Date: 15-Oct-2020

Ayush Ministry Clarifies On Licensing And Approval Of Various Dosage Forms Of ASU Products

The Union Ministry of Ayush has issued a directive to the state licensing authorities, clarifying licensing and approval of various dosage forms of ASU formulations and products.

Earlier, the Ayush ministry had received representations from state licensing authorities and Ayurveda, Siddha and Unani (ASU) drug manufacturers regarding manufacturing of ASU products in various dosage forms and their licensing or approval under the relevant provisions of Drugs & Cosmetics Rules, 1945.

The issues raised by the stakeholders have been examined in the light of legal definitions of ASU drug/medicine prescribed in Section 3(a) and (h)i) of the Drugs & Cosmetics Act, 1940 and the guidelines provided under Rule 158-B of the Drugs & Cosmetics Rules, 1945 for grant of license or approval for manufacturing of various categories and sub-categories of ASU products.

Accordingly, it is observed and hereby clarified that any ASU drug/medicine intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals can be manufactured in any dosage form/drug delivery system except for parenteral route administration, as per the statement issued by the Ministry of Ayush.

The State Licensing Authority and the Expert Committee may accordingly examine, process and dispose of the application of the licensed drug manufacturer seeking approval of any ASU formulation/product, it further stated.

Therefore, the standards of the formulation/ingredients are in accordance with the ASU pharmacopoeias & formularies or in-house standards of the licensed manufacturer and the excipients used in the manufacturing of concerned ASU drug/medicine are in accordance with the provisions of Rule 169 of Drugs & Cosmetics Rules, 1945 for permitted excipients.

The adequate manufacturing area and infrastructural facilities are available for the manufacturing of applied formulation/product in accordance with good manufacturing practice (GMP) requirements specified in Schedule T under Rule 157 of the Drugs & Cosmetics Rules, 1945.