How to Apply for CDSCO Registration in India?

The CDSCO (Central Drugs Standard Control Organization) is the National Regulatory Authority for Indian pharmaceuticals and medical devices under the Directorate General of Health Services, Ministry of Health and Family Welfare in India. It is the responsibility of CDSCO for approving new drugs and conduct of clinical trials in India under the Drugs and Cosmetics Act, 1940 (“Act”) and Drugs and Cosmetics Rules, 1945 (“Rules”). CDSCO regulates the matters relating to drugs and cosmetics as provided under the Act and Rules for ensuring the patients’ safety, rights, and well-being. It also regulates the efficiency and quality of a medical product manufactured, imported, and distributed in the country.

The CDSCO (Central Drugs Standard Control Organization) is headed by a Drugs Controller General of India (DCGI), an officer of the rank of Additional Secretary to the Government of India. The organization’s headquarters is in New Delhi, with zonal offices in Mumbai, Kolkata, Chennai, and Guwahati. There are also 27 State Drug Control Organizations at the state level, headed by State Drug Control Officers (SDCOs).  The DCGI is under the CDSCO and is responsible for controlling the standards and quality of drugs produced and marketed in India.

We at CDSCO help you get your CDSCO Drug license in the easiest, fastest, and most hassle-free manner. It also provides expert advice to State Drug Control Organisations and coordinates their activities. If you want to obtain a drug license for manufacturing, importing, or marketing drugs & cosmetics across India, then we are here to assist you in every possible manner. We ensure your compliance with regulatory requirements. Apart from guiding you with drug rules and regulations, we also offer complete assistance for getting a CDSCO Registration. Reach us and get the best professional service from our team of experts. We provide companies with a complete service for doing business in India, thus ensuring compliance with local regulatory requirements. Our team is updated with all the latest policies and conditions of industries and can assist you in getting registrations within 6-8 months. Submit the information about your company, and we will get back to you within 24 hours. We provide you with a complete package for regulatory services from start to finish. We assist the clients in acquiring all necessary approvals, including new and renewal license for the manufacture, import, and sale of drugs, cosmetics, and medical devices. We will guide you with our team of experts in all aspects of product testing, documentation preparation, legal compliance and marketing. We at CDSCO help you get your drug license in the easiest, fastest, and most hassle-free manner. We are CDSCO Registered with access to top drugs inspectors in all states of India. Our online portal helps you with the entire CDSCO Drug Registration process, from placing orders to document verification of your business premises and your products. We provide consultation for various compliance requirements for both Central Drug Standard Control Organisation (CDSCO) and Drug Controlling Authority (DCGI). CDSCO and the state regulators are jointly responsible for granting licenses for specific specialized categories of critical drugs such as vaccines, blood and blood products, IV fluids, and sera. We have an excellent team of CDSCO Certificate, and they will help you get your Drug License. We assist the clients in getting a CDSCO Registration for Manufacturing, Importing, Exporting, and Marketing Drugs & Cosmetics across India. We help you get a CDSCO by efficiently guiding you through the process and helping you achieve compliance with all regulatory requirements. We at CDSCO have a dedicated team and focused on ensuring that your drugs, medicines and cosmetics applications are licensed quickly. Our services include efficient guidance on all matters related to handling & storage, manufacturing procedures, and quality control of drugs and pharmaceuticals.

Important license and forms for CDSCO:

1. Medical Device/Cosmetic Registration Certification.
2. Import Authorization.
3. Import Test License.
4. Manufacturing Test License.
5. Approval for a clinical trial.
6. Market approval following a successful clinical trial.
7. Permission to produce following the completion of a satisfactory clinical trial.
8. Retail sale of a notified Cosmetic/Medical device.
9. Wholesale sale of a notified medical device.
10. Manufacturing license for a notified Cosmetics/Medical Device.
11. License to lend (manufactured in facility owned by third party).

Document Required for CDSCO Registration:

1. Id proof.
2. Rent agreement/ownership proof.
3. Undertaking issued by a government authority.
4. Manufacturing license or wholesale License in case of import.
5. Copy of Approved CDSCO.