Executive Summary:
This notification publishes draft amendments to the Drugs and Cosmetics Rules, 1945, proposed by the Central Government after consulting the Drugs Technical Advisory Board. The amendments relate to bioequivalence studies for certain drug categories. The draft rules are open for public comment, with objections and suggestions to be considered by the Central Government after a 45-day period from the date the Gazette of India containing the draft rules is made available to the public.
Key Points / Main Content:
* **Effective Date:** The rules will come into force on the date of their final publication in the Official Gazette.
* **Amendment to Rule 2:**
* A new clause (aa) is inserted, defining "biopharmaceutical classification system" as a system classifying drugs based on solubility and permeability.
* The system categorizes drugs into four classes:
* Category I: High solubility and high permeability
* Category II: Low solubility and high permeability
* Category III: High solubility and low permeability
* Category IV: Low solubility and low permeability
* **Amendments to Rules 74 and 74B:**
* A new clause (q) is inserted in Rule 74, and a new clause (8) in Rule 74B.
* Applicants for a license of oral dosage form of drugs specified under category II and category IV of the biopharmaceutical classification system must submit the result of bioequivalence study referred to in Schedule Y, along with the application.
* **Amendments to Rules 76 and 78:**
* A new clause (10) is inserted in Rule 76, and a new clause (r) in Rule 78.
* Applicants for a license of oral dosage form of drugs specified under category II and category IV of the biopharmaceutical classification system must submit the result of bioequivalence study referred to in Schedule Y, along with the application.
* **Amendments to Rule 78A:**
* A new clause (9) is inserted in Rule 78A.
* Applicants for a license of oral dosage form of drugs specified under category II and category IV of the biopharmaceutical classification system must submit the result of bioequivalence study referred to in Schedule Y, along with the application.
Impact Analysis:
* **Drug Manufacturers/License Applicants:**
* *Impact:* Additional requirement to conduct and submit bioequivalence studies for oral dosage form drugs falling under Categories II and IV of the biopharmaceutical classification system.
* *Action Required:* Implement bioequivalence study protocols and submit results with license applications for relevant drugs.
* **Central Government (Ministry of Health and Family Welfare):**
* *Impact:* Increased regulatory oversight and data evaluation related to bioequivalence studies.
* *Action Required:* Review and consider public feedback on the draft rules and finalize amendments.
* **Drug Technical Advisory Board:**
* *Impact:* Involvement in the consultation process for amending the Drugs and Cosmetics Rules.
* *Action Required:* Provide expert advice and recommendations on the proposed amendments.
* **Public:**
* *Impact:* Potential for improved drug quality and efficacy through bioequivalence requirements.
* *Action Required:* Review the draft rules and submit objections or suggestions to the Under Secretary Drugs within the specified period.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: The act that empowers the Central Government to make rules regarding drugs and cosmetics.
Drugs Technical Advisory Board: An advisory board consulted by the Central Government for making amendments to the Drugs and Cosmetics Rules.
Ministry of Health and Family Welfare: The ministry responsible for health and family welfare, under which the Department of Health and Family Welfare operates.
Department of Health and Family Welfare: The department within the Ministry of Health and Family Welfare that issued the notification.
New Delhi: The location where the notification was issued, New Delhi, Delhi
Drugs and Cosmetics Amendment Rules, 2017: The name given to the rules that are being amended in this notification.
Schedule Y: A schedule mentioned in the document in relation to bioequivalence study.
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EXTRAORDINARY
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PART II—Section 3—Sub-section (i)
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la- 79] ubZ fnYyh] c`gLifrokj] iQjojh 2] 2017@ek?k 13] 1938
No. 79] NEW DELHI, THURSDAY FEBRUARY 2, 2017/MAGHA 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, 2 फरवरी, 2017
सा.का.िन.
