Executive Summary:
This notification from the Ministry of Health and Family Welfare proposes amendments to the Drugs and Cosmetics Rules, 1945, to authenticate the genuineness of drugs via barcode encoding. It mandates specific barcode details on primary, secondary, and tertiary packaging levels for drug formulations. The final rules will come into force 180 days after publication in the Gazette of India. Any objections or suggestions must be submitted within 45 days of the draft rules being made available.
Key Points / Main Content:
Amendments to Drugs and Cosmetics Rules, 1945
* Rule 96, subrule 1 will be amended with a new clause xiii.
Barcode Encoding Requirements:
* Manufacturers must print specific details using barcode encoding for tracking and tracing at all packaging levels.
* Primary level: Two-dimensional barcode encoding (14-digit Global Trade Item Number format) with batch number, expiry date, and unique serial number.
* Secondary level: One or two-dimensional barcode encoding (14-digit Global Trade Item Number format) with batch number, expiry date, and unique serial number.
* Tertiary level: One-dimensional barcode encoding (14-digit Global Trade Item Number format) with batch number, expiry date, and unique serial number.
Data Maintenance and Upload:
* Manufacturers must maintain parent-child relationship data for all three packaging levels and their movement in the supply chain.
* This data must be uploaded to a central government portal before the drugs are released for sale or distribution.
Responsibilities and Exemptions:
* Manufacturers are responsible for the correctness, completeness, and timely uploading of data to the central portal.
* Exemption: The subrule does not apply to drug formulations manufactured for export if the importing country mandates specific requirements and the exporter obtains permission from the licensing authority to use the importing country's barcode format.
* Tertiary packaging for export must include the barcode as per subclause A in addition to any other requirements by the importing country.
Packaging Level Definitions:
* Primary packaging: Package in physical contact with the drug.
* Secondary packaging: Carton containing multiple primary packs (including a mono carton).
* Tertiary packaging: Shipper containing multiple secondary packs, as per Central Government guidelines.
* Parent-child relationship: Defines the relationship between tertiary, secondary, and primary packaging levels.
Impact Analysis:
Manufacturers of Drug Formulations:
* Impact: Required to implement barcode encoding at all packaging levels, maintain data, and upload to a central portal.
* Action Required: Update packaging processes to include barcode printing as specified, establish systems for data maintenance and uploading, and comply with data accuracy and timeliness requirements.
Central Government:
* Impact: Responsible for establishing and maintaining the central portal for data upload.
* Action Required: Establish a central portal for data uploads and provide guidelines for data requirements.
Drug Technical Advisory Board:
* Impact: Consulted for carrying out the amendments in the said rules;
* Action Required: No action required.
Licensing Authority:
* Impact: Provide permissions to exporters intending to avail the option of printing the bar codes in the format specified by the importing country with the permission of licensing authority appointed under rule 21.
* Action Required: Provide permissions to exporters.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules in India related to the regulation of drugs and cosmetics, which are being amended by this notification.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament relating to drugs and cosmetics. Section 12 and section 33 of the act grants powers related to rule making and are referenced in this notification.
Drugs Technical Advisory Board: A board consulted by the Central Government of India for carrying out the amendments in the Drugs and Cosmetics Rules, 1945.
Ministry of Health and Family Welfare: A ministry of the Government of India responsible for health policy. The Under Secretary Drugs of this ministry is mentioned as the point of contact for suggestions or objections to the proposed draft rules.
Nirman Bhawan, New Delhi 110011: Address of Ministry of Health and Family Welfare.
Drugs and Cosmetics Fifth Amendment Rules, 2015: The title of the rules being introduced to amend the Drugs and Cosmetics Rules, 1945.
Global Trade Item Number: A unique and universal global product identification code used for barcoding requirements.
