Three years ago the Council of Scientific and Industrial Research (CSIR) had announced that it would conduct a drug trial to test a novel drug – regimen for tuberculosis (TB). However, after three years, according to some officials who have been involved in this programme, the project is hampered by the lack of funds.
An officer revealed that the project was in the Intensive Care Unit (ICU) and unless the Council of Scientific and Industrial Research took a decision it was surely going to die.
In January 2014, a phase 26 trial was approved by the Drug Controller General of India. The DCGI acts as a referee for drug trial in the country.
A phase 26 trial, a limited test of a prospective drug in humans to prove its potency, is to test a combination of three TB drugs to treat Multi- Drug Resistant Tuberculosis (MDR-TB).
This combination has been termed PaMZ (PA-824 moxifloxacin + Pyrazinamide). This combination promises to shorter the treatment time by the least a third. Moreover, it was quite effective even when tested on HIV patients.
The drug was developed in collaboration with the International Global Alliance on Tuberculosis. It was ready to go through large – scale trials last years in South Africa. This large scale trial was named phase 3.
However, there appeared some reviews which are reconsidering these trials on the grounds that it has not performed as well as it was desired to in HIV patients.
World Health Organization has emphatically reported that the TB as one of the world’s deadliest diseases, kills an estimated 1.5 million people annually.
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According to WHO’s report approximately 190,000 people did of MDR-TB (Multi- Drug- Resistant Tuberculosis). It is very important to note here that about more than half people who did of this disease belonged to China, India Russian Federation.
In 2014, 1.5 million people died of TB of these people 0.4 million were HIV positive. TB now annually kills more people worldwide than HIV. People having both TB and HIV when they die are internationally classified as having died of HIV.
Currently, patients of MDR-TB need 18 to 24 months of treatment. This treatment involves several pills and daily injections for at least six months.
The drug trial would have provided not only the health benefits but also would have been the first such attempt by the Council of Scientific and Industrial Research- led Open Source Drug Development (OSDD) consortium. This attempt was a beginning for discovering and testing new drugs in India for infectious diseases, which are also widespread in poor countries, by engaging expertise outside the ambit of traditional pharmaceutical companies.
Most drugs available in India are reverse- engineered versions of drugs developed in the United States or Europe. The OSDD since 2015, however, has been suspended as a Council of Scientific and Industrial Research project. According to a senior doctor, who was involved with the PaMZ trial it was “uncertain” whether funds would be granted next year or not. He further said that there had been some concerns over the efficacy of this project at the international level; however, trial was still on.
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