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
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:
Dossier as per DCGI Guidelines.
8 to 12 months
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.
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:
Dossier as per DCGI Guidelines.
8 to 12 months
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