Executive Summary:
This notification, effective July 1, 2018, regulates and restricts the manufacture, sale, and distribution of Oxytocin in India. It addresses the drug's misuse, following observations by the High Court of Himachal Pradesh and recommendations from the Drugs Technical Advisory Board. Key changes include limiting domestic manufacture to the public sector and regulating its supply to registered hospitals and clinics.
Key Points / Main Content:
Manufacture of Oxytocin:
Domestic Use: Oxytocin formulations for domestic use must be manufactured exclusively by public sector undertakings or companies, and product labels must include barcodes.
Export Purposes: Both public and private sector companies can manufacture Oxytocin formulations for export. Export packaging must include barcodes.
Active Pharmaceutical Ingredient (API) Supply:
Domestic Use: Manufacturers of Oxytocin API must supply it only to public sector manufacturers licensed under the Drugs and Cosmetics Rules, 1945, for domestic formulation.
Export Purposes: API can be supplied to both public and private sector manufacturers licensed under the Drugs and Cosmetics Rules, 1945, for export formulation.
Distribution and Sale:
Distribution: Public sector companies manufacturing Oxytocin for domestic use must supply it directly to registered hospitals and clinics (public and private) or through designated government entities like Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) and AMRIT outlets.
Sale Restriction: Oxytocin in any form is prohibited from being sold through retail chemists.
Impact Analysis:
Public Sector Undertakings/Companies (Manufacturing Oxytocin):
Impact: These entities are now the sole manufacturers of Oxytocin formulations for domestic use and must ensure their products are labeled with barcodes.
Action Required: Ensure manufacturing processes align with the new regulations and that barcode labeling is implemented.
Private Sector Companies (Manufacturing Oxytocin for Export):
Impact: These companies can continue manufacturing Oxytocin for export purposes, provided the packaging includes barcodes.
Action Required: Ensure export packaging includes barcodes.
API Manufacturers:
Impact: API manufacturers must now differentiate supply chains for domestic and export formulation, supplying only to public sector manufacturers for domestic use.
Action Required: Adjust supply chains to comply with restrictions on supplying API for domestic Oxytocin formulation and ensure appropriate licensing.
Registered Hospitals and Clinics (Public and Private):
Impact: These entities are the primary recipients of Oxytocin formulations for human and veterinary use, supplied directly by public sector manufacturers or through government outlets.
Action Required: Establish or maintain relationships with authorized suppliers to ensure a consistent supply of Oxytocin.
Retail Chemists:
Impact: Retail chemists are now prohibited from selling Oxytocin in any form.
Action Required: Cease all sales of Oxytocin products.
Central Government:
Impact: Responsible for specifying other Government entities for distribution.
Action Required: Specify other Government entities for distribution, as needed.
Key Entities Referenced
Oxytocin: A drug whose manufacture, sale, and distribution are being regulated in India due to concerns about misuse.
Himachal Pradesh: State in India where the High Court raised concerns about the misuse of Oxytocin.
Drugs and Cosmetics Act, 1940: Indian legislation under which the Drugs Technical Advisory Board was constituted and powers are conferred to regulate drugs.
Drugs Technical Advisory Board: A board constituted under the Drugs and Cosmetics Act, 1940, that recommended regulating Oxytocin formulations.
Ministry of Health and Family Welfare: The Indian government ministry responsible for the notification regarding Oxytocin regulation.
Pradhan Mantri Bhartiya Janaushadhi Pariyojana PMBJP: An Indian government program for making affordable medicines available to the public.
Affordable Medicines and Reliable Implants for Treatment AMRIT: An initiative providing affordable medicines and implants.
High Court of Himachal Pradesh, Shimla: The court that observed the clandestine manufacture and sale of Oxytocin.
