Executive Summary:
This notification announces amendments to the Drugs and Cosmetics Rules, 1945, as per the Drugs and Cosmetics Act, 1940. It was published on January 31, 2017, following a draft publication on March 16, 2016, and consideration of public feedback. The amendments primarily concern exemptions and conditions for specific drug categories under Schedule K. These rules will be effective from the date of their final publication in the Official Gazette.
Key Points / Main Content:
Amendments to the Drugs and Cosmetics Rules, 1945:
* The Drugs and Cosmetics 3rd Amendment Rules, 2017 are established.
* The rules come into force on the date of their final publication in the Official Gazette.
Schedule K Amendments:
* Serial numbers 35 and 35 in Schedule K are substituted with new entries.
* Homeopathic hair oils with active ingredients up to 3X potency are exempt from Chapter IV of the Act and its rules, requiring regulation with a sale license, provided they are manufactured under a valid license and sold in original sealed packing.
* Custom-made devices are exempt from Chapter IV of the Act and its rules, provided they are made per a qualified medical practitioner's written prescription, follow specific design characteristics for a particular patient, and are labeled as "custom made device". Mass-produced devices requiring adoption are not considered custom-made.
* Zinc sulfate tablets and oral solutions (10mg and 20mg of elemental zinc) are exempt from sale license requirements under Chapter IV of the Act and its rules, if manufactured under a valid drug manufacturing license.
Impact Analysis:
Manufacturers of Homeopathic Hair Oils:
* Impact: Modified conditions for exemption from certain regulations.
* Action Required: Ensure products meet the specified potency and manufacturing license requirements, and are sold in original sealed packaging to qualify for the exemption.
Manufacturers of Custom-Made Devices:
* Impact: Exemption from certain regulations under specific conditions.
* Action Required: Comply with requirements regarding prescriptions, specific design, labeling, and intended use for a particular patient to qualify for exemption.
Manufacturers of Zinc Sulfate Tablets and Oral Solutions:
* Impact: Exemption from sale license requirements under certain conditions.
* Action Required: Ensure products are manufactured under a valid drug manufacturing license to qualify for the sale license exemption.
Regulatory Bodies:
* Impact: Enforcement and monitoring of compliance with the amended rules.
* Action Required: Update guidelines and procedures to reflect the new amendments and ensure proper implementation.
Medical Practitioners:
* Impact: Need to provide written prescriptions with specific design for custom-made devices, to ensure the custom-made devices meet the regulatory requirements.
* Action Required: Awareness of updated rules and regulations.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: An Indian law regulating the import, manufacture, distribution, and sale of drugs and cosmetics.
Drugs and Cosmetics Rules, 1945: Rules framed under the Drugs and Cosmetics Act, 1940, providing detailed regulations for drugs and cosmetics.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
Central Government: The executive branch of the Government of India.
Gazette of India: An official journal of the Government of India, publishing official notifications and rules.
Drugs Technical Advisory Board: A statutory body advising the Central Government on technical matters related to drugs and cosmetics.
Schedule K: A schedule within the Drugs and Cosmetics Rules, 1945 that lists the drugs that are exempted from certain provisions of the Act and Rules.
New Delhi: The capital of India, where the notification was issued.
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- 68] ubZ fnYyh] eaxyokj] tuojh 31] 2017@ek?k 11] 1938
No. 68] NEW DELHI, TUESDAY, JANUARY 31, 2017/MAGHA 11, 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, 31 जनवरी, 2017
सा.का.िन. 76
(अ).—vkS
षिध 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
vkS
षिध 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 16 माच(cid:6981), 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) अिधसूचना सं. सा.का.िन. 312(अ), तारीख 16 माच(cid:6981), 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) स,े िजनके उनसे (cid:7079)भािवत होने क(cid:7409) संभावना ह,ै उस तारीख से, िजसको उ(cid:7334) अिधसूचना वाले 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
थे;
और उ(cid:7334) राजप(cid:7074) क(cid:7409) (cid:7079)ित;ka जनता को तारीख 16 माच(cid:6981), 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 संबंध 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,
vkS
षिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) क(cid:7409) धारा 12 और धारा 33 के
अधीन शि(cid:7334)य(cid:7298) का (cid:7079)योग करते (cid:7263)ए,
vkS
षिध तकनीक(cid:7409) सलाहकार बोड(cid:6981) से परामश(cid:6981) करने के प(cid:7391)ात्,
vkS
षिध 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)त:्-
1. (1) इन िनयम(cid:7298) का संि(cid:6979)(cid:7385) नाम
vkS
षिध और (cid:7079)साधन साम(cid:7061)ी (तीसरा संशोधन) िनयम, 2017 ह ै।
(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.
