Executive Summary:
This notification from the Ministry of Health and Family Welfare amends the Drugs and Cosmetics Rules, 1945, regarding mercury content in cosmetics. The amendments regulate both the import and manufacturing of cosmetics, specifying permissible mercury levels. These rules, called the Drugs and Cosmetics 2nd Amendment Rules, 2017, take effect on the date of publication in the Official Gazette, January 19, 2017.
Key Points / Main Content:
Import of Cosmetics:
* Rule 135A is substituted to regulate the import of cosmetics containing mercury.
* Cosmetics for eye use shall not exceed 70 parts per million (0.007%) of mercury as a preservative.
* Other finished cosmetic products shall not exceed 1 part per million (1 ppm) of unintentional mercury.
Manufacturing of Cosmetics:
* Rule 145D is substituted to regulate the use of mercury compounds in cosmetics manufactured in the country.
* Cosmetics for eye use shall not exceed 70 parts per million (0.007%) of mercury as a preservative.
* Other finished cosmetic products shall not exceed 1 part per million (1 ppm) of unintentional mercury.
Impact Analysis:
Cosmetic Manufacturers:
* Impact: Must adhere to the new regulations regarding mercury content in cosmetics manufactured within the country.
* Action Required: Adjust manufacturing processes to ensure mercury levels comply with the specified limits (70 ppm for eye cosmetics, 1 ppm for other cosmetics).
Cosmetic Importers:
* Impact: Must ensure that imported cosmetics comply with the new mercury content regulations.
* Action Required: Verify that imported cosmetics meet the specified mercury limits (70 ppm for eye cosmetics, 1 ppm for other cosmetics) before importing them into India.
Regulatory Authorities:
* Impact: Responsible for enforcing the amended Drugs and Cosmetics Rules, 1945.
* Action Required: Implement and enforce the new regulations, including monitoring and testing cosmetics for mercury content to ensure compliance.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules in India related to the regulation of drugs and cosmetics, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India to regulate 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, Government of India.
Drugs Technical Advisory Board: A statutory body in India that advises the Central Government and the State Governments on technical matters arising out of the Drugs and Cosmetics Act.
New Delhi: The capital of India, where the notification was issued.
Drugs and Cosmetics 2nd Amendment Rules, 2017: The title of the amendments to the Drugs and Cosmetics Rules, 1945 introduced in 2017.
K. L. Sharma: Jt. Secy. - Joint Secretary in the Indian government, signatory of the notification.
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EXTRAORDINARY
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PART II—Section 3—Sub-section (i)
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PUBLISHED BY AUTHORITY
la- 49] ubZ fnYyh] c```gLifrokj] tuojh 19] 2017@ ikS"k 29] 1938
No. 49] NEW DELHI, THURSDAY, JANUARY 19, 2017/PAUSA 29, 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)ल ी, 19 जनवरी, 2017
सा.का.िन. 56(अ).—औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और संशोधन 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 12 और धारा 33 क(cid:7409)
अपे(cid:6979)ाऩुसार भारत के राजप(cid:7074), असाधारण, भाग II , खंड 3, उपखंड (i), तारीख 28 अ(cid:6989) तूबर, 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 और प(cid:7407)रवार क(cid:7016)याण िवभाग) क(cid:7409) अिधसचू ना
सं. सा.का.िन. 1017, तारीख 28 अ(cid:6989)त ूबर, 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 होन े क(cid:7409) संभावना ह,ै उस तारीख से, िजसको उ(cid:7334) अिधसूचना वाल े 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 28 अ(cid:6989) तूबर, 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 संबधं 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 12
और धारा 33 (cid:7367)ारा (cid:7079)द(cid:7275) क(cid:7409) गई शि(cid:7334)य(cid:7298) का (cid:7079)योग करते (cid:7263)ए, औषिध तकनीक(cid:7409) सलाहकार बोड(cid:6981) से परामश(cid:6981) करन े
के प(cid:7391)ात,् 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)ी (दसू रा संशोधन) िनयम, 2017 ह ै।
323 GI/2017 (1)(cid:32)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(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 (िजसे इसम(cid:7286) इसके प(cid:7019) चात उ(cid:6989) त िनयम कहा गया ह)ै म(cid:7286) िनयम
135क के (cid:7021)थ ान पर, िन(cid:7013) निलिखत िनयम रखा जाएगा, अथा(cid:6981)त्:-
