**Summary:**
This notification, S.O. 4244(E), issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, on November 26, 2020, addresses the potential disruption of drug supply due to the COVID-19 pandemic. Citing the pandemic and requests from pharmaceutical companies, the notification extends the validity of existing import licenses (Form 10) for drugs. Specifically, it directs that if a valid import license holder applies for a fresh license before the expiry of their existing license, the existing license will remain valid until orders are passed on the new application, effectively extending the license. This order, issued under the authority of Section 26B of the Drugs and Cosmetics Act, 1940, came into force on the date of its publication in the Official Gazette and remained valid for six months. The contact person is Dr. Mandeep K. Bhandari, Jt. Secy., and the file number is F.No. X.11014/01/2020-DR.
Key Entities Referenced
COVID 19: The ongoing pandemic that prompted the notification.
Form10: Import licences, the validity of which is being extended.
Central Government: The governing body issuing the notification.
Drugs and Cosmetics Act, 1940: The law under which the powers are exercised.
Drugs and Cosmetics Rules, 1945: The rules being modified by the notification.
Ministry of Health and Family Welfare: The ministry issuing the notification.
New Delhi: Location of publication of notification.
DR. MANDEEP K BHANDARI: Joint Secretary who issued the notification.
रजजस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एलxx.x-GअI.D-E2x7x1x 12020-223363
CG-DL-E-27112020-223363
ऄसाधारण
EXTRAORDINARY
भाग II—खण् ड 3—ईप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 3740] नइ दिल्ली, बृहस्ट्प जतवार, नवम्ब र 26, 2020/ऄग्रहायण 5, 1942
No. 3740] NEW DELHI, THURSDAY, NOVEMBER 26, 2020/AGRAHAYANA 5, 1942
स्ट्व ास्ट्् य रर पररवार कल्य ाण मरं ालय
(स्ट् वास्ट्् य रर पररवार कल्य ाण जवभाग)
ऄजधसचू ना
नइ दिल्ल ी, 26 नवम्ब र, 2020
का. अ. 4244 (ऄ).— भारत रर िजु नया भर म ें कोजवड -19 महामारी का प्रकोप जवद्यमान ह;ै
रर, प्ररूप -10 में कइ अयात ऄनुज्ञजि ऄजस्ट्तत्व में ह ैंरर ईनकी तीन साल की जवजधमान्य ऄवजध िीघ्र ही समाि
होने की संभावना ह;ै
रर, रषध कंपजनयों रर ईसके संघों ने कोजवड -19 महामारी के मद्देनजर अयात ऄनुज्ञजि (प्ररूप -10) की
जवजधमान्यता को छह मास के जलए बढान े का ऄनुरोध दकया ह;ै
रर, केन्रीय सरकार का जवचार ह ै दक रषजध की अपूर्तत प्रभाजवत नहीं हो रर रषजध जनता के जलए ईपलब्ध
रहना चाजहए;
ऄतः, ऄब, केन्रीय सरकार, रषजध रर प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23) की धारा 26ख द्वारा
प्रित्त िजियों का प्रयोग करत े हुए, यह जनिेि िते ी ह ै दक जबक्री रर जवतरण हते ु रषजध के अयात के जलए रषजध रर
प्रसाधन सामग्री जनयम, 1945 के जनयम 28 म ें दकसी बात के होते हुए भी, यदि ईि जनयमों के ऄधीन एक जवद्यमान वैध
अयात ऄनज्ञु जि धारक, जवद्यमान ऄनुज्ञजि की समाजि स े पहल े एक नए अयात ऄनुज्ञजि के जलए एक अवेिन करता ह,ै तो
जवद्यमान अयात ऄनज्ञु जि तब तक मान्य होगा जब तक दक अवेिन पर अिेि पाररत नहीं दकए जात े ह ैं रर यह सभी
प्रयोजनों के जलए जवजधमान्य माना जाएगा।
5773 GI/2020 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
2. यह अिेि राजपर म ें आसके प्रकािन की तारीख को प्रवृत्त होगा रर छह मास की ऄवजध के जलए जवजधमान्य
रहगे ा ।
[फा.सं. एक् स.11014/01/2020–डीअर]
डॉ. मनिीप के भण्डारी, संयुक् त सजचव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 26th November, 2020
S.O. 4244(E).—Whereas, an outbreak of COVID -19 pandemic is prevailing throughout India and
worldwide;
And whereas, several import licences in Form-10 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 import licence (Form-10) 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 28 of the Drugs and Cosmetics Rules, 1945, for import of drugs for sale or distribution, if an existing
valid import licence holder under the said rules, makes an application for a fresh import licence before the
expiry of the existing licence, the existing import licence 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.