The government has formulated action plan to standardise Ayurvedic, Siddha, Unani and Homoeopathy (ASU&H) medicines in the country, and has established Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H) under the Ministry of AYUSH, Sarbananda Sonowal, Minister of AYUSH, said in Rajya Sabha.
He also said that the prime mandate of the commission is to publish and revise Ayurvedic Pharmacopoeia of India (API), Siddha Pharmacopoeia of India (SPI), Unani Pharmacopoeia of India (UPI) and Homoeopathic Pharmacopoeia of India (HPI). The pharmacopoeial standards are to ensure the quality, safety and efficacy of Ayurvedic, Siddha, Unani and Homoeopathic medicines. The Pharmacopoeia Commission is also responsible to publish and revise Ayurvedic, Siddha and Unani official formularies and regulatory compendiums. These published standards become part of the Drugs and Cosmetics Act, 1940 and Rules, 1945 for ascertaining the quality standards of raw materials/drugs, and implemented uniformly across India.
It is mandatory for the manufacturer of ASU&H drugs to obtain a licence from the concerned State Licensing Authority (SLA) and comply with the prescribed Good Manufacturing Practices (GMP) and quality standards of drugs given in the respective pharmacopoeias. The SLA grants the licence after verification of the required infrastructural facilities, equipment/machinery, manpower of the manufacturing unit through the inspections conducted by the inspector. The government has also set up separate Central Research Councils for undertaking, promoting and coordinating research and scientific validation of Ayurvedic, Unani, Siddha and Homoeopathic medicines, Sonowal added.
The minister further said that so far, the government has published Ayurvedic Formulary of India (Part I-III) containing 986 formulations, Siddha Formulary of India (Part I-II) containing 400 formulations and National Formulary of Unani Medicine (Vol. I-VI) containing 1,230 formulations. Monographs of quality standards of 645 single drugs and 203 formulations of Ayurveda; 139 single drugs and one formulation of Siddha; 298 single drugs and 201 formulations of Unani; and 1,117 drugs of Homoeopathy (Vol. I-X).
The Central Council for Research in Homoeopathy (CCRH) has filed eight patents and the Central Council for Research in Ayurvedic Sciences (CCRAS) has obtained one patent, the Central Council for Research in Siddha (CCRS) has processed for patent of 10 products during the last five years, he concluded.