Measures Adopted for Authentication of Drugs and Medical Treatment Practices of AYUSH

Measures adopted for authentication and recognition of drugs and medical treatment practices of AYUSH and outcomes and achievements thereof are as under:

  • Analytical techniques and equipment used for the testing of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs and medical interventions are the same as applicable in modern system of medicine. Research Councils and Pharmacopoeia Committees of AYUSH undertake the work of standardization and quality testing of drugs by adopting pharmacognostical and physico-chemical methods including macroscopic, microscopic, and various instrumental techniques such as thin layer chromatographic fingerprints.  GCP guidelines, ICMR’s ethical guidelines, and WHO guidelines are followed, as and where required, for clinical validation of AYUSH interventions and evaluation of efficacy and safety of drugs.  Research and development interventions in AYUSH are by and large done on the basis of integrated protocols and methodologies involving both AYUSH and modern scientific parameters of analysis and assessment. In this direction, collaborative research activities in AYUSH are being promoted involving premier medical and scientific institutions and registration of clinical research studies for ASU&H drugs is done in Clinical Trials Registry of India (CTRI) maintained by the Indian Council for Medical Research (ICMR).
  • Regulatory provisions are laid down prescribing conditions required to be fulfilled for grant of license to manufacture Ayurvedic, Siddha, Unani and Homoeopathic (ASU&H) drugs, which include compliance to good manufacturing practices (GMP) and proof of safety and effectiveness as prescribed under Drugs & Cosmetics Rules and adherence to quality standards of identity, purity and strength of drugs as prescribed in the respective pharmacopoeia.  WHO-GMP and Certificate of Pharmaceutical Product (CoPP) guidelines are applicable for quality certification of ASU herbal drugs intended for export and international trade.
  • Indian Medicine Central Council (IMCC) Act, 1970 & Homoeopathic Central Council (HCC) Act, 1973 are modeled and implemented on the lines of Indian Medical Council (IMC) Act, 1956 for the purpose of regulating the education and practice of ASU&H systems of medicine and registration of the practitioners in central or state register is mandatory for doing medical practice in these systems.

Achievements and outcomes reflecting the acceptability and demand for AYUSH systems among the general public areas under:

  • National Health Policy-2017 contains much about promotion of AYUSH based healthcare services for the people.
  • There is increasing prevalence of AYUSH health facilities in the country.    As per available information AYUSH infrastructure in the country includes 771,468 registered practitioners, 550 teaching institutes, 170 Postgraduate institutes, 3639 hospitals and 26,405 dispensaries in Government sector and 8667 Drug manufacturing units. Besides, with the strategy of mainstreaming of AYUSH in place under National Health Mission and National AYUSH Mission, AYUSH facilities have been set up in about 506 District Hospitals, 374 Sub district hospitals, 2871 CHCs, 8995 PHCs, and 5716 in other medical centers.  15649 AYUSH practitioners are appointed for implementation of Rashtriye Bal Suraksha Karyakram (RBSK) under National Child Health Program and 12263 for imparting general health services from PHCs, CHCs, and District Hospitals.
  • Eleven national institutes, five research councils, two central pharmacopoeia laboratories, pharmacopoeia commission with four pharmacopoeia committees and two regulatory councils of AYUSH have been established under the purview of central government.
  • Quality standards of identity, purity and strength of about 2600 ASU&H drugs are published in the respective pharmacopoeias, which are mandatory for the industry to manufacture drugs under license.
  • Scientific publications in the form of books, monographs, research articles and case reports are brought out by the research councils and national institutes for enhancing recognition and appreciation of AYUSH. AYUSH Research Portal has also been created to place scientific inputs and interventions in public domain.
  • MoUs have been signed with certain foreign countries for international cooperation and promotion of AYUSH and Ministry of AYUSH has collaboration agreement with WHO Headquarters to develop benchmark documents of Ayurveda, Unani Medicine and Panchakarma. Morbidity codes and standardized terminology of AYUSH in accordance with the WHO publications and International Classification of Diseases (ICD) have been developed for global positioning of AYUSH. – PIB

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