Executive Summary:
This notification from the Ministry of Health and Family Welfare announces amendments to the Drugs and Cosmetics Rules, 1945. It follows the consideration of public feedback on draft rules published earlier. These amendments, called the Drugs and Cosmetics Seventh Amendment Rules, 2017, come into force on the date of their publication in the Official Gazette, April 3, 2017.
Key Points / Main Content:
* **Amendments to the Drugs and Cosmetics Rules, 1945**
* The Central Government is making the following rules further to amend the Drugs and Cosmetics Rules, 1945.
* **Title and Commencement**
* These rules are called the Drugs and Cosmetics Seventh Amendment Rules, 2017.
* The rules come into force on the date of their publication in the Official Gazette.
* **Schedule A, Form 44 Amendment**
* In the Drugs and Cosmetics Rules, 1945, in Schedule A, in Form 44, under paragraph 1, relating to "Particulars of new drug" item 8 and the entries relating thereto shall be omitted.
Impact Analysis:
* **Drug Manufacturers/Applicants:**
* *Impact:* Form 44, related to "Particulars of new drug" item 8, is amended, changing the requirements for new drug applications.
* *Action Required:* Adapt new drug application processes to reflect the omission of item 8 in Form 44.
* **Regulatory Bodies (Central Government, Drugs Technical Advisory Board):**
* *Impact:* Responsible for enforcing and overseeing the implementation of the amended rules.
* *Action Required:* Implement the amendments and ensure compliance from relevant stakeholders.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules in India governing the import, manufacture, distribution, and sale of drugs and cosmetics. This notification amends these rules.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture and distribution of drugs and cosmetics.
Ministry of Health and Family Welfare: A ministry of the Government of India responsible for health policy in India.
New Delhi: The capital of India, where the notification was issued.
Drugs Technical Advisory Board: A board consulted by the Central Government when amending the Drugs and Cosmetics Rules, 1945.
Drugs and Cosmetics Seventh Amendment Rules, 2017: The title of the amendment to the Drugs and Cosmetics Rules, 1945, being enacted through this notification.
K.L. SHARMA: The Joint Secretary who signed the notification.
Schedule A: A schedule within the Drugs and Cosmetics Rules, 1945, that is being amended by this notification.
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REGD. NO. D. L.-33004/99
EXTRAORDINARY
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PART II—Section 3—Sub-section (i)
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No. 262] NEW DELHI, MONDAY, APRIL 3, 2017/CHAITRA 13, 1939
स्वास्थ्य और पिरवार कल्याण मं(cid:7074)ालय
(स्वास्थ्य और पिरवार कल्याण िवभाग)
अिधसचू ना
नई िदल्ली, 3 अ(cid:7079)ैल, 2017
सा.का.िन. 329(अ).— औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और संशोधन करने के िलए
कितपय िनयम(cid:7298) का (cid:7079)ारूप औषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) की धारा 12 और धारा
33 की अपेक्षाऩुसार भारत के राजप(cid:7074), असाधारण, भाग II, खंड 3, उपखंड (i), तारीख 16 जनवरी, 2017 म(cid:7286)
(cid:7079)कािशत भारत सरकार के स्वास्थ्य और पिरवार कल्याण मं(cid:7074)ालय (स्वास्थ्य और पिरवार कल्याण िवभाग) की
अिधसूचना सं. सा.का.िन. 36(अ), तारीख 16 जनवरी, 2017 (cid:7367)ारा (cid:7079)कािशत िकया गया था िजसके (cid:7367)ारा उन सभी
