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Karnataka FDA shows zero tolerance to NSQ drugs: Dr S Umesh
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Nandita Vijayasimha, Bengaluru
November 27 , 2025
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The Karnataka Food and Drugs Administration (FDA) has reaffirmed its uncompromising stance against Not-of-Standard-Quality (NSQ) drugs, declaring that there is absolutely no room for tolerating such violations under any circumstances.
Emphasizing its zero-tolerance approach, Dr S Umesh, additional drugs controller, Karnataka FDA stated that safeguarding public health remains its highest priority, and any drug batch failing to meet mandated quality standards will face immediate regulatory action.
Noting that bioavailability and bioequivalence (BA/BE) studies are fundamental to the safety and efficacy of the medicines, Dr Umesh said this while speaking at the one-day workshop on ‘Managing regulatory changes in oral solid dosage (OSD) forms’. The workshop was organised by the Indian Pharmaceutical Association-Karnataka State branch and Karnataka Drugs and Pharmaceutical Manufacturers Association on November 22, 2025 in Bengaluru.
“BA/BE studies are the scientific backbone that establishes and maintains the trust on OSD forms. The OSDs constitute a major market share due to patient preference, ease of use, cost effectiveness, India’s manufacturing capabilities, transportation and ease of handling, he added.
OSDs as tablets and capsules hold a dominant position in the Indian pharmaceutical market, accounting for 56% of the share. Liquid orals hold 62% of the market share by route of administration. When such volumes and different molecules are produced, certainly the formulation of OSD should be safe, efficacious and cost effective, said Dr Umesh.
In fact, worldwide OSDs represent approximately 84% of best selling pharmaceuticals and about 68% of the overall contract manufacturing market, he said.
The pharma industry plays a crucial role in safeguarding the health of the nation and the world. To this end, India has earned global recognition as the ‘Pharmacy of the World’, and this reputation brings with it a responsibility to maintain the highest standards of quality, safety, and compliance. At its core healthcare is built on the trust. Here, the trust is that, the medication prescribed by the doctors will work as intended, he noted.
Delving into the reasons that BA/BE studies are all of a sudden so important, Dr Umesh said that a recent analysis by the central regulatory authority indicated that most of the NSQs are related to dissolution & disintegration which is due to lack of formulation development.
The recent circular by Central Drugs Standard Control Organisation (CDSCO), classifying gastro-resistant tablets and capsules as well as delayed-release tablets and capsules as ‘New Drugs’ under Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019, underscores the growing regulatory emphasis on product quality and performance. Also, an important regulatory change introduced by CDSCO for OSDs relates to BA/BE studies, he said.
This directive makes it imperative for manufacturers to develop robust and scientifically justified formulations, where BA/BE studies become intrinsic components of product development and approval. The strengthened requirement ensures that such modified-release dosage forms consistently deliver therapeutic outcomes, enhancing patient safety and aligning industry practices with uniform national standards, said Dr Umesh.
Under the revised framework, CDSCO has strengthened requirements to ensure that all generic formulations demonstrate therapeutic equivalence with the reference product. BA/BE studies are now mandatory for a wider range of molecules, especially for products classified under biopharmaceutics risk categories BCS Class II & IV, he said,
These regulatory changes aim to ensure that generic OSDs are not only pharmaceutically equivalent but also clinically interchangeable, improving public confidence and the quality of medicines in the market, said Dr Umesh adding that here Karnataka FDA will impose strict action against NSQ drugs.
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