More than 1000 small scale drug units are likely to be wiped out from the pharmaceutical manufacturing scene in India soon with the progress of implementation of revised Schedule M norms and the proposed Good Laboratory Practices.

If that happens, the total number of SSIs in the industry will shrink to less than 2500 units during in another one year.

The industry sources said that already more than 1000 units have closed down in the past one year in different parts of the country and at least another 1000 units are unlikely to apply for renewal of their licenses. Most of the units have to renew their manufacturing licenses by early 2007 after a five year license period.

As per recent official statistics, out of a total of 4176 registered SSI drug makers, 707 units have either closed or are in the process of getting their licenses suspended due to the Schedule M mandate. While 1672 units have already upgraded their facilities, another 1797 units are yet to comply with the norms.

Sources said that the actual figures of closed units are more than this figure as officially the units are yet to surrender their licenses. Many units are just operating due to various reasons like credit, raw material backlog etc. Many units which were hoping to comply with the norms, thanks to the lenient attitude of various State Drug Controllers, are now thinking of downing shutters due to the recently proposed GLP norm, which mandates another additional investment of more than Rs 1 crore. Those who managed the funds wisely migrated to excise free zones in North India.

As reported in Pharmabiz, the Subordinate Legislation Committee of Parliament, headed by A Vijayaraghavan MP is conducting an impact assessment on Schedule M, by visiting factories in various parts of the country. The team will be in Tamil Nadu and Kerala from January 1, 2007 in their Southern leg of inspection and is likely to submit their report within a month.

"If the committee had done this assessment at least an year ago, numerous units could have been saved. The GLP norms will hasten closure of more units and I am sure at least 1000 units are unlikely to renew their licenses" T S Jaishankar, chairman Confederation of Indian Pharmaceutical Industries (CIPI-ssi) told Pharmabiz.

As per the statistics, the states that saw most of closure or suspension of licenses were Maharashtra (107 units), Madhya Pradesh (72), Gujarat (64), West Bengal (40) and Andhra Pradesh (29). The maximum number of Schedule M compliant SSI units was also from these states with Gujarat (407), Maharashtra (358) and Andhra Pradesh (146) leading the list. The states of Karnataka (100), Uttar Pradesh (126) and Haryana (70) were also among the areas where maximum Schedule M compliance has taken place.