Compliance Calendar LLP

The Central Drugs Standard Control Organization (CDSCO) is a pivotal regulatory body in India, but there is often confusion about whether it is a government or private organization. To clarify, CDSCO is a government organization under the Ministry of Healt

Tentative Cost of CDSCO Registration

The cost of CDSCO registration varies depending on the type of product and the registration pathway. Here’s a tentative breakdown:

• Drugs: Registration fees for new drugs can range from INR 50,000 to INR 1,50,000, depending on the category and type of application.
• Medical Devices: Fees for medical device registration typically range from INR 10,000 to INR 1,00,000, depending on the device’s risk classification (Class A, B, C, or D).
• Cosmetics: Cosmetic registration fees are generally lower, starting from INR 5,000 to INR 20,000 per product.

These fees are subject to change and may include additional costs for testing, documentation, and consultancy services.

Validity of CDSCO Registration

The validity of CDSCO registration varies by product category:

• Drugs: Drug licenses are typically valid for 1 to 5 years, after which renewal is required.
• Medical Devices: Registration certificates are valid for 5 years and must be renewed before expiration.
• Cosmetics: Cosmetic registration is generally valid for 3 years, with renewal required thereafter.

Example of CDSCO Registration in India

For instance, a pharmaceutical company based in Mumbai seeking to market a new antibiotic in India must first apply for CDSCO approval. The company would submit detailed documentation, including clinical trial data, manufacturing details, and product specifications. After paying the requisite fee (e.g., INR 1,00,000 for a new drug), the CDSCO reviews the application and grants approval if the product meets safety and efficacy standards. The license is valid for 5 years, after which the company must apply for renewal.