This notification, G.S.R. 52(E), issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare on January 27, 2020, amends notification G.S.R. 577(E) dated July 23, 1983, under the authority of section 10A of the Drugs and Cosmetics Act, 1940.
The amendment modifies the prohibition on the import of Oxytocin and its formulations. While the import of Oxytocin and its formulations remains generally prohibited, an exception is now made for Oxytocin reference standards imported exclusively for examination, testing, or analysis purposes. This change addresses representations received by the Central Government from stakeholders who require Oxytocin reference standards for quality control and research activities related to the drug's manufacturing.
The responsible authority is Dr. Mandeep K. Bhandari, Jt. Secy., and the file number is F. No. X.11014/2/2018-DR. The principal notification, G.S.R. 577(E), was last amended vide notification number G.S.R. 1074(E), dated the 30th October, 2018.
Key Entities Referenced
Oxytocin: A drug whose import was initially prohibited but later allowed for reference standards for testing and analysis.
Ministry of Health and Family Welfare: The Indian government ministry responsible for the notification and related regulations.
Drugs and Cosmetics Act, 1940: The Indian law under which the Central Government exercises its powers to regulate drugs.
G.S.R. 577E, dated the 23rd July, 1983: The original notification prohibiting the import of Oxytocin.
G.S.R. 390E, dated the 24th April, 2018: A notification by the Government of India in the Ministry of Health and Family Welfare regarding the prohibition of import of Oxytocin.
G.S.R. 1074E, dated the 30th October, 2018: A notification amending the principal notification G.S.R. 577E.
New Delhi: The city in India where the notification was issued.
Mandeep K. Bhandari: Joint Secretary in the Government of India.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. NO. D. L.-33004/99
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असाधारण
EXTRAORDINARY
भाग II—खण्ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 49] नई दिल्ली, सामवार, िनवरी 27, 2020/माघ 7, 1941
No. 49] NEW DELHI, MONDAY, JANUARY 27, 2020/MAGHA 7, 1941
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल् ली, 27 िनवरी, 2020
सा.का.जन. 52(अ).—केन्द रीय सरकार का या समाधान ाा गया ा दक ऑक्सीटासीन औषजध का दकसी नाम
या रीजत म ें प्रयाग और उसकी जवजनर्ममजत, जिससे मानव और िन्दतुओं का जविेष िाजखम अन्दतववजलत ाान े की
संभावना ाा, और भारत सरकार के स्ट् वास्ट् ् य और पररवार कल् याण मंत्रालय, सं. सा.का.जन. 390(अ), तारीख
24 अप्र ल, 2018 की अजधसूचना द्वारा अजधसूचना स.ं सा.का.जन. 577(अ), तारीख 23 िलु ाई, 1983 के संिाधन
द्वारा लाक जात में उक्त औषजधयों के आयात का प्रजतजषद्ध करना आवश्यक और समीचीन ा;
और, औषजध ऑक्सीटासीन और दकसी नाम या रीजत में उसकी जवजनर्ममजत के आयात का प्रजतजषद्ध करने के
जलए उक्त अजधसूचना सं. सा.का.जन. 390(अ), तारीख 24 अप्र ल, 2018 का िारी दकए िाने के पश्चात,् केन्दरीय
सरकार न े परीक्षा, परीक्षण या जवश्लेषण के प्रयािन के जलए ऑक्सीटासीन के जनिेि मानकों के आयात का िारी करन े
के जलए जवजभन्न पणधाररयों स ेअभ्यावेिन प्राप्त दकया ा;
और, केन्दरीय सरकार का या समाधान ाा िाता ा दक ऑक्सीटासीन के जनिेि मानकों का आयात, उक्त
औषजध के वाजणजययक जनमावण करने से पूवव उसके परीक्षा, परीक्षण या जवश्लेषण के प्रयािन के जलए अनन्दय रूप स े
आवश्यक ा;
अत:, अब, केन्द रीय सरकार, औषजध और प्रसाधन साम्रग्री अजधजनयम, 1940 (1940 का 23) की धारा
10क द्वारा प्रित् त िजक्तयों का प्रयाग करते ुए, भारत सरकार के स्ट् वास्ट् ् य और पररवार कल् याण मंत्रालय की
अजधसूचना सं. सा.का.जन. 577(अ), तारीख 23 िुलाई, 1983 की अजधसूचना में जनम्न जलजखत संिाधन करती ा,
अर्ावत ् :―
506 GI/2020 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
उक्त अजधसूचना की सारणी म,ें क्रम संखयांक 12 और उससे संबंजधत प्रजवजि के स्ट्र्ान पर जनम्नजलजखत क्रम
स.ं और प्रजवजि अतं ःस्ट्र्ाजपत की िाएगी, अर्ावत ्:―
"12. परीक्षा, परीक्षण अर्वा जवश्लेषण के प्रयािन के जलए अनन्दय रूप से आयात दकए गए ऑक्सीटासीन जनिेि
मानकों के जसवाय, दकसी नाम या रीजत म ेंऑक्सीटासीन और उसकी जवजनर्ममजत ।"।
[फा. सं. एक् स.11014/2/2018-डीआर]
डॉ. मनिीप के. भण्डारी, संयुक् त सजचव
रटप्पण : मूल अजधसूचना भारत के रािपत्र, असाधारण, भाग II, खंड 3, उपखंड (i) अजधसूचना स.ं सा.का.जन.
577(अ), तारीख 23 िुलाई, 1983 द्वारा प्रकाजित की गई र्ी और उसमें अंजतम बार संिाधन
अजधसूचना स.ं सा.का.जन. 1074(अ), तारीख 30 अक्तूबर, 2018 द्वारा दकया गया।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 27th January, 2020
G.S.R. 52(E).—Whereas the Central Government, on being satisfied that the use of the drug
Oxytocin and its formulation in any name or manner is likely to involve certain risk to human beings
and animals, prohibited the import of the said drugs in public interest by amending the notification
number G.S.R. 577(E), dated the 23rd July, 1983 vide notification of the Government of India in the
Ministry of Health and Family Welfare number G.S.R. 390(E), dated the 24th April, 2018;
And whereas, subsequent to issuance of the said notification number G.S.R. 390(E), dated the
24th April, 2018 for prohibition of import of drug Oxytocin and its formulation in any name or
manner, the Central Government received representations from various stakeholders to allow import
of Oxytocin reference standards for the purpose of examination, test or analysis;
And whereas, the Central Government is satisfied that import of Oxytocin reference standards
is necessary exclusively for the purpose of examination, test or analysis before carrying out
commercial manufacturing of the said drug;
Now, therefore, in exercise of the powers conferred by section 10A of the Drugs and
Cosmetics Act, 1940 (23 of 1940), the Central Government hereby makes the following amendment
in the notification of the Government of India in the Ministry of Health and Family Welfare number
G.S.R. 577(E), dated the 23rd July, 1983, namely:―
In the said notification, in the Table, for serial number 12 and the entry relating thereto, the
following serial number and entry shall be inserted, namely:―
"12. Oxytocin and its formulation in any name or manner except Oxytocin reference standards
imported exclusively for the purpose of test and analysis.”.
[F. No. X.11014/2/2018-DR]
Dr. MANDEEP K. BHANDARI, Jt. Secy.
Note: The principal notification was published in the Gazette of India, Extraordinary, Part II, section
3, sub-section (i) vide G.S.R. 577(E), dated the 23rd July, 1983 and lastly amended vide
notification number G.S.R. 1074(E), dated the 30th October, 2018.
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