While 22 pharmaceutical manufacturers in Gujarat have surrendered their manufacturing licenses following the Gujarat Food & Drug Administration (FDA) directive to stop production and show cause for not complying with the provisions of Schedule M, another 100 units have informed the authorities of their compliance to escape closure.

The manufacturers informed the state FDA that business has become unviable for them due to various reasons and in the circumstances, it was difficult for them to comply with the rule and then continue production. "They informed us to surrender their manufacturing licenses and the process is going on" Dr.S.P.Adeshera, Commissioner, Gujarat FDA told Pharmabiz.

He said about 100 manufacturers, out of the 250 odd notice served units, have so far informed the FDA that they have complied with the Schedule M norms. The process of inspection is going on and these companies would be allowed to restart production, said the Commissioner. With this, the number of units facing closure due to the rule has come down to less than 150 in the state.

The state FDA had sent show cause notices to 256 units in the state for not complying with the provisions of Schedule M and to stop manufacturing with immediate effect, within a month of expiry of the Schedule M deadline of 1st July 2005. Gujarat is the first state in the country to implement the Schedule M norms strictly. The FDA had made it clear that it would cancel the manufacturing licenses of companies found to violate the directive to stop production for not complying with the norms.

As Pharmabiz reported earlier, the Gujarat FDA had categorized the 940 odd Revised Schedule M applicable units in the state into six groups, as part of monitoring the implementation process. The first group I (a) consists of units that have WHO GMP compliant facilities (about 20 to 30 units), 1 (b) of units with WHO GMP facilities but in the process of intimating the FDA of the compliance status. The second category was of units that were licensed after the revised Schedule M norms announcement in 2001, and the third category with old plants prior to the 2001 notification and has already intimated the FDA on complying with the norms. The fourth category was 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 were excluded from the FDA's hit list. The fifth category of units that have either initiated or completed the modernization process, but yet to intimate the FDA on the status of compliance, and the sixth category of units that have not initiated any move to comply with the norms, were served with notices to stop production immediately.