20 Mapping of ICEGATE with CDSCO-Notified Ports 2025-Oct-07 2401 KB

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Directorate General of Health Services Central Drugs Standard Control Organization

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imp-12018(19)/13/2025-eoffice Government of India

ee The Additional Director, Olo Additional Director General, National Customs Targeting Centre (Cargo), 13, Sir Vithaldas Thackersey Marg, Opp Patkar Hall, New Marine Lines, Mumbai- 400020.

FDA Bhawan, Kotla Road New Delhi-110002 Date: 0 7 OCT 2025

Subject: Mapping of ICEGATE with CDSCO-Notified Ports - Reg.

Sir,

This is to inform you that, Rule 43-A of the Drugs Rules, 1945 is a regulatory provision that specifies the entry points (notified ports) through which drugs can be legally imported into India. In accordance with this Rule, no drug shall be imported into the country except through the designated ports. A copy of Rule 43-A is enclosed herewith as Annexure-A for ready reference.

Further, the said notified ports of entry have been mapped with CDSCO Port Offices on ICEGATE of customs. Hence, it is requested to refer the Bills of Entry (BOE) on ICEGATE to the concerned port offices of CDSCO.

Please find annexed the list of CDSCO port offices and ports of entry( Annexure-B).

in view of the above it is requested to permit the entry of consignments of Drugs, Medical Devices and Cosmetics only through the notified ports of entry cited above.

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----- Start of picture text -----<br> urs faithfully,<br>(Dr. eey Singh Raghuvanshi)<br>rugs Controller General (India)<br>----- End of picture text -----<br>

Enclosures: As stated above

Copy to:

1. Joint Secretary( Customs), CBIC, Room No. 156-B, North Block, New Delhi 2. The Director General DGARM, 10th Floor, Tower-2, Jeevan Bharti Building, Connaught Place, New Delhi-110001

2. All CDSCO Zonal Offices and Port offices 4. All stakeholders through website.

sc 5 5 i aner A> [Rule 434 — The[Drugs] Rules, 1945 pee Sheva, Kandla, Inland Container : } Cochin, Nhava; 3Tuticorin and Kamrajar Port] WtChe Mumbai, C08’: | Delhi, 4{ Krishnapatnam utin sagenKolkata,slakabad and pian anj inGoa, —‘cakhapatnamAP Hazira “L, port and Inland Tamil Nadu, Mares a Andhra Prades? Mundra Bort] in gaa andContainer Gangavaram poeee [Gandhinag®’, — Tihi], Indore in Madhya 4 oad ho sr Depot at Dhanna ‘and [Inland Contain ae Pradesh]: ; sea into Inala, Goa, §[Bengaluru, in respect of drugs imported IY. Ahmedabad,_ Chennai,Visakhapatnam, Kolkata, Mumbal,oTananthapuram]: in Cochin rted by air into India.] _ through India ‘to: foreign 43B. respect of drugs impo ¢ which are in transit | pak +s acacia leon countriesvamgier[and] Drugs,[which] es consi[shall] noentsthe sold or0 distri‘ctributed in IndiaticsSs Act, 1940 (23R of19.1940) the III of the Drugs and Cosme ’ eerequirements ofa ee M de thereunder: tries to which the drugs are Provided t of the coun importer shall consigned that if the ae grant of import ——. the importe at oe tine imporregulate theirintoimporIndia, produce such importimpo licences. PART V [GOVERNMENT ECTORS, LICENSING AUTHORITIES ANDANALYSTS,STNG AUTHORITIES] (44. Qualifications of oo .aAoon appointed as a Government0). Analyst ee= Act ore ae ay orPI ceutical Chemistry ee ‘tablished i ia by the law or has an equivalent Cicin cvaet and noted by the Central Government for such Siete! at te had not less than five years’ post-graduate yp bare in the testing of drugs in a laboratory under the control of (i) a Government Analyst pletion under the Act, or (ii) the head of an Institution oFfee completedlaboratory approvedtwo years’fortraining the purposeon testing by theofmeidrugs, including authorityitems[orsta = in Schedule C, in Central Drugs Laboratory], or (b) ayyby sessesPhatinackotion’a post-graduate‘ Chemistrydegreeof in;a [UniversityMedicine= or Scienceestablished: or seinPharmacIndiaacy by the law or has an equivalent qualification recognised and notified the Central Government for such purpose] or possesses the . * 1 Subs. by G.S.R. 532(E), dated 18th may, 2016, for “Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva, Kandla, port in Goa: in respect of drugs imported by sea into India. Chennai, Kolkata, Mumbai, Delhi, Ahmedabad, Hyderabad, Goa and Bengaluru: in respect of drugs imported by air into India” (w.e.f. 18-5-2016). Earlier SOUTthese wordsante teakwere substituted by by GSR. 575(E), dated 17th July, 2012 (w.e.f. 17-7-2012), GS.R., 101(E), Sub. fly, 2003(ose eth GSR. 45(8), dated Zier January, 2010 (wef, 21-1-2010), GSR. 2. byCSR AIEY, dated 1h Jerre setd GSR. G47(E), dated 28th Chobe Wee (oak 18) Subs. by GSR. 41(E), dated 17th January, 2017, for “Chennai, Kolkata Mumbai, Cochin, Nhava Sheva, a j ee con and eae fuslakabad and Patparganjam in Delhi ’ Turicorin in Tamil Nadu. oe mais ) ry a — in Andhra Pradesh: in respect of drugs imported by sea inte 4 Subs. by GSR. 20(b), datec ‘January, 2019,for “Tutinci 5 Subs by CSK 410(F), dated 2nd June, 2023, for "ote Keuken — 2-6-2023) 6 Subs by GSK 20(F), dated 10th January, 2019, for “Gandhina ar” = . Liga feats : | Ins. by GSK. 65%), dated Ith September, 2019 (wef 139.2019) (Wet, 10-1-2019). aT 7. Subs by GSR. #44(h), dated iy ges 2021, for “Inland Containe De = 9-12-2021) p= 8 Subs by GSR 29Kb), dated 2th May, 2094 for “Bengaluru ana er Depot Dhannad” (w.e.t. 9- “or ik 9 Added by 5O 1056(F), dated 19th March, 1964 (wef 28-3-4 - Visakhapatnam” (w.e.f. 28-5-2024). ae 10. Subs. by GSR 443(8) dated 12th April, i9gg (wef weer == 11 Subs. by GSR. 1427, dated 10th October, 1977 (wef Sila = 12. Subs. by GSR. 71(E), dated 3th January, 1987 (Wek Mise, | 13. Ins by GSR. 697(E), dated 26th October, 1995 (wef 26-10-1999)

