Executive Summary:
This notification from the Ministry of Health and Family Welfare publishes draft amendments to the Drugs and Cosmetics Rules, 1945. The amendments are proposed under sections 12 and 33 of the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board. The public has 30 days from the date the notification is made available to submit objections or suggestions to the Ministry.
Key Points / Main Content:
* **Amendment Rules:**
* These rules are called the Drugs and Cosmetics Amendment Rules, 2017.
* **Rule Amendments:**
* In Rules 71 and 71B, the phrase "patent or proprietary medicines" is replaced with "drugs" in subrule 6.
* In Rules 76 and 76A, the phrase "patent or proprietary medicines" is replaced with "drugs" in subrule 7.
* **Schedule D Amendment:**
* In Schedule D, the entries under the "Class of drugs" column against item 1 are substituted with: "Substances not intended for medicinal use excluding those intended to be used as drugs after further purification or rendering them sterile."
Impact Analysis:
Government of India, Ministry of Health and Family Welfare:
Impact: Responsible for reviewing and considering objections and suggestions from the public regarding the draft amendments. They will finalize and implement the amended rules.
Action Required: Review and consider public feedback within the specified period. Finalize and publish the amendments to the Drugs and Cosmetics Rules, 1945.
Drugs Technical Advisory Board:
Impact: Already consulted regarding the amendments.
Action Required: No further action is required unless specifically requested by the Ministry of Health and Family Welfare.
Drug Manufacturers and Related Industries:
Impact: Need to be aware of the proposed changes to the Drugs and Cosmetics Rules, 1945, particularly the substitution of "patent or proprietary medicines" with "drugs" and the changes to Schedule D.
Action Required: Review the draft rules and submit any objections or suggestions to the Ministry of Health and Family Welfare within 30 days of the notification being made available. Adjust practices to comply with the amended rules once finalized.
Public:
Impact: Affected by changes to regulations regarding drugs and cosmetics.
Action Required: Review the draft rules and submit any objections or suggestions to the Ministry of Health and Family Welfare within 30 days of the notification being made available.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics, which is being amended by the current notification.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Drugs Technical Advisory Board: A board that is consulted by the Central Government regarding amendments to the Drugs and Cosmetics Rules, 1945.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
Drugs and Cosmetics Amendment Rules, 2017: The name of the rules that are being introduced as an amendment to the Drugs and Cosmetics Rules, 1945.
New Delhi: The location of the Ministry of Health and Family Welfare, and the place where the notification was issued.
Schedule D: A schedule within the Drugs and Cosmetics Rules, 1945, which is being amended in the notification.
Nirman Bhavan, New Delhi 110011: Address of Ministry of Health and Family Welfare.
REGD. NO. D. L.-33004/99
EXTRAORDINARY
II— — (i)
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
339]
No. 339] NEW DELHI, TUESDAY, MAY 2, 2017/VAISAKHA 12, 1939
स्वास््य और पररवार कल्याण मत्रं ालय
(स्वास््य और पररवार कल्याण ववभाग)
नई दिल्ली, 2 मई, 2017
सा.का.वन. 429(अ).—औषवि और प्रसािन सामग्री वनयम, 1945 का और संशोिन करन े के वलए कविपय
वनयमों का वनम्नवलविि प्रारूप, विस े केन्द्रीय सरकार का, औषवि और प्रसािन सामग्री अविवनयम,1940 (1940
का 23) की िारा 12 और िारा 33 द्वारा प्रित्त शवियों का प्रयोग करिे हुए, औषवि िकनीकी सलाहकार बोर् ड स े
परामशड करने के पश्चाि,् बनाने का प्रस्िाव ह,ै उि िारा 12 और िारा 33 के उपबंिों की अपेक्षानुसार उन सभी
व्यवियों की िानकारी के वलए प्रकावशि दकया िािा ह,ै विनके उससे प्रभाववि होने की संभावना है; और यह
सूचना िी िािी ह ै दक उि प्रारूप वनयमों पर उस िारीि से, विसको इन प्रारूप वनयमों वाले भारि के रािपत्र की
