Solan: Unable to upgrade to GMP norms, 410 MSMEs seek exit road map

Ambika Sharma

Solan, April 1

The Micro Small and Medium Sector (MSME) pharmaceutical units which have expressed inability to upgrade to the revised good manufacturing practices (GMP) within a year have sought an exit road map from the Central government.

To shut ops if deadline not extended

• As many as 410 pharma micro, small and medium enterprises (MSME) will have to close operations if the Central Government doesn’t extend the December timeline for the implementation of revised good manufacturing practices (GMP) notified in 2023, within a year.
• Those units which are unable to bear the financial liability of ugrade have been forced to opt for a smooth exit.
• A sum of Rs 3 crore to Rs 10 crore was required to make the requisite modifications in a running unit.

As many as 410 pharma micro, small and medium enterprises (MSME) will have to close operations if the Central Government doesn’t extend the timeline for the implementation of revised good manufacturing practices (GMP) notified in 2023, within a year.

In Himachal, out of 665 pharma units, 255 are WHO-GMP certified and have European Union-GMP and other international certifications like USFDA. The remaining 410 working under the existing Schedule M rules are supposed to upgrade as per the revised GMP norms till December end or else could face closure.

Rajesh Gupta, president, Himachal Drug Manufacturers Association, informed that those units which are unable to bear the financial liability of ugrade have been forced to opt for a smooth exit. A representation was given to the Central government in February to facilitate this exit as well as seek extension of the time limit to three years for implementing the norms.

He added that after the receipt of representations from the HDMA and Laghu Udyog Bharti, the Centrally sponsored Pharmaceutical Technology Upgradation Scheme has sanctioned 20 per cent subsidy up to maximum of Rs 1 crore for implementing the revised schedule M of the WHO. This was a welcome relief to the industry.

Elaborating the financial implication of this upgrade, he said the plight of units lacking adequate funds will worsen as a sum of Rs 3 crore to Rs 10 crore was required to make the requisite modifications in a running unit.

“Units unable to bear the additional financial burden will prefer to settle their existing loans within three years along with arranging workers wages and compensation to ensure a smooth exit and not become a non performing asset in the banks and financial institutions,” informed Gupta.

Under the Centrally sponsored Interest subvention scheme for strengthening of pharmaceutical industry, the association has sought extension of this scheme from the present three to seven years. This scheme will enable the industry to enhance their technological capabilities and upgrade to World Health Organisation-Good Manufacturing Practices norms. This extension will provide significant support to the MSMEs planning to upgrade to the new norms.

“Since many MSMEs are still burdened with credit-linked loans availed during the Covid pandemic, this current stipulation will further exacerbate will their financial condition. We have also requested for enhancing the scope of the central scheme to enable availability of finances for upgrading to the required norms,” added Gupta.