Taking patient safety into consideration amidst outbreak of coronovirus pandemic, the Gujarat FDCA has approved product licences of 189 hand sanitisers to tide over its growing demand due to the pandemic. The product licenses are mostly from small and medium Indian manufacturers which have Schedule M compliant units and which are complying with the provisions of cosmetic rules.
Adequate supply of sanitisers and antiretroviral (ARV) drugs like chloroquine phosphate has been maintained in the wake of pandemic. A state level committee has also been formed to oversee the consistent supply of ARV drugs, masks and sanitisers, according to an official associated with the development.
The committee is headed by Gujarat Food and Drug Control Administration (FDCA) Commissioner Dr HG Koshia with members from the state industry department and state pollution control board.
“This has to be followed religiously as the Central Government has notified Essential Commodities (EC) Order, 2020 to regulate the production, quality, distribution, logistics of masks (2ply and 3ply surgical masks, N95 masks) and hand sanitizers for COVID-19 management.
We have made the provision of approving licenses for sanitisers production and distribution under the emergency use authorization for consistent supply,” informs Dr Koshia. The EC order notification shall remain in force for a period up to June 30, 2020 from the date of its publication in the official gazette.
ARV drug chloroquine phosphate is a generic antimalarial drug derived from quinolone, marketed in the UK by Alinter Ltd in Essex, Crescent Pharma Ltd in Hampshire and The Boots Company in Nottingham and by other companies in multiple other regions.
It is in trials for COVID-19 in China, including one in combination with Kaletra, as chloroquine phosphate is believed to have broad-spectrum antiviral activities, although it is not approved as an antiviral agent.