102(अ).—vkS
षिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और संशोधन करन े के िलए कितपय
vkS
िनयम(cid:7298) का िन(cid:7388)िलिखत (cid:7079)ा(cid:7272)प, िजसे के(cid:7008)(cid:7076)ीय सरकार का, षिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम,1940 (1940
vkS
का 23) क(cid:7409) धारा 12 और धारा 33 (cid:7367)ारा (cid:7079)द(cid:7275) शि(cid:7334)य(cid:7298) का (cid:7079)योग करते (cid:7263)ए, षिध तकनीक(cid:7409) सलाहकार बोड (cid:6981) से
परामश(cid:6981) करने के प(cid:7391)ात्, बनाने का (cid:7079)(cid:7021)ताव ह,ै उन सभी (cid:7390)ि(cid:7334)य(cid:7298) क(cid:7409) जानकारी के िलए (cid:7079)कािशत (cid:7408)कया जाता ह,ै
िजनके उनसे (cid:7079)भािवत होने क(cid:7409) संभावना ह ै और यह सचू ना दी जाती ह ै (cid:7408)क उ(cid:7334) (cid:7079)ा(cid:7272)प िनयम(cid:7298) पर उस तारीख स,े
िजसको इन (cid:7079)ा(cid:7272)प िनयम(cid:7298) वाले भारत के राजप(cid:7074) क(cid:7409) (cid:7079)ितयां जनता को उपल(cid:7011)ध करा दी जाती ह,(cid:7289) प(cid:7289)तालीस (cid:7408)दन
क(cid:7409) अविध क(cid:7409) समाि(cid:7385) पर या उसके प(cid:7391)ात् िवचार (cid:7408)कया जाएगा;
के(cid:7008)(cid:7076)ीय सरकार (cid:7367)ारा ऐसे आ(cid:6979)ेप(cid:7298) और सुझाव(cid:7298) पर, जो उ(cid:7334) (cid:7079)ा(cid:7272)प िनयम(cid:7298) के सबं ंध म(cid:7286) ऊपर िविन(cid:7416)द(cid:7397)
अविध के भीतर (cid:7408)कसी (cid:7390)ि(cid:7334) से (cid:7079)ा(cid:7385) ह(cid:7298), िवचार (cid:7408)कया जाएगा ।
ऐसे आ(cid:6979)ेप और सुझाव, य़(cid:7408)द कोई ह(cid:7298), अवर सिचव (ओषिध), (cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण मं(cid:7074)ालय,
भारत सरकार 414-ए, डी (cid:7410)वग, िनमा(cid:6981)ण भवन, नई (cid:7408)द(cid:7016)ली-110011 को भेज े जा सकत े ह (cid:7289) या
drugsdiv-mohfw@ gov.in पर मेल (cid:7408)कए जा सकते ह (cid:7289)।
577 GI/2017 (1)(cid:32)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(cid:7079)ा(cid:7272)प िनयम
vkS
1. (1) इन िनयम(cid:7298) का संि(cid:6979)(cid:7385) नाम षिध और (cid:7079)साधन साम(cid:7061)ी(संशोधन) िनयम, 2017 ह ै ।
(2) ये राजप(cid:7074) म(cid:7286) उनके अंितम (cid:7079)काशन क(cid:7409) तारीख को (cid:7079)वृ(cid:7275) ह(cid:7298)गे ।
vkS
2. षिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 (िज(cid:7008)ह (cid:7286) इसम(cid:7286) इसके प(cid:7391)ात् उ(cid:7334) िनयम कहा गया ह)ै के िनयम
2 म(cid:7286), खंड (क) के प(cid:7391)ात् िन(cid:7388)िलिखत खंड अंतः(cid:7021)थािपत (cid:7408)कया जाएगा, अथात(cid:6981) :् -
“(कक) “जैवभेषज वग(cid:7278)करण (cid:7079)णाली” से ऐसी (cid:7079)णाली अिभ(cid:7079)ेत ह ै जो (cid:7079)वग(cid:6981) 1– उ(cid:7340) िवलेयता और उ(cid:7340)
पारग(cid:7013)यता, (cid:7079)वग(cid:6981) 2 – िन(cid:7388) िवलेयता और उ(cid:7340) पारग(cid:7013)यता, (cid:7079)वग(cid:6981) 3 – उ(cid:7340) िवलेयता और िन(cid:7388) पारग(cid:7013)यता
और (cid:7079)वग(cid:6981) 4-िन(cid:7388) िवलेयता और िन(cid:7388) पारग(cid:7013)यता के (cid:7272)प म(cid:7286) वग(cid:7278)कृत ओषिधय(cid:7298) को िवलेयता और पारग(cid:7013)यता
के आधार पर वग(cid:7278)कृत करने के िलए (cid:7079)योग म(cid:7286) लाई जाती ह ै ।”;
3. उ(cid:7334) िनयम(cid:7298) के िनयम 74 म(cid:7286), खंड (त) के प(cid:7391)ात् िन(cid:7388)िलिखत खंड अंतः(cid:7021)थािपत (cid:7408)कया जाएगा, अथा(cid:6981)त:् -
