Ministry of Micro, Small and Medium Enterprises (MSME), which is about to begin a detailed survey on the extent of cases of closures of small scale pharma units, has pointed out that the changes in IPR regime and amendments in Schedule M have put severe financial strain on the domestic pharma industry.

“The changes to the IPR regime post 2005, amendments in Schedule M of Drugs and Cosmetics Rules, and modifications in the international requirements for exports of drugs and pharmaceuticals have put severe strain on the Indian pharmaceutical industry especially the small enterprises,” according to a note prepared by the MSME ahead of launching the survey.

“They (units) have to make definite choices in terms of products, quality standards, prices, production, R &D, marketing and organisation. While the market for generic formulations/bulk drugs, loan-licensing could be considered an opportunity by the industry, lack of adequate awareness on the impact of the new patent regime and GMP compliance on the business mode and alternate courses of action would an inhibitor to industry growth and vibrancy,” it said.

The MSME said the requirements of international standards of manufacturing practices were increasing day by day. Some of the manufacturers were finding it difficult to comply with the revised norms while majority of units have enforced the norms. “As a result of this, it is reported that some of the small sale units have partially closed or completely closed down their manufacturing activities,’’ the note said.

The goal of the survey, as recommended by the Parliamentary committee on subordinate legislation, 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. The findings of the survey will be forwarded to be incorporated in the action taken report by the panel.