-PTI NEW DELHI: Notwithstanding strong warnings by the parliamentary standing committee on health, new drugs continue to be approved for marketing in the country without holding any clinical trials on Indian patients to test their safety and efficacy. Sources in the Health Ministry admit that as many as 26 new drug molecules have been approved since 2010 without testing them through drug trials on local populations. While eight new drug molecules of biologicals...

-The Economic Times Over a year ago, I had written a piece, Quo Vadis, Indian Pharma? (ET, May 11, 2012), in this column. Some key issues were highlighted in the article. Perhaps it is time to revisit the subject and bring out some current issues. Price control: Hurray, the department of pharmaceuticals has come out with a new non-intrusive price control methodology, moving from the cost-based model to the average market price...

-The Telegraph The proliferation and sales of anti-diabetes combination pills that contain two drugs to control blood sugar has stirred concerns in medical circles that a large proportion of diabetes patients in India are not receiving ideal treatment. A study by Indian and British researchers has shown that such two-drug combo pills accounted for more than half of the sales of all oral anti-diabetes medications in India last year, although doctors say...

-Newsclick.in A few weeks back Fortune magazine and CNN carried a long online blog titled ‘Dirty Medicine' by Dinesh Thakur, a former employ of Ranbaxy, where he recounts how he came across several procedural and other lapses in the company's manufacturing facilities. Since then the Fortune blog has become one of the most widely circulated and commented upon business stories in the world. The story received attention as it came in the...

-The Business Standard USFDA's zero tolerance policy requires our drug firms to reorient not just processes but organisational cultures to serve that market credibly The following two quotes from the United States Food and Drug Administration (FDA) news releases may help put the Ranbaxy controversy in perspective. The first sums up what it is that drives the FDA and the second is typical of the challenge the pharmaceutical industry faces. (1) "The consent...