In the wake of the Union Health Ministry's recent decision to revoke the suspension of all the three PSU vaccine units and allowing them three years time to fully comply with the GMP norms, the department of pharmaceuticals (DoP) will take up the issue of dilution of Schedule M compliance to the SSI pharma units with the Health Ministry.

According to sources, senior DoP officials have assured the SSI pharma associations that the department will take up the issue with the health ministry in the wake of the recent developments in which the Health Ministry not only revoked the suspension of the three PSU units but also allowed these units three years time to comply the GMP norms. The Health Ministry had suspended the manufacturing licenses of CRI Kasauli, PII Coonoor and the BCG Vaccine Laboratory Chennai on January 15, 2008 for non-compliance of GMP norms.

Buoyed by the Health Ministry's decision to revoke the suspension of all the three PSU vaccine units, the SSI pharma associations have been demanding to the government to relax the norms for them. Their demands stem from the argument that when the government itself, with its vast resources, could not comply with the GMP norms for its institutions for the last several years, how can the poor SSI units can comply the norms, that too without any support from the government.

Ever since the government introduced the stringent Schedule M norms way back in 2005, the SSIs, have been seeking for the dilution of the norms and for allowing more time to comply with the norms. The SSIs have also been demanding to provide some financial assistance from the government to upgrade their units to meet the stringent Schedule M norms. As the government dilly-dallied on the issue for several years, hundreds of SSI units across the country closed their units as they could not comply with the stringent Schedule M norms as it involved a huge amount which was beyond the capacity of the SSI units.

For long, the SSIs have been demanding to relax the clauses like space requirements, air handling units (AHU) and lengthy documentation in the revised schedule M. The SSIs are particularly upset over the mandatory space requirement, AHUs and documentation. They lament that while WHO GMP is silent on space stipulations, Schedule M has specified spaces for each section namely injectables, tablets, syrups and capsules, etc irrespective of the fact whether it is SSI or large units. Many SSIs do not have spare space available to extend and comply with Schedule M.