**Executive Summary:**
This notification from the Ministry of Health and Family Welfare announces amendments to the Drugs and Cosmetics Rules, 1945. These amendments, referred to as the Drugs and Cosmetics Ninth Amendment Rules, 2017, introduce a biopharmaceutical classification system and require bioequivalence studies for certain drug license applications. The rules came into force on April 3, 2017, the date of their publication in the Official Gazette.
**Key Points / Main Content:**
* **Nomenclature and Enforcement:**
* These rules are called the Drugs and Cosmetics Ninth Amendment Rules, 2017.
* The rules came into force on the date of their publication in the Official Gazette, April 3, 2017.
* **Amendment to Rule 2:**
* A biopharmaceutical classification system is defined, categorizing drugs based on solubility and permeability:
* 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, 74B, 76, 78 and 78A:**
* For license applications of oral dosage forms of drugs in Categories II and IV of the biopharmaceutical classification system, applicants must submit the results of bioequivalence studies as referred to in Schedule Y.
* This requirement is inserted into Rules 74, 74B, 76, 78 and 78A.
**Impact Analysis:**
* **Drug Manufacturers/License Applicants:**
* *Impact:* Manufacturers seeking licenses for oral dosage form drugs falling under Categories II and IV of the biopharmaceutical classification system must now conduct and submit bioequivalence studies.
* *Action Required:* Conduct bioequivalence studies as per Schedule Y and include the results with the license application.
* **Central Government:**
* *Impact:* The Central Government, after consulting with the Drugs Technical Advisory Board, has the power to amend the Drugs and Cosmetics Rules, 1945.
* *Action Required:* Enforce the new amendments to the Drugs and Cosmetics Rules, 1945.
* **Regulatory Bodies:**
* *Impact:* These bodies will need to evaluate the submitted bioequivalence study results as part of the drug licensing process.
* *Action Required:* Update evaluation procedures to include assessment of bioequivalence studies for relevant drug applications.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules governing drugs and cosmetics in India, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: The primary legislation authorizing the Drugs and Cosmetics Rules, 1945. Sections 12 and 33 of this act are mentioned.
Ministry of Health and Family Welfare: The government ministry responsible for health and family welfare in India, which is issuing the notification.
New Delhi: The location where the notification was issued. It is the capital of India.
Drugs Technical Advisory Board: A board consulted by the Central Government when amending the Drugs and Cosmetics Rules, 1945.
Drugs and Cosmetics Ninth Amendment Rules, 2017: The title of the amendment rules being introduced.
Schedule Y: A schedule within the Drugs and Cosmetics Rules, 1945, related to bioequivalence study requirements.
Biopharmaceutical Classification System: A system used to classify drugs based on solubility and permeability, with categories I, II, III, and IV mentioned.
