The Central Government has decided to extend the deadline for Schedule M by another six months, offering a big relief to the non-GMP complainant drug manufacturing SSI units in India facing closure threat after 31st December 2004.
The Drug Controller General of India (DCGI) confirmed this to a 45 member Confederation of Indian Pharmaceutical Industries (CIPI) delegation in New Delhi today. The extension comes in the wake of the consistent pressure from the SSIs, and considering the delay happened in notifying the amendments to Schedule M. The DCGI has recommended in this regard to the Union Health Minister, it is learnt.
As Pharmabiz reported earlier, the SSIs were complaining that the amendments to Schedule M came in the last moment, less than one month to the deadline, and it is necessary to have further time for complying with the deadline. Further, instead of further diluting the norms, the amendments brought in further stringent control measures.
Reacting to the development, T S Jaishankar, Chairman, CIPI said though it is a welcome move on the part of the Government to offer six more months for the units, it is also important to further dilute the Schedule M norms for practical considerations. "Our main demand is to further ease the norms, and the Government is yet to consider it" noted Jaishankar.
S.V.Veeramani, Chairman of the Indian Drug Manufacturers Association (IDMA) SSI Sub Committee, said though belated, the SSI units that were so far complacent should immediately wake up to comply with the norms. "Various banks like SIDBI and SBI are willing to help the units. It is upto them to avail of this generosity from Government and survive" said Veeramani.