Zydus Cadila receives drug regulator's nod for NAFLD medicine in India

Representative photo of pills

Drug firm ZydusCadila on Wednesday said it has received approval from the Drug Controller General of India (DCGI) for Saroglitazar Mg, used for the treatment of non-alcoholic fatty liver disease (NAFLD), in the country.

The Drug Controller General of India (DCGI) has approved the new drug application (NDA) for Saroglitazar Mg for the treatment of non-alcoholic fatty liver disease (NAFLD) in India, Zydus Cadila said in a regulatory filing.

Zydus Cadila said the prevalence of NAFLD in India is estimated to be nearly 25-30 per cent of the general population.

Non-Alcoholic Fatty Liver Disease (NAFLD) is a progressive disease of the liver, which starts with fat accumulation in the liver in patients who do not consume alcohol or take it in insignificant amounts, but have risk factors such as overweight or obesity, diabetes mellitus (high blood sugar), hypertension (high blood pressure) or dyslipidemia (abnormal blood lipids).

This NAFLD condition could progress to NASH, cirrhosis and liver failure.

It is a large unmet medical need as there is currently no approved drug for the treatment of NAFLD and NASH anywhere in the world, Zydus Cadila said.

Pankaj Patel, the Chairman of Zydus Group, said with Saroglitazar Mg, the company has been able to successfully offer an innovative medicine for dealing with chronic liver diseases like NAFLD and NASH and helping patients in leading healthier lives.

Saroglitazar Mg was launched in India in September 2013, for the treatment of diabetic dyslipidemia and hypertriglyceridemia in patients with type-2 diabetes not controlled by statins alone.

In January this year, Saroglitazar Mg received an approval for the treatment of Type 2 Diabetes Mellitus. In March 2020, Saroglitazar Mg had received approval for the treatment of NASH.


(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)


Dear Reader,


Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.

We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor

Business Standard is now on Telegram.
For insightful reports and views on business, markets, politics and other issues, subscribe to our official Telegram channel