With the implementation of Schedule M norms coupled with a number of external and internal factors are forcing closure of thousands of small scale pharmaceutical units, the health ministry has initiated some welcome moves and is in consultations with the chemicals ministry to extend some sops including financial assistance to the SSI sector.
The health ministry has written to the chemicals ministry on the possibility of extending soft loans to the struggling SSIs to help them comply with the Schedule M norms and survive the challenging circumstances.
Taking the initiative seriously, the health ministry also is collecting information from the Department of Small Scale Industry with a view to come out with some consolation schemes for the sector, sources said.
At the same time, the Centre made it clear that it could not go back on the mandatory Schedule M norms in view of ensuring the quality of drugs. The data available with the health ministry shows that a large number of SSI firms have been closed. In Mumbai region alone as many as 47 firms were closed after the Schedule M norms were made compulsory.
"Good Manufacturing Practices (GMP) were revised and upgraded in consultation with all stakeholders involved including the Small Scale Industries in 2000-2001. The concerns expressed during the draft stage were taken into account and incorporated in final Notification vide GSR 894 (E) dated 11.12.2001. Subsequently, based on consideration of representation from Small Scale industry, further relaxations were given vide GSR 431(E) dated 30.06.2005. Some manufacturers may find it difficult to follow the norms of Schedule M and to be able to manufacture quality and safe drugs. However, large numbers of manufacturers have complied with or are complying with the norms of Schedule M. These provisions are enforced by the State Drug Control Authorities,'' sources explained.
As per the latest records over 800 SSI pharma units have implemented the GMP norms. As many as 788 units have either cancelled or suspended operations while over 150 units are in the process of implementing Schedule M. Gujarat led the tally with 407 units now under Schedule M practices. At the same time, 176 units did not comply with the norms so far and 198 were exempted while 64 units cancelled the process during the process.