Executive Summary:
This document is a notification containing amendments to the Drugs and Cosmetics Rules, 1945, specifically concerning animal toxicology nonclinical toxicity studies. It mandates the use of non-animal alternative tests, as per OECD guidelines, for initial dermal and ocular toxicity studies. The amendments are called the Drugs and Cosmetics Seventh Amendment Rules, 2016, and came into force on November 4, 2016.
Key Points / Main Content:
* **General Information:**
* The notification number is G.S.R. 1041(E).
* Published by Authority on November 4, 2016.
* These rules may be called the Drugs and Cosmetics Seventh Amendment Rules, 2016.
* **Amendments to the Drugs and Cosmetics Rules, 1945:**
* Schedule Y, Appendix III, paragraph 1, sub-paragraph 1.4 relating to Local Toxicity is amended.
* **Dermal Toxicity Study Amendment:**
* In Note i (Dermal toxicity study), the phrase "Daily topical dermal application of test substance in its clinical dosage form should be done" is replaced with "the initial toxicity study shall be carried out by nonanimal alternative tests as given in Organisation for Economic Cooperation and Development Guidelines."
* **Ocular Toxicity Studies Amendment:**
* In Note vi (Ocular toxicity studies), after "need to include a recovery group," the following words are added "such initial toxicity studies shall be carried out by nonanimal alternative tests as given in Organisation for Economic Cooperation and Development Guidelines."
Impact Analysis:
* **Drug Manufacturers/Testing Laboratories:**
* Impact: Must adopt non-animal alternative testing methods (OECD guidelines) for initial dermal and ocular toxicity studies.
* Action Required: Update testing protocols and procedures to align with the amended rules and OECD guidelines.
* **Regulatory Authorities (Ministry of Health and Family Welfare):**
* Impact: Enforcement and oversight of the new testing guidelines.
* Action Required: Ensure compliance with the amended rules through inspections and regulatory processes.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics, frequently amended as indicated in the document.
Drugs and Cosmetics Act, 1940: An Act of the Indian Parliament regulating the import, manufacture, distribution and sale of drugs and cosmetics.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
Department of Health and Family Welfare: A department within the Ministry of Health and Family Welfare.
New Delhi: The location where the notification was issued.
Drugs Technical Advisory Board: A board consulted by the Central Government when amending the Drugs and Cosmetics Rules.
Drugs and Cosmetics Seventh Amendment Rules, 2016: The title of the amendment rules being introduced.
Organisation for Economic Cooperation and Development Guidelines: Guidelines for nonanimal alternative toxicity tests.
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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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No. 773] NEW DELHI, FRIDAY, NOVEMBER 4, 2016/KARTIKA 13, 1938
(cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण म(cid:7074)ं ालय
((cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण िवभाग)
अिधसचू ना
नई (cid:7408)द(cid:7016)ली, 4 नव(cid:7013) बर, 2016
सा.का.िन. 1041(अ).—औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और सशं ोधन करने के िलए
कितपय िनयम(cid:7298) का (cid:7079)ा(cid:7272)प औषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) क(cid:7409) धारा 33 के साथ
प(cid:7407)ठत धारा 12 क(cid:7409) अपे(cid:6979)ाऩसु ार भारत के राजप(cid:7074), असाधारण, भाग II, खंड 3, उपखंड (i), तारीख 23 अग(cid:7021) त,
2016 म(cid:7286) (cid:7079)कािशत भारत सरकार के (cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण मं(cid:7074)ालय ((cid:7021)वा(cid:7021)(cid:7005)य िवभाग) क(cid:7409) अिधसूचना सं.
सा.का.िन. 812(अ), तारीख 23 अग(cid:7021) त, 2016 (cid:7367)ारा (cid:7079)कािशत (cid:7408)कया गया था िजसके (cid:7367)ारा उन सभी (cid:7390)ि(cid:7334)य(cid:7298) से,
िजनके उनसे (cid:7079)भािवत होने क(cid:7409) संभावना ह,ै उस तारीख से, िजसको उ(cid:7334) अिधसूचना वाले भारत के राजप(cid:7074) क(cid:7409)
(cid:7079)ितयां जनता को उपल(cid:7011)ध करा दी गई थ(cid:7277), प(cid:7289)तालीस (cid:7408)दन क(cid:7409) अविध क(cid:7409) समाि(cid:7385) से पूव(cid:6981) आ(cid:6979)ेप और सुझाव आमंि(cid:7074)त
(cid:7408)कए गए थ;े
और राजप(cid:7074) क(cid:7409) (cid:7079)ितया ं जनता को तारीख 23-08-2016 को उपल(cid:7011)ध करा दी गई थ(cid:7277) ;
और के(cid:7008)(cid:7076)ीय सरकार (cid:7367)ारा उ(cid:7334) िनयम(cid:7298) के संबंध म(cid:7286) जनता से (cid:7079)ा(cid:7385) आ(cid:6979)ेप(cid:7298) और सुझाव(cid:7298) पर िवचार (cid:7408)कया
गया ह ै ।
अतः, अब, के(cid:7008)(cid:7076)ीय सरकार, औषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) क(cid:7409) धारा 33
के साथ प(cid:7407)ठत धारा 12 के अधीन (cid:7079)द(cid:7275) क(cid:7409) गई शि(cid:7334)य(cid:7298) का (cid:7079)योग करत े (cid:7263)ए, ओषिध तकनीक(cid:7409) सलाहकार बोड (cid:6981) स े