K. L. SHARMA: Jt. Secy. - Joint Secretary in the Government.
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PART II—Section 3—Sub-section (i)
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PUBLISHED BY AUTHORITY
la- 358] ubZ fnYyh] cq/okj] twu 3] 2015@T;s"B 13] 1937
No. 358] NEW DELHI, WEDNESDAY, JUNE 3, 2015/JYAISTHA 13, 1937
(cid:1)(cid:1)(cid:1)(cid:1)ववववाााा(cid:1)(cid:1)(cid:1)(cid:1)(cid:4)(cid:4)(cid:4)(cid:4)यययय औऔऔऔरररर पपपप(cid:7)(cid:7)(cid:7)(cid:7)ररररववववाााारररर कककक(cid:10)(cid:10)(cid:10)(cid:10)ययययााााणणणण ममममं(cid:14)ं(cid:14)ं(cid:14)ं(cid:14)ााााललललयययय
(((((cid:1)(cid:1)(cid:1)(cid:1)ववववाााा(cid:1)(cid:1)(cid:1)(cid:1)(cid:4)(cid:4)(cid:4)(cid:4)यययय औऔऔऔरररर पपपप(cid:7)(cid:7)(cid:7)(cid:7)रररर वव ववाााारररर कककक(cid:11)(cid:11)(cid:11)(cid:11)यय यय ााााणणणण ििििववववभभभभाााागगगग))))
नई (cid:1)द(cid:3)ली, 3 जून, 2015
अअअअििििधधधधससससचचूूचचूू ननननाााा
ससससाााा.... ककककाााा.... ििििनननन.... 449(अअअअ)....—क(cid:7)(cid:8)ीय सरकार क(cid:14) यह राय ह ै (cid:1)क ओषिधय(cid:21) क(cid:14) (cid:22)मािणकता को अिध(cid:22)मािणत करना आव(cid:31)य क
ह ै और इस (cid:22)योजन के िलए ओषिध और (cid:22)साधन साम%ी िनयम, 1945 का संशोधन करन े का (cid:22)(त ाव (cid:1)कया गया ह ै;
और, क(cid:7)(cid:8)ीय सरकार न े उ+ त िनयम(cid:21) म(cid:7) संशोधन करन े के िलए ओषिध तकनीक(cid:14) सलाहकार बोड. से परामश . (cid:1)कया ह ै;
ओषिध और (cid:22)साधन साम%ी िनयम,,,, 1945 का और संशोधन करन े के िलए ऐस े कितपय िनयम(cid:21) का, िजनको क(cid:7)(cid:8)ीय
सरकार का ओषिध और (cid:22)साधन साम%ी अिधिनयम,,,, 1940 (1940 का 23) क(cid:14) धारा 12 और धारा 33 0ारा (cid:22)द1त
शि+ तय(cid:21) का (cid:22)योग करत े 2ए बनाने का (cid:22)( ताव ह,ै िन3न िलिखत (cid:22)ा5प उन सभी 6ि7य(cid:21) क(cid:14) सूचना के िलए, िजनके उसके
0ारा (cid:22)भािवत होन े क(cid:14) संभावना ह,ै उ+त अिधिनयम क(cid:14) धारा 12 और धारा 33 के अधीन क(cid:14) अपे;ानुसार (cid:22)कािशत (cid:1)कया
जाता ह ै और इसके 0ारा यह सूचना दी जाती ह ै (cid:1)क उ+त (cid:22)ा5प िनयम(cid:21) पर, उस तारीख से, िजसको भारत के राजप= क(cid:14)
(cid:22)ितया,ं िजसम (cid:7) य े (cid:22)ा5प िनयम अतं >व? ट ह,ै जनसाधारण को उपलAध हो जाती ह,B पतB ालीस (cid:1)दन क(cid:14) अविध क(cid:14) समािCत पर
