ImageRegulatory experts also argue that the 20% change required in infrastructure includes additional space requirement, which is not possible for many units.

The country’s department of pharmaceuticals plans to provide financial assistance to micro, small and medium enterprises, or MSMEs, in the pharmaceutical sector for upgrading their facilities to meet manufacturing rules laid down by the ministry of health and family welfare, according to two government officials.

“Under this scheme, the MSMEs will get subsidy from us, under the department of MSME’s credit-linked capital subsidy scheme. Currently, the subsidy for pharmaceutical manufacturers is not enough,” said Ashok Kumar, secretary, department of pharmaceuticals under the ministry of fertilizers, chemicals and petrochemicals.

The subsidy scheme for upgrading facilities is likely to be finalized by March-end or early April. “We are holding discussions with the department of MSME and the scheme should be finalized by the end of this month or early April,” Kumar added.

This move comes after a parliamentary panel submitted a report in February on the amendment to so-called good manufacturing practices outlined in Schedule M of the Drugs and Cosmetics Rule that is aimed at ensuring that manufacturing units comply with global standards of production.

“Of course, the recommendations of the standing committee will also be looked into. The health ministry has also conveyed to us that it has no objection to our scheme,” Kumar said.

The department of MSME currently gives subsidy to small and medium enterprises, or SMEs, but, following the implementation of the revised Schedule M in 2005, this subsidy of up to Rs15 lakh has proved insufficient considering the changes various manufacturing units have to make.

In fact, within a year after its implementation in 2005, 185 MSMEs closed down in Maharashtra and 89 in Haryana. “After that additional licences to manufacture were not renewed for units if they didn’t comply with Schedule M. So, many more closed down but that has not been documented,” said Jagdeep Singh, secretary general, SME Pharma Industries Confederation, or SPIC, an industry group.

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