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EXTRAORDINARY
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PART II—Section 3—Sub-section (i)
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No. 260] NEW DELHI, MONDAY, APRIL 3, 2017/CHAITRA 13, 1939
(cid:1)(cid:1)(cid:1)(cid:1)ववववाााा(cid:1)(cid:1)(cid:1)(cid:1)(cid:4)(cid:4)(cid:4)(cid:4)यययय औऔऔऔरररर पपपप(cid:10)(cid:10)(cid:10)(cid:10)ररररववववाााारररर कककक(cid:12)(cid:12)(cid:12)(cid:12)ययययााााणणणण मममम(cid:16)(cid:16)ंं(cid:16)(cid:16)ंं ााााललललयययय
(((((cid:1)(cid:1)(cid:1)(cid:1)ववववाााा(cid:1)(cid:1)(cid:1)(cid:1)(cid:4)(cid:4)(cid:4)(cid:4)यययय औऔऔऔरररर पपपप(cid:10)(cid:10)(cid:10)(cid:10)ररररववववाााारररर कककक(cid:12)(cid:12)(cid:12)(cid:12)ययययााााणणणण ििििववववभभभभाााागगगग))))
अअअअििििधधधधससससचचूूचचूू ननननाााा
नई (cid:4)द(cid:6)ली, 3 अ(cid:12)ैल, 2017
ससससाााा....ककककाााा....ििििनननन....333322227777((((अअअअ))))....————औषिध और (cid:12)साधन साम(cid:26)ी िनयम, 1945 का और संशोधन करने के िलए कितपय िनयम’ का (cid:12)ा(प
औषिध और (cid:12)साधन साम(cid:26)ी अिधिनयम, 1940 (1940 का 23) क+ धारा 12 और धारा 33 क+ अपे,ाऩुसार भारत के राजप1,
असाधारण, भाग II, खंड 3, उपखंड (i), तारीख 2 फरवरी, 2017 म5 (cid:12)कािशत भारत सरकार के 6वा67य और प8रवार क(cid:6)याण मं1ालय
(6वा67य और प8रवार क(cid:6)याण िवभाग) क+ अिधसूचना सं. सा.का.िन. 102(अ), तारीख 2 फरवरी, 2017 >ारा (cid:12)कािशत (cid:4)कया गया था
िजसके >ारा उन सभी AिBय’ स,े िजनके उनसे (cid:12)भािवत होने क+ संभावना ह,ै उस तारीख से, िजसको उB अिधसूचना वाले भारत के
राजप1 क+ (cid:12)ितयां जनता को उपलDध करा दी गई थE, पFतालीस (cid:4)दन क+ अविध क+ समािG से पूवH आ,ेप और सुझाव आमंि1त (cid:4)कए गए
थे;
और उB मूल राजप1 क+ (cid:12)ितया ंजनता को तारीख 2 फरवरी, 2017 को उपलDध करा दी गई थE ।
और केLMीय सरकार >ारा उB िनयम’ के संबंध म5 जनता के (cid:12)ाG आ,ेप’ और सुझाव’ पर िवचार (cid:4)कया गया ह ै।
अतः, अब, केLMीय सरकार, औषिध और (cid:12)साधन साम(cid:26)ी अिधिनयम, 1940 (1940 का 23) क+ धारा 12 और धारा 33 के
अधीन शिBय’ का (cid:12)योग करते Pए, औषिध तकनीक+ सलाहकार बोडH से परामशH करने के पRात्, औषिध और (cid:12)साधन साम(cid:26)ी िनयम,
1945 का और संशोधन करने के िलए िनTिलिखत िनयम बनाती ह,ै अथाHत:्-
1. (1) इन िनयम’ का संि,G नाम औषिध और (cid:12)साधन साम(cid:26)ी ( नवां संशोधन) िनयम, 2017 ह ै।
(2) ये राजप1 म 5उनके (cid:12)काशन क+ तारीख को (cid:12)वृW ह’गे ।
2. औषिध और (cid:12)साधन साम(cid:26)ी िनयम, 1945 (िजLह 5इसम5 इसके पRात् उB िनयम कहा गया ह)ै के िनयम 2 म,5 खंड (क) के
पRात् िनTिलिखत खंड अंतः6थािपत (cid:4)कया जाएगा, अथाHत:्-
“(कक) “जैवभेषज वगXकरण (cid:12)णाली” से ऐसी (cid:12)णाली अिभ(cid:12)ेत ह ैजो (cid:12)वगH 1– उZ िवलेयता और उZ पारग[यता, (cid:12)वगH 2 – िनT
िवलेयता और उZ पारग[यता, (cid:12)वगH 3 – उZ िवलेयता और िनT पारग[यता और (cid:12)वगH 4-िनT िवलेयता और िनT पारग[यता के
1880 GI/2017 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(प म5 वगXकृत औषिधय’ को िवलेयता और पारग[यता के आधार पर वगXकृत करने के िलए (cid:12)योग म5 लाई जाती ह ै।”;
3. उB िनयम’ के िनयम 74 म5, खंड (त) के पRात् िनTिलिखत खंड अंतः6थािपत (cid:4)कया जाएगा, अथाHत:्-
“(थ) आवेदक, जैवभेषज वगXकरण (cid:12)णाली के (cid:12)वगH 2 और (cid:12)वगH 4 के अधीन िविन\द]H मुखी खुराक (प क+ औषिधय’ क+
