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639 MSMEs in Gujarat submit gap analysis reports under revised Schedule M guidelines ahead of deadline
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Shardul Nautiyal, Mumbai
June 04 , 2025
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In a significant regulatory milestone, 639 micro, small, and medium enterprises (MSMEs), out of the total number of 647 MSMEs officially listed in Gujarat, have successfully submitted their gap analysis reports through the Central Drugs Standard Control Organization’s (CDSCO) Online National Drug Licensing System (ONDLS). This achievement comes in compliance with the revised Schedule M of the Drugs and Cosmetics (D&C) Rules, which focuses on stricter Good Manufacturing Practices (GMP).
Gujarat Food and Drug Control Administration (FDCA) officials confirmed that this level of proactive compliance represents a robust step towards aligning the state’s MSME pharma sector with international quality norms.
“This initiative is part of a larger drive to bring pharmaceutical MSMEs, particularly those with turnovers below Rs. 250 crore, in line with the December 31, 2025 deadline for implementing revised GMP standards,” said Dr. H.G. Koshia, Commissioner of FDCA, Gujarat.
Gujarat is one of India’s leading pharmaceutical hubs, home to over 3,200 allopathic drug manufacturers. The central government, via notification GSR 127(E) dated February 11, 2025, granted MSMEs an extended timeline until December 31, 2025 to adapt to the upgraded Schedule M norms, which emphasize quality assurance, facility design, and product safety.
Under the revised framework, manufacturers are now required to conduct and submit gap analyses, prepare and file comprehensive roadmaps for upgrading facilities, adopt WHO’s Technical Report Series (TRS) as general guidance on GMP protocols—previously not mandated.
WHO guidelines serve as international reference points and include airflow direction and filtration standards, design and operation of pharmaceutical water systems, HVAC systems installation and validation, validation protocols across manufacturing operations and packaging standards for pharmaceutical products.
A critical update under the revised norms includes the required adoption of cleanroom protocols, especially the incorporation of Personnel Air Locks (PALs) and Material Air Locks (MALs).
“The integration of PALs and MALs is foundational for maintaining the hygienic and sterile environments required in pharmaceutical manufacturing. These systems play a pivotal role in ensuring compliance with international GMP standards,” Dr. Koshia emphasized.
Cleanroom design and environmental control highlights include PALs. These are controlled buffer zones for personnel entering cleanrooms to reduce risk of contamination.
MALs are dedicated zones for moving materials in and out while maintaining environmental integrity.
Airlocks act as transitions between cleanroom classes—from Class A (most sterile) to Class D (least controlled). Cleanroom design emphasizes flush surfaces, seamless construction, and microbial control.
Heating, ventilation, and air conditioning (HVAC) systems are crucial for maintaining pressure differentials and air cleanliness. Interlocks, sinks, and drainage systems are designed to minimize reverse contamination. Environmental monitoring is mandatory routine checks for both microbiological and physical parameters.
Operational modes are defined protocols for both “at rest” and “in operation” states to validate room classifications.
Airlock configurations may include Cascade, Bubble, or Sink types, selected based on facility and product needs, particularly vital for sterile drugs, biologics, vaccines, and emerging therapies like cell and gene therapy.
Gujarat’s early compliance rate indicates that the state is well-positioned to meet the national deadline. FDCA officials believe the structured approach and proactive engagement by the industry reflect the growing commitment to raising global competitiveness and product safety.
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