Express Pharma

Gujarat FDCA collects 362 hand sanitiser samples for quality check

Of the 60-70 samples analysed so far, 14 have failed to meet the required quality requirements

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To ensure the quality of manufactured and marketed hand sanitisers in the State, the Gujarat Food and Drug Control Administration (FDCA) has collected a total of 362 samples on a random basis from hospitals, pharmacy stores and manufacturers’ sites and sent them to its laboratory for a quality check. These samples were collected between March-May 2020. It is likely that the FDCA will announce the outcome of these analysed samples by the end of the month.

Dr Hemant Koshia, Commissioner, Gujarat FDCA, said, “Due to spread of coronavirus in the country, the demand for hand sanitisers has increased. Since it is acting as a first-line defence, the quality of the products also needs to be analysed. AYUSH products do not have to follow the stringent procedures that allopathic drugs have to undergo. But, at the Gujarat FDCA, we are checking the quality of hand sanitisers beyond the required standards, particularly in the AYUSH category. And for that, I have instructed all the government lab analysts to check and find out the percentage of active ingredients like isopropyl alcohol and ethyl alcohol in AYUSH and cosmetic hand sanitisers.”

He also informed, “So far we have analysed around 60-70 samples and so far 14 samples have failed to meet the required quality requirements. 13 of the failed samples are from the Ayush category and from a single manufacturer known as Nirav Healthcare. The other one belongs to the cosmetics category. It is from Raj Cosmetics, Ahmedabad. We have reported that their products have failed to prove the quality claims they have provided on the label and hence legal actions will be taken against them.”

While responding to delay in analysis, he mentioned, “There are multiple reasons, one of the factors is that many of our people come from containment zones, and considering the rising number of COVID-19 cases in the state, we have to take extra precautions. Another factor which is responsible for the slow process is that we are conducting rigorous quality and impurity profile checks of each sample.”

He continued, “Our lab is equipped with advanced laboratory technology solutions, and in 2011 we had launched the Extended Laboratory Node (XLN India) software platform which was later adopted by 19 States in the country. To name a few, Maharashtra, Karnataka, Tamil Nadu etc. We are updating the quality results of the collected samples on the XLN India platform, which also helps the masses to have an update about the failed analysed samples.

Reportedly, since March 2020, the Gujarat FDCA has issued a total of 2600 product licenses and around 75 new firms have started manufacturing hand sanitisers.

Koshia also informed that some players like Rellis India, Asian Paints, Marico, Nivea etc., have set up manufacturing units during the lockdown period. Manufacturing licenses were issued to them after proper assessment by Gujarat FDCA.

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