Under the Drugs and Cosmetics Act 1940 and Rules 1945 the Ministry of health and Family Welfare passed a set of laws giving authority to the Drugs Controller General of India (DCGI) to regulate the quality of drug product and drug substance imported into India or manufactured in India . The DCGI is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs .
Product Registration
Under the Drugs and Cosmetics Act 1940 and Rules 1945 the Ministry of health and Family Welfare passed a set of laws giving authority to the Drugs Controller General of India (DCGI) to regulate the quality of drug product and drug substance imported into India or manufactured in India . The DCGI is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs .
The DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India. For Overseas manufacturers the DCGI requires the Drug and Medical Device manufacturers to register their products in India through an agent who must be a holder of a valid FDA license
Our Flagship Projects
Rifa Pharma supports its suppliers during the process of submitting applications for API’s , Finished Products and medical devices as per the client requirement. Our team of qualified experts will successfully review , compile and submit the regulatory documents for the international clients as per DCGI requirements . These applications include:
- API Registration
- Drug Product Registration
- Medical Devices Registration
- Cosmetic Registration
- Test License
- Import License
We Specialize in Helping our Customers to obtain the following:
- Pre review of Documentation
- Filing
- Follow up and replies on query
- Import clearance and submission of samples to the qualified Test lab
- Coordination with the testing lab for certification
We Specialize in Helping our Customers to obtain the following:
- Communicate to DCGI on behalf of our client
- Prepare clarifications to questions from DCGI
- Assistance in transfer of registration and testing fees to relevant authorities
- Notify the client about the registration with DCGI
API Registration
Requirement :
Dossier as per DCGI Guidelines.
Time Taken :
8 to 12 months
- Factory Registration $10000
- Product Registration $5000 / Product
- Factory Inspection ( if demanded by DCGI) $25000
- New Drug Application $3500
- Consulting Fees as per required service
Tie-Ups
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Product
Registration
The DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India. For Overseas manufacturers the DCGI requires the Drug and Medical Device manufacturers to register their products in India through an agent who must be a holder of a valid FDA license.
Our Flagship Projects
Rifa Pharma supports its suppliers during the process of submitting applications for API’s , Finished Products and medical devices as per the client requirement. Our team of qualified experts will successfully review , compile and submit the regulatory documents for the international clients as per DCGI requirements . These applications include:
■ API Registration
■ Drug Product Registration
■ Medical Devices Registration
■ Cosmetic Registration
■ Test License
■ Import License
API Registration
Requirement :
Dossier as per DCGI Guidelines.
Time Taken :
8 to 12 months
■ Factory Registration $10000
■ Product Registration $5000 / Product
■ Factory Inspection ( if demanded by DCGI) $25000
■ New Drug Application $3500
