The new deadline for complying with the Schedule M norms in the pharmaceutical industry is June 30. This could be the last and the final date for compliance for pharmaceutical units. The six months extension from last December 31 was granted by the Centre after a desperate plea for some more time by the small drugs units. But, there are no indications of a total compliance of these provisions by the SSIs even by June end. A Pharmabiz report last week said that out of 5000 SSIs in the country only 1000 units have adopted the norms so far. And the other 4000 units have not even started the process of implementation of the norms. Resistance to comply with the norms are more from the SSIs located in Gujarat, Maharashtra and West Bengal. Only a few units from Karnataka, Tamil Nadu, Andhra Pradesh and Kerala are refusing to fall in line. The latest excuse, the SSIs point out, for not complying with the norms is the additional financial burden being incurred by the imposition of MRP based excise duty on medicines. No doubt, the new system of excise levy has caused some inconvenience to the industry but that should not be a reason for not adopting the basic manufacturing standard in this industry.

As the government appears to be quite firm against granting any further extension, majority of these 4000 units will be forced to close down by July if they are not opting for some of the schemes already available for upgradation of their facilities. As the export production is a major activity in the pharmaceutical industry today, a total compliance of Schedule M is vital for its international image. The suggestion made by National Manufacturing Competitiveness Council in its recent meeting in Delhi last week that the Schedule M compliance should a pre requisite for export of drugs is thus significant. But the SSIs are in no mood to adopt the norms that easily. Confederation of Indian Pharmaceutical Industries, representing the SSIs, is now demanding appointment of a review committee for Schedule M norms and suspension of the June 30 deadline. SSIs are demanding a further dilution of Schedule M norms as they feel that 40 per cent of the provisions incorporated in the Schedule M are difficult to be implemented. With political support of the left parties, CIPI may be successful in exerting pressure on the government for further dilution and extension. If that happens, it is unfortunate. It is high time that CIPI realized that it should take a proactive role and convince SSIs the need for adopting already diluted norms without any further delay.