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In a bid to ensure availability of hand sanitizers in adequate quantity and quality in the country in the wake of coronavirus outbreak, the Drugs Controller General of India (DCGI) has directed the state drugs controllers to expedite the licensing of manufacturers of such products and monitor quality standards of the products as per Drugs and Cosmetics Act, 1940.
Hand sanitizers are licensed under Drugs and Cosmetics Rules, 1945. The standards of such products shall be prescribed in the Second Schedule of Drugs and Cosmetics Act and rules made thereunder.
Further, on March 13, 2020, the central government had notified masks (2ply and 3ply surgical masks, N95 masks) and hand sanitizers under Essential Commodities Act, 1955 to regulate their production, quality, distribution and logistics.
In light of existing circumstances arising out of coronavirus outbreak, it is required that the regulatory activities should be intensified to keep strict vigil in the matter so that the people can be protected from malpractices, said DCGI in a letter to state drug authorities on March 17, 2020.
Accordingly, the DCGI has asked state drugs controllers to submit the list of manufacturers who are manufacturing hand sanitizers under their jurisdiction along with product details and further exercise strict vigil and regulatory oversight on manufacturing and distribution of such products.
Similarly, state drugs controllers have also been directed to expedite the licensing process for manufacturers of hand sanitizers by taking proactive measures to meet the present challenges of increased demand of such product in the country.
The DCGI has further asked all zonal and sub zonal offices of CDSCO to coordinate with state and Union territory drugs control authorities in the matter.
Welcoming the DCGI’s initiative to expedite the issuance of manufacturing license for hand sanitizers, Amit Chawla, general secretary of Madhya Pradesh Small Scale Drug Manufacturers Association, said, “To meet domestic supply shortage of hand sanitizer, the government should grant permission to exporters to manufacture the product for export as well as domestic market. It will help meet global as well as domestic demand for the product. There are 152 countries across the globe affected by the new virus.”
Recently Prime Minister Narendra Modi has called on the South Asian Association of Regional Cooperation (SAARC) to fight the coronavirus threat jointly.
Chawla cited the example of Food and Drug Administration of the United States which has called upon licensed pharmacists and physicians to manufacture their own batches of hand sanitizer to meet its growing demand. The agency is concerned that home-made sanitizers are not as safe to use as what pharmacists and doctors could make, using high-quality ingredients and at least 60% alcohol. Most of the stores have reported non-availability of hand sanitizers.
Meanwhile MP licensing authority Rajiv Aggarwal has issued three manufacturing licenses for hand sanitizer in last two weeks to tide over its increasing demand. Gujarat FDCA has also approved product licenses of 189 hand sanitizers.
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