“(थ) आवेदक, जैवभेषज वग(cid:7278)करण (cid:7079)णाली के (cid:7079)वग(cid:6981) 2 और (cid:7079)वग(cid:6981) 4 के अधीन िविन(cid:7416)द(cid:7397) मुखी खुराक (cid:7272)प क(cid:7409)
vkS
षिधय(cid:7298) क(cid:7409) अनु(cid:6980)ि(cid:7385) के अनुदान के िलए आवेदन के साथ अनुसूची म म(cid:7286) िन(cid:7416)द(cid:7397) जैवसमतु(cid:7016)यता अ(cid:7007)ययन के
प(cid:7407)रणाम (cid:7079)(cid:7021)तुत करेगा ।”।
4. उ(cid:7334) िनयम(cid:7298) के िनयम 74ख म(cid:7286), खंड (7) के प(cid:7391)ात् िन(cid:7388)िलिखत खंड अंतः(cid:7021)थािपत (cid:7408)कया जाएगा, अथा(cid:6981)त्:-
“(8) आवेदक, जैवभेषज वग(cid:7278)करण (cid:7079)णाली के (cid:7079)वग(cid:6981) 2 और (cid:7079)वग(cid:6981) 4 के अधीन िविन(cid:7416)द(cid:7397) मुखी खुराक (cid:7272)प क(cid:7409)
vkS
षिधय(cid:7298) क(cid:7409) अनु(cid:6980)ि(cid:7385) के अनुदान के िलए आवेदन के साथ अनुसूची म म(cid:7286) िन(cid:7416)द(cid:7397) जैवसमतु(cid:7016)यता अ(cid:7007)ययन के
प(cid:7407)रणाम (cid:7079)(cid:7021)तुत करेगा ।”।
5. उ(cid:7334) िनयम(cid:7298) के िनयम 76 म(cid:7286), खंड (9) के प(cid:7391)ात् िन(cid:7388)िलिखत खंड अंतः(cid:7021)थािपत (cid:7408)कया जाएगा, अथा(cid:6981)त:् -
“(10) आवेदक, जैवभेषज वग(cid:7278)करण (cid:7079)णाली के (cid:7079)वग(cid:6981) 2 और (cid:7079)वग(cid:6981) 4 के अधीन िविन(cid:7416)द(cid:7397) मुखी खुराक (cid:7272)प
vkS
क(cid:7409) षिधय(cid:7298) क(cid:7409) अनु(cid:6980)ि(cid:7385) के अनुदान के िलए आवेदन के साथ अनसु ूची म म(cid:7286) िन(cid:7416)द(cid:7397) जैवसमतु(cid:7016)यता
अ(cid:7007)ययन के प(cid:7407)रणाम (cid:7079)(cid:7021)तुत करेगा ।”।
6. उ(cid:7334) िनयम(cid:7298) के िनयम 78 म(cid:7286), खंड (थ) के प(cid:7391)ात् िन(cid:7388)िलिखत खंड अंतः(cid:7021)थािपत (cid:7408)कया जाएगा, अथा(cid:6981)त:् -
“(द) आवेदक, जैवभेषज वग(cid:7278)करण (cid:7079)णाली के (cid:7079)वग(cid:6981) 2 और (cid:7079)वग(cid:6981) 4 के अधीन िविन(cid:7416)द(cid:7397) मुखी खुराक (cid:7272)प क(cid:7409)
vkS
षिधय(cid:7298) क(cid:7409) अनु(cid:6980)ि(cid:7385) के अनुदान के िलए आवेदन के साथ अनुसूची म म(cid:7286) िन(cid:7416)द(cid:7397) जैवसमतु(cid:7016)यता अ(cid:7007)ययन के
प(cid:7407)रणाम (cid:7079)(cid:7021)तुत करेगा ।”।
7. उ(cid:7334) िनयम(cid:7298) के िनयम 78क म(cid:7286), खंड (8) के प(cid:7391)ात् िन(cid:7388)िलिखत खंड अंतः(cid:7021)थािपत (cid:7408)कया जाएगा, अथा(cid:6981)त्:-
“(9) आवेदक, जैवभेषज वग(cid:7278)करण (cid:7079)णाली के (cid:7079)वग(cid:6981) 2 और (cid:7079)वग(cid:6981) 4 के अधीन िविन(cid:7416)द(cid:7397) मुखी खुराक (cid:7272)प क(cid:7409)
vkS
षिधय(cid:7298) क(cid:7409) अनु(cid:6980)ि(cid:7385) के अनुदान के िलए आवेदन के साथ अनुसूची म म(cid:7286) िन(cid:7416)द(cid:7397) जैवसमतु(cid:7016)यता अ(cid:7007)ययन के
प(cid:7407)रणाम (cid:7079)(cid:7021)तुत करेगा ।”।
[फा. सं. ए(cid:6989)स. 11014/12/2016-डी.आर.एस.]
कु(cid:7008)दन लाल शमा(cid:6981), संयु(cid:7334) सिचव¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
(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. 76(अ), तारीख 31 जनवरी,
2017, (cid:7367)ारा (cid:7408)कया गया था ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 2nd February, 2017
G.S.R. 102(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 forty-five days from the date on which copies of the
