Zydus Cadila on Thursday said it has received approval from the Drug Controller General of India (DCGI) for its new drug application for Saroglitazar to treat a particular condition of liver, known as NASH in India.

According to the company, with this approval, Saroglitazar has become the first global drug to be used in the treatment of NASH.

The condition starts with fat accumulation in the liver, known as non-alcoholic fatty liver disease, and progresses to cirrhosis and liver failure.

Zydus sees huge potential for the drug not only in India but also in the global markets as 10-30 per cent of the world population is affected by NASH. In India, it is estimated that NASH is prevalent in around 25 per cent of the population.

Incidentally, this is the third indication for Sarogloitazar. The drug, which was launched in India in September 2013, is at present used to treat type 2 diabetes and control high triglycerides.

Sharvil Patel, managing director of Zydus, said the company has completed phase III clinical trials for the latest indication in India.

In the US, phase II trials have been completed and the company will approach the US Food and Drug Administration (FDA) for the phase III trials there.

Patel did not rule out the possibility of the company entering into a licensing agreement with a global player to market the drug in the overseas markets at a later date.

Zydus spends around 8 per cent of its revenues on research and development.

Zydus which spends close to 8 per cent of its revenues on research & development (R&D) has a team of around 1400 research professionals of which nearly 400 scientists are involved in new molecule research programme.