Kapil Sibal

New Delhi, Sept. 6: A new drug developed in India has emerged as the “most promising” candidate drug against tuberculosis in 40 years and might reduce treatment duration from eight to two months, industry and government officials claimed today.

The drug, developed under a research-industry partnership programme, has cleared animal trials and is now awaiting approval for clinical trials on humans, science and technology minister Kapil Sibal said.

The drug was discovered by industry partner Lupin while several laboratories of the Council of Scientific and Industrial Research (CSIR) helped establish that it is effective in animals and does not have adverse effects. “This will change the way the world looks at India,” Sibal said. “It establishes India’s leadership in drug development.”

TB is now treated with a combination of four drugs; the last one — Rifampicin — was discovered in the early 1960s. But though the existing drugs can easily cure a patient, the treatment takes about six to eight months and scientists have long looked forward to a drug that can cure in a much shorter time.

Lupin officials said their studies on animals have shown that the new drug, called Sudoterb, can completely clear tubercular infection within two months.

Lupin has sought permission from the Drugs Controller General of India to conduct clinical trials on humans. The first set of trials will be to find out whether the drug is safe for humans, while subsequent trials will examine whether it is effective.

The human trials are expected to cost Rs 50 crore and will take about four years to complete.

The Rs 25-crore development effort has so far been funded by the New Millennium Indian Technology Leadership Initiative programme managed by the CSIR that seeks to synthesise ideas from industry and research centres and get them to work together.

Lupin has filed patents on the new drug in India and in the US. CSIR director-general R. Mashelkar said Lupin was an ideal partner because the company was the world’s leading producer of standard TB drugs and had invested in research aimed at finding new drugs.

Lupin officials took the opportunity to remind Sibal that it is difficult to conduct animal trials in India because of the influence of animal rights activists on ethics committees. The trials on dogs were conducted in a foreign country.

Industry sources estimate that the market for TB drugs today is about $600 million. Multinational drug companies have not invested significantly in TB drug research because tuberculosis has not been a major concern in developed countries.