Executive Summary:
This notification announces a draft of amendments to the Drugs and Cosmetics Rules, 1945, proposed by the Central Government in consultation with the Drugs Technical Advisory Board. The amendments are made in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940. The public has 45 days to submit objections and suggestions, which will be considered by the Central Government.
Key Points / Main Content:
Amendments to the Drugs and Cosmetics Rules, 1945:
* These rules may be called the Drugs and Cosmetics Amendment Rules, 2018, and shall come into force on the date of its final publication in the Official Gazette.
Rule 150B Amendment:
* In sub-rule 1, the phrase "for sale of drugs or cosmetics, shall be made in Form 36" is replaced with "for sale of drugs and cosmetics or an individual or organization or procurement agency shall be made in Form 36."
Rule 150E Amendment:
* Clause f is replaced.
* The approved institution shall furnish reports of the results of tests or analysis on the samples received:
* From manufacturer in Form 39
* From an individual or organization or procurement agency in Form 39A.
Schedule A Amendment:
* After Form 39, Form 39A is inserted.
* Form 39A is the Report of test or analysis by approved institution.
* Contains fields for: Name of individual organization agency from whom received, Serial number and date of senders memorandum, Number of samples, Date of receipt of the sample, Name of drug cosmetics raw material purporting to be contained in the sample, Details of raw material final product in bulk final product in finished pack as obtained by sender, Results of test or analysis with protocols of test or analysis applied, the opinion of the undersigned of standard quality or not of standard quality.
Impact Analysis:
Manufacturers, Individuals, Organizations, and Procurement Agencies:
* Impact: Changes in reporting requirements and forms for drug and cosmetic sales and testing.
* Action Required: Familiarize themselves with the new Form 39A and reporting requirements for test results.
Approved Institutions:
* Impact: Changes in reporting requirements for test results. Required to use both Form 39 and Form 39A depending on the source of the sample.
* Action Required: Use Form 39A for reporting test results from individuals, organizations, or procurement agencies.
Central Government:
* Impact: Responsible for reviewing objections and suggestions from the public.
* Action Required: Consider all objections and suggestions received within the specified period before finalizing the amendments.
Public:
* Impact: Affected by changes in the regulations for drugs and cosmetics.
* Action Required: Submit any objections or suggestions regarding the draft rules within 45 days of the Gazette publication to the Under Secretary Drugs, Ministry of Health and Family Welfare.
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 under which the Drugs and Cosmetics Rules are framed and amended. Section 12 and Section 33 are specifically mentioned.
Drugs Technical Advisory Board: An advisory board consulted during the amendment of the Drugs and Cosmetics Rules.
Ministry of Health and Family Welfare: The government ministry responsible for the notification and the amendment of the rules.
Nirman Bhavan, New Delhi 110011: The location of the Ministry of Health and Family Welfare where objections and suggestions can be addressed.
Drugs and Cosmetics Amendment Rules, 2018: The name given to the amendment rules being introduced.
Form 36: A form mentioned in the draft rules related to the sale of drugs and cosmetics.
Form 39: A form mentioned in the draft rules related to test or analysis reports from manufacturers.
