Mapping ICEGATE with CDSCO-Notified Ports for Regulatory Compliance

The Directorate General of Health Services, under the Central Drugs Standard Control Organization (CDSCO), has taken a significant step to streamline and regulate the import of drugs, medical devices, and cosmetics into India. This initiative involves mapping the Indian Customs Electronic Gateway (ICEGATE) with CDSCO-notified ports, ensuring compliance with Rule 43-A of the Drugs Rules, 1945.

Understanding Rule 43-A of the Drugs Rules, 1945 

Rule 43-A is a critical regulatory provision that specifies the entry points (notified ports) through which drugs can be legally imported into India. According to this rule, no drug shall be imported into the country except through designated ports. This ensures that all imports are monitored and meet the required standards for quality and safety.

Mapping ICEGATE with CDSCO Ports 

To enhance regulatory oversight, the CDSCO has mapped its port offices with ICEGATE, the digital interface for customs clearance. This mapping allows customs officials to refer Bills of Entry (BOE) to the respective CDSCO port offices, ensuring that consignments are processed only through the notified ports.

Notified Ports for Drug Imports 

The notified ports under Rule 43-A include seaports, airports, and inland container depots across India.

S.No	CDSCO Port Office	Address	Notified Ports
1	CDSCO Seaport, Kolkata	Customs House, 15/I, Strand Road, Kolkata-700001	Kolkata Air Port, Kolkata Sea Port, Ranaghat, Bongaon, Mohiassan Railway Station
2	CDSCO Airport, Kolkata	Air Cargo Complex, N.S.C. Bose International Airport, Kolkata-700052	Kolkata Air Port (West Bengal)
3	CDSCO Port Office, Hyderabad	Cargo Satellite Building, RGI Air Port, Shamshabad, Hyderabad-500409	Hyderabad Air Port (Telangana)
4	Bangalore Airport	Air India SATS Airfreight Terminal, Bengaluru International Airport	Bangalore Airport (Karnataka)
5	CDSCO Sea Port, Mumbai	Panvel-JNPT Highway, Village Padeghar, Panvel-410206	Mumbai Sea Port, Nhava Sheva Port (Maharashtra)
6	COSCO Airport, Mumbai	International Air Cargo Complex, Sahar Village, Andheri East, Mumbai-400099	Mumbai Air Port (Maharashtra)
7	CDSCO Sea Port, Kochi	Custom House, Willingdon Island, Kochi-682009	Cochin Air Port, Thiruvananthapuram Air Port (Kerala)
8	Port Office (Indore)	Inland Container Depot, Pithampur Industrial Area, Pithampur, Dist. Dhar	Indore ICD at Dhannad and Tihi (Madhya Pradesh)
9	CDSCO Seaport, Chennai	Custom House, Rajaji Salai, Chennai-600001	Chennai Sea Port, Chennai Air Port, Tuticorin, Kamrajar Port (Tamil Nadu)
10	COSCO Airport, Chennai	Air Cargo Complex, Meenambakkam, Chennai-600027	Chennai Air Port (Tamil Nadu)
11	GOA Port Office	Air Cargo Terminal Building, Manohar International Airport, Goa-403512	Goa Airport, Marmugao Port (Goa)
12	CDSCO Port Office, Visakhapatnam	Visakhapatnam Port Authority, Visakhapatnam-530001	Visakhapatnam Sea Port, Visakhapatnam Airport, Gangavaram Port (Andhra Pradesh)
13	Port Office, Delhi	Cargo Terminal, IGI Airport, New Delhi	Delhi Air Port, Firozepur Cantonment, Amritsar Railway Stations (Punjab)
14	Tughlakabad & Patparganj Office	CONCOR Administrative Building, ICD Tughlakabad, New Delhi-110020	ICD Tughlakabad & Patparganj (New Delhi)
15	Ahmedabad Airport	Air Cargo Complex, Ahmedabad-380003	Ahmedabad Airport, Kandla, ICD Khohdiyar, Mundra Port (Gujarat)
16	Hazira Seaport	M/s Adani Hazira Port Pvt. Ltd, PO Hazira, Surat-394270	Hazira Port (Gujarat)

Seaports: Mumbai, Chennai, Visakhapatnam, Marmugao, Kandla, Nhava Sheva, and Hazira.
Airports: Delhi, Mumbai, Kolkata, Hyderabad, Bengaluru, Ahmedabad, and Goa.
Inland Container Depots (ICDs): Tughlakabad, Patparganj, and Pithampur.

Additionally, specific railway stations and road entry points are designated for imports from neighboring countries like Pakistan, Bangladesh, and Nepal.

Ensuring Compliance

The CDSCO has requested customs authorities to permit the entry of consignments of drugs, medical devices, and cosmetics only through these notified ports. This measure aims to prevent unauthorized imports and ensure that all products entering the country meet the required standards.

Role of CDSCO Port Offices

Each CDSCO port office is equipped to handle imports at its respective location. These offices are responsible for inspecting consignments, verifying compliance, and ensuring that imported products adhere to the Drugs and Cosmetics Act, 1940, and its rules.

Impact on Stakeholders

This initiative benefits multiple stakeholders, including importers, customs officials, and regulatory authorities. By centralizing the import process through notified ports, the CDSCO ensures transparency, efficiency, and adherence to quality standards.

Conclusion

The mapping of ICEGATE with CDSCO-notified ports is a significant step toward strengthening India’s regulatory framework for drug imports. It ensures that all consignments entering the country are subject to rigorous checks, safeguarding public health and maintaining the integrity of the pharmaceutical supply chain.

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Source: CDSCO

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