Lupin sets off down Indian pharma's road to redemption

In 28 years in India's pharmaceuticals sector, Rajiv Desai has never been busier. Most of the last six months on his desk calendar is marked green, indicating visits to the 12 plants of Lupin, India's No. 2 drugmaker, where Desai is a senior quality control executive. Only one day is red - a day off. That's what is needed these days to satisfy the US Food and Drug Administration that standards are being met. "In this sector, you're only as good as your last inspection," Desai said in his office in suburban Mumbai.

Often dubbed "the pharmacy of the world", India is home to the most FDA-approved plants outside of the United States and supplies about 40 percent of the $70 billion worth of generic drugs sold in the country. But sanctions and bans have badly damaged India's reputation and slowed growth in the $16 billion sector. Drug exports fell in the fiscal year ending in March 2017.

More than 40 plants have been banned by the FDA for issues ranging from data fraud to hygiene since India's then-largest drugmaker Ranbaxy was pulled up for serious violations in 2008. Drug companies have spent millions of dollars on training, new equipment and foreign consultants.

Yet the Indian Pharmaceutical Alliance of the top 20 firms says its members still need at least five more years to get manufacturing standards and data reliability up to scratch. The case of Lupin, whose shares are down about 27 percent since 2015 compared to a 13 percent drop in the Nifty pharma index, shows why.

The FDA is in the next few months expected to clear Lupin's Goa plant, which supplies around a third of its US sales, of problems found in 2015, Desai said.

-Reuters, Goa