Mumbai: The Maharashtra FDA will prioritise process audits of drug manufacturing units across the state to assess compliance with the revised Schedule M requirements, with no exemption for pharmaceutical MSMEs, informs Maharashtra Food and Drug Administration (FDA) Commissioner Tukaram Mundhe. The intensified inspections come after the extended compliance timeline for pharma MSMEs until December 31, 2025.
The Maharashtra FDA is now planning process audits, also referred to as Good Manufacturing Practice (GMP) inspections, as a key regulatory measure to assess whether drug manufacturing units are meeting statutory requirements for quality, safety, hygiene and manufacturing controls. The inspections are aimed at identifying and addressing deficiencies that could affect the quality, safety and efficacy of medicines and ensuring that manufacturers operate in accordance with the Drugs and Cosmetics Act and revised Schedule M requirements.
Mundhe said the revised Schedule M requirements will apply to all drug manufacturing units, including pharmaceutical MSMEs, and that the department has prioritised the implementation following the expiry of the extension granted to smaller manufacturers. “No drug manufacturing unit or pharma MSMEs will be exempted from Revised Schedule M implementation and it has been prioritised and planned as the timeline for extension of pharma MSMEs has already finished,” Mundhe said.
Process audits will examine critical manufacturing and quality systems, including Quality Control (QC), equipment calibration, cleaning validation, contamination controls and data integrity. Depending on the nature and severity of deficiencies identified during inspections, the regulatory action can include formal observations, show-cause notices, directions for Corrective and Preventive Actions (CAPA), suspension of manufacturing activities and, in cases of serious and unresolved violations, cancellation of licences.
The revised Schedule M framework was originally notified in December 2023. Drug manufacturing units with an annual turnover of more than Rs. 250 crore were required to comply within six months, with the initial compliance deadline for these larger units falling on June 28, 2024. Units with turnover below Rs. 250 crore were provided a longer timeline.
The Union ministry of health and family welfare subsequently allowed pharmaceutical MSMEs an additional 12 months to comply, extending the deadline to December 31, 2025. Manufacturers with turnover of less than Rs. 250 crore seeking the extension were required to submit an application to the Central Drugs Standard Control Organization (CDSCO) by May 11, 2025, along with details of their planned upgradation and compliance measures.
With this extended timeline having ended, the Maharashtra FDA is moving towards closer assessment of implementation at the manufacturing-unit level. The process audits are expected to examine not only whether required infrastructure has been established but also whether the revised systems and procedures are being effectively implemented in day-to-day manufacturing operations.
Maharashtra FDA and CDSCO have already conducted 64 risk-based inspections jointly across the state between April 1, 2025 and January 31, 2026 to assess compliance among drug manufacturing units. Regulatory action following these inspections included Stop Production Orders (SPOs), suspension and cancellation of licences, warning letters and Show Cause Notices, depending on the nature and seriousness of the deficiencies identified.
During the same period, the Maharashtra FDA inspected 642 of the state’s 896 existing allopathic drug manufacturing units and 140 of 455 ayurvedic drug manufacturing units. Following inspections, licences of 27 allopathic drug manufacturing units were cancelled and 94 were suspended for violations of the Drugs and Cosmetics Act. Among ayurvedic drug manufacturers, three licences were cancelled and 14 were suspended during the period.
Mundhe said the inspections have also helped the regulator identify manufacturing practices requiring corrective measures. “This initiative has also provided valuable insights into the manufacturing practices of these units and has led to relevant corrective and preventive actions (CAPAs) with the aim of making improvements in the regulatory framework,” he said.
“The Maharashtra FDA has enhanced regulatory oversight to ensure compliance to Good Manufacturing Practices (GMPs) by inspecting all Allopathic and ayurvedic drug manufacturing units in the state on an annual basis. These inspections have uncovered several violations, including cases of adulterated ayurvedic products containing allopathic ingredients,” Mundhe said.
The revised Schedule M places greater emphasis on manufacturing systems designed to consistently ensure the quality of medicines. Its key provisions include modernised manufacturing facilities to minimise contamination and improve cleanliness, validated equipment and stronger maintenance systems, and environmental controls covering air, water and waste management.
The framework also requires manufacturers to establish robust Pharmaceutical Quality Systems (PQS) to maintain consistent product quality and regulatory compliance. Product Quality Reviews (PQRs), which provide periodic assessments of manufacturing and product quality performance, are another important component intended to identify trends, recurring deficiencies and areas requiring improvement.
Source : Pharmabiz