Awnwer. 73 ae - \ \

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Rule 43A] The Drugs Rules, 1945 subject to the approval of the Central Government reports to = Seas Collector that the samples of any drug in a consignment are not o uals - quality, or that the drug contravenes in any other respect the provis wanes Chaptersuch thatIIIit ofcannotthe Actbe remediedor the rulesby thethereunderimporter,andthethat Customsthe contraventioCollector see hall communicate the report forthwith to the importer who shall, within a Si sae of his receiving the communication either export all the drugs of that pig ote in the consignment, to the country in which they were manufactured or io them to the Central Government which shall cause them to be destroyed:] 5 Provided that the importer may within fifteen days of receipt of the ee make a representation against the report to the Customs Collector, an “8 Customs Collector shall forward the representation with a further sampleto the licensing authority, who after obtaining, if necessary, the report of the peor of the Central Drugs Laboratory, shall pass orders thereon which shall be final. 1{(2) If the Director of the laboratory appointed for the purpose oy oe Central Government or any other officer empowered by him on this behalf, subject to the approval of the Central Government reports to the Customs Collector that the samples of any drug contravene in any respect the provisions of Chapter III of the Act or the rules thereunder and that the contravention is such that it can be remedied by the importer, the Customs Collector aa communicate the report forthwith to the importer and permit him to import the drug on his giving an undertaking in writing not to dispose of the drug without the permission of the office authorised in this behalf by the Central Government. ] ms faa | 43. The drugs specified in Schedule D shall be exempt from the provisions of Chapter III of the Act and of the Rules made thereunder to the extent, and subject to the conditions specified in that Schedule. 3[43A. No drug shall be imported into India except through one of the following places, namely:—

_ :

Firozepur Cantonment and Amritsar Railway Stations: In respect of drugs imported by rail across the frontier with Pakistan; Ranaghat, Bongaon and Mohiassan Railway Stations:

In respect of drugs imported by rail across the frontier with Bangladesh; 4{Petrapole Road in West Bengal, Sutarkandi in Assam, old Raghna Bazar and Agartala in Tripura: In respect of drugs imported by road from Bangladesh;] 5[Raxaul: In respect of drugs imported by road and railway lines connecting Raxaul in India and Birganj in Nepal;]

1. Added by Notification No. 7-11-47/D, dated 15th October, 1951. :. Subs._.was mre MeeeeSR:by Notification, da No.atsF77/47-D,ugust,F, eemariadated, for rul dated ng 3rdshi November,.e.f,co1953.——: 4. Ins. by G.S.R. 116(E), dated 24th February, 2009 (w.e.f. 24-2-2009). 5. Ins. by G.S.R. 120(E), dated 5th March, 1998 (w.e.f. 5-3-1998).

