Executive Summary:
This notification announces amendments to the Drugs and Cosmetics Rules, 1945, following consideration of public feedback on a draft published on June 24, 2019. The amendments, made under the authority of the Drugs and Cosmetics Act, 1940, introduce definitions and responsibilities for drug marketers. These rules are called the Drugs and Cosmetics Amendment Rules, 2020 and will come into force on March 1, 2021.
Key Points / Main Content:
* **Amendment Title and Effective Date:**
* These rules are called the Drugs and Cosmetics Amendment Rules, 2020.
* They come into force on March 1, 2021.
* **Definition of "Marketer":**
* A "marketer" is defined as someone who, as an agent or in any capacity, markets a drug manufactured by another manufacturer under an agreement, by labeling or affixing their name for sale and distribution.
* **Agreement for Marketing:**
* A marketer must have an agreement with the manufacturer to market a drug by labeling or affixing their name.
* **Responsibilities of Marketers:**
* Marketers are responsible for the quality of the drug they sell or distribute.
* Marketers are responsible for regulatory compliance along with the manufacturer.
* **Labeling Requirements:**
* The name and address of the marketer must be on the drug label.
* For drugs in ampoules or small containers, only the marketer's name is required.
Impact Analysis:
**Manufacturers:**
* *Impact:* Manufacturers must have agreements in place with marketers who label or affix their name to the drugs. They also share responsibility for the drug's quality and regulatory compliance with the marketer.
* *Action Required:* Review and update agreements with marketers to comply with the new rules.
**Marketers:**
* *Impact:* Marketers now have defined responsibilities for the quality and regulatory compliance of the drugs they market. They are also required to have a formal agreement with the manufacturer. Their name and address must appear on the drug label (or at least their name, for small containers).
* *Action Required:* Establish formal agreements with manufacturers, ensure quality control measures are in place, and update drug labels to include the marketer's name and address where required.
**Regulatory Bodies:**
* *Impact:* These bodies are responsible for enforcing the new regulations related to marketers and ensuring compliance with the quality and labeling requirements.
* *Action Required:* Update inspection and enforcement procedures to include the new marketer regulations.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: An Indian law that regulates the import, manufacture, distribution, and sale of drugs and cosmetics.
Drugs and Cosmetics Rules, 1945: Rules framed under the Drugs and Cosmetics Act, 1940, to regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India.
Ministry of Health and Family Welfare: A ministry in the Government of India responsible for health policy and family welfare.
Central Government: The executive authority of the Union of India.
Drugs Technical Advisory Board: A statutory body constituted by the Government of India to advise on technical matters related to drugs and cosmetics.
Drugs and Cosmetics Amendment Rules, 2020: An amendment to the Drugs and Cosmetics Rules, 1945.
New Delhi: The capital of India, where the notification was issued.
Dr. Mandeep K. Bhandari: Joint Secretary in the relevant Ministry who signed the notification.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. NO. D. L.-33004/99
