New Delhi, India – March 2025
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 Health and Family Welfare. It is responsible for the approval, regulation, and control of drugs, medical devices, and cosmetics in India, confirming their safety, efficacy, and quality.
Mandatory Industry Compliance in India
CDSCO plays a key function in regulating industries that manufacture, import, or distribute pharmaceuticals, medical devices, and cosmetics. Compliance with CDSCO Registration and regulations is mandatory for:
- Pharmaceutical Companies: Manufacturers and importers of drugs must obtain CDSCO approval before marketing their products in India.
- Medical Device Companies: With the introduction of the Medical Devices Rules, 2017, medical devices are now classified and regulated under CDSCO.
- Cosmetic Companies: Importers and manufacturers of cosmetics must comply with CDSCO standards to make sure product safety.
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.
Final Remarks
CDSCO is a vital government organization ensuring the safety and quality of drugs, medical devices, and cosmetics in India. Compliance with its regulations is mandatory for relevant industries, and the cost of registration depends on the product type. With its rigorous approval process, CDSCO continues to safeguard public health while fostering industry growth Read More News