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Indian pharma ramps up quality & compliance efforts to meet evolving oral dosage form BA/BE requirements
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Nandita Vijayasimha, Bengaluru
November 24 , 2025
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Indian pharma industry is intensifying its focus on quality systems, regulatory alignment, and scientific rigor as the Central Drugs Standard Control Organisation (CDSCO) continues to strengthen expectations around bioavailability and bioequivalence (BA/BE) requirements for oral dosage forms.
With increasing scrutiny on post-approval changes ranging from formulation updates to site transfers, companies are investing in more robust data packages, enhanced dissolution testing strategies, and risk-based change-management frameworks to ensure therapeutic consistency.
This shift reflects India’s broader push toward global regulatory harmonization, improved patient safety, and greater confidence in generic medicines both domestically and in export markets, said Dr Premnath Shenoy, former director, QA/RA/patient safety, immediate past president Indian Pharmaceutical Association Karnataka State Branch.
Until recently, the requirement to conduct bioequivalence (BE) studies for generic and branded generic medicines was not uniformly enforced under Indian regulatory frameworks. As a result, many pharmaceutical companies routinely conducted BE studies to meet the regulatory expectations of international markets—not only for exports to the US, EU, but other tiny countries which includes most of the Asian and middle east markets as well, while simultaneously marketing different formulation of the same drug domestically without generating BE data, he added.
This regulatory gap raised significant concerns from a public health and ethical standpoint. Without BE studies, there was no scientific assurance that domestically marketed generics would deliver the same therapeutic outcomes as their innovator counterparts. This posed a risk to patient safety, especially in critical therapeutic areas where even minor variations in drug absorption could lead to suboptimal efficacy or adverse effects, Dr Shenoy told Pharmabiz.
Recognizing this, the Indian regulatory authorities introduced pivotal amendments in recent years—most notably through the New Drugs and Clinical Trials Rules, 2019 and subsequent notifications—to mandate BE studies for certain classes of generic drugs intended for the Indian market. These reforms aimed to harmonize domestic regulatory expectations with global standards, enhance the credibility of Indian generics, and safeguard patient interests, he said.
Today, pharma manufacturers are required to submit BE data for specified oral dosage forms, particularly for drugs listed under Category II of the CDSCO’s BE notification list, which includes critical dose drugs, narrow therapeutic index drugs, and modified-release formulations. Furthermore, BE studies must be conducted at CDSCO-approved BA/BE centres under the oversight of registered Ethics Committees, ensuring adherence to Good Clinical Practice (GCP) and data integrity standards, said Dr Shenoy.
These regulatory advancements mark a significant step toward strengthening India’s pharmacovigilance ecosystem, restoring public trust in generic medicines, and aligning the domestic pharmaceutical landscape with international norms. However, consistent enforcement, capacity building, and transparent communication remain essential to fully realize the intended benefits of these reforms, noted Dr Shenoy.
In a bid to be updated and leave no stone unturned in this compliance, the Indian Pharmaceutical Association (Karnataka State Branch) and KDPMA (Karnataka Drugs and Pharmaceutical Manufacturers Association) have a one day workshop on November 22, 2025 in Bengaluru. The technical session titled ‘Managing Regulatory Changes in Solid Oral Dosage forms’ is positioned to provide the much-needed confidence to companies across MSMEs.
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