FDA issued 42 GMP drug warning letters in FY 2015, a 6% reduction compared to the previous year. The agency’s enforcement efforts continue to focus on compounding pharmacies and foreign manufacturing sites, while data integrity lapses continue to grow and a UK MHRA inspector said that a different mindset is needed to resolve these problems.

For the last few years, Indian generic companies have been making headlines for all the wrong reasons, rapped by the US Food and Drug Administration over problems ranging from fudged test results to poor-quality manufacturing standards. But lately, the firms have been enjoying a run of good regulatory tidings, giving a fillip to their share prices.

Asia’s biggest biotech company, India’s Biocon Ltd, has announced it will conduct what it says is the first-ever clinical trial of a siRNA therapy in India with US partner Quark, is aimed at tackling a rare eye condition.