The regulatory and quality control provisions for the manufacturing of Ayurvedic, Siddha and Unani drugs/ medicines, under the Drugs and Cosmetics Act, 1940, has expedited the process for granting the license to manufacture ASU drugs which can boost immunity to fight COVID-19 disease.1

Background

Due to COVID-19 outbreak, the need for public use of ASU-based immunity boosting products for healthy people and hand sanitizers has been significantly emphasized upon and their demand has increased manifold. In this regard, some drug manufacturers engaged in or interested in producing ASU ingredients-based such products have represented to the Central Government about the problems being faced in the States/UTs for grant or renewal of license/approval in the current situation.

The government, during interaction with stakeholders, has suggested ASU medicines manufacturers to utilize their resources for producing essential items like sanitizers and has highlighted that the impact of traditional practices for boosting immunity of healthy people is set to play an important role in India's fight against COVID-19.

According to the resource information, during the urgent need to manufacture essential healthcare products at the time of emergency all the State AYUSH Licensing Authorities/Drug Controllers and Expert Committees thereunder, have been directed to complete the licensing/approval/renewal process expeditiously and dispose off the applications of the manufacturers maximum within a week's time provided the prescribed standards and relevant provisions of the Drugs & Cosmetics Rules, 1945, in terms of use of ingredients and permitted excipients in accordance with the authoritative books including Pharmacopoeias and Formularies, are fulfilled. It is also been appealed that the list of manufacturers and details of such ASU products being licensed /approved under respective jurisdiction be sent to Drug Controller and AYUSH Licensing Authorities ....

Conclusion

At the time of emergency when all the departments of health ministries are coming forward to combat or stop the aggravation of this pandemic disease, Ayush ministry has taken a welcome forward step in producing the immune booster products which can be considered as a preventive measure against COVID-19.

Footnote

1 http://ayush.gov.in/event/expediting-process-grant-approval-license-renewal-license-manufacturing-asu-immunity-boosting

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