सी.जी.-डी.एल.-अ.-13022020-216113
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CG-DL-E-13022020-216113
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 83] नई दि्ली, तगं लवार, फरवरी 11, 2020/ताघ 22, 1941
No. 83] NEW DELHI, TUESDAY, FEBRUARY 11, 2020/MAGHA 22, 1941
स्ट्व ास्ट्् य रर पिरवार क्य ाण तरालं ालय
(स्ट्व ास्ट्् य रर पिरवार क्य ाण जवभाग)
अजधसचू ना
नई दि्ली, 11 फरवरी, 2020
सा.का.जन. 101 (अ).—ओषजध रर प्रसाधन सातग्री जनयत, 1945 का रर संिोधन करने के जलए कजतपय
जनयतों का प्रारूप, ओषजध रर प्रसाधन सातग्री अजधजनयत, 1940 (1940 का 23) की धारा 12 की उप-धारा (1)
रर धारा 33 की उप-धारा (1) की अपेक्षानुसार भारत के रािपराल, असाधारण, भाग II, खंड 3, उप-खंड (i) तें
भारत सरकार के स्ट् वास्ट् ् य रर पिरवार क् याण तंरालालय (स्ट् वास्ट् ् य रर पिरवार क् याण जवभाग) की अजधसूचना स.ं
सा.का.जन. 447(अ), तारीख 24 िून, 2019 द्वारा प्रकाजित दकए गए थ,े जिसत ें उन सभी व् यजययों स,े जिनके उससे
प्रभाजवत होने की संभावना ह,ै उस तारीख स,े जिसको उक्त अजधसूचना को अन्तर्विष्ट करन े वाली रािपराल की प्रजतया ं
िनता को उपलब् ध कराई गई थी, तीस दिन की अवजध के अवसान के पूव,ि आपजि रर सुझाव आंतजरालत दकए गए थ;े
रर, रािपराल की प्रजतयां िनता को 24 िून, 2019 को उपलब्ध करा िी गई थी;
रर उय जनयतों पर िनता स ेप्राप्त आक्षपे ों रर सुझावों पर केंद्रीय सरकार द्वारा जवचार कर जलया गया ह;ै
अत:, अब, केन् द्रीय सरकार, ओषजध रर प्रसाधन सातग्री अजधजनयत, 1940 (1940 का 23) की धारा 12 रर
धारा 33 के अधीन प्रित् त िजययों का प्रयोग करत े हुए, ओषजध तकनीकी सलाहकार बोड ि स े पराति ि करन े के पश् चात ्
ओषजध रर प्रसाधन सातग्री जनयत, 1945 का रर संिोधन करने के जलए जनम्न जलजखत जनयत बनाती ह,ै अथाित:्―
824 GI/2020 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
1. (1) इन जनयतों का संजक्षप्त नात ओषजध रर प्रसाधन सातग्री ( संिोधन) जनयत, 2020 ह।ै
(2) ये जनयत 1 ताच,ि 2021 की तारीख को प्रवृि होंगे।
2. ओषजध रर प्रसाधन सातग्री जनयत 1945 (जिसे इसत ें इसके पश्चात ् उय जनयत कहा गया ह)ै त,ें जनयत 2
त,ें ―
(i) जवद्यतान खंड (ड़क) को खंड (ड़ख) के रूप त ें पुनःअक्षिरत दकया िाएगा, रर ऐसे पनु ःअक्षिरत खडं (ड़ख)
स े पूवि, जनम्नजलजखत खंड अतं ःस्ट्थाजपत दकया िाएगा, अथाित:्―
"(ड़क) जवपणनकताि स े ऐसा व्यजय अजभप्रेत ह ै िो दकसी अजभकता ि के रूप त ें या दकसी अन्य क्षतता त ें दकसी
िसू रे उत्पािनकताि द्वारा एक अनुबंध के अधीन उत्पादित ओषजध को जवपणन की िजृ ष्ट स े उस ओषजध पर लैबल करके
या अपना नात चस्ट्पा करके उस ओषजध के जवक्रय रर जवतरण के जलए अंगीकार करता ह।ै "
(ii) जवद्यतान खंड (ड़ क) रर (ड़ ख) को क्रतिः (ड़ ख) रर (ड़ ग) के रूप त ें पनु ःअक्षिरत दकया
िाएगा ।
3. उय जनयतों त ेंजनयत 84ग के पश्चात ् जनम्नजलजखत जनयत अंतःस्ट्थाजपत दकया िाएगा, अथाित:्―
"84घ. जवपणन के जलए करार: कोई जवपणनकता ि जनयत 2 के खंड (ड़क) त ें जवजनर्िष्टि दकसी करार के जबना
दकसी िसू रे उत्पािनकताि द्वारा उत्पादित ओषजध को जवपणन की िजृ ष्ट स े उस ओषजध पर लैबल करके या अपना नात
चस्ट्पा करके उस ओषजध के जवक्रय रर जवतरण को अगं ीकार नहीं करेगा। ।
84ड़. ओषजध जवपणनकताि की जिम्तेवारी: ऐसा कोई जवपणनकता,ि िो दकसी ओषजध का जवक्रय या जवतरण
करता ह,ै इन जनयतों के अधीन ओषजध की गुणविा के साथ साथ अन्य जवजनयातक अनुपालनाओं हते ु उत्पािनकताि के
साथ जिम्तेिार होगा।”
4. उय जनयत के जनयत 96 त ें खडं (1) के उप-खंड (xii) के पश्चात् जनम्नजलजखत उप-खंड अतं ःस्ट्थाजपत दकया
िाएगा, अथाित:्―
"(xiii) दकसी ओषजध के जवपणनकता ि द्वारा ओषजध के जवपणन की जस्ट्थजत त ेंजवपणनकता ि का नात रर पता:
परन्त ु यदि ओषजध दकसी एम््यूल या वैसे ही छोटे आधान त ें ह,ै तो केवल जवपणनकताि का नात प्रिर्िित
दकया िाना ही पयािप्त होगा।"
[फा. स.ं एक् स. 11014/22/2018 –डीआर]
डॉ. तनिीप के भण्डारी, संयुक् त सजचव
िट्प ण:- तूल जनयत भारत के रािपराल त ें अजधसूचना संख् या एफ.28-10/45-एच (1), तारीख 21 दिसम् बर, 1945
