Executive Summary:
This notification from the Ministry of Health and Family Welfare publishes draft amendments to the Drugs and Cosmetics Rules, 1945. The amendments relate to the duration of licenses and loan licenses, along with modifications to specific forms and rules. Objections and suggestions regarding these amendments must be submitted within thirty days of the gazette being made available to the public.
Key Points / Main Content:
Duration of Licenses:
* A license issued in Form 28, 28B, and 28D remains valid if a license retention fee is deposited every five years from the date of issue, unless suspended or canceled.
* The license retention fee is equivalent to the original license fee, excluding the initial inspection fee.
* Failure to pay the retention fee on time incurs a late fee of 2% of the license fee per month (up to six months); non-payment results in license cancellation.
Duration of Loan Licenses:
* A loan license issued in Form 28A and 28DA remains valid if a license retention fee is deposited every five years from the date of issue, unless suspended or canceled.
* The license retention fee is equivalent to the original license fee, excluding the initial inspection fee.
* Failure to pay the retention fee on time incurs a late fee of 2% of the license fee per month (up to six months); non-payment results in license cancellation.
Other Amendments:
* In rule 140, subrule 1, the words and figures and Form 33 shall be omitted.
* In rule 143A, subrule 1, the words and figures or Form 33 shall be omitted.
* In Schedule A, in Form 24C:
* In the heading, after the words GRANT, the words OR RENEWAL shall be inserted.
* In paragraph 1, for the words grant, the words grant or renewal shall be substituted.
Impact Analysis:
Central Government:
* Impact: Responsible for considering objections and suggestions to the draft rules and finalizing the amendments.
* Action Required: Review and address any objections or suggestions received within the specified timeframe.
License Holders (Forms 28, 28A, 28B, 28D, 28DA):
* Impact: Must pay a license retention fee every five years to maintain the validity of their licenses. Subject to late fees and potential cancellation for non-compliance.
* Action Required: Ensure timely payment of license retention fees to avoid penalties and license cancellation.
Public:
* Impact: Affected by changes to drug regulations and licensing procedures.
* Action Required: Review the draft rules and submit any objections or suggestions to the Ministry of Health and Family Welfare within thirty days of the gazette being made available.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules governing the import, manufacture, distribution, and sale of drugs and cosmetics in India. 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. Section 12 and section 33 of this act confer powers to the Central Government to make rules.
Central Government: The executive authority of the Union of India, responsible for proposing and implementing the amendments to the Drugs and Cosmetics Rules.
Drug Technical Advisory Board: A statutory body constituted by the Government of India to advise on technical matters related to drugs and cosmetics.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India. This ministry's Department of Health and Family Welfare is issuing the notification.
New Delhi: The location of the Ministry of Health and Family Welfare, where objections and suggestions regarding the draft rules can be addressed, New Delhi, Delhi
Drugs and Cosmetics Amendment Rules, 2018: The name given to the rules that amend the Drugs and Cosmetics Rules, 1945, as proposed in the notification.
Form 28: A form mentioned in the notification, related to licenses issued under the Drugs and Cosmetics Rules.
jftLVªh laö Mhö ,yö&33004@99 REGD. NO. D. L.-33004/99
vlk/kj.k
EXTRAORDINARY
Hkkx II—[k.M 3—mi&[k.M (i)
PART II—Section 3—Sub-section (i)
izkf/dkj ls izdkf'kr
PUBLISHED BY AUTHORITY
la- 447] ubZ fnYyh] eaxyokj] tqykbZ 3] 2018@vk"kk<+ 12] 1940
No. 447] NEW DELHI, TUESDAY, JULY 3, 2018/ASHADHA 12, 1940