(cid:7390)ि(cid:7334)य(cid:7298) स,े िजनके उनसे (cid:7079)भािवत होने की संभावना ह,ै उस तारीख स,े िजसको उ(cid:7334) अिधसूचना वाले भारत के
राजप(cid:7074) की (cid:7079)ितयां जनता को उपलब्ध करा दी गई थ(cid:7277), प(cid:7289)तालीस िदन की अविध की समाि(cid:7385) से पूवर् आक्षेप और
सुझाव आमंि(cid:7074)त िकए गए थे;
और उ(cid:7334) मूल राजप(cid:7074) की (cid:7079)ितयां जनता को तारीख 16 जनवरी, 2017 को उपलब्ध करा दी गई थ(cid:7277) ।
और केन्(cid:7076)ीय सरकार (cid:7367)ारा उ(cid:7334) िनयम(cid:7298) के संबंध म(cid:7286) जनता के (cid:7079)ा(cid:7385) आक्षेप(cid:7298) और सुझाव(cid:7298) पर िवचार िकया
गया ह।ै
अतः, अब, केन्(cid:7076)ीय सरकार, औषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) की धारा 12
और धारा 33 के अधीन शि(cid:7334)य(cid:7298) का (cid:7079)योग करते हुए, औषिध तकनीकी सलाहकार बोडर् से परामशर् करने के प(cid:7391)ात्,
ओषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और संशोधन करने के िलए िन(cid:7388)िलिखत िनयम बनाती ह,ै अथार्त:् -
1. (1) इन िनयम(cid:7298) का संिक्ष(cid:7385) नाम औषिध और (cid:7079)साधन साम(cid:7061)ी (सातवां संशोधन) िनयम, 2017 ह ै।
1882 GI/2017 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART I—SEC. 3(i)]
(2) ये राजप(cid:7074) म(cid:7286) उनके (cid:7079)काशन की तारीख को (cid:7079)वृ(cid:7275) ह(cid:7298)गे ।
2. औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 की अनुसूची क के (cid:7079)रूप 44 म(cid:7286), “नई औषिध की
िविशि(cid:7397)या”ं से संबंिधत पैरा 1 की मद (8) और उससे संबंिधत (cid:7079)िवि(cid:7397)य(cid:7298) का लोप िकया जाएगा ।
[फा. सं. एक्स.11014/9/2016-डी.आर.एस.]
कुन्दन लाल शमा,र् संयु(cid:7334) सिचव
िटप्पण: मूल िनयम भारत के राजप(cid:7074) म(cid:7286) अिधसूचना सं. एफ.28-10/45-एच(1), तारीख 21 िदसम्बर, 1945 (cid:7367)ारा
(cid:7079)कािशत िकए गए थे और उनम(cid:7286) अंितम संशोधन अिधसूचना सं. सा.का.िन. 303 (अ), तारीख 30 माचर्, 2017
(cid:7367)ारा िकया गया था ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 3rd April, 2017
G.S.R. 329(E).—Whereas the draft of certain rules further to amend the Drugs and Cosmetics Rules,
1945 was published as required by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) in
the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), dated the 16th January, 2017 vide
notification of the Government of India in the Ministry of Health and Family Welfare, number G.S.R. 36(E),
dated the 16th January, 2017 for inviting objections and suggestions from all persons likely to be affected
thereby before the expiry of a period of forty-five days from the date on which copies of the Official Gazette
containing the said notification was made available to the public;
And whereas the copies of the said Gazette were made available to the public on 16th January, 2017;
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 by sections 12 and 33 of the said Act, 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 Drugs and Cosmetics (Seventh Amendment) Rules, 2017.
(2) They shall come into force on the date of their publication in the Official Gazette.
2.In the Drugs and Cosmetics Rules, 1945, in Schedule A, in Form 44, under paragraph 1, relating to
"Particulars of new drug" item (8) and the entries relating thereto shall be omitted.
[F. No. X. 11014/9/2016-DRS]
K.L. SHARMA, Jt. Secy.
Foot note.- The principal rules were published in the Official Gazette vide notification number
F.28-10/45-H (1), dated the 21st December, 1945 and last amended vide notification number
G.S.R. 303(E), dated the 30th March, 2017.
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.