Schedule M implementation gets six months extension

EHM News Bureau - New Delhi

The government has given in again to the demands of the small scale sector and extended the implementation of Schedule M by another six months to June 30, 2005.

The SSI players have been strongly lobbying with the government to get additional time as they are yet to upgrade their facilities to the new Schedule M requirement.

The notification says that in view of the representations received from SSI associations it was decided that the cut off date in case of manufacturers existing as on 11/12/2001 will be further extended by six months, i.e., up to 30/06/2005.

The government had previously also extended the deadline from December 31, 2003 to December 31, 2004, owing to pressure from industry segments. Once it was clear that the government is keen to implement the norms starting January 1, 2005, the SSI associations collectively took up the issue with the Health Minister and sought support from several MPs as well.

The Confederation of Indian Pharmaceutical Industry (CIPI) was leading in the group seeking delay in Schedule M implementation and it went ahead to demand the assessment of real need in the Indian context before going ahead with Schedule M. Rather than exploring options to upgrade the units SSIs have been buying time and continuously pestering the government to extend Schedule M deadline. It may be noted that in the notification dated November 8, 2004 had relaxed space requirements for SSI segment.

The notification said that the requirement of ancillary area shall not apply to units registered before January 1, 2002, and manufactures external preparations, oral liquids preparations, tablets, powders, capsules, ophthalmic preparations and parenteral preparations. The Schedule gives general and specific requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for certain categories of drugs.