The explosive growth of the Indian pharmaceutical industry over the last decade has made the nation the host of most FDA-approved plants outside the United States.
Leaders of two of India's largest drug manufacturers said the integration of electronic systems to avoid quality failures in factories is proceeding more slowly than expected, as industry intends to adapt to Enhanced regulatory oversight in developed countries.
"This is a much more digital world than where pharmaceutical companies are and definitely where generic companies are," Nilesh Gupta, Managing Director of Lupine Ltd, the second largest Indian pharmaceutical company, told Indian Pharmaceutical Forum in Mumbai. "I think we should use technology and data a lot more." Gupta said his company has been trying to build a computerized early warning system in its factories, but has not been able to find an information technology provider that can do it.
At the same time, a project by Sun Pharmaceutical Industries Ltd., the largest drug manufacturer in India, to make all its paperless laboratories and register all processes electronically is 12 to 15 months late, Director General Dilip Shanghvi at the same conference. "We underestimated the scale and complexity of what we were trying to do," he said.
A wave of unfavorable inspections of Indian pharmaceutical plants by the U.S. Food and Drug Administration have put pressure on the industry that supplies 40 percent of the generic medications consumed in the U.S. That’s also resulted in sanctions against some firms and crimped revenue in their largest export market. Generic drugs account for more than 8 in 10 U.S. prescriptions.
The regulator has increased staff in India in recent years, facilitating an inspection blitz that has uncovered violations of several companies - removed data from unsanitary conditions - and resulted in regulatory sanctions, import. India's reputation as a leader in the development of technology could help pharmaceutical companies, said Shanghvi.
"We have the technology and the ability to develop computer tools in this country," he said. "So how can we use these capabilities to ensure almost all of the data we generate is captured electronically so that the flexibility and potential risk we carry as companies can be greatly reduced.”
