CDSCO (INDIA)

Drugs are the Medicines consumed for Internal or External use, the medicines for diagnostics, treatment, mitigation, prevention etc. In India, import, manufacturing, sale and distribution of drugs is regulated under the Drugs and Cosmetics Act 1940 and Rules 1945.

The Drugs and Cosmetic rules, 1945 are the rules which the government of India established through the Drugs and Cosmetics Act, 1940. These rules classify drugs under given schedules and present guidelines for the storage, sale, display and prescription of the schedule.

CDSCO, the Central Drugs Standard Control Organisation is one of the most powerful organizations of India. It is responsible for the approval of new drugs, conduct of clinical trials, granting of the license of certain specialized categories of critical drugs such as Blood and Blood Products, I.V Fluids, Vaccine and Sera.

In India, import, manufacturing, sale and distribution of drugs is regulated under Drugs and Cosmetics Act 1940 and Rules 1945.

Process for doing CDSCO Registration for Drug Manufacturing in India is as follows :

Cdsco Registration gives access to numerous benefits as:

• Ensuring Compliance with Laws and Regulations: CDSCO registration is a mandatory process to ensure that an organization follows relevant laws, regulations, and business rules, allowing for approval from the regulatory authority to maintain the efficiency and quality of Cosmetic Products.
• Safety & Quality Assurance: CDSCO registration ensures that cosmetic products are free from harmful ingredients and are suitable for all, guaranteeing the safety and quality of these products for consumption by the general public.
• Public Health Safeguard: The vision and mission of the Central Drugs Standard Control Organisation is to protect, promote, safeguard, and enhance public health by ensuring the safety, efficacy, and quality of medical devices and products intended for mass consumption.

The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Cokion.

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

Registering for Drug Manufacturing in India under CDSCO will access several benefits as it majorly acts as a legal and formal approval to work with Drugs in the domain for various activities. As the Indian government has announced its plan to bring all the medical devices, drugs and cosmetics to work under a review of CDSCO.