Heads of two of India’s largest drug makers said integration of electronic systems to prevent quality lapses in factories is going slower than expected, as the industry looks to adapt to increased scrutiny from regulators in the developed world that have resulted in sanctions and slowed sales.
Heads of two of India’s largest drug makers said integration of electronic systems to prevent quality lapses in factories is going slower than expected, as the industry looks to adapt to increased scrutiny from regulators in the developed world that have resulted in sanctions and slowed sales. “This is a much more digital world than where pharma companies are and definitely where generic companies are,” Nilesh Gupta, managing director of Lupin Ltd., India’s second most valuable pharmaceutical company, said at the the Indian Pharmaceutical Forum in Mumbai. “I think we should use technology and data a lot more.”
Gupta said his firm has been trying to build a computerized early warning system in its factories but hasn’t been able to find an information technology vendor that can do it. Meanwhile, a project by Sun Pharmaceutical Industries Ltd., India’s largest drug maker, to make all its labs paperless and record all the processes electronically is 12-15 months behind schedule, Managing Director Dilip Shanghvi said at the same conference. “We underestimated the scale and complexity of what we were trying to do,” he said.
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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 Indian pharmaceutical industry’s explosive growth over the past decade has made the nation host to the most FDA-approved plants outside the U.S. The regulator has increased staff in India in recent years, facilitating an inspection blitz that uncovered violations at multiple companies — ranging from deleted data to unsanitary conditions — and resulted in regulatory sanctions, including import bans.
India’s reputation as a leader in technology development could help pharmaceutical companies, Shanghvi said.
“We have the technology and capability to develop IT tools in this country,” he said. “So how do we use those capabilities to ensure almost all the data that we generate is captured electronically so that the flexibility and potential risk we carry as companies can be significantly reduced.”