Executive Summary:
This document contains draft rules to amend the Drugs and Cosmetics Rules, 1945. It includes provisions for clinical trials intended for academic purposes and animal toxicity studies. The draft rules will be considered after 45 days from the date the Gazette of India is made available to the public. Objections and suggestions may be addressed to the Under Secretary Drugs, Ministry of Health and Family Welfare.
Key Points / Main Content:
Clinical Trials for Academic Purposes:
* No permission is required for clinical trials intended for academic purposes for approved drug formulations regarding new indications, routes of administration, doses, or dosage forms if:
* The trial is approved by the Ethics Committee.
* The data generated is not intended for submission to the licensing authority, subject to subrule 5.
* The Ethics Committee must inform the licensing authority about approved cases and cases with potential overlap between academic and regulatory clinical trials.
* If the licensing authority does not provide comments to the Ethics Committee within 30 days of receiving communication, permission from the licensing authority is presumed unnecessary.
Animal Toxicity Studies:
* If animal toxicity data, as per Appendix III, has been submitted and considered by the regulatory authority of the country that previously approved the drug, animal toxicity studies are not required in India.
* Exceptions exist if specific concerns are recorded in writing.
Impact Analysis:
Central Government:
* Impact: The Central Government will consider objections and suggestions regarding the draft rules.
* Action Required: To review and consider objections/suggestions received within the specified period and finalize the amendments.
Drug Manufacturers/Researchers:
* Impact: Reduced regulatory burden for certain academic clinical trials and potential reduction in animal toxicity study requirements.
* Action Required: To comply with the new rules regarding academic clinical trials and animal toxicity studies, once finalized.
Ethics Committees:
* Impact: Increased responsibility in approving and monitoring academic clinical trials.
* Action Required: To inform the licensing authority about approved academic clinical trial cases and potential overlaps with regulatory trials.
Licensing Authority:
* Impact: To review communications from Ethics Committees regarding academic clinical trials.
* Action Required: To provide comments to the Ethics Committee within 30 days if permission is required; otherwise, permission is presumed unnecessary.
Public:
* Impact: The public is invited to provide feedback on the proposed changes.
* Action Required: To submit objections and suggestions regarding the draft rules to the Under Secretary Drugs within the specified period.
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 proposes amendments to 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.
Drugs Technical Advisory Board: A board consulted by the Central Government in India regarding the formulation of rules related to 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 city of India, where the notification was issued and where the Ministry of Health and Family Welfare is located.
Ethics Committee: A committee that reviews and approves clinical trials, ensuring ethical considerations are met.
Schedule Y: A schedule within the Drugs and Cosmetics Rules, likely pertaining to specific guidelines or requirements for certain drugs or procedures.
Drugs and Cosmetics 9th Amendment Rules, 2016: The title of the amendment being proposed to the Drugs and Cosmetics Rules, 1945.
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EXTRAORDINARY
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PART II—Section 3—Sub-section (i)
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PUBLISHED BY AUTHORITY
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िन(cid:20)िलिखत (cid:14)ा(cid:23)प िनयम, िजनको के(cid:29)(cid:30)ीय सरकार का औषिध और (cid:14)साधन साम(cid:18)ी अिधिनयम, 1940(1940
का 23) क(cid:31) धारा 12 और धारा 33 ारा (cid:14)द! शि#य$ का (cid:14)योग करते &ए, औषिध तकनीक(cid:31) सलाहकार बोड+ स े
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िजनके उनस े (cid:14)भािवत होन े क(cid:31) संभावना ह ै और यह सूचना दी जाती ह ै (cid:4)क उ# (cid:14)ा(cid:23)प िनयम$ पर उस तारीख स,े
िजसको इन (cid:14)ा(cid:23)प िनयम$ वाले भारत के राजप9 क(cid:31) (cid:14)ितयां जनता को उपल:ध करा दी जाती ह,ै प4तालीस (cid:4)दन
क(cid:31) अविध क(cid:31) समाि< पर या उसके प,ात् िवचार (cid:4)कया जाएगा;
के(cid:29)(cid:30)ीय सरकार ारा ऐस े आ?ेप$ और सुझाव$ पर, जो उ# (cid:14)ा(cid:23)प िनयम$ के संबधं मB ऊपर िविनDदE
अविध के भीतर (cid:4)कसी 3ि# से (cid:14)ा< ह$, िवचार (cid:4)कया जाएगा ।
ऐसे आ?ेप और सुझाव, य(cid:4)द कोई हो, अवर सिचव (औषिध), .वा.Gय और पHरवार क(cid:6)याण मं9ालय,
भारत सरकार, कमरा सं. 414ए, डी. Jवग, िनमा+ण भवन, नई (cid:4)द(cid:6)ली-110011 को भजे े जा सकते ह 4।
