An Overview of CDSCO Registration

Are you a medical device manufacturer looking to sell your products in India? 

If so, you need to be aware of the regulatory process involved in getting your products approved for use in the Indian market. 

The CDSCO stands for Central drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services of the Ministry of Health and Family Welfare. Several CDSCO responsibilities are outlined in the Drugs and Cosmetics Act, ranging from approval of drugs to clinical trials, providing standards for drugs and quality checking of imported drugs.  

All-in-all CDSCO promises coordination of the activities of SDCO (State Drug Control Organisation) while providing expert advice and training in uniformity in the implementation of the Drugs and Cosmetics Act in mind. No wonder, it has to ensure smooth coordination with SDCO to undertake the operations smoothly.

Role of CDSCO Certificate

A CDSCO Certificate refers to an approval granted by the regulatory authority in ensuring the efficiency and quality of Pharmaceuticals, medical devices & cosmetics. It stands as a testament to the commitment to complying with stringent regulations and adhering to the stated standards for the products. 

Under the Drug & Cosmetics Act, the arrangement of manufacture, sale & distribution of Drugs is a priority of State Authorities while Central Authorities are only responsible for permitting new drugs or clinical experiments in the country. 

With CDSCO Certificate in hand, you can rest assured that the product you are using has undergone rigorous testing, adhering to standards, and has been thoroughly evaluated for its composition, manufacturing processes, and packaging, leaving no room for compromise. Moreover, CDSCO is also a part of permitting specified categories of drugs such as blood and blood products, I. V. Fluids, and vaccines.