**Executive Summary:**
This notification announces amendments to the Drugs and Cosmetics Rules, 1945, specifically regarding import locations for drugs. The amendments are made under the authority of the Drugs and Cosmetics Act, 1940, following consideration of public feedback. These rules, called the Drugs and Cosmetics First Amendment Rules, 2017, come into force on the date of their final publication in the Official Gazette.
**Key Points / Main Content:**
* **Amendment Authority:**
* The amendments are made under section 12 read with section 33 of the Drugs and Cosmetics Act, 1940.
* **Rule Title and Effective Date:**
* The rules are called the Drugs and Cosmetics First Amendment Rules, 2017.
* They shall come into force on the date of their final publication in the Official Gazette.
* **Amendment to Rule 43A:**
* Rule 43A of the Drugs and Cosmetics Rules, 1945 is amended.
* The list of ports and container depots for drug imports by sea is updated.
* **Updated List of Import Locations:**
* The following locations are added/substituted: Krishnapatnam port in Andhra Pradesh and Hazira port and Inland Container Depot Khohdiyar, Gandhinagar in Gujarat
**Impact Analysis**
**Stakeholder: Drug Importers**
* *Impact:* Drug importers are affected by the changes to the allowed import locations, which may impact logistics and supply chains.
* *Action Required:* Importers need to be aware of the updated list of approved locations to ensure compliance with import regulations and adjust their import operations accordingly.
**Stakeholder: Regulatory Authorities**
* *Impact:* Regulatory authorities such as customs and drug control agencies need to enforce the updated regulations regarding drug import locations.
* *Action Required:* Update their procedures and documentation to reflect the changes in Rule 43A and ensure staff are informed of the new import locations.
**Stakeholder: Ports and Inland Container Depots**
* *Impact:* The included ports and depots may experience changes in volume/activity.
* *Action Required:* Ensure appropriate facilities/infrastructure are in place to handle any changes in volume/activity.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules governing drugs and cosmetics, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: The principal act that provides the legal framework for the regulation of drugs and cosmetics.
Drugs and Cosmetics First Amendment Rules, 2017: The name given to the set of amendments to the Drugs and Cosmetics Rules, 1945, introduced by this notification.
Ministry of Health and Family Welfare: The government ministry responsible for health and family welfare policies and regulations.
New Delhi: The location where the notification was issued.
Drugs Technical Advisory Board: A board consulted by the Central Government when amending the Drugs and Cosmetics Rules, 1945.
Chennai, Tamil Nadu: A port city in Tamil Nadu, mentioned in the context of importing drugs by sea into India.
Krishnapatnam port, Andhra Pradesh: A port in Andhra Pradesh, added to the list of ports for importing drugs by sea into India.
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- 36] ubZ fnYyh] मंगलokj] tuojh 17] 2017@ ikS"k 27] 1938
No. 36] NEW DELHI, TUESDAY, JANUARY 17, 2017/PAUSA 27, 1938
(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 पपपप(cid:7)(cid:7)(cid:7)(cid:7)ररररववववााााररररकककक(cid:10)(cid:10)(cid:10)(cid:10)ययययााााणणणण मममम(cid:14)(cid:14)ंं(cid:14)(cid:14)ंं ााााललललयययय
औऔऔऔरररर
(((((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:7)(cid:7)(cid:7)(cid:7)ररररववववाााारररर कककक(cid:10)(cid:10)(cid:10)(cid:10)ययययााााणणणण ििििववववभभभभाााागगगग))))
अअअअििििधधधधससससचचूूचचूू ननननाााा
नई (cid:4)द(cid:6)ल ी, 17 जनवरी, 2017
ससससाााा....ककककाााा....ििििनननन.... 44441111((((अअअअ))))....————औषिध और (cid:7)साधन साम(cid:12)ी िनयम, 1945 का और संशोधन करन े के िलए कितपय