Anniexure-B

) CDSCO Seaport, Kolkata Kolkata Air Port (West Bengal), ‘entral Drugs Standard Control Organization, Asst. Drugs Kolkata Sea Port (West Bengal), ontroller (1), Customs House, 15/1, Strand Road, Kolkata—700 Ranaghat (West Bengal), Bongaon (West Bengal), 10 |CDSCOab 3 Airport, Kolkata, Mohiassan(West Bengal) Railway, Sutarkandi Station (Assam),(Assam), OldPetrapoleRaghna Road Central Drugs Standard Control Organization, Asst. Drugs Bazar (Tripura), Agartala ( Tripura) Raxaul( Bihar) Controller (1), Air Cargo Complex, N.S.C. Bose International 1 _| CDSCO,Airport, Kolkata-700Port Office, 052Hyderabad Hyderabad Air Port ( Telangana) Office of the ADC (I), CDSCO, Unit No. 16,17& 18 Second Floor, Cargo Satellite Building, RGI Air Port, SHAMSHABAD, RR Dist., Hyderabad — 500409. \2 |Bangalore Airport Bangalore Airport (Karnataka) )ffice of theADC (I), CDSCO, Air India SATS Airfreight lerminal Plot No. C-05 Ist Floor Bengaluru International Airport Devanahalli Bangalore-560300 : 1% Office|CDSCO ofSeathe ADCPort, (I),Mumbai CDSCO, Central Drugs Standard Mumbai Sea Port, Nhava Sheva Port (Maharashtra) Control Organization, M/s JWR Logistic Pvt Itd 15-45, National Highway 4B, Panvel-JNPT Highway, Village _|Padeghar, post-Vahal, Panvel-410206 |& |CDSCO Airport, Mumbai Mumbai Air Port (Maharashtra) Office of Asst. Drugs Controller (1), Central Drug Standard Control Organization, airport, Room No. 10, Ist Floor, International Air Cargo Complex, Sahar Village, Andheri East, __|Mumbai-400099. es} DSCO, Sea Port, Kochi ochin Air Port (Kerala) Yffice of the ADC (1), CDSCO, Office of the Technical hiruvananthapuram Air Port (Kerala) Officer& Room no.15, Custom House, Willingdon Island, Kochi 682009. 16[Port Office (Indore) Indore (Madhya Pradesh) Office of the ADC (1), C/o. Container Corporation of India Ltd.,||CD at Dhannad and Tihi (Madhya Pradesh) Inland Container Depot, 113, Concor Complex,Sector-3, i Pithampur Industrial Area, Pithampur, Dist. Dhar, Madhya Uh. Pradesh

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Annexure-B

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List of CDSCO Port Offices and addresses Notified Ports as per Rule 43-A (copy annexed) nearest to the CDSCO Port Offices Mapped with ICGATE for import of Drugs, Medical Devices and Cosmetics. *DSCO Seaport, Chennai ffice of the ADC(I), CDSCO, Seaport, Room No. 12, 13, 22 & 23, IV Floor, Annex Building, Rajaji Salai, Custom House,|Chennai Sea Port, Chennai Air Port (Tamil Nadu) hennai — 600 00 Tuticorin and Kamrajar Port (Tamil Nadu) 2 |eDSCO Airport, Chennai Krishnapatnam Port (Andhra Pradesh) Office of the ADC (I), CDSCO, Air Port Office, Air Cargo Complex, Meenambakkam, Chennai-600027 3. |GOA Port Goa Airport Office of the ADC (1), CDSCO, Room No 07 & 08 First Floor, Marmugao Port ( Goa) Air Cargo Terminal Building Manohar International Airport, Dadachiwadi Road Nagzar Taluka Pernem, Mopa, North Goa, Goa-403512 4 |CDSCO Port Office, Visakhapatnam Visakhapatnam Sea Port (Andhra Pradesh) CDSCO Port Office (Air & Sea), Ministry of Health & Family | Visakhapatnam Airport (Andhra Pradesh) Welfare, Directorate General of Health Services, Sth Floor, Gangavaram Port (Andhra Pradesh) Karmika Jyothi Building, Visakhapatnam Port Authority, Visakhapatnam-530001, A.P, 5 Port Office, Delhi Air Port, Delhi Office of ADC(I) CDSCO Room No. 4 A, Import Building III, |Firozepur Cantonment and Amritsar Railway Cargo Terminal, IGI Airport New Delhi stations (Punjab 6 |ICD Tughlakabad & Patparganj ICD Tughlakabad & Patparganj, New Delhi Office of ADC(I), Room No. 230/2, CONCOR Administrative Building, ICD Tughlakabad, New Delhi-1 10020 7 |Ahmedabad Airport Ahmedabad Airport (Gujarat) Office of the ADC (I), CDSCO, Old Terminal Building, Air |Kandla (Gujarat) Cargo Complex, Airport, Ahmedabad-380 003 Gujarat ICD Khohdiyar (Gandhinagar and Mundra Port): Gujarat 8 _|Hazira Seaport Hazira Port (Gujarat) Office of the Technical Officer, Port Office, M/s Adani Hazira Port Pvt. Ltd at PO Hazira, Surat-394270

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