This notice, issued by the Central Drugs Standard Control Organization (CDSCO), Import Registration Division, Government of India, addresses the documentation requirements for importing drugs and cosmetics into India, as regulated under Chapter III of the Drugs and Cosmetics Act, 1940, and its associated rules.
The notice clarifies that importers must comply with the conditions of their import license or No Objection Certificates (NOCs) issued under the Act. At the time of import, importers are required to furnish the label of the respective consignment, Certificate of Analysis (COA) of batch release, and import license/permission, along with the bill of entry and other documents as per the Drugs and Cosmetics Rules, 1945, at the port office. This process is to be utilized with ICEGATE.
Furthermore, in the interest of ease of doing business and to leverage the Risk Management System (RMS) with ICEGATE integration for online clearance, the notice proposes reducing human interface while maintaining the integrity of the drug/cosmetic, its packaging, and seal. To this end, importers are required to furnish a prescribed undertaking with each Integrated Declaration or Bill of Entry, attesting that the packaging is intact, undamaged, and the contents have not deteriorated. The format for this undertaking is provided within the notice, requiring the importer's name, address, Bill of Entry number and date, a declaration regarding the integrity of the consignment, and the name, signature, stamp, and date of the authorized person.
This information is disseminated to all stakeholders via the CDSCO website for necessary action utilizing ICEGATE and integration with RMS. The Drugs Controller General of India, Dr. V.G. Somani, authorized the notice.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: A law regulating the import, manufacture, distribution and sale of drugs and cosmetics in India. Chapter III is specifically mentioned for import regulations.
Drugs and Cosmetics Rules, 1945: Rules formulated under the Drugs and Cosmetics Act, 1940, providing detailed regulations for various aspects of drugs and cosmetics, including import procedures.
Directorate General of Health Services: A government organization under the Ministry of Health and Family Welfare responsible for public health matters in India.
Central Drugs Standard Control Organization: The national regulatory body for pharmaceuticals and medical devices in India.
ICEGATE: Indian Customs Electronic Commerce Gateway, a portal for electronic filing of import/export declarations and other related documents with Indian Customs.
Dr. V.G. Somani: Drugs Controller General of India (DCGI), the head of the Central Drugs Standard Control Organization.
Risk Management System: A system by customs to facilitate trade by using differential treatment based on risk assessment, for faster clearances. Abbreviated as RMS in the text.
New Delhi: Capital of India
File No. Import/Misc./89/2015-DC
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(Import & Registration Division)
FDA Bhawan, Kotla Road
New Delhi-110002
Dated: 17; q[ 2<ne
Notice
Subject: Documents required for the import -Reg.
The imported Drugs and Cosmetics are regulated as per the Chapter III of Drugs and
Cosmetics Act, 1940 and Rules there under wherein mandatory requirements are
mentioned. Each importer is required to comply with the conditions of the import
license or the NOCs issued under the said Act.
At the time of import, all importers are required to furnish label of respective
consignment, Certificate of Analysis (COA) of release of batch and import
license/permission along with bill of entry and other documents as per Drugs and
Cosmetics Rules, 1945 at the port office.
This is for information and necessary action for utilizing ICEGATE.
ee
(Dr. V.G. Somani)
Drugs Controller General (India)
To
All the stakeholders through website of CDSCOFile No. Import/Misc./89/2015-DC
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(Import & Registration Division)
FDA Bhawan, Kotla Road
New Delhi-110002
Dated: \7] 4) 2e12
Notice
Subject: Documents required for the import -Reg.
The imported Drugs and Cosmetics are regulated as per the Chapter III of Drugs and
Cosmetics Act, 1940 and Rules there under. Each importer is required to comply
with the conditions of the import license or the NOCs issued under the said Act.
In light of ease of doing business and for utilizing fast track system of Risk
Management System, with ICEGATE integration for online clearance of imported
Drugs and Cosmetics, it is proposed that the human interface may be reduced by
devising method, while ensuring that the integrity of drug/cosmetic, its packages and
seal is intact before the release and out of charge. Therefore, it is responsibility of
the importer to ensure the same and furnish the undertaking with each Integrated
Declaration or Bill of entry that the packaging is not damaged/broken/destroyed and
the content of drug/cosmetic has not deteriorated in the following prescribed format:
FORMAT FOR UNDERTAKING
| (Name & Address of Importer) ----------------------------- hereby undertake with respect to the consignment
imported vide Bill of Entry No. ------- Dated---------- that the drug/cosmetic packages seal is intact, the packaging
is not damaged/ broken/destroyed and the content of drug has not deteriorated.
Importer
Name and signature with Stamp & Date
(Authorized person)
This is for information and necessary action for utilizing ICEGATE and integration
with RMS.
a be
(Dr. V.G. Somani)
Drugs Controller General (India)
To
All the stakeholders through website of CDSCO