Safety and Quality of Ayush Medicines

By PIB Delhi

As per the provisions of Drugs and Cosmetics Rules, 1945, the manufacture of Ayurvedic (Including Siddha) or Unani drugs are to be carried out in such premises and such hygienic conditions as are specified in Schedule-T (Good Manufacturing Practices) and homoeopathy manufacturers are required to comply with the provisions of Schedule M1(Good Manufacturing Practices). It is mandatory for the manufacturers to comply with this for obtaining license of Ayurveda, Siddha and Unani (ASU) and Homoeopathy drug manufacturing.

For Standardization of Indian medicines and Homoeopathy in the country, the Government has established Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H) under the Ministry of AYUSH. 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 basic need to ensure quality, safety and efficacy of Ayurvedic, Siddha, Unani and Homoeopathic medicines.

 Ministry of AYUSH is implementing a Central Sector Scheme of Pharmacovigilance of Ayurveda, Siddha Unani& Homeopathy Drugs since June 2018 for inculcating the culture of Adverse Drug Events (ADE) reporting, documentation and analysis for further regulatory action. The Scheme has an established three tier network. All India Institute of Ayurveda (AIIA), New Delhi has been designated as the National Pharmacovigilance Coordination Centre (NPvCC), 5 Intermediary Pharmacovigilance Centres (IPvC’s) and 74 Peripheral Pharmacovigilance Centres (PPvC’s).

In addition to the above, for facilitating export, Ministry of AYUSH encourages following certifications of AYUSH products as per details below:-

(i) Certification of Pharmaceutical Products (CoPP) as per WHO Guidelines for herbal products.

(ii) Quality Certifications Scheme implemented by the Quality Council of India (QCI) for

grant of AYUSH Premium mark to Ayurvedic, Siddha and Unani products on the basis of

third party evaluation of quality in accordance with the status of compliance to international standards.

The licence of Ayush products are granted by the concerned State Licensing Authorities in accordance with the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder. There are about  7345 (Ayurveda), 151 (Siddha), 566 (Unani) and 345 (Homoeopathy) manufacturers producing Ayush products.

State-wise/System-wise number of Licensed Pharmacies under AYUSH as on 01-04-2019

This information was given by Minister of Ayush Shri Sarbananda Sonowal in a written reply in Lok Sabha today.