अनु^िG के अनुदान के िलए आवेदन के साथ अनुसूची म म5 िन\द]H जैवसमतु(cid:6)यता अ_ययन के प8रणाम (cid:12)6तुत करेगा ।”।
4. उB िनयम’ के िनयम 74ख म5, खंड (7) के पRात् िनTिलिखत खंड अंतः6थािपत (cid:4)कया जाएगा, अथाHत:्-
“(8) आवेदक, जैवभेषज वगXकरण (cid:12)णाली के (cid:12)वगH 2 और (cid:12)वगH 4 के अधीन िविन\द]H मुखी खुराक (प क+ औषिधय’ क+
अनु^िG के अनुदान के िलए आवेदन के साथ अनुसूची म म5 िन\द]H जैवसमतु(cid:6)यता अ_ययन के प8रणाम (cid:12)6तुत करेगा ।”।
5. उB िनयम’ के िनयम 76 म5, खंड (9) के पRात् िनTिलिखत खंड अंतः6थािपत (cid:4)कया जाएगा, अथाHत:्-
“(10) आवेदक, जैवभेषज वगXकरण (cid:12)णाली के (cid:12)वगH 2 और (cid:12)वगH 4 के अधीन िविन\द]H मुखी खुराक (प क+ औषिधय’ क+
अनु^िG के अनुदान के िलए आवेदन के साथ अनुसूची म म5 िन\द]H जैवसमतु(cid:6)यता अ_ययन के प8रणाम (cid:12)6तुत करेगा ।”।
6. उB िनयम’ के िनयम 78 म5, खंड (थ) के पRात् िनTिलिखत खंड अंतः6थािपत (cid:4)कया जाएगा, अथाHत:्-
“(द) आवेदक, जैवभेषज वगXकरण (cid:12)णाली के (cid:12)वगH 2 और (cid:12)वगH 4 के अधीन िविन\द]H मुखी खुराक (प क+ औषिधय’ क+
अनु^िG के अनुदान के िलए आवेदन के साथ अनुसूची म म5 िन\द]H जैवसमतु(cid:6)यता अ_ययन के प8रणाम (cid:12)6तुत करेगा ।”।
7. उB िनयम’ के िनयम 78क म5, खंड (8) के पRात् िनTिलिखत खंड अंतः6थािपत (cid:4)कया जाएगा, अथाHत:्-
“(9) आवेदक, जैवभेषज वगXकरण (cid:12)णाली के (cid:12)वगH 2 और (cid:12)वगH 4 के अधीन िविन\द]H मुखी खुराक (प क+ औषिधय’ क+
अनु^िG के अनुदान के िलए आवेदन के साथ अनुसूची म म5 िन\द]H जैवसमतु(cid:6)यता अ_ययन के प8रणाम (cid:12)6तुत करेगा ।”।
[फा. सं. एbस. 11014/12/2016-डीआरएस]
कुLदन लाल शमाH, संयुB सिचव
(cid:10)(cid:10)(cid:10)(cid:10)टटटट(cid:24)(cid:24)(cid:24)(cid:24)पपपपणणणण – मूल िनयम भारत के राजप1 म5 अिधसूचना सं. एफ.28-10/45-एच(1), तारीख 21 (cid:4)दस[बर, 1945 >ारा (cid:12)कािशत (cid:4)कए गए थे
और उनम5 अंितम संशोधन अिधसचू ना सं. सा.का.िन. 303 (अ),तारीख 30 माचH, 2017 >ारा (cid:4)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. 327(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 2nd February, 2017 vide notification of the Government of
India in the Ministry of Health and Family Welfare, number G.S.R. 102(E), dated the 2nd February, 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 2nd February, 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 (Ninth Amendment) Rules, 2017.
(2) They shall come into force on the date of their publication in the Official Gazette.¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
2. 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. In the said rules, in rule 74, after clause (p), the following clause shall 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. In the said rules, in rule 74B, after clause (7), the following clause shall 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. In the said rules, in rule 76, after clause (9), the following clause shall 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. In the said rules, in rule 78, after clause (q), the following clause shall 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.”.
7. In the said rules, in rule 78A, after clause (8), the following clause shall 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.
Foot 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. 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.