vkS
षिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 क(cid:7409) अनुसूची ट म(cid:7286) (cid:7059)म सं(cid:6990)यांक 35 और 35 और उससे संबंिधत (cid:7079)िवि(cid:7397)य(cid:7298) के
(cid:7021)थान पर िन(cid:7388)िलिखत (cid:7059)म सं(cid:6990)यांक और (cid:7079)िवि(cid:7397)यां रखी जाएंगी, अथा(cid:6981)त्:-
502 GI/2017 (1)(cid:32)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
vkS
षिधय(cid:7298) का वग(cid:6981) छूट का िव(cid:7021)तार और शत(cid:7288)
“35. हो(cid:7013)योपैिथक केश तेल, िजसम(cid:7286) केवल 3X (cid:7079)बलता अिधिनयम के अ(cid:7007)याय 4 और उसके अधीन बनाए गए िनयम(cid:7298) के उपबंध,
िजनम(cid:7286) उ(cid:7008)ह (cid:7286)इस शत(cid:6981) के अधीन रहते (cid:7263)ए (cid:7408)क ऐसे उ(cid:7004)पाद िविधमा(cid:7008)य िविनमाण(cid:6981)
तक के स(cid:7408)(cid:7059)य संघटक ह (cid:7289)।
अनु(cid:6980)ि(cid:7385) के अधीन िविन(cid:7414)मत (cid:7408)कए गए ह(cid:7298) और अनु(cid:6980)(cid:7385) िविनमा(cid:6981)ता(cid:7312) क(cid:7409) मूल
सीलबंद पै(cid:7412)कग म(cid:7286) िव(cid:7059)य (cid:7408)कए गए ह(cid:7298), िव(cid:7059)य अनु(cid:6980)ि(cid:7385) के साथ िविनयिमत
(cid:7408)कया जाना अपेि(cid:6979)त ह ै।
36. िनदश(cid:7287) अनु(cid:7272)प िन(cid:7414)मत युि(cid:7334)यां अिधिनयम के अ(cid:7007)याय 4 और उसके अधीन बनाए गए िनयम(cid:7298) के सभी
उपबंध, इस शत(cid:6981) के अधीन रहते (cid:7263)ए (cid:7408)क युि(cid:7334) स(cid:7013)यक् (cid:7272)प से अ(cid:7414)हत िच(cid:7408)क(cid:7004)सा
(cid:7390)वसायी के नु(cid:7021)खे के अनुसार, उसके उ(cid:7275)रदािय(cid:7004)व के अधीन, िविन(cid:7416)द(cid:7397)
िडजाइन, िवशेषता(cid:7312) के अनुसार िविन(cid:7416)द(cid:7397) (cid:7272)प से बनाई गई हो और वह
(cid:7408)कसी िविश(cid:7397) रोगी के एकमा(cid:7074) (cid:7079)योग के िलए आशियत हो तथा उसके लेबल
पर ‘िनदश(cid:7287) अनु(cid:7272)प िन(cid:7414)मत युि(cid:7334)’ श(cid:7011)द िलखे (cid:7263)ए ह(cid:7298) ।
(cid:7021)प(cid:7397)ीकरण – ब(cid:7263)मा(cid:7074)ा म(cid:7286) तैयार युि(cid:7334)य(cid:7298) को, िजनको (cid:7408)कसी िच(cid:7408)क(cid:7004)सा
(cid:7390)वसायी या (cid:7408)कसी अ(cid:7008)य (cid:7390)ावसाियक उपयोगकता(cid:6981) क(cid:7409) िविन(cid:7416)द(cid:7397) अपे(cid:6979)ा को
पूरा करने के िलए अपनाए जाने क(cid:7409) आव(cid:7019)यकता ह,ै िनदश(cid:7287) अनु(cid:7272)प िन(cid:7414)मत
युि(cid:7334)यां नह(cid:7277) माना जाएगा ।
37. (cid:7410)जक स(cid:7016)फेट टेबले(cid:6999)स और ओरल घोल, िजनम(cid:7286) 10 अिधिनयम के अ(cid:7007)याय 4 और उसके अधीन बनाए गए िनयम(cid:7298) के उपबंध,
िम.(cid:7061)ा. और 20 िम.(cid:7061)ा. का एिलमे(cid:7008)टल (cid:7410)जक ह ै। िजनम(cid:7286) उ(cid:7008)ह (cid:7286) इस शत(cid:6981) के अधीन रहते (cid:7263)ए (cid:7408)क ऐसे उ(cid:7004)पाद िविधमा(cid:7008)य ओषिध
िविनमाण(cid:6981) अनु(cid:6980)ि(cid:7385) के अधीन िविन(cid:7414)मत (cid:7408)कए गए ह,(cid:7289) (cid:7408)कसी िव(cid:7059)य अनु(cid:6980)ि(cid:7385)
(cid:7367)ारा िविनयिमत (cid:7408)कया जाना अपेि(cid:6979)त ह ै।”।
[फा. सं.ए(cid:6989)स.11014/5/2012-डी.एफ.(cid:6989)यू.सी.]