(cid:18)(cid:18)(cid:18)(cid:18)ाााा(cid:19)(cid:19)(cid:19)(cid:19)पपपप ििििननननययययमममम
1. (1) इन िनयम$ का संि?< नाम औषिध और (cid:14)साधन साम(cid:18)ी (नौवा ँ संशोधन) िनयम, 2016 ह ै।
(2) ये राजप9 मB उनके अंितम (cid:14)काशन क(cid:31) तारीख को (cid:14)वृ! ह$गे ।
66 GI/2016 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. औषिध और (cid:14)साधन साम(cid:18)ी िनयम, 1945 (िज(cid:29)ह B इसमB इसके प,ात् उ# िनयम कहा गया ह)ै के िनयम
122घक के उपिनयम (3) म,B .पEीकरण से पूव+ िन(cid:20)िलिखत उपिनयम अंतः.थािपत (cid:4)कया जाएगा, अथा+त:्-
“(4) अनुमो(cid:4)दत औषिध िविनNमित क(cid:31) बाबत शै?िणक (cid:14)योजन$ के िलए आशियत नैदािनक परी?ण के
संचालन के िलए (cid:4)कसी नए िनदश+न या नए (cid:14)दान-माग+ या नई मा9ा या नए मा9ा (cid:23)प के िलए कोई अनOु ा
अपेि?त नहP होगी, जहां,-
(क) परी?ण आचार सिमित ारा अनुमो(cid:4)दत ह;ै और
(ख) उपिनयम (5) के उपबंध$ के अधीन रहते &ए, तयै ार (cid:4)कया गया डाटा अनOु ापन (cid:14)ािधकारी को
(cid:14).तुत (cid:4)कए जाने के िलए आशियत नहP ह ै।
(5) तथािप आचार सिमित, अनुOापन (cid:14)ािधकारी को उसके ारा अनुमो(cid:4)दत मामल$ के बारे मB और ऐस े
मामल$ के बारे म,B जहां शै?िणक और िविनयमनकारी (cid:14)योजन$ के िलए नैदािनक परी?ण$ के बीच अित3ाि< हो
सकती ह,ै सूिचत करेगी और जहां उ# (cid:14)ािधकारी आचार सिमित से संसूचना (cid:14)ा< होने क(cid:31) तारीख स े तीस (cid:4)दन
क(cid:31) अविध के भीतर आचार सिमित को अपनी HटRपिणयां सूिचत नहP करता ह ैवहां यह उपधारणा क(cid:31) जाएगी (cid:4)क
अनुOापन (cid:14)ािधकारी से कोई अनुOा अपेि?त नहP ह ै।”
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अंतः.थािपत (cid:4)कया जाएगा, अथा+त:् -
““““(cid:10)(cid:10)(cid:10)(cid:10)टटटट(cid:23)(cid:23)(cid:23)(cid:23)पपपपणणणण –––– जहां पशु िवषा#ता संबंधी डाटा पHरिशE 3 के िविनदशS के अनुसार (cid:14).ततु (cid:4)कया गया ह ै और
उस पर दशे के उस िविनयामक (cid:14)ािधकारी ारा, िजसने इसस े पूव + औषिध का अनमु ोदन (cid:4)कया था, िवचार कर
िलया गया ह,ै वहां भारत मB पशु िवषा#ता अTययन (cid:4)कए जाने क(cid:31) आवUयकता नहP होगी िसवाय उन मामल$ के,
जहां िलिखत मB िविनDदE िच(cid:29)ताएं अिभिलिखत क(cid:31) गई ह 4।”।
[फा. सं. एVस.11035/289/2015-डी एफ Vयू सी]
कु(cid:29)दन लाल शमा,+ सयं ु# सिचव
(cid:10)(cid:10)(cid:10)(cid:10)टटटट(cid:23)(cid:23)(cid:23)(cid:23)पपपपणणणण:::: मूल िनयम, भारत के राजप9 मB अिधसूचना स.ं एफ.28-10/45-एच (1), तारीख 21 (cid:4)दसWबर, 1945
ारा (cid:14)कािशत (cid:4)कए गए थे और उनमB अंितम संशोधन अिधसूचना स.ं सा.का.िन. 918 (अ) तारीख 30/11/2015
ारा (cid:14)कािशत (cid:4)कया गया था ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 6th January, 2016
G.S.R. 11(E).—The following draft 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 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.¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
The objections and suggestions which may be received from any person with respect to the said
draft rules within the period specified above, will be considered by the Central Government.
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 Bhawan,
New Delhi- 110011.
Draft rules
1. (1) These rules may be called the Drugs and Cosmetics (9th Amendment) Rules, 2016.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945, (hereinafter referred to as the said rules), in rule 122DA,
in sub-rule (3), before the Explanation, the following sub-rule shall be inserted, namely:-
“(4) No permission for conduct of clinical trial intended for academic purposes in respect of
approved drug formulation shall be required for any new indication or new route of
administration or new dose or new dosage form where,-
(a) the trial is approved by the Ethics Committee; and
(b) subject to the provisions of sub-rule (5), the data generated is not intended for
submission to the licensing authority.
(5) The Ethics Committee shall however inform the licensing authority about the cases
approved by it and also about cases where there could be an overlap between the clinical trials
for academic and regulatory purposes and where the said authority does not convey its
comments to the Ethics Committee within a period of thirty days from the date of receipt of
communication from the Ethics Committee, it shall be presumed that no permission from the
licensing authority is required.”.
3. In Schedule Y to the said rules, in Appendix I, in item 4, after sub-item 4.8, the following note
shall be inserted, namely:-
“Note.- Where data on animal toxicity as per the specification of Appendix III has been
submitted and the same has been considered by the regulatory authority of the country which
had earlier approved the drug, the animal toxicity studies shall not be required to be conducted
in India except in cases where there are specific concerns recorded in writing.”.
[F. No. X.11035/289/2015-DFQC]
K. L. SHARMA, Jt. Secy.
Note: The principal rules were published in the Gazette of India vide notification number F.28-10/45-H (1)
dated 21st December, 1945 and last amended vide notification number GSR 918(E) dated
30.11.2015.
Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.