Quality standards prescribed in pharmacopoeias mandatory for manufacturing of AYUSH drugs: Shri Shripad Naik

The Minister of State (Independent Charge) for AYUSH, Shri Shripad Yesso Naik through a written reply to a question in Lok Sabha informed that the quality standards prescribed in the pharmacopoeias are mandatory for manufacturing of AYUSH drugs.

As per the provisions of Drugs & Cosmetics Rules, 1945, quality standards prescribed in the pharmacopoeias are mandatory for the manufacturing of AYUSH drugs and the enforcement of these provisions is vested with the State Licensing Authorities/Drug Controllers appointed by the Government. Ayurvedic pharmacopoeia contains 645 monographs of single drugs and 202 monographs of compound formulations (including 24 Asava-Arishta, 12 Arka, 24 Avaleha, 7 Kwath Churna, 17 Guggul, 20 Ghrit, 25 Churna, 37 Tel, 8 Lavan & Kshar, 11 Lepa, 15 Vati-Gutika, 1 Kshar Sutra and 1 Mandoor); Unani Pharmacopoeia contains 298 monographs of single drugs and 150 monographs of compound formulations; Siddha

Ayurvedic pharmacopoeia contains 645 monographs of single drugs and 202 monographs of compound formulations (including 24 Asava-Arishta, 12 Arka, 24 Avaleha, 7 Kwath Churna, 17 Guggul, 20 Ghrit, 25 Churna, 37 Tel, 8 Lavan & Kshar, 11 Lepa, 15 Vati-Gutika, 1 Kshar Sutra and 1 Mandoor); Unani Pharmacopoeia contains 298 monographs of single drugs and 150 monographs of compound formulations; Siddha pharmacopoeia contains 139 monographs of single drugs and Homeopathic Pharmacopoeia contains 1117 monographs.

Similarly, Ayurvedic Formulary encompasses 985 standardized formulations, Unani Formulary 1229 standardized formulations and Siddha Formulary contains 399 standardized formulations. The Government has established Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM) under the Ministry of AYUSH to develop and revise the norms of quality standards of Ayurvedic, Siddha, Unani and Homoeopathic drugs and publish them in the form of monographs in respective pharmacopieas and formularies.

Medicinal Plants are the major resource base of raw materials used in the manufacturing of AYUSH medicines. In order to augment the availability of plant raw materials, agro techniques for cultivation of medicinal plants and Good Agricultural & Collection Practices have been developed and financial support is provided to the states for large scale cultivation of medicinal plants under the Centrally Sponsored Scheme of National AYUSH Mission.

Through the “Central Sector Scheme on Conservation, Development and Sustainable Management of Medicinal Plants” National Medicinal Plants Board is providing project based support for resource augmentation of medicinal plants in forest areas and for the establishment of Herbal Gardens.

Educational & training modules of pharmacy are included in the AYUSH course curricula and qualifications & experience of personnel associated with the manufacturing of Ayurvedic, Siddha and Unani medicines and manufacturing & sale of Homoeopathic medicines are prescribed in the Drugs & Cosmetics Rules, 1945.

Acquisition of valid license and compliance with quality standards of drugs prescribed in the respective pharmacopoeias and Good Manufacturing Practices is legally mandatory for the drug manufacturers. State Licensing Authorities/Drug Controllers are responsible to enforce these provisions of quality control of AYUSH medicines. Clinical practice of AYUSH is not allowed without registration of the practitioner and the qualifications required for registration of the practitioners are prescribed in the Indian Medicine Central Council Act, 1970 and Homoeopathy Central Council Act, 1973.