Ministry of Micro, Small and Medium Enterprises (MSME) will soon launch a comprehensive survey of small scale drugs and pharma units in the country to assess the impact the amendment of Drugs and Cosmetics Act with regard to the Schedule M norms, as suggested by the Parliamentary panel on subordinate legislation last year.

The goal of the survey is to collect information on the total number of pharma units including state-wise break-up, total number of Schedule M compliant units, names of units with full addresses which have been closed since July 1, 2005 due to the non-compliance of Schedule M norms, cases in which licenses have been surrendered by the manufacturers, and cases in which licenses have been suspended or cancelled by the authorities due to the non-compliance of revised norm. It will also collect the names of units which are partly compliant in respect of categories while license for other categories either suspended or cancelled, sources said.

The 181st report of the Committee on Subordinate Legislation, Rajya Sabha, had called for such a survey. "The committee takes a very serious view of instances of closure of small units in certain states. The committee takes into cognizance the concerns raised by the small manufacturers over the possibility that the proposed amendments were likely to favour the big manufacturers and the MNCs and deny the smaller units the level-playing filed even in the domestic market. The Committee therefore recommends that MSME Development Organisation along with the DTAB should conduct a survey to ascertain the extent of cases of closure of SSIs in the pharma sector due to non-compliance of revised Schedule M ever since it became applicable," the report had said.

The report was considered by the MSME after it was forwarded by the Health Ministry and has decided to hold the survey mainly to ascertain the cases of closure of units. Following this, the additional development commissioner (MSME) is meeting all the stakeholders and subject matter specialists on April 16 to examine the terms of reference of the proposed study, sources said.