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Pankaj Tyagi
| Updated: 28 Dec, 2020 | Category: Drug License

Legal Obligation under CDSCO for Obtaining Wholesale Drug License

CDSCO

Are you a proactive entrepreneur who wishes to earn unparalleled credibility in the field of pharmaceuticals? The drug-selling business is wrapped around many complexities due to the presence of countless compliance, which is indeed hard to comply with. Quality plays a critical role in the pharmaceuticals business. The competition in the drug business is quite stiff, but fastening up with the best approach can help the businesses overcome that obstacle.

Laying a foundation of a wholesale firm dealing in pharmaceuticals is complex but not difficult. Once you become accustomed to every detail of the wholesale drug licensing process, things become pretty straightforward. The advent of digitalization has helped many government offices to go online, and it has drastically reduced the time needed to file an application. Before you get engaged with the registration process of wholesale drug license, we suggested you get familiar with rules, regulations, and norms in the first place. 

What is the Legal Obligation under CDSCO for Obtaining Wholesale Drug License? 

An applicant seeking a wholesale drug license is required to meet the certain criteria inculcated by the Central Drugs Standard control organization (CDSCO), in view of the Drugs and Cosmetic Act, 1999[1].

Legal Obligation under CDSCO
  • The proposed area where the applicant wants to conduct the business of drugs and cosmetics must adhere to the minimum area limit, which is 15 square meters to be exact.
  • The proposed area must be equipped with ample cooling equipment such as air conditioners and refrigerators.
  • Such kind of license is granted under the personal supervision of a competent person/certified pharmacist. In some of the states, these licenses are granted only to the entity that has a competent person having a degree in pharmacy from an accredited institution.
  • As per the education criteria set by CDSCO , an applicant seeking a wholesale drug license must be a certified pharmacist and should hold experience of not less than one year in the area of drug selling. A person with a 10th standard certificate and 4 years of experience in the drug business can also apply for this license. 
  • After the issuance of the license, the same must be displayed at the premise where the applicant wants to conduct the drug business. 

CDSCO seeks following Document for issuing the Wholesale Drug License 

  • Covering letter enclosing the purpose of the application 
  • Duly filled application pertaining to wholesale drug license in form 19.
  • Challan of fees deposited for the wholesale drug license. 
  • Declaration form in the format suggested by the concerned authority. 
  • Detailed drawing of the premises precisely indicating the perimeter and area in a standard format. This is also being referred to as a floor plan. 
  • Documentation proofing the ownership of the applicant in relation to the premises.
  • Documents stating the type of business established by the applicant, such as a certificate of incorporation, MOA, or AOA.
  • Affidavit indicating the non-indulgence of the applicant with the criminal activities under the drug and cosmetic act, 1940. Make sure the authorized person must sign the affidavit.
  • Appointment letter of the applicant appointed as a full-time registered pharmacist.
  • After submitting the requested documents, CDSCO ensures that the premises investigations are held by the designated officers. Strict regulations have been inculcated by the authority to maintain the storage, display & sale of drugs.  

What is the Procedure of the Obtainment of Wholesale Drug License? 

For the seamless obtainment of a Wholesale Drug license from the CDSCO the applicant is required to follow the procedure mention below. 

  • For the renewal of the certificates, one has to make an application in Form 21C (Allopathic Drugs/ Schedule X Drugs), 20E for homeopathic drugs. Applicant must make an application in Form 19, 19B, and 19C, respectively, for wholesale drug license. 
  • The applicant must leverage E-challan for the payment of the prescribed fees. The number of fees which is payable against such application has been capped at Rs 3000. Keep in mind that the applicant is required to pay additional fees of Rs 250 and Rs 500 for homeopathic and Schedule x drugs, respectively. 
  • Using login ID & password as rendered, the applicant has to log in and create a new eform by selecting “New Inward” & upload the requested documents as per the sales guidelines. 
  • After filing the entire application, take a hard copy of the same as in Form 19/19B/19C. Also, do not forget to save the system-generated inward ID for future reference. 
  • Submit the physical copy of all documents as well as the real copy of e-challan and submit fees to the entry clerk in the inward section within seventy-two hours of the submission of the application. 
  • A hard copy of the application will be routed to the inward entry section. 
  • The file will then submitted by the clerk at the account section for the verification of the amount paid via e-challan. 
  • After successful verification of the e-challan, the accounting department will forward the file to concerned officials. 
  • Up next, the concerned official will annex the application in the file and also verify the same along with the documents. 
  • The official will then forward the file to the Director for the appointment of the Drugs inspector/ADC. 
  • The director will verify the file and then forward it for further online processing. 
  • The drug official appointed by the Director shall verify the entire documents and the premises of the business. 
  • After getting satisfactory results from the verification process, the Drugs Inspector/ADC will confer his approval for the grant of renewal certificate.

Conclusion 

Since the rejection rate in Wholesale drug licenses is quite high, it is advisable to exercise extra caution while meeting the requirement for the same. Documentation is a delicate part of the registration process; thus, it should be handled with a deliberate approach. Feel free to avail of professional help from Corpbiz professional in case if you find it hard to tackle the complexity of the process.

Read our article:Analysis on Generic Pharmaceutical Drugs from an Intellectual Property Perspective

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Pankaj Tyagi

Pankaj has a diverse experience of writing research papers, blog, and articles during his college time. Earlier, he was working as a tax consultant in a financial firm, but his interest in writing drives him to pursue a career in the writing field.

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