Every country in the world has its competent governing authority under the ministry of health to look after every aspect of drugs and medical devices. In India, the CDSCO is responsible for regulating the registration & sale of notified medical devices. In this write-up, we will discuss, what is CDSCO Wholesale License?
What is CDSCO?
The Central Drugs Standard Control Organization (also known as CDSCO) is a regulator of the Indian medical device industry. It operates under the Drugs & Cosmetics Act 1940 & Rules 1945. Indian drugs are registered under the CDSCO process. The Central Drugs Standard Control Organization is the nation’s regulatory body for Indian pharmaceuticals and medical devices.
Foreign manufacturers may appoint Indian Authorized Agents (IAA). It is a licensing agency that approves new chemical entities (drugs) for import into India. Each country has its own dedicated governing body, part of the Ministry of Health. It oversees all aspects of medical and pharmaceutical devices.
CDSCO Wholesale License – An Overview
The CDSCO is responsible for regulating the sale and registration of notified medical equipment in India. The Directorate General of Health Services, which falls under India’s Ministry of Health and Family Welfare Government controls and governs CDSCO.
For the CDSCO Wholesale License, a duly notarized and valid copy of the Wholesale License for sale or distribution of drugs under Drugs and Cosmetics Rules in Form 20B & 21B must be submitted.
In case of the CDSCO Whole License renewal, Form 21C is issued to the manufacturer (subsidiary office/representative of the parent company or its agent by the State Licensing Authority in India.
Below mentioned products or devices may get CDSCO License-
- Drug Products
- Medical Devices
- Clinical Trials
Purposes For Which CDSCO License Can be Obtained
CDSCO can grant registrations for various purposes. There are various purposes for which an applicant may register through the CDSCO portal:
- Cosmetics Registration;
- Import, Manufacture, or Selling of drugs;
- Export NOC (Zone);
- Test License;
- Ethics Committee Registration;
- Formulation R&D Organization;
- Blood Bank Registration;
- Blood Product Registration;
- Dual Use NOC (Trader);
- BA/BE Approved Sites;
- Sponsors (BA/BE and CT);
Legal obligations under CDSCO Wholesale License
- A wholesale drug license applicant must meet specific criteria set forth by the Central Drugs Standard Control Organization (CDSCO) following the 1999 Drugs and Cosmetic Act.
- The area in which the applicant intends to do business with cosmetics and drugs must be within the prescribed area. In addition, it must not exceed 15 square meters.
- The proposed area must have adequate cooling equipment, such as refrigerators and air conditioners.
- This type of license can only be granted under the supervision of a certified pharmacist or competent person. In addition, these licenses can only be granted in certain states to an entity that has a qualified person with a pharmacy degree from an accredited institution.
- According to CDSCO’s education requirements, applicants for wholesale drug licenses must be certified pharmacists and have at least one year of experience in drug selling. This license is also available to applicants with having a 10th-standard certificate and four years of experience in the drug industry.
- The license must be displayed at any location where the applicant intends to operate a drug business after being issued.
Who can register under CDSCO Wholesale License?
The given below are the applicants who can register on CDSCO online portal:
- Indian Agents
- Foreign Enterprises holding Indian Subsidiary
Pre-requisite for CDSCO Wholesale License
Below mentioned key points are required for CDSCO Wholesale License-
- Generic Name / Brand Name
- Intended Use
- Material of construction
- Mode of application
Documents Required for Registration Under CDSCO Wholesale License
Below mentioned documents are required for CDSCO Wholesale License-
- ID Proof of the Authorised person
- Address Proof of the Authorized person
- Certificate of registration or Certificate of Incorporation
- Undertaking issued by a Government Authority
- Disclosure of the purpose of the application
- Duly filled application concerning wholesale drug license in form 19 and the receipts of fees deposited for the wholesale drug license.
- Declaration form in the pattern suggested by the respective authority.
- Specification of the premises, which in general refer to as a floor plan.
- Signed Affidavit indicating the non-involvement of the applicant with the criminal activities under the drug and cosmetic act, 1940.
- Appointment letter of the applicant appointed as a full-time registered pharmacist.
Note- Once the documents are submitted by the applicant, CDSCO ensures that the designated officers hold the examination of the premise.
Procedure for CDSCO Wholesale License
Below mentioned steps are required for CDSCO Wholesale License. CDSCO Wholesale License can be done online. These are the steps to register under the CDSCO portal:
Step 1: Visit the CDSCO registration portal. Click on the “Login/Sign up” button at the top of the portal.
Step 2: Next, go to “Sign up Here” is the option to register. This will take you to the ‘Registration Purpose’ Page. Finally, click on the button to submit.
Step 3: Click on the ‘Applicant Registration Page. Complete the application details form. It contains details like the Applicant Type’ and Password’.
Next, upload the ID Proof Details and the Undertaking.’ Next, fill in the Registered Indian address form’.
This contains information such as the Organization Name’, the Organization Type’ and Contact Number.’ Finally, upload the’ Corporate Address proof.’ Once you have completed all details, click the “Submit” button.
Step 4: After Submission, a confirmation link will be sent via email to your registered email address. To activate your CDSCO account, click on the link in your email.
Step 5: After clicking the confirmation link, the application will be sent to the appropriate Authority (CDSCO Officials).
In case of approval, an email for approval will be sent on the respective email ID. If the application is denied, an email of rejection will be sent to your registered email ID. After getting an email of approval, your registration for CDSCO Wholesale license is complete.
In a nutshell, we can say CDSCO regulates drug approval and clinical trials. It also lays down the standards for usage of drugs and looks after the quality control of drugs imported into the country. The arrangement of manufacturing, wholesale, and distribution of drugs is the priority of state Authorities. At the same time, Central Authorities are only responsible for giving permits to new drugs and clinical tests in the country. CDSCO is also a part of giving permits to specified categories of drugs.
Read our Article:CDSCO Medical Devices Manufacturing Registration Requirement