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CDSCO Registration for Drugs Manufacture in India

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CDSCO Registration for Drug Manufacturing in India | Process, Documents, Fees

The Central Drugs Standard Control Organisation (CDSCO) is India’s National Regulatory Body for Cosmetics, Pharmaceuticals, and Medical Devices.

Under the Drugs and Cosmetics Act 1940 and Rules 1945, CDSCO is responsible for the approval of drugs, conducting clinical trials, setting standards for drugs, ensuring control over the quality of imported drugs in the country, and coordinating the activities of the state drug control organization by providing expert guidance and advice.

Checklist for LLPRegistration 69

Drug Manufacturing in India.

Drugs are substances used for internal or external medical treatment, diagnosis, prevention, or alleviation of symptoms. In India, the import, manufacturing, sale, and distribution of drugs are regulated under the Drugs and Cosmetics Act 1940 and Rules 1945.

The Drugs and Cosmetics Rules, 1945, established by the Government of India through the Drugs and Cosmetics Act, 1940, classify drugs into various schedules and provide guidelines for their storage, sale, display, and prescription.

Documents required in the CDSCO Drug Manufacturing process in India.

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Documents required in CDSCO Registration are as follows:

  • Form 24/24A
  • Attested copies of education
  • List related to machinery and lab equipment
  • Description of the Product
  • Details of the approval of the New Drug in the Drug
  • Fee Challan
  • Copy of Valid Test License
  • Consent Letter from the supplier of the Drug

CDSCO Fee for Product

The fee for CDSCO import certificate for cosmetic products is INR 99,999/- with taxvilla.

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