Abstract

REGULATORY SYSTEMS OF INDIA CONTROLLING RESIDUAL LIMIT OF HEAVY METALS IN ASU DRUGS

Shilpa Gawande Kolarkar* and Tushar Khairnar

Abstract

Ayurveda is an ancient science of medicine. In number of Ayurveda Sidha Unani Herbo-mineral formulations whether generic or branded, metals are purposefully used to enhance the efficacy of these formulations. Many times, only Bhasmas are also used as a single medicine or in combination with other herbal powders used by many Ayurveda practitioners. These metals are used after purification process called as Shodhana of the respective metal powders with certain plant extracts or decoctions or Ghrit or Madhu and heating them to a certain temperature to get rid of impurities as mentioned in Ayurveda literatures. Objective:- There are many regulators in India, controlling the manufacturing standards of these drugs which have defined the permissible residual limit for heavy metals that every Ayurveda practitioner should be aware of. Patients with prolonged use of these drugs may suffer with chronic toxicity of either liver or kidneys or both. Methodology by going through various declarations done by these regulators, appendices provided and literatures published by Government of India or Ayush, we have tried to enlighten this aspect of regulatory system and permissible residual amount stated for heavy metals by the Indian regulatory system. Conclusion (Results and interpretation) Though creating awareness regarding these heavy metal residual permissible limits, regulation system among ASU drug manufacturers, Ayurveda practitioners and pharmacokinetics of these formulations when consumed in prescribed dosage with limited time duration, controlling over the counter (OTC) sale without prescription of these drugs are many challenges before ASU manufacturers and Ayurveda practitioners.

Keywords: Bhasmas, Herbo-mineral formulations, permissible residual-amount of heavy metals, regulators.