FDA warning letters and bans on products from Indian drugmakers has generated substantial debate in the last year, both in the U.S. and in India. Some Indian pharma officials and regulators have responded defensively, saying the country is being picked on. Still, others are suggesting it is time for the industry to step up its manufacturing game with management taking the lead to overcome organizational inertia.
AG Raghu, technical director for Indian active pharmaceutical ingredient maker Gland Chemicals, recently told an industry group that Indian drugmakers need to create a "culture of continuous improvement." They need to rely on FDA guidance and then learn the processes necessary to make drugs "right the first time," Pharmabiz reports. Raghu told the publication that Indian drugmakers want to meet higher standards but have not always understood the processes.
Raghu laid out his rational in a presentation to the Karnataka branch of the Indian Pharmaceutical Association, Pharmabiz reports. He told the group that warning letters from the FDA have called into question laboratory procedures from some drugmakers and their failure to take corrective action. This has led Indian regulators to look more closely at drugmakers there as well, he pointed out.
Serious problems found by the FDA at two Ranbaxy Laboratories plants, two from Wockhardt, one from Sun Pharmaceuticals, and a plant in India operated by Canada's Apotex, have resulted in bans on most of their products being imported into the U.S. Retesting and often faking analytics of APIs and drugs that initially failed sample testing was a theme common to all of them.
A small group of doctors and researchers have been trying to get congressional notice for their claims that Indian-made drugs are not as safe and effective as those made by Western generics companies. They have pointed to the FDA actions to support their claims that Indian-made generic drugs don't work well on their patients, although the FDA has questioned the validity of some of their research. Some Indian officials have, in turn, said the FDA actions indicate minor shortcomings with laboratory processes but not necessarily with the quality of Indian products. They see a conspiracy.
"We have heard doctors making generalized statements, without being specific on any product or company," D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, has said. "This is a deliberate and serious campaign to malign the Indian generic industry."
But Raghu told Pharmabiz it is time for drugmakers to move away from "blind compliance." It is time for management to get team leaders onto plant floors, expect continual improvements and work toward zero defects. And achieving operational excellence will bring added rewards in efficiency. "It is now evident that the global regulatory expectations are moving towards operational excellence where quality becomes the fabric of operation," he said.
- read the Pharmabiz story