Himachal Pradesh MSME Pharma Units Seek Three-Year Extension For GMP Compliance

New Delhi, Sep 2 (KNN) Pharmaceutical units in Himachal Pradesh operating under the Micro, Small, and Medium Enterprises (MSME) category have appealed for a three-year extension to meet the revised Schedule M norms of Good Manufacturing Practices (GMP).

Compliance with these updated norms, aligned with World Health Organisation (WHO) standards, is expected to enhance the quality of drug production in the state.

As per the Union Government’s notification issued in December 2023, small and medium pharmaceutical manufacturers were given one year to adopt these stringent norms, with the deadline set to expire in December 2024. Failure to comply could result in the suspension of licenses or financial penalties.

Dr. Rajesh Gupta, President, Himachal Drug Manufacturers Association (HDMA), expressed concerns over the feasibility of meeting this deadline.

"None of the MSME pharmaceutical units is capable of converting their structure fr0m 10,000 sq ft to 50,000 sq ft within a year, which requires an investment of Rs 5-6 crore," he stated.

Out of the 655 pharmaceutical units in Himachal Pradesh, only 251 are currently GMP-certified, while the remaining 404 units need to be upgraded to comply with the revised Schedule M guidelines.

Although the Government of India has introduced a subsidy scheme offering up to Rs 1 crore to assist with infrastructure upgrades and the implementation of WHO’s GMP, industry representatives argue that it is not feasible to complete the necessary improvements within a year.

Consequently, the HDMA has requested a three-year extension fr0m Union Health and Family Welfare Minister J.P. Nadda.

The association warns that strict enforcement of the current deadline could lead to the closure of numerous small units.

"While the ministry has adopted global standards in amending Schedule M, they have incorporated these standards as rules rather than guidelines, making compliance a more stringent requirement," Gupta explained.

Many MSMEs are already burdened with existing loan liabilities, and securing additional financing for the required upgrades is expected to be a challenging and time-consuming process.

The necessary upgrades include significant changes such as the introduction of a pharmaceutical quality system, quality risk management, product quality review, equipment validation, self-inspection, supplier audits, and the validation of GMP-related computerised systems.

Regulatory authorities have identified several compliance issues during risk-based assessments, including inadequate documentation, improper record-keeping of drug batch testing, lack of machinery maintenance, non-functional air handling units, faulty lab equipment, lack of self-assessment, absence of internal product quality review, and poor design of manufacturing and testing processes.

The HDMA’s request for an extension highlights the challenges faced by Himachal Pradesh's MSME pharmaceutical units as they work to meet international standards while maintaining their operations in a highly competitive and regulated environment.

(KNN Bureau)