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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. 522] NEW DELHI, MONDAY, JULY 30, 2018/SHRAVANA 8, 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:1)द(cid:3)ली, 30 जुलाई, 2018
ससससाााा....ककककाााा....ििििनननन.... 777722220000((((अअअअ))))....————औषिध और (cid:7)साधन साम(cid:12)ी िनयम, 1945 का और संशोधन करने के िलए कितपय िनयम(cid:28) के
िन(cid:29)िलिखत (cid:7)ा(cid:31)प, िजसे क!" सरकार औषिध तकनीक# सलाहकार बोड ’के परामश’ से औषिध और (cid:7)साधन साम(cid:12)ी अिधिनयम, 1940 (23
के 1940) क# धारा 12 और धारा 33 -ारा (cid:7)द/ शि0य(cid:28) का (cid:7)योग करते 2ए, इसके -ारा (cid:7)भािवत होने क# संभावना वाले सभी 6ि0य(cid:28)
क# जानकारी के िलए (cid:7)कािशत 7कया जाता है और एतद-् ारा सूचना दी जाती ह ै7क उ< त (cid:7)ा(cid:31)प िनयम(cid:28) पर उस तारीख से प=तालीस 7दन(cid:28)
क# अविध समा>त होन े पर या उसके बाद िवचार 7कया जाएगा िजस तारीख को इन (cid:7)ा(cid:31)प िनयम(cid:28) वाले भारत के राजप? क# (cid:7)ितया ं
जनता को उपल@ध कराई जाएंगी।
क!" सरकार -ारा उपयु’0 िनCदD’ अविध के भीतर 7कसी भी 6ि0 से (cid:7)ाE होन े वाली आपि/य(cid:28) और सुझाव(cid:28) पर िवचार 7कया
जाएगा।
आपि/यां और सुझाव, य7द कोई ह(cid:28), तो अवर सिचव (औषिध), HवाHIय और पJरवार कKयाण मं?ालय, भारत सरकार, कमरा
सं. 414ए, डी Mवंग, िनमा’ण भवन, नई 7दKली - 110011 को अ(cid:12)ेिषत 7कया जाए अथवा drugsdiv-mohfw@gov.in पर ई-मेल 7कया
जाए।
(cid:19)(cid:19)(cid:19)(cid:19)ाााा(cid:20)(cid:20)(cid:20)(cid:20)पपपप ििििननननययययमममम
1. (1) इन िनयम(cid:28) को औषिध एवं (cid:7)साधन साम(cid:12)ी (…… संशोधन) िनयम, 2018 कहा जाएगा।
(2) ये सरकारी राजप? म! इसके अंितम (cid:7)काशन क# ितिथ से लागू ह(cid:28)गे।
4395 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. औषिध एवं (cid:7)साधन साम(cid:12)ी िनयम, 1945 म! (बाद म! िनयम(cid:28) के (cid:31)प म! संदQभ’त 7कया जाएगा), के िनयम 150 ख के
उप िनयम (i) म! ‘औषिध अथवा (cid:7)साधन के िलए’ श@ द(cid:28) को (cid:7)(cid:31)प 36 म! बनाया जाएगा; ‘औषिध एवं (cid:7)साधन साम(cid:12)ी अथवा
Sय ि0गत या संगठन या अिध(cid:7)ािE एज!सी क# िबU# के िलए श@ द(cid:28) को (cid:7)(cid:31)प 36 म! 7कया जाएगा’ उV ह !(cid:7)ित H थािपत 7कया जाएगा।
3. इन िनयम(cid:28) म! िनयम 150 ड़ म! खंड (च) के िलए िनX निलिखत खंड को (cid:7)ितH थािपत 7कया जाएगा यथा,-
“(च) अनुमो7दत संHथान (cid:7)(cid:31)प 39 म! िनमा’ता से (cid:7)ाE नमून(cid:28) पर परीYण या िवZेषण के पJरणाम(cid:28) और (cid:7)(cid:31)प 39 क म!
7कसी 6ि0 या संगठन या खरीद एज!सी से Jरपोट ’(cid:7)Hतुत कर!गे।”
4. इन िनयम(cid:28) क# अनुसूची क म! (cid:7)(cid:31)प 39 के बाद िनX न (cid:7)(cid:31)प को जोड़ा जाएगा,-
(cid:19)(cid:19)(cid:19)(cid:19)(cid:20)(cid:20)(cid:20)(cid:20)पपपप 33339999 कककक
[[[[((((ििििननननययययमममम 111155550000 ड़ड़ड़ड़((((चचचच)))) ददददखखेेखखेे ]](cid:31)(cid:31)]](cid:31)(cid:31)
अनुमो(cid:6)दत सं(cid:12) थान (cid:15)ारा जांच अथवा िव(cid:21) लेषण क(cid:27) (cid:28)रपोट (cid:31)
(1) Sय ि0 / संगठन / एज!सी का नाम िजसे (cid:7)ा> त 2आ ह ै---------------------------------------------------------
(2) भेजने वाले \ापन क# Uम सं] या और ितिथ ----------------------------------------------------------------
(3) नमून(cid:28) क# सं]य ा ---------------------------------------------------------------------------------------------
(4) नमूने क# (cid:7)ािE क# ितिथ ------------------------------------------------------------------------------------
(5) औषिध / (cid:7)साधन साम(cid:12)ी / क^ ची साम(cid:12)ी का नाम िजसको नमूने म! िनिध होने का दावा 7कया गया ह ै-----------
--------------------------------------------------------
(6) क_ा साम(cid:12)ी / अंितम उa पाद थोक म! / अंितम उa पाद (7फिनcड पैक म!) का @ यौरा जैसा (cid:7)ेषक -ारा (cid:7)ा> त 7कया
गया ह:ै
