Gujarat FDA orders 300 pharma units to close down
The Gujarat Food and Drugs Control Administration (FDA) has decided to close down in between 200 to 300 pharmaceutical units immediately for not complying with the revised Schedule M provisions.
Notices to stop manufacturing with immediate effect have been already sent to 80 units in the last week and rest of the units would be served closure notices within a couple of weeks.
"Now we are scrutinizing the 1000 odd files with us, since we had done the necessary homework before the 30th June deadline. The notice served units will have to immediately stop production. They can come back to us and inform they have complied with the Revised Schedule M. We will inspect and then think of allowing them to restart manufacturing activities and restoration of their manufacturing licenses," S P Adeshera, Commissioner, Gujarat FDA told Pharmabiz.
He said the Gujarat FDA had categorized the 950 odd Revised Schedule M applicable units in the state into six categories, as part of monitoring the implementation process. The first category I (a) is of units that have WHO GMP compliant facilities (about 20 to 30 units), 1 (b) of units that have WHO GMP facilities but in the process of intimating the FDA of the compliance status.
The second category is of units that have been licensed after the revised Schedule M norms announcement in 2001, and complies with the norms. The third category is of units with old plants prior to the 2001 notification and already intimated the FDA on complying with the norms. The fourth category is of units that have their plan approved and spent about Rs 40-50 lakhs for complying with the norms, but with minor works remaining for the final approval. These four categories have been excluded from the FDA's hit list.
The fifth category is on units that have either initiated or completed the modernization process, but yet to intimate the FDA on the status of compliance. The sixth category is the list of units that have not initiated any move to comply with the norms. Notices to stop production and intimation on suspension of manufacturing licenses are being sent to about 200 to 300 units falling under these two categories, informed the FDA Commissioner.
June 18, 2005