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Date: 2020-03-18 Category: Not Applicable State: Union Government Country: India

Monitoring of the quality standards of hand sanitizer as per Drugs and Cosmetics Act, 1940 and Rules made thereunder and expediting the licensing of manufacturers of such products

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

**Summary:** This document, reference number OCGIMisc202096, issued by the Drugs Controller General of India (DCGI) Secretariat on March 18, 2020, addresses all State/UT Drugs Controllers regarding the monitoring of quality standards for hand sanitizers. This directive is a continuation of a previous communication dated March 7, 2020, and responds to the increased demand for hand sanitizers due to the COVID-19 outbreak. The DCGI emphasizes the need to ensure manufacturers adhere to the provisions of the Drugs and Cosmetics Act, 1940, and its associated rules, particularly concerning the manufacturing and supply of hand sanitizers. State/UT Drugs Controllers are requested to treat this matter with high priority in the public interest. The communication includes copies to all Zonal/Sub-Zonal offices of the Central Drugs Standard Control Organisation (CDSCO) for coordination and to the PS to JS (R) and PPS to DGHS, Ministry of Health & Family Welfare, New Delhi, for information. The contact person is Dr. V.G. Somani, Drugs Controller General of India. The CDSCO address is FDA Bhawan, Kotla Road, New Delhi - 110002.

Key Entities Referenced

Drugs and Cosmetics Act, 1940: A legislative act in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics. Covid 19: The infectious disease caused by the SARS-CoV-2 virus, responsible for a global pandemic. Dr. V.G. Somani: The Drugs Controller General of India. Drugs Controller General of India (DCGI): The head of the Central Drugs Standard Control Organization (CDSCO) in India, responsible for regulating pharmaceuticals and medical devices. Central Drugs Standard Control Organization (CDSCO): National Regulatory Authority (NRA) of India. Ministry of Health and Family Welfare: A ministry of the Government of India responsible for health policy in India. New Delhi: Capital of India. All State/UT Drugs Controllers: The collective body of drug regulatory authorities in each of the states and union territories of India.
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File — OCGI/Misc/2020(96) CeD ni tr re ac lt o Dr ra ut gev s Ge e Sr n tn e am r ne a dn l at ro do ff CH I oen nad tli rta oh lS eOrrvgiacneiszation (DCGI Secretariat) oad ga RF Ko FDA Bhar 410002 DN ae tw ed D :e l 1h 8! .- 03.20 To, All State/UT Drugs Controllers r Drugs & Subject:: Monitoring of the quality standards of hand sanitizer® as editing od Cosmetics Act, 1940 and Rules made thereunder and licensing of manufacturers of such products -reg Sir/ Madam, 7.03.2020, in view : In continuation to this office letter of even number dated 1 ng demand © present situation due to outbreak of Covid —19 and to meet the grow! tions for such ph ra on dd u cs ta sn i wt ii tz her i, n 3y o wu o ra kr ie n gr e dq au ye ss t fe od r gto r ap nr to oc fe s ms a nt uh fe a cm tu a rn iu nfa gc lt iu cr ei nn sg e a up npl di ec ra ‘ he provisions of Drugs & Cosmetics Act, 1940 and rules made thereunder. Matter shall be treated as high priority in public interest. Yours faithfully, \ a . (Dr.V.G.Somani) Drugs Controller General (india) Copy to: 1. All Zonal/Sub Zonal offices of CDSCO - to coordinate with State/UT Drugs Control authorities in the matter. Copy for Information to : 1. PS to JS (R), Ministry of Health & Family Welfare, Nirman Bhavan, New Delhi. 2. PPS to DGHS, Ministry of Health & Family Welfare, Nirman Bhavan, New Delhi.

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