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Maharashtra FDA, CDSCO jointly conduct 64 risk-based inspections between April 1, 2025 & Jan 31, 2026
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Shardul Nautiyal, Mumbai
February 21 , 2026
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In order to assess the compliance of drug manufacturing units, the Maharashtra Food and Drug Administration (FDA) and the Central Drugs Standard Control Organization (CDSCO) have jointly conducted a total of 64 risk-based inspections across the state. These inspections were conducted between April 1, 2025 and January 31, 2026.
According to a senior official, actions taken based on these inspections included Stop Production Orders (SPO), license suspensions and cancellations, warning letters, and Show Cause Notices (SCNs), depending on the severity of non-compliance. The goal of these inspections is to enforce Good Manufacturing Practices (GMPs) and ensure the safety, efficacy, and quality of medicines.
“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,” the official added.
The CDSCO, in collaboration with the state drug regulators, has been conducting nationwide risk-based inspections of drug manufacturing units to ensure compliance with the Drugs & Cosmetics (D&C) Act, 1940, and to maintain high standards of quality. It had initiated risk-based inspections of drug manufacturing and testing firms in December 2022 across the country. Since December 2022, over 905 units have been inspected nationwide, resulting in over 694 actions.
Following reports of child deaths linked to contaminated cough syrup in 2025, the CDSCO had initiated risk-based inspections of drug manufacturing units in six states following the collection of 19 samples, including cough syrups, antipyretics, and antibiotics, in the wake of child deaths in Madhya Pradesh and Rajasthan allegedly linked to contaminated cough syrups.
Under the D&C Act 1940 and the Rules framed thereunder, the regulatory control over the manufacture and sale of the drugs is exercised through a system of licensing and inspection by the State Licensing Authorities (SLAs).
The Union ministry of health and family welfare had also revised the date of the implementation of the revised Schedule M of the D&C Act allowing pharma MSMEs an additional 12 months to comply, extending the date to December 31, 2025. To avail of this extension, pharma companies with a turnover of less than Rs. 250 crore were also directed to file an application by May 11, 2025, to the CDSCO with details of their upgradation plan.
MSME firms that had sought an extension after submitting an upgradation plan by May 11, 2025, inspections have already begun from January 2026. Around 80 per cent of the total 10,500 drug manufacturing units in India fall under the MSME category.
The union health ministry had stated that the reason for allowing this extension is to enable pharma MSMEs to arrange the finances for upgradation and time for implementation of the required changes. It also informed that it is as per request by several associations that represent the pharma MSMEs.
Originally mandated in December 2023, the revised guidelines required units with turnovers above Rs. 250 crore to comply within six months, while those below the threshold had a one-year timeline. Drug manufacturers who met the initial deadline for large companies (June 28, 2024) have already transitioned.
Key provisions of revised Schedule M guidelines include modernized facilities to prevent contamination and improve cleanliness, validated equipment towards stringent maintenance of production equipment, environmental controls towards adherence to global standards for air, water, and waste management, Pharmaceutical Quality Systems (PQS): robust systems to guarantee consistent quality, Product Quality Reviews (PQR), which are regular evaluations to ensure ongoing compliance.
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