Acceptance of Indian Pharmacopoeia risks medicine quality, Says Prof. Channa Jayasumana

• Additional systemic weaknesses in IP have been highlighted by regulatory scientists 

The acceptance of the Indian Pharmacopoeia alongside BP, Ph. Eur., and USP—without transparent scientific review or stakeholder consultation—poses potential risks to medicine quality, patient safety, and regulatory credibility, former State Minister of Health Channa Jayasumana, who is also a professor of pharmacology, said in a statement. 

Prof. Jayasumana said the recent public disclosures have revealed a Memorandum of Understanding (MoU) between the National Medicines Regulatory Authority (NMRA) of Sri Lanka and the Indian Pharmacopoeia Commission (IPC), under which Sri Lanka accepts the Indian Pharmacopoeia (IP) as a recognised standard for medicines. This decision merits critical examination, particularly because Sri Lanka already accepts internationally stringent pharmacopoeias such as the British Pharmacopoeia (BP), European Pharmacopoeia (Ph. Eur..), and the United States Pharmacopoeia (USP). 

He said, “Sri Lanka’s regulatory system has historically aligned itself with pharmacopoeias that adopt conservative impurity limits, validated modern analytical methods, and robust control strategies to minimise batch-to-batch variability. BP/Ph. Eur. and USP standards are developed within highly regulated environments, subject to continuous peer review, toxicological reassessment, and alignment with International Council for Harmonisation (ICH) principles. Against this background, the parallel acceptance of IP raises concerns not of harmonisation, but of regulatory dilution. 

Using metformin hydrochloride as an example, a clear weakness of the Indian Pharmacopoeia (IP) compared with BP and USP is seen in the control of impurities. In BP and USP, the related-substances section for metformin applies stricter impurity limits, lower reporting thresholds, and more explicit system-suitability criteria, reflecting stronger alignment with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) expectations and global safety concerns, especially for nitrogen-rich and degradation-related impurities. In contrast, the IP monograph historically specifies comparatively higher allowable limits for certain related substances and less detailed chromatographic performance requirements, which can permit a wider impurity profile while still remaining IP-compliant. This difference became particularly evident during global scrutiny of metformin quality, where BP/USP standards were perceived as more protective due to tighter impurity control and faster regulatory responsiveness. 

Beyond numerical impurity limits, analytical methodology is a key area of divergence. BP/Ph. Eur. and USP increasingly rely on high-resolution, stability-indicating chromatographic methods, with strict requirements for method validation, impurity profiling, and reference standards. IP, in several monographs, continues to rely on older or less discriminatory analytical techniques, which may be less sensitive to low-level or structurally related impurities. Such methodological limitations increase the risk of undetected or under-quantified impurities, particularly in large-scale generic manufacturing. 

These methodological gaps have direct implications for inter-batch variability. Wider impurity limits combined with less stringent analytical controls allow significant batch-to-batch differences to remain technically compliant. In medicines used chronically by millions—such as paracetamol—this variability can translate into uneven exposure to toxic impurities across populations. BP/Ph. Eur. and USP frameworks are specifically designed to minimise such variability through tighter specifications and harmonised analytical expectations. 

Additional systemic weaknesses in IP have been highlighted by regulatory scientists, including slower incorporation of updated toxicological data, limited transparency in monograph revision processes, and variability in the quality and availability of impurity reference standards. While IP serves a critical role within India’s domestic pharmaceutical ecosystem, these limitations are precisely why many stringent regulatory authorities do not rely on IP as a primary benchmark for medicine quality. 

Equally concerning is the apparent lack of documented consultation with Sri Lanka’s professional medical colleges, pharmacologists, toxicologists, or academic regulatory experts prior to signing this MoU. Decisions that affect national medicine quality standards cannot be reduced to administrative agreements. The NMRA Chairman’s authority derives from legislation designed to protect public health, not to unilaterally lower or substitute established safety benchmarks without scientific justification and institutional oversight.  Sri Lanka already recognises USP, alongside BP/Ph. Eur., eliminating any regulatory necessity to adopt standards with broader impurity tolerances or weaker analytical controls. Arguments that IP acceptance will enhance affordability or access are unconvincing; cost containment should never be achieved by compromising analytical rigour or impurity control.”