Drug Makers in India Get Busier than ever, Stays Steps Ahead of FDA

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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 U.S. 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.