**Summary:**
This notification, S.O. 2451(E), issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, Government of India, on July 27, 2020, exempts hand sanitizers from the requirement of a sale license for stocking or sale under Chapter IV of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. This decision was made in response to the COVID-19 pandemic and the recognized need to ensure the widespread availability of hand sanitizers to the public. The exemption is granted under the powers conferred by section 26B of the Drugs and Cosmetics Act, 1940 (23 of 1940). The exemption is conditional, requiring compliance with condition 17 of rule 65 of the Drugs and Cosmetics Rules, 1945. The order took effect on the date of its publication in the Official Gazette. The file number for this notification is F. No. X.11014/32020-DR. The issuing authority is Dr. Mandeep K Bhandari, Jt. Secy.
Key Entities Referenced
COVID19 pandemic: The global pandemic caused by the SARS-CoV-2 virus, which prompted the policy regarding hand sanitizers.
Drugs and Cosmetics Act, 1940: An Indian law regulating the import, manufacture, distribution, and sale of drugs and cosmetics. Chapter IV is specifically referenced regarding sale licenses.
Drugs and Cosmetics Rules, 1945: The rules framed under the Drugs and Cosmetics Act, 1940, providing detailed regulations for drugs and cosmetics.
Central Government: The executive branch of the Government of India, which issued the notification.
hand sanitizer: The specific product exempted from sale license requirements due to the COVID19 pandemic.
Section 26B of the Drugs and Cosmetics Act, 1940: The specific section of the Drugs and Cosmetics Act, 1940 that grants the Central Government the power to issue the directive.
New Delhi: The capital of India, where the notification was issued.
Dr. Mandeep K Bhandari: The Joint Secretary who signed the notification.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-28072020-220716
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CG-DL-E-28072020-220716
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 2164] नई दिल्ली, सोतवार, िलु ाई 27, 2020/श्रावण 5, 1942
No. 2164] NEW DELHI, MONDAY, JULY 27, 2020/SHRAVANA 5, 1942
स्ट्व ास्ट्् य रर पररवार कल्य ाण तरं ालय
(स्ट्व ास्ट्् य रर पररवार कल्य ाण जवभाग)
अजधसचू ना
नई दिल् ली, 27 िुलाई, 2020
का.आ. 2451(अ).— भारत रर िजु नया भर त ेंकोजवड -19 तहातारी का प्रकोप हुआ ह;ै
रषजध का स्ट्टॉक रखन े या जवक्रय करन े के जलए रषजध रर प्रसाधन सातग्री अजधजनयत, 1940 के अध्याय 4 के
उपबंधों रर रषजध रर प्रसाधन सातग्री जनयत, 1945 के उपबंधों के अधीन जबक्री अनुज्ञजि की अपेक्षाओं से हडैं
सैजनटाइिर को छूट िेन े का अनुरोध करने वाल ेकई अभ्यावेिन प्राि हुए ह;ैं
केंद्रीय सरकार का यह सताधान हो िाता ह ै दक कोजवड -19 तहातारी के कारण उद्भूत आपात जस्ट्िजत की
अपेक्षाओं को पूरा करने के जलए हडैं सैजनटाइिर आवश्यक ह ैरर उनकी सहि उपलब्धता लोकजहत त ेंबनी ह;ै
केंद्रीय सरकार यह आवश्यक सतझती ह ैदक हडैं सैजनटाइिर व्यापक रूप स े बडे पैताने पर िनता के जलए उपलब्ध
कराने की आवश्यकता ह;ै
अतः ,अब ,केन्द्द्रीय सरकार ,रषजध रर प्रसाधन सातग्री अजधजनयत, 1940 (1940 का 23) की धारा 26ख
द्वारा प्रित्त िजियों का प्रयोग करते हुए ,यह जनिेि िेती ह ै दक उि रषजध अिाात ् "हडैं सैजनटाइिर" का स्ट्टॉक रखने या
3318 GI/2020 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
जवक्रय करने के जलए रषजध रर प्रसाधन सातग्री अजधजनयत, 1940 के अध्याय 4 रर रषजध रर प्रसाधन सातग्री
जनयत, 1945 के उपबंधों के अधीन हडैं सैजनटाइिर का स्ट्टॉक रखन े या जवक्रय करन े वाले व्यजि द्वारा उि जनयतों के
जनयत 65 की ित ा (17) के उपबंध के अध्यधीन जबक्री अनुज्ञजि की आवश्यकता से छूट िी िाएगी ।
2. यह आििे रािपर त ें इसके प्रकािन की तारीख को प्रवृत्त होगा।
[फा. सं. एक् स.1111/ 3 2120–डीआर]
डॉ. तनिीप के भण्डारी, संयुक् त सजचव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 27th July, 2020
S.O. 2451(E).— Whereas, there has been an outbreak of COVID-19 pandemic in India and worldwide;
Whereas, several representations requesting to exempt hand sanitizers from the requirement of sale licence
under the provisions of Chapter IV of the Drugs and Cosmetics Act, 1940 and the provisions of the Drugs and
Cosmetics Rules, 1945 for stocking or sale of the drug have been received;
Whereas, the Central Government is satisfied that hand sanitizers are essential to meet the requirements of
emergency arising due to COVID-19 pandemic and their easy availability is made in public interest;
Whereas, the Central Government considers it necessary that hand sanitizers are required to be made widely
available to the public at large;
Now, therefore, in exercise of the powers conferred by section 26B of the Drugs and Cosmetics Act, 1940
(23 of 1940), the Central Government, hereby directs that the drug, namely, hand sanitizer shall be exempted from the
requirement of sale licence for its stocking or sale under the provisions of Chapter IV of the Drugs and Cosmetics
Act, 1940 and the Drugs and Cosmetics Rules, 1945, subject to the condition that provisions of condition (17) of rule
65 of the said Rules are complied with by the person stocking or selling hand sanitizers.
2. This order shall come into force on the date of its publication in the Official Gazette.
[F. No. X.11014/3/2020-DR]
Dr. MANDEEP K BHANDARI, Jt. Secy.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.