प्रवियां िनिा को उपलब्ि करा िी िािी ह,ैं िीस दिन की अववि की समावि पर या उसके पश्चाि् ववचार दकया
िाएगा;
ऐसे आक्षेप और सुझाव, यदि कोई हों, अवर सवचव (औषवि), स्वास््य और पररवार कल्याण मंत्रालय,
भारि सरकार, कमरा नम् बर 414-ए, र्ी ववंग, वनमाडण भवन, नई दिल्ली-110011 को भेिे िा सकेंगे या ई मले
पिे drugsdiv-mohfw@gov.in पर मेल दकए िा सकेंगे ।
केन्द्रीय सरकार द्वारा ऐस े आक्षेपों और सुझावों पर, िो पूवोक् ि अववि के भीिर दकसी व्यवि से प्राि हों,
ववचार दकया िाएगा ।
2895 GI/2017 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्रारूप वनयम
1. इन वनयमों का संवक्षि नाम औषवि और प्रसािन सामग्री (संशोिन) वनयम, 2017 ह ै ।
2. औषवि और प्रसािन सामग्री वनयम, 1945 (विन्द्ह ें इसमें इसके पश्चाि् उि वनयम कहा गया ह)ै के वनयम
71 के उपवनयम (6) में, “पेटेंट या सांपवत्तक औषवियों” शब्िों के स्थान पर, िोनों स्थानों पर, िहां-िहां वे आिे ह,ैं
“ओषवियों” शब्ि रिा िाएगा ।
3. उि वनयमों के वनयम 71ि में, “पेटेंट या सांपवत्तक औषवियों” शब्िों के स्थान पर, िोनों स्थानों पर, िहां-
िहां वे आि े ह,ैं “ओषवियों” शब्ि रिा िाएगा ।
4. उि वनयमों के वनयम 76 के उपवनयम (7) में, “पेटेंट या सांपवत्तक औषवियों” शब्िों के स्थान पर, िोनों
स्थानों पर, िहा-ं िहां वे आिे ह,ैं “ओषवियों” शब्ि रिा िाएगा ।
5. उि वनयमों के वनयम 76क में, “पेटेंट या सांपवत्तक औषवियों” शब्िों के स्थान पर, िोनों स्थानों पर, िहां-
िहां वे आि े ह,ैं “ओषवियों” शब्ि रिा िाएगा ।
6. उि वनयमों की अनुसूची घ की सारणी में, ‘ओषवियों के वगड’ स्िंभ के नीचे मि संखयांक 1 के सामने,
ववद्यमान प्रवववियों के स्थान पर वनम्नवलविि प्रवववियां रिी िाएगं ी, अथाडि्:-
“ऐसे पिाथड, िो वचदकत्सीय उपयोग के वलए आशवयि नहीं ह,ैं उन पिाथों को अपवर्िडि करिे हुए, िो
और शोविि िथा उनको ववसंक्रवमि करन े के पश्चाि् औषवि के रूप में उपयोग दकए िाने के वलए आशवयि
ह”ैं ।
[फा. सं. एक्स.-11014/2/2014-र्ी.एफ.क्यू.सी.]
कुन्द्िन लाल शमाड, संयुि सवचव
रटप्पण : मूल वनयम भारि के रािपत्र में अविसूचना सं. एफ.28-10/45-एच(1), िारीि 21 दिसम्बर, 1945
द्वारा प्रकावशि दकए गए थ े और उनमें अंविम संशोिन अविसूचना सं. सा.का.वन. 327 (अ), िारीि
3 अप्रैल, 2017 द्वारा दकया गया था ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 2nd May, 2017
G.S.R.429(E).—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), after consultation with the Drugs Technical Advisory Board, is hereby
published for information of all persons likely to be affected thereby, and notice is hereby given that said draft rules will
be taken into consideration on or after the expiry of a period of thirty days from the date on which copies of the Gazette
of India containing these draft rules are made available to the public.II (i) 3
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and
Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or sent on email
at drugsdiv-mohfw@gov.in .
Objections and suggestions which may be received from any person within the period of specified above will be
considered by the Central Government.
Draft rules
1. These rules may be called the Drugs and Cosmetics (______Amendment) Rules, 2017.
2. In the Drugs and Cosmetics Rules, 1945, (hereinafter referred to as the said rules), in rule 71, in sub-rule (6), for
the words “patent or proprietary medicines” at both places where they occur, the word “drugs” shall be
substituted.
3. In the said rules, in rule 71-B, for the words “patent or proprietary medicines” at both places where they occur,
the word “drugs” shall be substituted.
4. In the said rules, in rule 76, in sub-rule (7), for the words “patent or proprietary medicines” at both places where
they occur, the word “drugs” shall be substituted.
5. In the said rules, in rule 76A, for the words “patent or proprietary medicines” at both places where they occur,
the word “drugs” shall be substituted.
6. In the said rules, in Schedule D, in the Table, against item 1, under the column “Class of drugs”, for the existing
entries, the following entries shall be substituted, namely:-
“Substances not intended for medicinal use excluding those intended to be used as drugs after further
purification or rendering them sterile.”.
[F. No. X-11014/2/2014-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
21st December, 1945 and last amended vide notification number G.S.R. 327 (E) dated 3rd April, 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.