Even as the final deadline for complying with revised Schedule M only eight months'away, the small scale drug manufacturers in the country are in a 'to be or not to be' mood. Most of them are undecided to go ahead with implementing the norms or to wait for dilution of certain specific clauses that could reduce the financial burden.
While extending the deadline by one year during the last week of December 2003, the government had agreed in principle to dilute certain provisions in the revised Schedule M norms with a view to help the industry adopt the standards within the extended 12 months and to resolve a few practical difficulties in implementing the norms.
However, the same has not been notified even after four months. Since the parliament election process was on, an official announcement in this regard was likely to be delayed further by many months. Since the parliament was dissolved within a few weeks after the grant of deadline extension, neither the officialdom nor the ministry could do much progress in re-evaluating and incorporating the changes in rules.
Currently, most of the units that were in the process of implementing the norms, have virtually suspended the work -- anticipating the announcement from the new government at the Centre, informed sources told Pharmabiz.
The proposed clauses include dilution of norms related to setting up of mandatory air-handling facilities in production and storage, ancillary area specifications like requirement of area for tableting, capsuling and punching, mandatory quality control equipments etc.
During the final lap of discussions for extending the deadline, the Government had also agreed to do away with a few provisions related to mandatory quality control equipments like HPLC machines. It was brought to the notice of the authorities that such a machine has capacity to the tune of testing about 500 samples per day and costs about Rs.7 lakhs.
However, the requirement for an SSI drug unit is usually about 10 samples per day, and hence such a machine is a burden on the manufacturers.
Numerous high quality laboratories with advanced infrastructure were available in most of the pharma hubs in the country, and the industry could outsource their services as done so far, the SSI leaders had represented the Union Health Minister and the officials. The authorities had agreed to favourably review the norms, though not implemented yet.
Though it was a welcome move to give powers to the state drug control authorities to relax or alter the provisions of Schedule M, the Centre should come out with the promised dilution of provisions in Revised Schedule M, felt the sources.