**Policy Summary:**
This notification, S.O. 2450(E), issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, Government of India, addresses the potential disruption of drug supplies due to the COVID-19 pandemic. Effective from July 27, 2020, and valid for six months, the order extends the validity of existing Registration Certificates (Form 41) for import of drugs for sale or distribution. Specifically, if a Registration Certificate holder applies for a fresh certificate before the expiry of their current one, the existing certificate remains valid until a decision is made on the new application and shall be deemed valid for all purposes. This measure, enacted under the authority of Section 26B of the Drugs and Cosmetics Act, 1940, aims to ensure the continued availability of drugs to the public during the pandemic. The notification was issued under F. No. X.11014/01/2020-DR by Dr. Mandeep K. Bhandari, Jt. Secy.
Key Entities Referenced
COVID 19: A global pandemic that prompted the extension of Registration Certificate Form41 validity.
Registration Certificate Form41: A certificate related to pharmaceutical companies, the validity of which was extended due to the COVID-19 pandemic.
Central Government: The governing body responsible for directing the extension of the Registration Certificate validity.
Drugs and Cosmetics Act, 1940: The legal act under which the Central Government exercised its powers to extend the Registration Certificate validity.
Drugs and Cosmetics Rules, 1945: The rules related to the import of drugs for sale or distribution, which are temporarily superseded by the notification.
Ministry of Health and Family Welfare: The government ministry that issued the notification regarding the extension of Registration Certificate Form41 validity.
Dr. Mandeep K Bhandari: Joint Secretary who signed the notification.
New Delhi: The location where the notification was issued.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-28072020-220713
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CG-DL-E-28072020-220713
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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.ं 2163] नई दिल्ली, सोतवार, िलु ाई 27, 2020/श्रावण 5, 1942
No. 2163] 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. 2450(अ).—भारत रर िजु नया भर त ेंकोजवड -19 तहातारी का प्रकोप जवद्यतान ह;ै
रर, प्ररूप -41 तें कई रजिस्ट्रीकरण प्रताण पर अजस्ट्तत्व तें ह ैं रर उनकी तीन साल की जवजधतान्य अवजध िीघ्र
ही सताप्त होने की संभावना ह;ै
रर, रषध कंपजनयों रर उसके संघों ने कोजवड -19 तहातारी के तद्देनिर रजिस्ट्रीकरण प्रताण पर (प्ररूप -41)
की जवजधतान्यता को छह तास के जलए बढाने का अनुरोध दकया ह;ै
रर, केन्रीय सरकार का जवचार ह ै दक रषजध की आपूर्त ि प्रभाजवत नहीं हो रर रषजध िनता के जलए उपलब्ध
रहना चाजहए;
अतः, अब, केन्रीय 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 जबक्री रर जवतरण हते ु रषजध के आयात के जलए रषजध
रर प्रसाधन सातग्री जनयत, 1945 के जनयत 28क त ें अंतर्विष्ट होते हुए भी, यदि उि जनयतों के अधीन एक जवद्यतान
रजिस्ट्रीकरण प्रताणपर धारक, जवद्यतान प्रताणपर की सताजप्त से पहल े एक नए रजिस्ट्रीकरण प्रताण पर के जलए एक
3317 GI/2020 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
आवेिन करता ह,ै तो जवद्यतान रजिस्ट्रीकरण प्रताण पर तब तक तान्य होगा िब तक दक आवेिन पर आिेि पाररत नहीं
दकए िाते ह ैंरर यह सभी प्रयोिनों के जलए जवजधतान्य ताना िाएगा।
2. यह आिेि रािपर त ें इसके प्रकािन की तारीख को प्रवृत्त होगा रर छह तास की अवजध के जलए जवजधतान्य
रहगे ा ।
[फा. सं. एक् स.11114 01 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. 2450(E).---Whereas, an outbreak of COVID -19 pandemic is prevailing throughout India and
worldwide;
And whereas, several Registration Certificates in Form-41 are in existence and their validity periods of three
years are likely to expire shortly;
And whereas, pharmaceutical companies and their associations have requested for extension of the validity
of Registration Certificate (Form-41) for six months in the wake of COVID-19 pandemic;
And whereas, the Central Government is of the considered view that supply of drugs may not get affected
and the drugs must remain available to the public;
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 notwithstanding anything contained in rule 28A of the
Drugs and Cosmetics Rules, 1945, for import of drugs for sale or distribution, if an existing Registration Certificate
holder under the said rules, makes an application for a fresh Registration Certificate before the expiry of the existing
certificate, the existing Registration Certificate shall be valid until orders are passed on the application and shall be
deemed to be valid for all purposes.
2. This order shall come into force on the date of its publication in the Official Gazette and shall remain valid for
a period of six months.
[F. No. X.11014/01/2020-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.