5135 GI/2016 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
परामश(cid:6981) करने के प(cid:7391)ात्, औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और संशोधन करने के िलए िन(cid:7388)िलिखत
िनयम बनाती ह,ै अथा(cid:6981)त्:-
1. (1) इन िनयम(cid:7298) का संि(cid:6979)(cid:7385) नाम औषिध और (cid:7079)साधन साम(cid:7061)ी (सातवा ंसंशोधन) िनयम, 2016 ह ै।
(2) ये राजप(cid:7074) म(cid:7286) (cid:7079)काशन क(cid:7409) तारीख को (cid:7079)वृ(cid:7275) ह(cid:7298)गे ।
2. औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 क(cid:7409) अनुसूची म के पशु िवषिव(cid:6980)ान (गैर नैदािनक िवषा(cid:6989) तता
अ(cid:7007) ययन) से संबंिधत प(cid:7407)रिश(cid:7020) ट 3 के पैरा 1 के (cid:7021) थानीय िवषा(cid:6989) तता स े संबंिधत उपपैरा 1.4 म,(cid:7286) —
(अ) चम(cid:6981) िवषा(cid:6989) तता अ(cid:7007) ययन स े संबंिधत (cid:7407)ट(cid:7009) पण (i) म(cid:7286), “परी(cid:6979)ण पदाथ(cid:6981) क(cid:7409) नैदािनक मा(cid:7074)ा (cid:7079)ित(cid:7408)दन उनके अंग
(चम(cid:6981)) पर लगाई जानी चािहए” श(cid:7011) द(cid:7298) और को(cid:7020) ठक(cid:7298) के (cid:7021) थान पर “आ(cid:7414)थक िवकास और सहयोग संगठन
(आ.िव.स.सं.) म(cid:7286) (cid:7408)दए गए (cid:7408)दशािनदश(cid:7288) (cid:7298) के अनुसार आरंिभक िवषा(cid:6989) तता अ(cid:7007) ययन गैर पशु आनुक(cid:7016) पी परी(cid:6979)ण (cid:7408)कया
जाएगा”, श(cid:7011) द और को(cid:7020) ठक रखे जाएगं े;
(आ) ने(cid:7074) िवषा(cid:6989) तता अ(cid:7007) ययन (नैि(cid:7074)क (cid:7410)बदपु ात के िलए बनाए गए उ(cid:7004) पाद(cid:7298) के िलए) से संबंिधत (cid:7407)ट(cid:7009) पण (vi) म(cid:7286),
“पुन(cid:7272)जीवन समूह को सि(cid:7013)मिलत करने क(cid:7409) आव(cid:7019) यकता” श(cid:7011) द(cid:7298) के प(cid:7019) चात् “आ(cid:7414)थक िवकास और सहयोग संगठन
(आ.िव.स.सं.) म(cid:7286) (cid:7408)दए गए (cid:7408)दशािनदश(cid:7288) (cid:7298) के अनुसार ऐसे आरंिभक िवषा(cid:6989) तता अ(cid:7007) ययन, गैर पशु आनकु (cid:7016) पी परी(cid:6979)ण
(cid:7408)कया जाएगा ।” श(cid:7011) द अ(cid:7008) त:(cid:7021) थािपत (cid:7408)कए जाएगं े।
[फा. सं. ए(cid:6989)स 11014/7/2016-डी.एफ.(cid:6989)यू.सी.]
कु(cid:7008)दन लाल शमा(cid:6981), संयु(cid:7334) सिचव
(cid:7407)ट(cid:7009)पण - मूल िनयम, भारत के राजप(cid:7074) म(cid:7286) अिधसूचना सं. एफ.28-10/45-एच(1), तारीख 21 (cid:7408)दस(cid:7013)बर, 1945
(cid:7367)ारा (cid:7079)कािशत (cid:7408)कए गए थे और उनम(cid:7286) अंितम संशोधन अिधसूचना सं. सा.का.िन. 897(अ) तारीख 21.09.2016
(cid:7367)ारा (cid:7408)कया गया था ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 4th November, 2016
G.S.R.1041(E).— Whereas a draft of certain rules further to amend the Drugs and Cosmetics
Rules, 1945, was published, as required by section 12 read with section 33 of the Drugs and
Cosmetics Act, 1940 (23 of 1940), (cid:105)(cid:100)(cid:101)(cid:118) notification of the Government of India in the Ministry of
Health and Family Welfare (Department of Health), number G.S.R. 812(E), dated the 23rd August,
2016, published in the Gazette of India, Extraordinary, Part II, Section 3, sub-section (i), dated the
23rd August, 2016, 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 the copies of the Official
Gazette containing the said notification were made available to the public;
And whereas copies of the Gazette were made available to the public on 23.08.2016;
And, whereas, objections and suggestions received from the public on the said rules have been
considered by the Central Government;¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
Now, therefore, in exercise of the powers conferred under section 12 read with section 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.(cid:32) (1)These rules may be called the Drugs and Cosmetics (Seventh Amendment) Rules, 2016.
(2)They shall come into force on the date of their publication in the Official Gazette.
2.(cid:32) In the Drugs and Cosmetics Rules, 1945, in Schedule Y, in Appendix III relating to Animal
Toxicology (non-clinical toxicity studies), in paragraph 1, in sub- paragraph 1.4 relating to Local
Toxicity,-
(A)(cid:32)In Note (i) relating to Dermal toxicity study, for the words and brackets “Daily topical (dermal)
application of test substance in its clinical dosage form should be done”, the words and brackets
“the initial toxicity study shall be carried out by non-animal alternative tests as given in
Organisation for Economic Cooperation and Development Guidelines”, shall be substituted.
(B)(cid:32) In Note (vi) relating to Ocular toxicity studies (for products meant for ocular instillation), after the
words “need to include a recovery group.” the words “such initial toxicity studies shall be carried
out by non-animal alternative tests as given in Organisation for Economic Cooperation and
Development Guidelines.” shall be substituted.
[F.No. X.11014/7/2016-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 GSR 897(E) dated 21.09.2016.
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.