CDSCO (Central Drugs Standard Control Organization)

CDSCO (Central Drugs Standard Control Organization) certification is a mandatory certification required for the manufacture, import, or sale of drugs and medical devices in India. Here are some key points that further explain what CDSCO certification entails:

CDSCO Certification Process: To obtain CDSCO certification, a manufacturer or importer must submit an application to CDSCO along with the required documents and fees. The application is then reviewed by CDSCO, and if the product meets the necessary standards, a certificate is issued.

CDSCO Standards: CDSCO sets standards for the manufacture, import, and sale of drugs and medical devices in India. These standards cover aspects such as safety, quality, and efficacy. To obtain CDSCO certification, the product must comply with these standards.

Validity of CDSCO Certificate: CDSCO certification is valid for a period of five years. After this period, the product must be recertified to continue to be sold in India.

Benefits of CDSCO Certification: CDSCO certification ensures that drugs and medical devices meet the necessary standards and are safe and effective to use. It also helps to build trust and confidence in the product among customers and stakeholders.

Consequences of Non-Compliance: Non-compliance with CDSCO standards and certification requirements can lead to penalties, fines, and even legal action. It can also damage a company’s reputation and lead to loss of business.