द्वारा प्रकाजित दकए गए थ े रर अजधसूचना सख्ं या सा.का.जन. 828(अ), तारीख 6 नवंबर, 2019 द्वारा
अंजतत बार संिोजधत दकए गए थे।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department Of Health And Family Welfare)
NOTIFICATION
New Delhi, the 11th February, 2020
G.S.R. 101 (E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules,
1945, was published as required under sub-section(1) of section 12 and sub-section(1) of section 33 of the Drugs
and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Healthभाग II खण् ड 3(i) भारत का रािपराल : असाधारण 3
and Family Welfare (Department of Health and Family Welfare) number G.S.R. 447(E), dated the 24th June,
2019, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and
suggestions from persons likely to be affected thereby before the expiry of a period of thirty days from the date
on which the copies of the Official Gazette containing the said notification were made available to the public;
And whereas copies of the said Official Gazette were made available to the public on the 24th June,
2019;
And whereas objections and suggestions received from the public on the said rules have been
considered by the Central Government;
Now, therefore, in exercise of the powers conferred under sections 12 and 33 of the Drugs and
Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical
Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945,
namely:―
1. (1) These rules may be called the Drugs and Cosmetics (Amendment) Rules, 2020.
(2) They shall come into force on the 1st day of March, 2021.
2. In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the said rules), in rule 2,-
(i) existing clause (ea) shall be re-lettered as clause (eb), and before clause (eb) as so re-lettered, the
following clause shall be inserted, namely:―
‘(ea) “Marketer” means a person who as an agent or in any other capacity adopts any drug manufactured by
another manufacturer under an agreement for marketing of such drug by labeling or affixing his name on the
label of the drug with a view for its sale and distribution;’ ;
(ii) existing clauses (ea) and (eb) shall respectively be re-lettered as (eb) and (ec).
3. In the said rules, after rule 84C, the following rules shall be inserted, namely:―
“84D. Agreement for marketing.- No marketer shall adopt any drug manufactured by another manufacturer for
marketing of such drug by labeling or affixing his name on the label of the drug with a view for its sale and
distribution without an agreement as referred to in clause (ea) of rule 2.
84E. Responsibility of marketer of the drugs.- Any marketer who sells or distributes any drug shall be
responsible for quality of that drug as well as other regulatory compliances along with the manufacturer under
these rules.” .
4. In the said rules, in rule 96, after sub-clause (xii) of clause (1), the following sub-clause shall be
inserted, namely:―
“(xiii) The name of the marketer of the drug and its address, in case the drug is marketed by a marketer:
Provided that if the drug is contained in an ampoule or a similar small container, it shall be
enough if only the name of the marketer is shown.”.
[F. No. X.11014/22/2018 -DR]
Dr. MANDEEP K. BHANDARI, Jt. Secy.
Note:- The principal rules were published in the Official Gazette vide notification number F.28-10/45-H (1)
dated 21st December, 1945 and last amended vide notification number G.S.R. 828(E), dated the 6th
November, 2019.
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.