Gazette of India containing these draft rules are made available to the public.
Objections and suggestions which may be received from any person 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 Bhavan, New Delhi – 110011 or sent on email
drugsdiv-mohfw@gov.in
(cid:32)
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(cid:32)
(cid:32)
1.(cid:32) (1) These rules may be called the Drugs and Cosmetics (____________Amendment) Rules, 2017.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2.(cid:32) In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the said rules), in rule 2, after clause (a),
following shall be inserted, namely,-
(aa) “biopharmaceutical classification system” means a system used to classify drugs on the basis of solubility
and permeability, classified as category I- high solubility and high permeability, category II- low
solubility and high permeability, category III- high solubility and low permeability, and category IV- low
solubility and low permeability.”;
3.(cid:32) In the said rules, in rule 74, after clause (p), the following clause shall be inserted, namely.-
“(q) the applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with the
application for grant of a licence of oral dosage form of drugs specified under category II and category IV
of the biopharmaceutical classification system.”.
4.(cid:32) In the said rules, in rule 74B, after clause (7), the following clause shall be inserted, namely.-
“(8) the applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with the
application for grant of a licence of oral dosage form of drugs specified under category II and category IV
of the biopharmaceutical classification system.”.
5.(cid:32) In the said rules, in rule 76, after clause (9), the following clause shall be inserted, namely.-
“(10) the applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with the
application for grant of a licence of oral dosage form of drugs specified under category II and category IV
of the biopharmaceutical classification system.”.
6.(cid:32) In the said rules, in rule 78, after clause (q), the following clause shall be inserted, namely.-
“(r) the applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with
the application for grant of a licence of oral dosage form of drugs specified under category II and
category IV of the biopharmaceutical classification system.”.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
7.(cid:32) In the said rules, in rule 78A, after clause (8), the following clause shall be inserted, namely.-
“(9) the applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with
the application for grant of a licence of oral dosage form of drugs specified under category II and
category IV of the biopharmaceutical classification system.”.
[F. No. X.11014/12/2016-DRS]
K. L. SHARMA, Jt Secy.
Note : 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. 76(E) dated the 31st January, 2017.
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and Published by the Controller of Publications, Delhi-110054.