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International Journal of Science, Strategic Management and Technology

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SCENARIO OF INDIAN PHARMA MSMES IN THE CONTEXT OF REVISED SCHEDULE M

AUTHORS:
Dr. Joymalya Bhattacharya
Mentor
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CC BY 4.0 License:
This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract

The revised Schedule M under India’s Drugs and Cosmetics Rules, 1945 has emerged as one of the most significant regulatory reforms in the pharmaceutical manufacturing landscape in recent years. It upgrades the framework for good manufacturing practices (GMP) by emphasizing pharmaceutical quality systems, quality risk management, product quality review, validation, computerized record control, and enhanced accountability in premises, plant, and equipment. This review examines the scenario of Indian pharmaceutical micro, small, and medium enterprises (MSMEs) in the context of the revised Schedule M, with a focus on the regulatory shift, compliance burden, preparedness, and policy implications. Using publicly reported secondary data, the paper performs descriptive statistical analysis, proportion testing, confidence interval estimation, and state-level comparison to quantify the readiness gap. The results indicate that 1,700 of 6,500 non-GMP MSME drug manufacturers had submitted upgrade plans, equivalent to 26.15% preparedness, while 73.85% remained outside the reported transition pipeline. The 95% confidence interval for readiness is 25.08%–27.23%, indicating a stable but low compliance rate. Gujarat’s reported gap-analysis submission rate of 98.77% stands far above the national MSME average, underscoring sharp interstate variation. The review concludes that while revised Schedule M can strengthen product quality, export readiness, and patient safety, its success among MSMEs depends on phased implementation, technical handholding, affordable financing, and cluster-based infrastructure support.

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Bhattacharya, J. (2026). Scenario of Indian Pharma MSMES in the Context of Revised Schedule M. International Journal of Science, Strategic Management and Technology, 02(03). https://doi.org/10.55041/ijsmt.v2i3.213

Bhattacharya, Joymalya. "Scenario of Indian Pharma MSMES in the Context of Revised Schedule M." International Journal of Science, Strategic Management and Technology, vol. 02, no. 03, 2026, pp. . doi:https://doi.org/10.55041/ijsmt.v2i3.213.

Bhattacharya, Joymalya. "Scenario of Indian Pharma MSMES in the Context of Revised Schedule M." International Journal of Science, Strategic Management and Technology 02, no. 03 (2026). https://doi.org/https://doi.org/10.55041/ijsmt.v2i3.213.

References
1.Azawei, A. Al, et al. (2025). The management of good manufacturing practice (GMP) inspections: A scoping review of the evidence. PMC.

2.Arunagiri, T., et al. (2024). Enhancing pharmaceutical product quality with a CAPA-based approach. PMC.

3.Business Standard. (2024). Health ministry revises pharma manufacturing rules under Schedule M.

4.Business Standard. (2025). Just 1 in 4 MSME pharma units set for GMP transition as deadline nears.

5.Business Standard. (2025). Pharma units likely to face action for Schedule M violations: Experts.

6.Chen, Y., et al. (2023). The impact of Covid-19 containment lockdowns on MSMEs in India. PMC.

7.Covarrubias, C. E., et al. (2022). Current GMP standards for the production of vaccines and antibodies. PMC.

8.Deshmukh, S. G., et al. (2020). Framework for manufacturing in post-COVID-19 world order. PMC.

9.Fabio, P., et al. (2019). The requirements for manufacturing highly active or sensitising ingredients. PMC.

10.Government of India. (2023). Drugs (Amendment) Rules, 2023 / Revised Schedule M notification (G.S.R. 922(E)).
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This article has undergone plagiarism screening and double-blind peer review. Editorial policies have been followed. Authors retain copyright under CC BY-NC 4.0 license. The research complies with ethical standards and institutional guidelines.
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