started to take over and you can see them all over the world. Despite the limited resources, the Indian scientists and students are doing remarkably well.