(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:2)(cid:2)(cid:2)(cid:2)ववववाााा(cid:2)(cid:2)(cid:2)(cid:2)(cid:5)(cid:5)(cid:5)(cid:5)यययय औऔऔऔरररर पपपप(cid:11)(cid:11)(cid:11)(cid:11)ररररववववाााारररर कककक(cid:13)(cid:13)(cid:13)(cid:13)ययययााााणणणण ििििववववभभभभाााागगगग))))
अअअअििििधधधधससससचचूूचचूू ननननाााा
नई (cid:4)द(cid:6)ली, 3 जुलाई, 2018
ससससाााा....ककककाााा....ििििनननन.... 666600008888((((अअअअ))))....————औषिध और (cid:14)साधन साम(cid:18)ी िनयम, 1945 का और संशोधन करने के िलए कितपय िनयम के
िन!िलिखत (cid:14)ा#प, िजसे क%& सरकार औषध तकनीक’ सलाहकार बोड+ के परामश+ स े औषिध और (cid:14)साधन साम(cid:18)ी अिधिनयम,
1940 (23 के 1940) क’ धारा 12 और धारा 33 2ारा (cid:14)द3 शि4य का (cid:14)योग करते 6ए, इसके 2ारा (cid:14)भािवत होने क’
संभावना वाले सभी :ि4य क’ जानकारी के िलए (cid:14)कािशत (cid:4)कया जाता ह ै और एतद2् ारा सूचना दी जाती ह ै(cid:4)क उ?त (cid:14)ा#प
िनयम पर उस तारीख स े तीस (cid:4)दन क’ अविध समा@त होने पर या उसके बाद िवचार (cid:4)कया जाएगा िजस तारीख को इन
(cid:14)ा#प िनयम वाले भारत के राजपA क’ (cid:14)ितयां जनता को उपलBध कराई जाएगी ।
क%& सरकार 2ारा उपयु+4 िनDदE अविध के भीतर (cid:4)कसी भी :ि4 से (cid:14)ाF होने वाली आपि3य और सुझाव पर
िवचार (cid:4)कया जाएगा।
आपि3यां और सुझाव, य(cid:4)द कोई ह , तो अवर सिचव, (औषिध), JवाJKय और पLरवार क(cid:6)याण मंAालय, भारत
सरकार, कमरा सं. 414ए, डी Nवग, िनमा+ण भवन, नई (cid:4)द(cid:6)ली - 110011 को अ(cid:18)ेिषत (cid:4)कया जाए अथवा drugsdiv-
mohfw@gov.in पर ई-मेल (cid:4)कया जाए ।
(cid:18)(cid:18)(cid:18)(cid:18)ाााा(cid:19)(cid:19)(cid:19)(cid:19)पपपप ििििननननययययमममम
1. (1) इन िनयम को औषिध एवं (cid:14)साधन साम(cid:18)ी (…… संशोधन) िनयम, 2018 कहा जाएगा ।
(2) य े सरकारी राजपA म % इसके अंितम (cid:14)काशन क’ ितिथ स ेलाग ू ह ग े ।
2. उ? त िनयम म,% िनयम 76क के बाद, िन!िलिखत नए िनयम शािमल (cid:4)कए जाएंग,े अथात+ ्: -"77. लाइस%स क’
अविध.- (1) (cid:14)#प 28, (cid:14)#प 28ख और (cid:14)#प 28घ म % जारी लाइस%स वैध रहगे ा य(cid:4)द लाइस%सधारक इसके जारी होन े
क’ तारीख स े (cid:14)Tयेक आगामी पांच वषU क’ अविध समाF होन े से पहल े उप-िनयम (2) म% िनDदE लाइस%स (cid:14)ितधारण
शु(cid:6)क जमा करता ह,ै जब तक (cid:4)क, यह लाइस%Nसग (cid:14)ािधकारी 2ारा िनलंिबत या रV नहW (cid:4)कया जाता ह ै ।
3763 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(2) उप-िनयम (1) म % िनDदE लाइस%स (cid:14)ितधारण शु(cid:6)क लाइस%स (cid:14)दान करन े के िलए भगु तान (cid:4)कए गए िनरीXण
शु(cid:6)क को छोड़कर ऐसे लाइस%स के अनुदान के िलए अपेिXत संब\ शु(cid:6)क के बराबर होगा ।
(3) य(cid:4)द लाइस%स धारक उप-िनयम (1) म % उि(cid:6)लिखत देय ितिथ को या उससे पहल े लाइस%स (cid:14)ितधारण शु(cid:6)क का
भुगतान करने म% िवफल रहता ह,ै तो वह (cid:14)Tयेक माह के िलए लाइस%स शु(cid:6)क का (cid:14)ितशत या उसके छह महीने
तक का िहJसा, दो (cid:14)ितशत क’ दर से गणना क’ गई िवलंब श(cid:6)ु क के साथ लाइस%स (cid:14)ितधारण शु(cid:6)क का भगु तान
करने के िलए उ3रदायी होगा, और इस तरह के श(cid:6)ु क के भगु तान के मामल े म,% लाइस%स रV कर (cid:4)दया जाएगा ।"
3. उ? त िनयम म,% िनयम 82 के बाद, िन!िलिखत नए िनयम शािमल (cid:4)कए जाएंग,े अथा+त:् -
""""88883333.... ऋऋऋऋणणणण ललललााााइइइइसससससस(cid:29)(cid:29)सस(cid:29)(cid:29) कककक(cid:30)(cid:30)(cid:30)(cid:30) अअअअववववििििधधधध....————(1) (cid:14)#प 28क और (cid:14)#प 28घ क म% जारी कोई ऋण लाइस%स वैध रहगे ा य(cid:4)द
लाइस%सधारक इसके जारी होन े क’ तारीख से पांच साल (cid:14)Tयेक आगामी अविध समाF होन े से पहल े उप-िनयम (2)
म% िनDदE लाइस%स (cid:14)ितधारण शु(cid:6)क जमा करता ह,ै जब तक (cid:4)क यह लाइस%Nसग (cid:14)ािधकारी 2ारा िनलंिबत या रV नहW
(cid:4)कया जाता ह ै।
(2) उप-िनयम (1) म % िनDदE लाइस%स (cid:14)ितधारण शु(cid:6)क लाइस%स (cid:14)दान करने के िलए भुगतान (cid:4)कए गए िनरीXण
शु(cid:6)क को छोड़कर ऐसे लाइस%स के अनुदान के िलए अपेिXत संब\ शु(cid:6)क के बराबर होगा ।
(3) य(cid:4)द लाइस%स धारक उप-िनयम (1) म % उि(cid:6)लिखत देय ितिथ को या उससे पहल े लाइस%स (cid:14)ितधारण शु(cid:6)क का
भुगतान करने म% िवफल रहता ह,ै तो वह (cid:14)Tयेक माह के िलए लाइस%स शु(cid:6)क का (cid:14)ितशत या उसके छह महीने
तक का िहJसा, दो (cid:14)ितशत क’ दर से गणना क’ गई िवलंब श(cid:6)ु क के साथ लाइस%स (cid:14)ितधारण शु(cid:6)क का भगु तान
करने के िलए उ3रदायी होगा, और इस तरह के श(cid:6)ु क के भगु तान के मामल े म,% लाइस%स रV कर (cid:4)दया जाएगा।"
4. उ? त िनयम म,% िनयम 140 उप-िनयम (1) म % शBद और आकं ड़े "और (cid:14)#प 33" हटाया जाएगा ।