या उसके प(cid:31) चात् िवचार (cid:1)कया जाएगा ;
(cid:22)( तािवत (cid:22)ा5प िनयम(cid:21) पर, क(cid:7)(cid:8)ीय सरकार के िवचाराथ. कोई आ;ेप करने या सुझाव देने के िलए िहतबH कोई
I यि+ त, ऐसी यथािविनKद? ट अविध के भीतर, िलिखत 5प म(cid:7) अवर सिचव (ओषिध), (व ा(L य और पMरवार क(cid:3)य ाण मं=ालय,
भारत सरकार, िनमा.ण भवन, नई (cid:1)द(cid:3) ली-110011111 को कर सकता ह ै ;
(cid:1)(cid:1)(cid:1)(cid:1)ाााा(cid:3)(cid:3)(cid:3)(cid:3)पपपप ििििननननययययमममम
1111.... (1) इन िनयम(cid:21) का संि;N नाम ओषिध और (cid:22)साधन साम%ी (पंचम संशोधन) िनयम, 2015 ह ै ।
(2) ये भारत के राजप= म (cid:7) अंितम िनयम(cid:21) के (cid:22)काशन क(cid:14) तारीख से एक सौ अ(स ी (cid:1)दन के अवसान के प(cid:31)च ात ् (cid:22)भावी
ह(cid:21)गे ।
2443 GI/2015 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2222.... ओषिध और (cid:22)साधन साम%ी िनयम, 1945 के िनयम 96 के उपिनयम (1) के खंड (xii) के प(cid:31)च ात्, िनQिलिखत खंड
अंतः(थािपत (cid:1)कया जाएगा, अथा.त् :--
"(xiii) (अ) ओषिध सू=(cid:21) के िविनमा.ता, अपने उ1प ाद(cid:21) क(cid:14) खोज करने या उनका पता लगान े को सुकर बनाने के िलए
नीचे िविनKद? ट A यौरे मु(cid:1)(cid:8)त कर(cid:7)ग,े--
(क) (cid:22)ाथिमक ( तर क(cid:14) पैकेSजग म,(cid:7) ि0-आयामी बारकोड, िजसम(cid:7) 14 अंक(cid:14)य Tल ोबल Uेड आइटम नंबर (cid:22)ा5प म (cid:7)
िविश? ट और साव.जिनक वैि(cid:31) वक उ1पाद पहचान कोड का कूटकरण तथा बैच संVय ाकं , अवसान क(cid:14) तारीख तथा
मुV य पैक का एक िविश? ट Wम संV याकं ;
(ख) ि0तीयक ( तर क(cid:14) पैकेSजग म,(cid:7) एकल या ि0-आयामी बारकोड, िजसम(cid:7) 14 अंक(cid:14)य Tल ोबल Uेड आइटम नंबर
(cid:22)ा5प म (cid:7) िविश? ट और साव.जिनक वैि(cid:31)व क उ1पाद पहचान कोड का कूटकरण तथा बैच संVय ाकं , अवसान क(cid:14)
तारीख तथा ि0तीयक पैक का एक िविश?ट Wम संVय ाकं ;
(ग) तृतीयक (त र क(cid:14) पैकेSजग म,(cid:7) एकल आयामी बारकोड, िजसम(cid:7) 14 अंक(cid:14)य Tल ोबल Uेड आइटम नंबर (cid:22)ा5प म (cid:7)
िविश? ट और साव.जिनक वैि(cid:31) वक उ1पाद पहचान कोड का कूटकरण तथा बैच संVय ाकं , अवसान क(cid:14) तारीख
तथा ततृ ीयक पैक का एक िविश? ट Wम संVय ाकं ;
(आ) ओषिध सू=(cid:21) का िविनमा.ता पैकेSजग के सभी तीन(cid:21) (त र(cid:21) के िलए और अपनी (cid:22)दाय Yखृं ला म(cid:7) उनके संचलन के
