CDSCO Drugs Import License
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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.
Documents required For CDSCO Drugs Import License
Important documents required in the process are as follows:
- 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)
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla
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