Introduction: Wholesale Drug License in India

Drug license is granted according to the Drugs and Cosmetics Act, of 1940 to regulate the Manufacture/Wholesale/retailing of the drug business in India. The Drug license is granted by the Central Drug Standard Control Organization (CDSCO) or State Drugs Standard Control Organisation (SDSCO). The Registration of Drug sellers/wholesalers/Manufacturers/Distributor etc is regulated from the very initial stage of the medicine, from the raw material stage to manufacturing, sale, distribution, etc till the medicine reaches the Customer by the Seller/Pharmacist in the local drug store or dispensary.

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Requirements To Obtain Drug License 

• Premises

The premise where the project is going to run must have an area of a leased 10 square meters both for Pharmacy or wholesale establishment. These are clearly defined at the State portal of drug Licensing. The National Building Code, 2005 (Amended provisions) applies to the building structure.

The premises must have commercial residence certification from the local authority.

• Storage Capacity

The applicant must have the essential equipment for the drugs storage such as a refrigerator and & air conditioner according to the specification of the drugs to be stored.

• Technical staffs/Pharmacist Competency

For the Projects such as Wholesale/manufacturing/retail licensing, the applicant must have skilled and experienced technical staff, and the Pharmacist should have at least one year of experience and the required qualification (varies from state to state), and approval in a similar field from the department of drug control for the purpose.

• Location-based license

The License for the opening of the Drug plant location shall be fixed and each other location relating to the drug has to be a separate license, at the time of filling out the application each of the locations should be mentioned therein.

• Importer of Drugs or Cosmetics

The drug safety and quality standard of the drug have to conform to the Standard quality fixed by the state. The drugs mentioned in Schedule X can be imported into India getting a license for the same.

Procedure For Grant Of Wholesale/Manufacturing Of Drug License

• The applicant has to open the official website of the State Drugs Standard Control Organisation (SDSCO). 
• The applicant has to register himself at the portal providing essential information for registration;
• Click on the login tab subsequently at apply for new license tab and fill in the application form.
• The applicant shall have an option where wants to apply for the retail license chooses the retail license option, and for the wholesale license chooses a wholesale license option.
• The applicant shall Upload the required attachments in the formats prescribed on the website;
• Subsequently, the applicant has to fill out the application fee at the payment gateway;
• The Successful applicant shall get the confirmation of the submission through the system-generated acknowledgment;
• The applicant shall be sent to the concerned department;
• The application shall be investigated by the concerned inspector of the Drug control;’
• On verification of the application, the drug control Inspector shall inspect the unit and submits its report to the Competent Authority.
• The competent authority shall accept or reject the application within the given time and if the application is approved the massage of completion and issuance of the license is given to the applicant.

Documents Required For The Wholesale/Retailer Drug Licensing

• TR6 Challan
• ISO 13485 Certificate 
• Cover Letter (Describing your experience and skills)
• Challan fees (copy)
• Application Form (along with Proof of qualification, Registration Certificate of Chemist/Experience certificate, and appointment letter)
• Memorandum of association (MoA) and Article of Association (AoA); (proof of  Constitution of the firm) 
• List of all the Directors/Partners with age & complete postal & residential address.
• Declaration of Managing Director(s)/Proprietor/ Partners 
• Documents of ownership or Tenancy agreement 
• Plant Master File 

Additional Documents Should Also Be Submitted:

• Id proof (Aadhar card, PAN card, etc)
• Proof of drug storage at the site.
• Registration from District Industries Centre. 
• Declaration of Analytical Chemist.
• Declaration of Manufacturing Chemist.

Procedure of Renewal for The Wholesale Drug License

• The applicant shall open the official website of the concerned State Drugs Standard Control Organisation (SDSCO). 
• Open the portal, and register yourself through the application registration portal, wherein the applicant login credentials shall be sent to the applicant for further processing;
• The applicant shall log in through the login credentials provided by the website;
• Fill out the form and provide the information  about the company along with the License details of the company and renewal receipt as well;
• The applicant shall select one of the options of Retention of Wholesale or Retention of Retail license.
• The Licensee shall attach the attachments in the format mentioned on the website;
• The applicant shall apply after reviewing the form; 
• The form shall go through the automatic process to the concerned department of the State government, who verifies the documents submitted, and the applicant is informed about the approval or rejection of the application to the applicant through SMS/Emails. The successful applicant shall pay the one-time application fee.
• The applicant submits the retention option which shall be sent to the applicant through the official portal
• The uploaded retention license can be downloaded.
• The authority may ask the applicant for any confidential information for the purpose of confirmation of the documents.

Documents Required For The Renewal Of The Drug Licensing Application

The applicant applying for renewal of the drug license have to apply through the renewal Certification form which is different for the different type of drugs, these are:

• Applicant ID proof 
• Form 19, 19B, and 19C - these forms are additional information about the Drug
• Form 20E- The application form is required for the Homeopathic drugs 
• Form 21 C-  The application form is required for allopathic drugs and schedule X drugs.
• Online receipt of Challan fee.
• Self-authorisation and declaration of the applicant which should be notarized.
• Registration certificate of the Pharmacist
• The updated business plan (if there is one)
• Changes in business area and documents relating to the changes brought (if there are)
• Previous Renewal license.

Fee Required For The Drug License 

The remittance fee of Rs. 3000 is required to be paid along with the additional charge of Rs. 250 and Rs. 500 for homeopathic and Schedule X drugs through E-challan. (The licensing fee may differ from State to State which the applicant is required to pay.)

Licesning Process of Wholesale Drugs License

• Registration of Applicant
• Logging in to the portal and filling up of application form and submitting the details;
• Attachment of the required documents 
• Online payment through the payment gateway;
• Acknowledgment from the department;
• Inspection of the site from the Competent authority
• submission of report
• Issuance of license 

Licensing Process of Drug Manufacturing License

• Applicant fills and applies;
• The Director of Drug Control approves or rejects it;
• Ast. director through the Inspector of drug control inspects the project;
• The inspection results go to the director of Drug Control
• And the License is issued.

Conclusion

Looking into the sensitivity of drug trafficking and illegal manufacturing and selling of drugs in the market, The process involved in the Drugs and Cosmetics act, are highly cumbersome and time-taking, therefore the individuals looking for the establishment of drugs manufacturing/wholesale units shall have to come up with the proper planning and consultation process for the ease and efficient licensing process as per the Drugs and Cosmetics Act, 1940.

Consult us for your Drug licensing, we have an expert team of more than100 members who are well-versed in the standard procedure and complete the licensing mechanism with ease for the clients and enable them to focus on their business development without any worry.