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  2. Volume 3 | Issue 3 [July to September]
  3. SHELF LIFE (SAVIRYATA AVADHI) OF AYURVEDIC DOSAGE FORMS: CLASSICAL LIMITS, RULE 161-B AND THE EVIDENCE FROM STABILITY STUDIES
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Dr. Abhay Gandhi

SHELF LIFE (SAVIRYATA AVADHI) OF AYURVEDIC DOSAGE FORMS: CLASSICAL LIMITS, RULE 161-B AND THE EVIDENCE FROM STABILITY STUDIES

Background: Classical Ayurvedic texts specify the period for which each dosage form retains its potency (saviryata avadhi), while Indian regulations under Rule 161-B of the Drugs and Cosmetics Rules prescribe fixed shelf lives for Ayurvedic, Siddha and Unani medicines. The two sets of figures differ widely, and the scientific basis of both is debated. Objective: To compare classical and regulatory shelf-life norms and to review the evidence from stability studies of Ayurvedic formulations. Methods: A critical narrative review of classical sources, the regulatory framework and published stability studies, with reference to international stability-testing guidelines. Results: The Sharangadhara Samhita gives two months for churna, one year for gutika and avaleha, and four months for sneha kalpana, while asava, arishta and rasa preparations are said to improve with age. Rule 161-B, as amended in 2016, assigns two years to churna and ghrita, three years to avaleha and taila, five years to guggulu and to vati containing minerals, and ten years to asava, arishta, bhasma, kupipakva rasayana and parpati. A 2024 appraisal of 49 stability studies found that 54.7% of calculated shelf lives were shorter than the regulatory norm and 35.9% longer, that only two studies used real-time testing and that most tested a single batch. Conclusion: Neither classical nor regulatory figures are fully supported by data. Product-specific stability studies following ICH principles, with multiple batches, real-time confirmation and potency markers, should replace fixed categorical periods.