िलए उZम-पMरमित समभाव (पेर(cid:7)ट-चाइ(cid:3)ड Mरलेशनिशप) म (cid:7) डाटा बलाए रखगे ा ;
(इ) उपखडं (आ) म(cid:7) िनKद? ट डाटा िविनमा.ता या उसके अिभिहत अिभकरण 0ारा ओषिधय(cid:21) के िवWय या िवतरण के
िलए जारी (cid:1)कए जाने के पूव. क(cid:7)(cid:8)ीय सरकार के क(cid:7)(cid:8)ीय पोट.ल पर अपलोड (cid:1)कया जाएगा ;
(ई) क(cid:7)(cid:8)ीय पोट.ल पर डाटा क(cid:14) स1 यता, संपूण.ता और समय पर अपलोड करन े का उ[रदािय1व िविनमा.ता का होगा :
परंत ु इस उपिनयम के उपबंध ऐसे ओषिध सू= को लागू नह\ ह(cid:21)ग,े जो िनया.त के (cid:22)योजन(cid:21) के िलए िविन>मत क(cid:14)
जानी ह ै और जहा ं आयात करने वाल े देश क(cid:14) सरकार न े िविनKद?ट अप;े ा को आ]ापक बनाया 2आ ह ै और िनयात. कता. का
आशय, िनयम 21 के अधीन िनयु+ त अन]ु ापन (cid:22)ािधकारी क(cid:14) अनु]ा स,े आयात करने वाल े दशे 0ारा िविनKद?ट (cid:22)5प म (cid:7) बार
कोड मु(cid:1)(cid:8)त करन े का िवक(cid:3) प अपनाने का ह ै:
परंत ु यह और (cid:1)क तृतीयक ( तर क(cid:14) पैकेSजग म (cid:7) आयात करन े वाले दशे क(cid:14) (cid:1)कसी अ^य अप;े ा के अितMर+त उपखडं
(अ) के अनुसार बार कोड का अितMर+ त मु(cid:8)ण भी (cid:1)कया जाएगा ।
(cid:10)(cid:10)(cid:10)(cid:10)पप पप (cid:11)(cid:11)(cid:11)(cid:11)टट टट ीीीीककककररररणणणण————इस खंड के (cid:22)योजन(cid:21) के िलए,--
(i)(क) (cid:22)ाथिमक पैकेSजग (त र से ऐसा पैकेज अिभ(cid:22)ेत ह ै जो ओषिध के भौितक संसग . म(cid:7) ह ै;
(ख) ि0तीयक पैकेSजग (त र स े ब2ल (cid:22)ाथिमक पैक(cid:21) वाला काट.न अिभ(cid:22)ेत ह ै िजसके अंतग.त मोनो
काट.न भी ह B; और
(ग) ततृ ीयक पैकेSजग (त र स े क(cid:7)(cid:8)ीय सरकार 0ारा डाटा क(cid:14) अपे;ा के संबंध म(cid:7) जारी (cid:1)कए गए
माग.दश.क िसHांत(cid:21) के अनुसार ब2ल ि0तीयक पैक(cid:21) वाला पोतविणक अिभ(cid:22)ेत ह ै;
(ii) ततृ ीयक, ि0तीयक और (cid:22)ाथिमक पैकेSजग (त र(cid:21) के बीच परे (cid:7)ट-चाइ(cid:3)ट Mरलेशनिशप स े
िन3 निलिखत अिभ(cid:22)ेत ह,ै--
(क) तृतीयक और ि0तीयक पकै (cid:21) के बीच समभाव म(cid:7) तृतीयक पैक परे (cid:7)ट और ि0तीयक पकै
चाइ(cid:3) ड ह ै; और
(ख) ि0तीयक और (cid:22)ाथिमक पकै (cid:21) के बीच समभाव म (cid:7) ि0तीयक पैक परे (cid:7)ट और (cid:22)ाथिमक पैक
चाइ(cid:3) ड ह ै ।"।
[फा. सं. 02/(cid:22)क(cid:14)ण/.2010-डी.सी./डी.एफ.+य.ू सी.]
