Pharmaceutical units that do not comply with the revised Schedule M guidelines of the Drugs and Cosmetics Act by December 2004 will face closure and the deadline for meeting the requirements will not be extended any further, Food and Drugs Control Administration commissioner S P Adeshara said.
While medium- and large-scale units have already upgraded their systems, the small-scale pharma units, those with a turnover of less than Rs two crore, are yet to take any action in this regard, mainly because of the costs involved.
Originally scheduled to come into force from January 1, 2002, implementation of Schedule M guidelines was postponed by a year to December 2003 and again by another year to December 2004, after a series of representations made by several associations of pharmaceutical industries and even state governments.
The revised Schedule M guidelines require pharmaceutical companies to upgrade their air and water handling systems, observe strict guidelines as far as control systems are concerned, ensuring proper documentation.
There are around 300 SSI pharmaceutical units in the state, all of which are required to adhere to Schedule M guidelines by December 31, 2004.
Each SSI unit will require to spend between Rs 40 lakh and 50 lakh to upgrade air conditioning systems, water handling systems and other facilities in their units.
Less than ten per cent of the SSI pharmaceutical units have taken steps to conform to the guidelines.
Medium and large pharmaceutical units have already secured the World Health Organisation-Good Manufacturing Practices certification, which qualifies them for Schedule M guidelines.
"A meeting of all state FDCA officials was held in New Delhi last week, and the health ministry has decided that there will not be any further relaxation in the deadline. The FDCA will begin issuing closure notices to pharma companies that do not meet the deadline," Adeshara said.
The FDCA commissioner said chief minister Narendra Modi had requested for a three-year extension in the deadline, but this has not been granted.
"Units now have 11 months to upgrade their systems," he said.
Adeshara said it has been decided to revise the guidelines further, but the major areas will remain the same.
"The changes will shortly be published in the gazette, but the guidelines will more or less remain the same as far as air systems, water systems and documentation are concerned," the commissioner said.
Neeraj Kumar Singh, convener of Quality Circle, a co-operative of small-scale pharma units formed to enable the SSI pharma units to adhere to the revised guidelines, said all attempts are being made to rope in as many units as possible.
"We are attempting to ensure that the units adhere to the guidelines by working together, hence halving the costs," he said.
