Indian Drugmakers Seek to Partner, Not Compete With U.S. Firms

India's continued emergence as one of the world's leading drug-manufacturing centers may be causing some U.S. firms to look over their shoulders, but Indian drugmakers say their goal is to partner with their American counterparts, not compete with them.

"The perception of India is that Indian companies are coming in as competitors," said Dilip Shah, secretary general of the Indian Pharmaceutical Alliance, an organization formed by eight of India's largest drug firms. "[This is] not true. They are integrated players seeking niche markets. They have no intention of coming and integrating in markets outside of India."

India's drug-manufacturing industry has taken off in recent years, particularly in the area of active pharmaceutical ingredient (API) production. In 1985, India didn't have a single FDA-approved API facility, but as of 2004, the country had a total of 105 operating API plants, said Shah, who spoke at the Generic Pharmaceutical Association's API conference.

Similarly, the number of drug master file (DMF) submissions to the FDA from Indian firms has grown sharply, rising from 38 DMFs in 1995 to nearly 580 in 2004, Shah said.