Karnataka drugs control department has stated that in the absence of the final notification by the Union health ministry on revised Schedule M norms, it would not be possible to take stringent action against the non-complying units in the State.
Right now, all State drugs control departments in the country have only the draft of the new Schedule M. If the pharma units have failed to comply with Schedule M, then action has to be taken. But without a final notification of Schedule M, it would be difficult to take action against the defaulters, expressed Ramakrishna Gandhi, Karnataka drugs controller.
Karnataka is emerging most regulatory compliant state with largest number of Schedule M compliant units in the country. Out of 153 units including 55 bulk drug units, 80 formulation companies, 3 Large Volume Parenterals and 15 manufacturers of injectibles, diagnostic kits, contraceptives and vaccines only 10 have not complied with Schedule M norms. “We are extremely relieved to note that Karnataka pharma units have been determined to become compliant which is an achievement in terms of excellence in quality standards,” stated the Karnataka drugs controller.
To ensure that units are well informed about the deadline and surprise checks thereafter, the Karnataka drugs controller has now issued a circular calling to ensure strict compliance of Schedule M and from July 1, 2005, the drugs inspectors will undertake a surprise checks on units to certify the facilities. If they fail to conform, then the units will be issued show cause notices after which they will be called for hearing and until such time the units will be prevented from undertaking production.
While the drug controller was non-committal on the exact number of units which are Schedule M ready he stated that he was confident that it would be over 75 per cent in the State. The department will also be able to provide a clear picture in the first week of July 2005 when the drugs control department inspectors evaluate the status of compliance, he informed.
The state’s small scale sector has made concerted efforts to gear up for Schedule M by sourcing funds from financial institutions, mainly banks. “This is a good sign as the new Schedule M requirements are on par with WHO-GMP. This will allow units to enter global markets faster when the situation in the domestic market is not that lucrative for the present,” he stated.
A practise followed in Karnataka is that all units which had set up base since 2001 are all Schedule M compliant. Units set up a decade ago are the ones, which have been recently upgraded as Schedule M plants. In some cases new facilities adhering to Schedule M standards have been set up.