Indian Pharma Companies Should Follow Strict Regulations: U.S. FDA


"If there is a deficiency in a firm and the firm knows or does not know and we point deficiency in the firm that is in the interest of the public health, that is in the interest of India's health and global health," he said.

"Our mandate is to ensure that the medicines and medical products that come into the U.S. are of the same quality, have same standards and have same safety standards as medicines that come out in the U.S.

"So this requires us to be more proactive, be more engaging. That was not the case 10 years ago," Lal said.

FDA has a special focus on India given that it ranks number two in pharmaceuticals trade with the U.S., and that 40 percent of the over the counter prescription drug comes from India, he said.

FDA mission is to make sure that the products that come into the United States are of the highest quality, have safety built into them and are effective, he said.

"India office of the agency allows it to work with the regulators to share, to listen, to learn. It allows us to build capacity when needed and requested. It allows us to work with the industry, to explain what are the system, what are the qualities that we prescribe," he added.

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Source: PTI