Pondicherry FDA to take action against Schedule M non-compliant units by mid-April
Gireesh Babu, Chennai

The Food and Drugs Administration of Pondicherry will initiate stringent action against the drug manufacturing companies which have not complied with Schedule M, from the middle of April 2006.

The administration has sent show-cause notice to all drug manufacturing units in the state, seeking the status of Schedule M implementation until the last week of March 2006. The administration has completed its first round inspections and will commence the second round within a couple of weeks.

"We are sending show-cause notices to each and every drug manufacturers in the state, to ascertain a written status of implementation. The authority has decided to give about a month's time for the companies to comply with Schedule M. After this period, we will commence suspending the licenses of non-compliant players," G. Deenadayalan, Assistant Commissioner, FDA, Pondicherry told Pharmabiz.

In Pondicherry, where about 40 companies are active out of a total number of 70 companies. Almost 60% of the players have already complied with Schedule M and another 30% are in the process of complying with. Once the FDA commences action against the companies, 7 to 9 units in the state would have to close down, according to the officials.

"We are taking a pragmatic approach towards the implementation, as we realize that many of the small scale units are operating in rented buildings and reasonable time is needed to change their facilities. The administration has decided to wait for a month more, as the companies also have to close their accounts as the financial year ending," added Deenadayalan.

Courtesy : www.pharmabiz.com
1st April, 2006

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