Small pharma firms in Himachal want deadline for upgrade extended

Pharmaceutical units having a turnover of below Rs 50 crore, which have been facing a grim financial scenario ever since the Covid breakout in 2020, have sought the extension of the timeline for the implementation of the revised Schedule M manufacturing standards till December 2026.

Notified in December 2023, these norms targeting quality improvement are to be implemented by the year-end. The Union Ministry of Health and Family Welfare had granted a conditional extension to Micro Small and Medium Enterprises (MSME) having a turnover of less than Rs 250 crore in January this year. They were to submit their plans for the upgrade of their units to the central licensing authority by May 11 to convey their seriousness.

“Only 122 of the 655 firms have complied with this stipulation while at least 400 small firms having investment less than Rs 50 crore in Himachal now face an uncertain future if the Centre does not grant any extension,” fear industry sources. Once upgraded, these units will be on a par with the global World Health Organisation’s manufacturing standards.

Rajesh Gupta, Laghu Udyog Bharti’s All India Pharma wing head, who recently met Union Health and Family Welfare Minister JP Nadda in New Delhi, says that industries, which are unable to bear the huge financial liability required for ugrade, are largely smaller firms having a turnover of up to Rs 50 crore. “We have sought extension of the timeline till December 2026 for the implementation of the Schedule M as smaller units are facing problems in arranging requisite funds for upgrade to the desired level.”

He says that at least 400 such units in Himachal and more than 4,000 at the national level have failed to submit their extension plans in the stipulated period, which will force them to close their firms if the ministry doesn’t extend the timeline. “Bigger units can’t be equated with smaller ones having a turnover of up to Rs 50 crore, as the latter have limited financial resources at their disposal and arranging funds through loans or by selling their other assets will require time, which should be granted,” says Gupta.

The association also argues that In Himachal, out of 665 pharma units, 255 are World Health Organisation-GMP certified and have European Union-GMP and other international certifications like the US Food and Drug Administration certifications. The remaining 410 working under the existing Schedule M rules are supposed to upgrade, as per the revised GMP norms.