300 drug units in Gujarat get closure notices

Food and Drug Control Administration (FDCA) has served closure notices to three hundred pharmaceutical manufacturing units in Gujarat, owing to non-compliance of quality manufacturing norms, current Good Manufacturing Practices (cGMP), announced by the Union Health ministry.

The drug units that have been issued final notices of closure were given extensions as per the small scale industry (SSI) relaxations in the manufacturing quality norms announced in 2001. The final deadline for implementing the quality norms expired on June 30 this year.

Subodh P Adeshara, commissioner, FDCA, Gujarat, said that notices have been issued to 225 units to stop manufacturing immediately.

"We had scrutinised about 1200 licences as a preparatory exercise just before the expiry of the deadline. Exempting about 260 medical disposable manufacturing units, we have now picked up 940 units under the purview of the quality manufacturing norms, Schedule M of the Drugs & Cosmetics Act, in the state. Out of this 940 units, some are currently in the process of implementing the desired standards in the facilities. Though these units may be given some more time to comply with the standards, rest will be issued closure notices immediately" Adeshara said.

Meanwhile, the sources from the Indian Drug Manufacturers Association (IDMA), Gujarat chapter, said that the association has met the state health minister, I K Jadeja, to put pressure on the central government for further extension to the cGMP deadline.

Though the IDMA sources confirmed that few hundred units are likely to be closed , it would seek immediate financial and other assistance from the state government to protect the rest.

Massive industry closure would make about 1,50,000 people jobless and the pharma production will lose around Rs 1500 crore.