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EXTRAORDINARY
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PART II—Section 3—Sub-section (i)
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अअअअििििधधधधससससचचूूचचूू ननननाााा
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और अ(cid:23)य नामक 2014 क% िसिवल &रट जनिहत यािचका सं+या 16 म- अपने िनण/य, तारीख 15.03.2016 म- यह सं(cid:10)े4ण (cid:4)कया ह ै (cid:4)क
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पशुA और मानवB के िलए हािनकारक ह ै;
और, माननीय उ(cid:22) (cid:23)यायालय ने यह भी सं(cid:10)े4ण (cid:4)कया ह ै(cid:4)क पिEलक से6टर कंपिनयB म- ही ऑ6सीटोसीन के िविनमा/ण को िनबFिधत
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प&रसीिमत करने क% भी साMयता पर िवचार (cid:4)कया जाना चािहए ;
और, ओषिध और (cid:10)साधन सामNी अिधिनयम, 1940 (1940 का 23) क% धारा 5 के अधीन ग&ठत ओषिध तकनीक% सलाहकार
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िविनयिमत क% जाएं और िनबFिधत क% जाएं िजससे (cid:4)क उW ओषिध का द?ु पयोग रोका जा सके ;
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िव>य के िलए या िवतरण के िलए िविनZमत या िव>%त क% जाएगी, अथा/त् :-
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जाएगा और उjपाद के लेबल पर बार कोड लगा होगा ;
(ii) िनया/त के (cid:10)योजनB के िलए ऑ6सीटोसीन िनZमितयB का िविनमा/ण पिEलक और (cid:10)ाइवेट से6टर कंपिनयां, दोनB के िलए
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2429 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(iii) ऑ6सीटोसीन के स(cid:4)>य औषध-भेषजीय घटकB के िविनमा/ता घरेलू उपयोग के िलए उW ओषिध क% िनZमितयB के
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भेषजीय घटक का (cid:10)दाय कर-गे ;
(iv) ऑ6सीटोसीन के स(cid:4)>य औषध-भेषजीय घटक के िविनमा/ता िनयात/ (cid:10)योजन के िलए उW ओषिध क% िनZमितयB के
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को उW स(cid:4)>य औषध-भेषजीय घटक का (cid:10)दाय कर-गे ;
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िनkिलिखत को कर-गे,-
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(ख) (cid:10)धानमंlी भारतीय जनऔषिध प&रयोजना (पीएमबीजेपी) तथा उपचार हते ु स(cid:24)ती औषिधयB और िवmसनीय
रोपन (अमृत) आउटलेटB या ऐसी (cid:4)कसी अ(cid:23)य सरकारी अि(cid:24)तjव को, जो दशे म- इस (cid:10)योजन के िलए के(cid:23)^ीय
सरकार Hारा िविनgदh (cid:4)कया जाए जो पिEलक और (cid:10)ाइवेट से6टर म- रिज(cid:24)\ीकृत अ(cid:24)पतालB और 6लीनीकB को
ओषिध का आगे (cid:10)दाय कर-गे ।
(vi) (cid:4)कसी भी =प या नाम से ऑ6सीटोसीन को खुदरा रसानI के माMयम से िव>य (cid:4)कए जान े के िलए अनुIात नहo (cid:4)कया
जाएगा ।
2. यह अिधसूचना 1 जुलाई, 2018 को (cid:10)वृK होगी ।
[फा. सं. X.11014/3/2018-डीआर]
सुधीर कुमार, संयुW सिचव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 27th April, 2018
G.S.R. 411(E).—Whereas the Hon’ble High Court of Himachal Pradesh, Shimla, has, in its judgment dated
15.3.2016 in CWPIL No. 16 of 2014 titled ‘Court on its own motion’ versus State of Himachal Pradesh and others, observed
that there is large scale clandestine manufacture and sale of the drug Oxytocin leading to its grave misuse, which is harmful
to animals and humans;
And whereas, the said Hon’ble High Court also observed that the feasibility of restricting the manufacture of
Oxytocin only in public sector companies and also restricting and limiting the manufacture of Oxytocin by companies to
whom licenses have already been granted should be considered;
And whereas, the Drugs Technical Advisory Board constituted under section 5 of the Drugs and Cosmetics Act,
1940 (23 of 1940) considered the said issue in its meeting held on the 12th February 2018 and recommended that Oxytocin
formulations for human use be regulated and restricted to be supplied only to registered hospitals and clinics in public and
private sector to prevent misuse of the said drug;
And whereas, the Central Government, on the basis of the recommendations of the said Board and after
examination of the matter, is satisfied that unregulated and illegal use of the drug Oxytocin is likely to involve risk to human
beings or animals and that in the public interest it is necessary and expedient to regulate and restrict the manufacture, sale
and distribution of the drug Oxytocin in the country to prevent its misuse by unauthorised persons or otherwise;
Now, therefore, in exercise of the powers conferred by section 26A of the said Act, and in supersession of the
notification number G.S.R. 29(E) dated 17th January, 2014, the Central Government hereby directs that the drug Oxytocin
shall be manufactured for sale or for distribution or sold in the manner specified below, namely:-
(i) The manufacture of Oxytocin formulations for domestic use shall be by public sector undertakings or companies
only and the label of the product shall bear barcodes.
(ii) The manufacture of Oxytocin formulations for export purposes shall be open to both public and private sector
companies and the packs of such manufacture for exports shall bear barcodes.¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
(iii) The manufacturers of active pharmaceutical ingredient of Oxytocin shall supply the active pharmaceutical
ingredient only to the public sector manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for
manufacture of formulations of the said drug for domestic use.
(iv) The manufacturers of active pharmaceutical ingredient of Oxytocin shall supply the said active pharmaceutical
ingredient to the manufacturers in public and private sector licensed under the Drugs and Cosmetics Rules, 1945
for manufacture of formulations of the said drug for export purpose.
(v) The Oxytocin formulations manufactured by the public sector companies or undertakings licensed under the
Drugs and Cosmetics Rules, 1945 for domestic use shall supply the formulations meant for human and
veterinary use only,-
(a) to the registered hospitals and clinics in public and private sector directly; or
(b) to the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) and Affordable Medicines and
Reliable Implants for Treatment (AMRIT) outlets or any other Government entity which may be
specified by the Central Government for this purpose in the country which shall further supply the
drug to the registered hospitals and clinics in public and private sector.
(vi) The Oxytocin in any form or name shall not be allowed to be sold through retail Chemist.
2. This notification shall come into force on the first day of July 2018.
[F. No. X.11014/3/2018-DR]
SUDHIR KUMAR, 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.