How to Get CDSCO Wholesale License?

All countries in the world have their competent governing Department by the ministry of health to see all aspects of drugs and medical equipment. CDSCO is accountable for regulating the registration and sale of verified medical equipment in India. In this column, we will learn how to get a CDSCO Wholesale License?

About CDSCO

The CDSCO (Central Drugs Standard Control Organisation)  under the Directorate General of Health Services, Ministry of Health & Family Welfare, and Government of India are the National Regulatory Authority (NRA) of India. Its headquarters is located at FDA Bhawan, Kotla Road, New Delhi 110002 and has six zonal offices, four sub-zonal offices, thirteen Port offices and seven laboratories spread across the country.

The Drugs & Cosmetics Act, 1940 ^[1]and rules 1945 have consigned various responsibilities to Central & State regulators for regulating drugs &cosmetics. It proposes the uniform implementation of the provisions of the Act & Rules, thereby ensuring the safety, rights &wellbeing of the patients by regulating the drugs and cosmetics. CDSCO constantly strives to bring out transparency, accountability and uniformity in its services to ensure the safety, quality and benefit of the medical product manufactured, imported and distributed in the country.

Under the Drugs & Cosmetics Act, CDSCO is accountable for the approval of Drugs, Conduct of Clinical Trials, constituting the standards for Drugs, control over the quality of imported drugs in the country and harmonise the activities of State Drug Control Organizations by providing expert guidance with a view of bringing about the constancy in the enforcement of the Drugs and Cosmetics Act.

An Overview of CDSCO Wholesale License

The CDSCO is accountable for controlling the registration & sale of notified medical devices. The Directorate General of Health Services, which falls in India’s Ministry of Health and Family Welfare Government, regulates and governs CDSCO. Must submit the CDSCO Wholesale License for Sale & Distribution of drugs under Drugs and Cosmetics Rules in Forms 20B and 21B.

If the CDSCO Wholesale License is renewed, Form 21C is granted to the manufacturer (subsidiary office or representative of the parent company or its agent) by the State Licensing Authority in India.

The Legal Obligation under CDSCO Wholesale License

The applicant seeking a wholesale drug license must meet the criteria inculcated under the CDSCO, given the Drugs and Cosmetic Act, 1999.

• The area where the applicant wants to plan the drug and cosmetics business adheres adhere to the minimum area limit, which is 15 square meters, to be exact.
• The planned area must have ample cooling equipment such as air conditioners and refrigerators.
• Such license is granted under the personal supervision of a competent person/certified pharmacist. In some states, these licenses are granted only to the entity with a qualified person with a pharmacy degree from a recognise institution.
• According to the education criteria set under CDSCO, an applicant seeking a wholesale drug license need to be a certified pharmacist and should carry an experience of not less than one year in the premise of drug selling. A person with a standard certificate and four years of experience in the drug business can also apply for this license.
• After the license issuance must display the same at the premise where the applicant wants to conduct the drug business.

Documents required to get CDSCO Wholesale License

Following are some vital documents are required to get CDSCO Wholesale License:

• Covering letter surrounding the purpose of the application
• Duly filled application about wholesale license in form 19.
• Challan of fees invested for the wholesale drug license.
• Declaration form in the format suggested under the concerned authority.
• A detailed drawing of the premises indicates the perimeter and area in a standard format. This is also referred to as a floor plan.
• Documentation proofing the ownership of the applicant concerning the areas.
• Documents stating the type of business build by the applicant, such as a certificate of incorporation and MOA/ AOA.
• Affidavit designate the non-indulgence of the applicant with the criminal activities under the drug and cosmetic Act, 1940. Make sure the authorised person need to sign the affidavit.
• Appointment letter of the applicant assigned as a full-time registered pharmacist.

Note: CDSCO ensures that the designated officers hold the premises investigations after submitting the requested documents. The authority to maintain drug storage, display & sale has inculcated strict regulations.

The process to get CDSCO Wholesale License

Following are the procedure to obtain CDSCO Wholesale License:

• First, you have to visit the CDSCO Registration portal.
• Then you have to apply for registration for that, and you have to go to the Registration Purpose page and click on submit.
• Once you open the Application Registration page, fill in all the vital information as provided in the application form, such as:
• Applicant Type;
• Name;
• User Name;
• Password;
• Mobile Number;
• Email ID.
• Fill out the Registered Indian Address Form, which contains details like:

1. Organisation Name and Type;
2. CIN;
3. Contact Number;
4. Address;
5. Upload the Corporate Address Proof.
6. Once you submit the application form correctly, you will get a confirmation link to your registered email id to verify the registration. Then you have to click on the link to activate your account on the CDSCO portal.
7. Once the confirmation link is clicked, we will send the application for CDSCO Registration to the concerned authority for approval.
8. Once the CDSCO Wholesale License application is approved, send an approval email to your registered email id. If the application rejects, send an email for rejection to your email id. Once you get the approval mail, will complete your CDSCO Wholesale License.

Conclusion

In short, we say that CDSCO controls drug approval & clinical trials. It lays down the standards for the usage of drugs and looks after the quality control of medicines imported into the country. The positioning of drug manufacturing, distribution and wholesale is the priority of State Departments. Moreover, at the same time, Central Departments are accountable for giving permits to new drugs & clinical tests in the country. CDSCO is also a part providing approvals to specified categories of drugs.