(क) लेबल पर उिKलिखत िविनमा’णकता’ का नाम और पता तथा अनु\िE सं] या
(ख) क^ ची सामि(cid:12)य(cid:28) और Jरपै< ड औषिधय(cid:28) के मामले म! मूल िनमा’ता का नाम
(ग) बैच सं]य ा
(घ) िविनमा’ण क# ितिथ, य7द कोई है
(ङ) समािE क# ितिथ, य7द कोई ह ै
(7) परीYण अथवा लागू 7कए गए िवc लेषण के साथ परीYण या िवc लेषण के पJरणाम
अधोहHत ाYरी क# राय म! उपरो< त m¼`r नमूना अिधिनयम और तa संबंधी िनयम(cid:28) म! दी गई पJरभाषा के अनुसार नीचे 7दए
गए कारण(cid:28) के चलते मानक गुणवaत ा के ह= / मानक गुणवa ता के नहe ह =।
7दनांक :
परीYण के (cid:7)भारी के हH ताYर
(cid:11)(cid:11)(cid:11)(cid:11)टटटट!!!!पपपपणणणण:::: अंितम उaप ाद म! Jरपै<ड साम(cid:12)ी सिXमिलत है।
*जो लागू न हो उसे काट द! ।”
[एफ. सं. ए< स.11014/14/2018-डीआर]
सुधीर कुमार, संयु< त सिचव
(cid:11)(cid:11)(cid:11)(cid:11)टटटट!!!!पपपपणणणण:::: मु]य िनयम(cid:28) को 7दनांक 21 7दसXब र, 1945 क# अिधसूचना सं. एफ. 28-10/45-एच (1) के तहत सरकारी राजप? म!
(cid:7)कािशत 7कया गया और अंितम बार अिधसूचना सं. सा.का.िन. ………(अ), तारीख.............. के तहत संशोिधत 7कया गया।¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 30th July, 2018
G.S.R. 720(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), in 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 emailed at
drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (1) These rules may be called the Drugs and Cosmetics (……Amendment) Rules, 2018.
(2) It shall come into force on the date of its final publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945 (hereinafter to be referred as said rules), in rule 150B, in sub-
rule (1) for the words “for sale of drugs or cosmetics, shall be made in Form 36” the words “for sale of
drugs and cosmetics or an individual or organization or procurement agency shall be made in Form 36”
shall be substituted.
3. In the said rules, in rule 150E, for clause (f) the following clause shall be substituted namely,-
“(f) The approved institution shall furnish reports of the results of test or analysis on the samples
received from manufacturer in Form 39 and from an individual or organization or procurement agency
in Form 39A.”
4. In the said rules, in Schedule A, after the Form 39, the following Form shall be inserted namely,-
“Form 39A
[See rule 150E(f)]
Report of test or analysis by approved institution
(1) Name of individual/ organization/ agency from whom received………………………………...
(2) Serial number and date of sender’s memorandum………………………………………………..
(3) Number of samples…………………………………………………………………………………
(4) Date of receipt of the sample………………………………………………………………………
(5) Name of drug / cosmetics / raw material purporting to be contained in the sample…………….
(6) Details of raw material/ final product in bulk/ final product (in finished pack)* as obtained by sender:
a) Name and address of the Manufacturer and Licence number mentioned on the label
b) Name of original Manufacturer in the case of raw materials and repacked drugs
c) Batch number
d) Date of manufacture, if any
e) Date of expiry, if any
(7) Results of test or analysis with protocols of test or analysis applied.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
In the opinion of the undersigned, the sample referred to above is *of standard quality/is not of standard quality
as defined in the Act and the rules made thereunder for the reasons given below.
Date...........................
Signature of Person-in-charge of testing
Note : Final product includes repacked material.
*Delete whichever is not applicable.”
[F.No. X.11014/14/2018-DR]
SUDHIR KUMAR, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification No. 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.