कु^दन लाल शमा,. संयु7 सिचव¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
(cid:14)(cid:14)(cid:14)(cid:14)टटटट(cid:15)(cid:15)(cid:15)(cid:15)पपपपणणणण :::: मूल िनयम भारत के राजप= म (cid:7) अिधसूचना संVयांक एफ 28-10/45-एच(1), तारीख 21 (cid:1)दसंबर, 1945 0ारा
(cid:22)कािशत (cid:1)कए गए थे और उनको अंितम बार अिधसूचना संVय ाकं सा.का.िन. 390(अ), (cid:1)दनांक 18 मई, 2015 0ारा
संशोिधत (cid:1)कया गया ह ै ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, dated the 3rd June, 2015
G.S.R. 449(E).—Whereas, the Central Government is of opinion that it is necessary to authenticate
the genuineness of drugs and for this purpose, it has been proposed to amend the Drugs and Cosmetics Rules,
1945;
And Whereas, the Central Government has consulted the Drugs Technical Advisory Board for
carrying out the amendments in the said rules;
The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, which the
Central Government proposes to make in exercise of the powers conferred by section 12 and section 33 of the
Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published as required under sections 12 and 33 of the
said Act, for the information of all persons likely to be affected thereby and notice is hereby given that the
said draft rules shall be taken into consideration on or after the expiry of a period of forty-five days from the
date on which the copies of the Gazette of India containing these draft rules are made available to the public;
Any person interested in making any objection or suggestion on the proposed draft rules may do so in
writing for consideration of the Central Government within the period so specified to the Under Secretary
(Drugs), Ministry of Health and Family Welfare, Government of India, Nirman Bhawan, New Delhi- 110011.
DRAFT RULES
1. (1) These rules may be called the Drugs and Cosmetics (Fifth Amendment) Rules, 2015.
(2) They shall come into force after the expiry of 180 days from the date of the publication of
the final rules in the Gazette of India.
2. In the Drugs and Cosmetics Rules, 1945, in rule 96, in sub-rule (1), after clause (xii) the following
clause shall be inserted, namely:-
“(xiii) (A). The manufacturers of drug formulations shall print the details specified below to n
facilitate tracking and tracing of their product-
(a) at primary level packaging of two dimensional barcode encoding unique and
universal global product identification code in the 14 digits Global Trade Item
Number format along with batch number, expiry date and a unique serial
number of the primary pack;
(b) at secondary level packaging of one or two dimensional barcode encoding
unique and universal global product identification code in the 14 digits Global
Trade Item Number format along with batch number, expiry date and a unique
serial number of the secondary pack;
(c) at tertiary level packaging of one dimensional barcode encoding unique and
universal global product identification code in the 14 digits Global Trade Item
Number format along with batch number, expiry date and a unique serial
number of the tertiary pack.
(B) The manufacturer of drug formulation shall maintain the data in the parent – child
relationship for all three level of packaging and their movement in its supply chain.
(C) The data referred to in sub-clause (B) shall be uploaded on the central portal of the
Central Government by the manufacturer or its designated agency before release of the
drugs for sale or distribution.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(D) The responsibility of the correctness, completeness and timely uploading of data on the
Central portal shall be that of the manufacturer:
Provided that the provision of this sub-rule shall not be applicable to such drug formulation which is
manufactured for export purpose and where the Government of the importing country has mandated a specific
requirement and the exporter intends to avail the option of printing the bar codes in the format specified by
the importing country with the permission of licensing authority appointed under rule 21:
Provided further that the tertiary level of the packaging shall have an additional printing of barcode as
per sub-clause (A) in addition to any other requirement by the importing country.
Explanation.– For the purposes of this clause, -
(i) (a) primary packaging level means the package which is in physical contact with the
drug;
(b) secondary packaging level means the carton containing multiple primary packs
including a mono carton; and
(c) tertiary packaging level means a shipper containing multiple secondary packs as
per guidelines issued for data requirement, by the Central Government;
(ii) parent-child relationship between tertiary, secondary and primary packaging levels
means-
(a) relationship between tertiary and secondary packs is the tertiary pack as the
parent and secondary pack is the child; and
(b) relationship between secondary and primary packs is the secondary pack as
the parent and primary as the child.”.
[F. No. 02/Misc./2010-DC/DFQC]
K. L. SHARMA, Jt. Secy.
Note: The principal rules were published in the Gazette of India vide notification No. F. 28-10/45-H (1)
dated the 21st December, 1945 and last amended vide notification number GSR 390(E), dated the 18th May,
2015.
Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.