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Breaking new: FDA cancels licences of 4 pharma companies in pune division over violation of GMP norms

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The Food and Drug Administration (FDA) has cancelled licences of four pharmaceutical companies in Pune division after they were found violating norms.

The four companies were found flouting Good Manufacturing Practices (GMP) norms. Licences of 23 other errant manufacturing companies were also suspended
The four companies — three in Pune district and one in Solapur — have appealed against the decision.
The licences were cancelled/suspended after drug inspectors made surprise visits to these facilities between April 1, 2017, and March 31, 2018, an official said.

“All the companies have been asked to take corrective measures for the lacunae found by the inspectors,” said Vidyadhar Jawadekar, joint commissioner (drugs), FDA, Pune division.

“Our inspectors routinely visit drug manufacturing companies to see whether they follow GMP in their manufacturing processes,” Jawadekar elaborated.

“The inspectors found that the four pharma companies were not following the norms. Initially, we issued them show cause notices. They submitted responses, which were unsatisfactory, so we cancelled their licences,” he said.

All the four are small manufacturing units. “Most of them are new,” he said.

“These regulations contain the minimum requirements for the methods, facilities, equipment, personnel and control activities used in the manufacturing, processing and packaging of a therapeutic product,” states the government framework on the GMP in drug manufacturing. GMP also applies to active pharmaceutical ingredients (APIs).
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