“135क: पारायु(cid:6989) त (cid:7079)साधन सामि(cid:7061)य(cid:7298) के आयात का िविनयमन- दशे म(cid:7286) आयाितत (cid:7079)साधन सामि(cid:7061)य(cid:7298) म(cid:7286)
िन(cid:7013) निलिखत अनुपात म(cid:7286) पारा अ(cid:7008) त(cid:7414)व(cid:7020) ट होगा, अथा(cid:6981)त्:-
(क) केवल न(cid:7074)े के (cid:6979)े(cid:7074) म(cid:7286) उपयोग के िलए आशियत (cid:7079)साधन सामि(cid:7061)य(cid:7298) म(cid:7286), प(cid:7407)रर(cid:6979)ी के (cid:7272)प म(cid:7286), धातु के (cid:7272)प म (cid:7286)
संगिणत, पारे का (cid:7021) तर पारे के (cid:7079)ित दस लाख के lÙkjos aभाग (0.007 (cid:7079)ितशत) से अिधक नह(cid:7277) होगा;
(ख) अ(cid:7008) य प(cid:7407)रसािधत (cid:7079)साधन उ(cid:7004) पाद(cid:7298) म,(cid:7286) अनाशियत पारा (cid:7079)ित दस लाख के एक भाग (पी पी एम) स े अिधक
नह(cid:7277) होगा’’,
3. उ(cid:6989) त िनयम(cid:7298) म(cid:7286), िनयम 145घ के (cid:7021) थान पर, िन(cid:7013) निलिखत िनयम रखा जाएगा, अथा(cid:6981)त्:-
‘‘145घ: (cid:7079)साधन साम(cid:7061)ी म (cid:7286) पारा यौिगक के उपयोग का िविनयमन- दशे म(cid:7286) िविन(cid:7414)मत (cid:7079)साधन साम(cid:7061)ी म(cid:7286)
िन(cid:7013) निलिखत अनुपात म(cid:7286) पारा अंत(cid:7414)व(cid:7020) ट होगा, अथा(cid:6981)त्:-
(i) केवल न(cid:7074)े के (cid:6979)े(cid:7074) म(cid:7286) उपयोग के िलए आशियत (cid:7079)साधन सामि(cid:7061)य(cid:7298) म(cid:7286), प(cid:7407)रर(cid:6979)ी के (cid:7272)प म,(cid:7286) धातु के (cid:7272)प म (cid:7286)
सगं िणत पारे का (cid:7021)त र पारे के (cid:7079)ित दस लाख के lÙkjos aभाग (0.007 (cid:7079)ितशत) से अिधक नह(cid:7277) होगा,
(ii) अ(cid:7008) य प(cid:7407)रसािधत (cid:7079)साधन उ(cid:7004) पाद(cid:7298) म(cid:7286), अनाशियत पारा (cid:7079)ित दस लाख के एक भाग (पी पी एम) से
अिधक नह(cid:7277) होगा’’।
[फा.सं. ए(cid:6989)स -11035/276/2015-डीएफ(cid:6989) यूसी]
कुंदन लाल शमा(cid:6981), संयु(cid:6989) त सिचव
पाद (cid:7407)ट(cid:7009) पण:- मूल िनयम, भारत के राजप(cid:7074) म,(cid:7286) अिधसूचना सं(cid:6990) यांक 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 बार संशोधन सा.का.िन. 41(अ), तारीख
17 जनवरी, 2017 (cid:7367)ारा (cid:7408)कया गया ह।ै
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 19th January, 2017
G.S.R. 56(E).—(cid:32) Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules,
1945 was published, as required by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of
1940), vide notification of the Government of India in the Ministry of Health and Family Welfare
(Department of Health and Family Welfare), number G.S.R. 1017, dated the 28th October, 2016, in the Gazette
of India, Extraordinary, Part II, Section 3, sub-section (i), dated the 28th October, 2016, for inviting objections
and suggestions from 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;¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
And Whereas copies of the said Official Gazette were made available to the public on 28th
October, 2016;
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 section 12 and 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 (2nd Amendment) Rules, 2017.
(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 (hereinafter referred to as the said rules), for rule 135A, the
following rule shall be substituted, namely,-
“135A. Regulation of import of cosmetics containing mercury. Cosmetics imported into
India shall contain mercury in the following proportion, namely;
(a) in cosmetics intended for use only in the area of eye, the level of mercury not exceeding
seventy parts per million (0.007 per cent.) of mercury, calculated as the metal, as a
preservative;
(b) in other finished cosmetic products, unintentional mercury shall not exceed one part per
million (1 ppm).”.
3.(cid:32) In the said rules, for rule 145D, the following rule shall be substituted, namely,-
“145D: Regulation of use of mercury compounds in cosmetics. Cosmetics manufactured in
the country shall contain mercury in the following proportions, namely,-
(a) in cosmetics intended for use only in the area of eye, the level of mercury not exceeding
seventy parts per million (0.007 per cent.) of mercury, calculated as the metal, as a
preservative;
(b) in other finished cosmetic products, unintentional mercury shall not exceed one part per
million (1 ppm).”.
[F.No. X 11035 / 276 /2015-DFQC]
K. L. SHARMA, Jt. Secy.
Foot-note.- The principal rules were published in the Gazette of India vide notification Number F.28-10/45-
H (1) dated the 21st December, 1945 and lastly amended vide notification number G.S.R. 41(E)
dated the 17th January, 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.