An assessment carried out by the Ministry of Small Scale Industries (SSI) on the compliance level of Schedule M by small scale drug units has revealed that 82% of the SSI drug makers have either completed, or on the path of completing the upgradation as prescribed under the revised good manufacturing norms. Expressing surprise over the findings of the SSI ministry, Confederation of Indian Pharmaceutical Industries (CIPI) SSI, has termed the report misleading.
Interestingly, the survey was carried out by the SSI ministry after the Parliamentary Standing Committee on Subordinate Legislation (Rajya Sabha) wanted the exact position of Schedule M compliance in the country. The parliamentary panel was looking into the plea made by CIPI on the need for further relaxation of Schedule M as majority of the SSI units are finding it difficult to implement. The SSI ministry assessment has now contradicted this claim.
According to the ministry assessment, only 9% of the SSI drug units are likely to be closed down due to non-compliance of Schedule M. Another 9% have shifted to excise free zones thereby building new Schedule M compliant facilities. The rest (82%) are in the process of complying with the mandatory norms, the survey suggested.
Commenting on the ministry finding, Lalit Kumar Jain, Co-chairman, CIPI said that the survey has been cleverly done to create an impression that majority of the SSI units are complying with the new norms. "The survey does not give a clear indication of how many SSIs have really upgraded their facilities. While the actual compliance level could be as less as 2% and 80% having merely shown their intention to upgrade their facilities and remain functional, it cannot be clubbed together to say that 82% are finding the present Schedule M norms acceptable," he said.
Citing an example, he pointed out that the Haryana drugs control department, which had asked the SSI units to come forward and seek department help to upgrade their facilities, is yet to get any proposals from the SSIs.
It should be noted that all earlier attempts of the SSIs to pressurise the Health Ministry for a further extension of review committee had failed. The ministry had clarified that the SSIs had already been given sufficient time to comply with the changed requirements as per new Schedule M and no further relaxation was needed.