कु(cid:7008)दन लाल शमा(cid:6981), संयु(cid:7334) सिचव
(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 अिधसचू ना सं. सा. का. िन. 56(अ), तारीख 19 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 31st January, 2017
—
G.S.R. 76 (E). Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, was
published, as required by section 12 read with 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. 312 (E), dated the 16th March, 2016, published in the Gazette of India, Extraordinary, Part II,
Section 3, Sub-section (i), dated the 16th March, 2016, 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;
And whereas copies of the Gazette were made available to the public on 16th March, 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 under section 12 read with 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 (3rd Amendment) Rules, 2017.
(2) They shall come into force on the date of their final publication in the Official Gazette.¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
2.(cid:32) In the Drugs and Cosmetics Rules, 1945, in Schedule K, for serial numbers 35 and 35 and the entries relating
there to, the following serial numbers and entries shall be substituted, namely:-
Class of Drugs Extent and Conditions of Exemption
“35. Homeopathic hair oils having active The provisions of Chapter IV of the Act and the rules made thereunder
ingredients up to 3X potency only. which require them to be regulated with a sale license subject to the
condition that such products have been manufactured under a valid
manufacturing license and sold in the original sealed packing of the
licensed manufacturers.
36. Custom made devices. All provisions of Chapter IV of the Act and the rules made thereunder,
subject to the condition that the device being specifically made in
accordance with a duly qualified medical practitioner’s written
prescription under his responsibility, in accordance with specific
design, characteristics and the same is intended for the sole use of a
particular patient and the label contain the words ‘custom made device’.
Explanation.- Mass produced devices, which only need adoption to
meet the specific requirement of a medical practitioner or any other
professional user, shall not be considered as custom made device.
37. Zinc sulphate tablets and oral solutions The provisions of Chapter IV of the Act and rules thereunder which
having 10 mg and 20 mg of elemental zinc. require them to be covered by a sale licence, subject to the condition
that such a product has been manufactured under a valid drug
manufacturing licence.”.
[F. No. X 11014/5/2012-DFQC]
K. L. SHARMA, Jt. Secy.
Note.- The principal rules were published in the Gazette of India vide notification No. F.28-10/45-H (1), dated the
21st December, 1945 and last amended vide notification number G.S.R. 56(E), dated the 19th 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.