CDSCO Drugs Import License - Fees, Procedure, Documents
The Central Drugs Standard Control Organisation along with state regulators are responsible for granting licenses for Specialized Categories of Critical Drugs such as blood and blood products, I.V fluids, Vaccine and Sera. Drugs Import License is required to Import Drugs into India by following government regulations.
CDSCO is the National Regulatory Authority (NRA) of India. In India, Import, Manufacturing, Sale and Distribution of Drugs is regulated under Drugs & Cosmetics Act 1940 and Rules 1945.
What are Drugs in CDSCO?
Drugs are referred to the Medicines utilized for Internal or External use, such as Medicines for diagnosis, treatment, mitigation, prevention etc.
A Drug is a medicine or medication taken to cure any symptoms of an illness or medical condition. The use may also be as preventive medicine that has future benefits but it does not treat any existing or pre-existing diseases or symptoms.
What is CDSCO registration For a Drug Import License?
CDSCO registration is an online procedure to be done on the official website of Central Drugs Standard Control Organisation at SUGAM portal. This is a required prior registration process to be completed for acquiring the license for Drug Import.
CDSCO registration is a process to take an approval from the official authority to ensure the efficiency and quality of Drugs. Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of new drugs, conduct of clinical trials, laying down the standards for drugs, control over the quality of Imported drugs in the country and coordination of activities of state drug control organization by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
Importance of CDSCO Drugs Import License
Importance of Drugs Import License can be seen as follows:
- Improving a Company’s Reputation: Holding a CDSCO license serves as proof of completing the government policy and working under all the terms and conditions, which improves the reputation of the Company in the domain.
- No Custom Stoppage: Having a CDSCO license shows the transparency of following all the government policies for the import activity of Drugs. In India, import, manufacture, sale, and distribution of drugs are regulated by DCGI under the Central Drugs Standard Control Organisation.
- Safeguard the Public Health: The vision and mission of Central Drugs Standard Control Organisation is to protect, promote, safeguard, and enhance the public health by assuring the safety, efficacy, and quality of Drugs to be consumed by the masses.
CDSCO Fee for Product
The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Monitrix.
Documents required For CDSCO Drugs Import License
Important documents required in the process are as follows:
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- Covering Letter
- Form 8 or 8-A
- TR6 Challan
- Testing Protocol
- Product Label and Brochures
- FSC Certificate in the Country of Origin
- Notarized Agreement
- Ethics Committee Approval
- Original Power of Attorney
- Plant Master File
- Drug Master File
- Copy of BA/BE site registration as approved by CDSCO in case of BA/BE approved sites registration
- Manufacturing license or wholesale license (in the case of Import)
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Conclusion
CDSCO stands for Central Drugs Standard Control Organisation which is responsible for authorizing the Drug Import License to the Individuals who deals with it in the domain. Owning a CDSCO License gives official access to deal with import activity and have several Importance.
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