5. उ? त िनयम म,% िनयम 143क, उप-िनयम (1) म %शBद और आंकड़े "या (cid:14)#प 33" हटाया जाएगा ।
6. उ? त िनयम म,% अनुसूची क म,% (cid:14)#प 24 ग - म %
(क) शीष+क म,% 'अनुदान' शBद के बाद, "या नवीनीकरण" शBद शािमल (cid:4)कया जाएगा;
(ख) पैरा 1 म,% "अनुदान" शBद के िलए, "अनुदान या नवीनीकरण" शBद (cid:14)ितJथािपत (cid:4)कया जाएगा;
[फा. सं. ए?स .11014/9/2018-डीआर]
सुधीर कुमार, संयु?त सिचव
(cid:10)(cid:10)(cid:10)(cid:10)टटटट""""पपपपणणणण :::: मुb य िनयम को (cid:4)दनांक 21 (cid:4)दसc बर, 1945 क’ अिधसूचना सं. एफ. 28-10/45-एच (1) के तहत सरकारी
राजपA म % (cid:14)कािशत (cid:4)कया गया और अंितम बार अिधसूचना सं. सा.का.िन. ………(अ), तारीख.............. के
तहत संशोिधत (cid:4)कया गया ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 3rd July, 2018
G.S.R. 608(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 drug
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 the copies of the Gazette of India containing these draft rules are made
available to the public.
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of
Health and Family Welfare, Government of India, Room No. 414A, D-Wing, Nirman Bhavan, New Delhi -
110011 or emailed at rq.singh72@nic.in.¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
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. (1) These rules may be called Drugs and Cosmetics (___Amendment) Rules, 2018.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the said rules, after rule 76A, the following new rule shall be inserted, namely:-
“77. Duration of licence.—(1) A licence issued in Form 28, Form 28B and Form 28D shall remain
valid if the licencee deposits a licence retention fee referred to in sub-rule (2) before the expiry of
period of every succeeding five years from the date of its issue, unless, it is suspended or cancelled by
the licensing authority.
(2) The licence retention fee referred to in sub-rule (1) shall be equivalent to the respective fee
required for the grant of such licence excluding inspection fee paid for grant of licence.
(3) If the licence holder fails to pay licence retention fee on or before the due date as referred to in
sub-rule (1), he shall be liable to pay licence retention fee along with a late fee calculated at the
rate of two per cent, of the licence fee for every month or part thereof up to six months, and in the
event of non-payment of such fee, the licence shall be deemed to have been cancelled.”.
3. In the said rules, after rule 82, the following new rule shall be inserted, namely:-
“83.Duration of loan licence.—(1) A loan licence issued in Form 28A and Form 28DA shall remain
valid if the licencee deposits a licence retention fee referred to in sub-rule (2) before the expiry of
period of every succeeding five years from the date of its issue, unless, it is suspended or cancelled by
the licensing authority.
(2) The licence retention fee referred to in sub-rule (1) shall be equivalent to the respective fee
required for the grant of such licence excluding inspection fee paid for grant of licence.
(3) If the licence holder fails to pay licence retention fee on or before the due date as referred to in
sub-rule (1), he shall be liable to pay licence retention fee along with a late fee calculated at the
rate of two per cent, of the licence fee for every month or part thereof up to six months, and in the
event of non-payment of such fee, the licence shall be deemed to have been cancelled.”.
4. In the said rules, in rule 140, sub-rule (1), the words and figures “and Form 33” shall be omitted.
5. In the said rules, in rule 143A, sub-rule (1), the words and figures “or Form 33” shall be omitted.
6. In the said rules, in Schedule A, in Form 24C-
(a) In the heading, after the words ‘GRANT’, the words “OR RENEWAL” shall be inserted;
(b) In paragraph 1, for the words “grant”, the words “grant or renewal” shall be substituted;
[F. No. X. 11014/9/2018-DR]
SUDHIR KUMAR, Jt. Secy.
Note : The principal rules were published in the Official Gazette vide notification number F. 28-10/45-H(1),
dated 21st December, 1945 and last amended vide notification number G.S.R. … (E), dated ………
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.