िनयम(cid:29) का (cid:7)ा(cid:30)प औषिध और (cid:7)साधन साम(cid:12)ी अिधिनयम, 1940 (1940 का 23) क% धारा 12 और धारा 33 क%
II
अपे&ाऩुसार भारत के राजप+, असाधारण, भाग , खंड 3, उपखंड (i), तारीख 8 नव1बर,2016 म4 (cid:7)कािशत
भारत सरकार के 5वा56य और प7रवार क8याण मं+ालय (5वा56य और प7रवार क8याण िवभाग) क% अिधसूचना
सं. सा.का.िन. 1050(अ), तारीख 8 नव1बर, 2016 <ारा (cid:7)कािशत =कया गया था िजसके <ारा उन सभी @िAय(cid:29)
से, िजनके उनसे (cid:7)भािवत होने क% संभावना ह,ै उस तारीख से, िजसको उA अिधसूचना वाले भारत के राजप+ क%
(cid:7)ितयां जनता को उपलDध करा दी गई थG, पHतालीस =दन क% अविध क% समािI से पूवJ आ&ेप और सुझाव आमंि+त
=कए गए थ;े
;ka
और उA राजप+ क% (cid:7)ित जनता को तारीख 8 नव1बर, 2016 को उपलDध करा दी गई थG ।
और केNOीय सरकार <ारा उA िनयम(cid:29) के संबंध म4 जनता के (cid:7)ाI आ&ेप(cid:29) और सुझाव(cid:29) पर िवचार =कया
गया ह ै ।
अतः, अब, केNOीय सरकार, औषिध और (cid:7)साधन साम(cid:12)ी अिधिनयम, 1940 (1940 का 23) क% धारा 12
और धारा 33 के अधीन शिAय(cid:29) का (cid:7)योग करते Qए, औषिध तकनीक% सलाहकार बोड J से परामशJ करने के पSात्,
औषिध और (cid:7)साधन साम(cid:12)ी िनयम, 1945 का और संशोधन करने के िलए िनUिलिखत िनयम बनाती ह,ै अथाJत:् -
1. (1) इन िनयम(cid:29) का संि&I नाम औषिध और (cid:7)साधन साम(cid:12)ी ( पहला संशोधन) िनयम, 2017 ह ै ।
(2) ये राजप+ म4 उनके अंितम (cid:7)काशन क% तारीख को (cid:7)वृY ह(cid:29)गे ।
2. औषिध और (cid:7)साधन साम(cid:12)ी िनयम, 1945 के िनयम 43क म4 “चेZई, कोलकाता, म1ु बई, कोचीन, Nहावा
शेवा, कांडला, =द8ली म4 तुगलकाबाद और पटपड़गंज, तिमलनाडु म4 तूतीको7रन, गोवा म4 मारमुगाव पYन और
278 GI/2017 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
आN] (cid:7)दशे म4 िवशाखाप^नम के अंतदश_ ीय आधान िडपो: भारत म 4 समुO माग J <ारा आयाितत औषिधय(cid:29) क%
बाबत” शDद(cid:29) के 5थान पर िनUिलिखत शDद रखे जाएगं े, अथाJत्:-
“चेZई, कोलकाता, मु1बई, कोचीन, Nहावा शेवा, कांडला, =द8ली म 4 तुगलकाबाद और पटपड़गंज के अंतदश_ ीय
आधान िडपो, तिमलनाडु म4 तूतीको7रन, गोवा म4 मारमुगाव पYन, आN] (cid:7)दशे म4 िवशाखाप^नम और
कृ`णप^नम तथा गुजरात म4 हज़ीरा पYन और खोिडयार, गांधीनगर अंतदश_ ीय आधान िडपो: भारत म4 समुO
मागJ <ारा आयाितत ओषिधय(cid:29) क% बाबत;”
Mh-,iQ-D;w-lh-
[फा. सं. एcस -11014/1/2015- ]
कुNद न लाल शमाJ, संयुcत सिचव
(cid:7)(cid:7)(cid:7)(cid:7)टटटट(cid:17)(cid:17)(cid:17)(cid:17)पप पप
णणणण::::---- मूल िनयम भारत के राजप+ म4, अिधसूचना संdय ांक एफ. 28-10/45-एच(1), तारीख 21 =दस1ब र,
1945 <ारा (cid:7)कािशत =कए गए थे और उनम 4 अंितम सशं ोधन सा.का.िन. 1041(अ), तारीख 4 नव1ब र
g S
2016 <ारा =कया गया ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfere)
NOTIFICATION
New Delhi, the 17th January, 2017
G.S.R. 41(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. 1050 (E), dated the 08th November, 2016,
published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), dated the 08th November,
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 08th November, 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) These rules may be called the Drugs and Cosmetics (First 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.In the Drugs and Cosmetics Rules, 1945, in rule 43-A, for the words “Chennai, Kolkata, Mumbai,
Cochin, Nhava Sheva, Kandla, Inland Container Depots at Tuglakabad and Patparganj in Delhi,
Tuticorin in Tamil Nadu, Marmugao port in Goa and Visakhapatnam in Andhra Pradesh: in respect of
drugs imported by sea into India.”, the following words shall be substituted, namely:-
“Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva, Kandla, Inland Container Depots at Tuglakabad and
Patparganj in Delhi, Tuticorin in Tamil Nadu, Marmugao port in Goa, Visakhapatnam and Krishnapatnam
port in Andhra Pradesh and Hazira port and Inland Container Depot Khohdiyar, Gandhinagar in Gujarat:
in respect of drugs imported by sea into India;”
[F. No. X.-11014/1/2015-DFQC]
K. L. SHARMA, Jt. Secy.
Foonote.- The 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. 1041(E), dated the 4th
November 2016.
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.