The mechanism of licensing and certification of Good Manufacturing Practices to manufacture Ayurvedic medicines is provided under Rule 152 and Rule 155-B of the Drugs and Cosmetics Rules, 1945. For this purpose the Licensing Authorities are appointed by the State Governments. Scheme of certification of pharmaceutical products (COPP) under WHO Guidelines is extended to Ayurvedic medicines and it is administered by the Office of Drugs Controller General (India). Voluntary certification scheme for Ayurvedic medicines has also been implemented by the Quality Council of India.
For doing medical practice of Ayurveda, recognized qualification and registration of the Ayurvedic practitioner is required as per the provisions of Indian Medicine Central Council Act, 1970. Sale license is not required for Ayurvedic medicines, however medicines containing poisonous substances specified in Schedule E1 of the Drugs and Cosmetics Rules, 1945 have to be labeled conspicuously with the words Caution: to be taken under medical supervision both in English and Hindi languages.
The legal definition of Ayurvedic drug is given in Section 3(a) the Drugs and Cosmetics Act, 1940, which includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic system specified in the First Schedule of the Act. Patent or Proprietary medicines in relation to Ayurvedic system are all formulations containing only such ingredients, which are mentioned in the formulae described in the authoritative books of Ayurveda specified in the First Schedule of the Drugs and Cosmetics Act and does not include a medicine administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a) of Section 3 of the Act.
This information was given by the Minister of State, AYUSH(IC), Shri Shripad Yesso Naik in a written reply to a question in Rajya Sabha today.
For doing medical practice of Ayurveda, recognized qualification and registration of the Ayurvedic practitioner is required as per the provisions of Indian Medicine Central Council Act, 1970. Sale license is not required for Ayurvedic medicines, however medicines containing poisonous substances specified in Schedule E1 of the Drugs and Cosmetics Rules, 1945 have to be labeled conspicuously with the words Caution: to be taken under medical supervision both in English and Hindi languages.
The legal definition of Ayurvedic drug is given in Section 3(a) the Drugs and Cosmetics Act, 1940, which includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic system specified in the First Schedule of the Act. Patent or Proprietary medicines in relation to Ayurvedic system are all formulations containing only such ingredients, which are mentioned in the formulae described in the authoritative books of Ayurveda specified in the First Schedule of the Drugs and Cosmetics Act and does not include a medicine administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a) of Section 3 of the Act.
This information was given by the Minister of State, AYUSH(IC), Shri Shripad Yesso Naik in a written reply to a question in Rajya Sabha today.
