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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
S.No. State / UT Ayurveda Unani Siddha Homoeopathy Total (1) (2) (3) (4) (5) (6) (7) 1 Andhra Pradesh 288 9 0 7 304 2 Arunachal Pradesh 1 0 0 0 1 3 Assam 40 0 0 0 40 4 Bihar 191 23 0 38 252 5 Chhattisgarh 32 0 0 0 32 6 Delhi 83 20 0 0 103 7 Goa 6 0 0 0 6 8 Gujarat 578 0 0 9 587 9 Haryana 514 4 0 0 518 10 Himachal Pradesh 132 0 0 6 138 11 Jammu &Kashmir 8 5 0 2 15 12 Jharkhand 19 0 0 8 27 13 Karnataka 210 0 0 12 222 14 Kerala 897 4 4 0 905 15 Madhya Pradesh 555 8 0 21 584 16 Maharashtra 725 0 0 0 725 17 Manipur 0 0 0 0 0 18 Meghalaya 0 0 0 0 0 19 Mizoram 0 0 0 0 0 20 Nagaland 0 0 0 0 0 21 Odisha 85 0 0 5 90 22 Punjab 232 0 0 0 232 23 Rajasthan 349 1 0 0 350 24 Sikkim 2 0 0 1 3 25 Tamil Nadu 152 5 139 9 305 26 Telangana 429 173 0 32 634 27 Tripura 0 0 0 0 0 28 Uttar Pradesh 1416 309 0 30 1755 29 Uttarakhand 196 0 0 0 196 30 WestBengal 160 5 0 160 325 31 A&NIsland 0 0 0 0 0 32 Chandigarh 1 0 0 0 1 33 D&NHaveli 7 0 0 0 7 34 Daman&Diu 10 0 0 0 10 35 Lakshadweep 0 0 0 0 0 36 Puducherry 27 0 8 5 40 TOTAL 7345 566 151 345 8407
This information was given by Minister of Ayush Shri Sarbananda Sonowal in a written reply in Lok Sabha today.
