Licensing is mandatory to do business in Drugs & Cosmetics in India. The company/distributor/independent agent to be an authorized Indian Agent for a local/foreign wholesale business obtains a license from the Central Drugs Standard Control Organisations (CDSCO). They must hold a valid wholesale drug license by applying in Form 20B and Form 21B. The wholesale drug license is submitted to and granted by individual State Licensing Authorities. The provisions for this have been made in the Drugs & Cosmetics Act, 1940, which is applicable to the whole of India.
The Act has consolidated all the laws relating to drugs & cosmetics, which established the Drugs Control Department. If drugs are sold or stocked for sale at more than one place, the application must be made, and license has to be issued. Once the license is granted to the business, all such License must ensure that all the requirements for obtaining the drug license is complied with for starting the course of wholesale business. All the records /registers /Forms must be maintained in the manner specified by the licensing authorities, and authorities must be kept informed for all the changes or modifications made in the business activities.
Salient Points are kept in mind while obtaining a Wholesale Drug License.
- One must have a good space to start the wholesale drugs and cosmetics business.
- Both air-conditioners and refrigerators are necessary to avoid bio-molecular damage of injections, insulin, vaccines, and sera.
- The place must be safe from rodents, and adequate cleanliness is to be maintained.
- Proper hygiene must be maintained on the premises to avoid any contamination.
- Acquire a license from the Central Drugs Standard Control Organization or CDSCO.
- The person applied for the license should possess a degree or diploma in pharmacy from some recognized university or institute.
- Also, the person should have experience in dealing with drugs.
- In the light of the latest change brought in India, it is mandatory to get the GST registration number.
- Area: The shop/ premises area must have a minimum requirement of 15 square meters.
- Storage facility: The shop/ premises must have the refrigerator and also the air conditioner to store the medicines. According to the labeling specifications, certain drugs like vaccines, Sera, Insulin Injections, etc., are required to be stored in the refrigerator.
- Issuance of License: The wholesale drug license can be made under the personal supervision of the registered pharmacist/ competent person. In some states, a wholesale drug license is issued only to a company/entity that has a person with a degree or diploma in the pharmacy from a recognized institute/university.
- Technical Staff: The pharmacist or a competent person should be graduated with a 1-year experience in dealing with the drugs or be an SSLC passed with 4 years of experience in dealing in drugs.
- Inspection: Once the drug license is obtained, the same should be displayed clearly on the premises for the purpose of any future inspection.
- Qualifications: A person who applies for drug licenses should possess one of the following qualifications:
- Registered pharmacist under the state Pharma council
- Minimum 1-year experience as a salesman in a registered wholesale drug licensed firm after graduation or
- Minimum 4 years experience as a salesman in a registered drug licensed firm after giving the senior secondary examination.
Procedure for Wholesale Drug License
- Documentation of Documents: Under the procedure for obtaining the drug license, a businessman or an applicant of the new venture must have the complete documentary file, which includes preparation of the key plan, various legal affidavits, declaration, and site plan under the law.
- Filing Application for Drug License: The second procedure for drug license is the filing up the application. An applicant needs to filing up to an application form. This process for drug license is available online only. At the moment of filing the application, all the essential documents are scanned and uploaded properly online, including the payment of government fees. However, all the verified documents are verified by the inspector personally.
- Inspector Visits Personally: This comes as a third procedure for drug license. After the filing of a drug license, all the documents are marked for inspection, and the inspector visits the pharmaceutical shop personally only for the final verification and correctness of filled data.
- The Grant Of Drug License: Now, this procedure is mainly the final step through which a businessman attains the drug license all after the process of inspection. The competent person cleared up all the data or information all via the verification or interview, and the documents are corrected by the controller of drugs & issues the Drug License.
Documents for Wholesale Drug License
Here is a list of documents needed for wholesale drug license in India which may vary across different states:
- Duly filled application form in a prescribed format.
- Cover letter with name and designation of the applicant
- Challan of fees deposited for the license
- Declaration form in a prescribed format
- Blueprint of a key plan and site plan of the premises
- The documents of possession of the premises
- Proof of the ownership
- Incorporation certificate, MOA or AOA, Partnership deed as applicable
- Affidavit regarding non-conviction under the Drugs and Cosmetic Act 1940, it must be signed by proprietors, partners, directors as the case may be
- Appointment letter on being appointed as a full-time registered pharmacist
After submission of all the documents, Central Drugs Standard Control Organisations (CDSCO) ensures that regular inspections are held by a Pharmacy Inspector. Strict norms have been formulated to maintain the storage, display, and sale of drugs.
Read our article:Punishment for Selling of Medicines Without a Drug License
Procedure for obtaining renewal of Wholesale Drug Licences
For obtaining Wholesale drug Licences from this Directorate, the applicant must follow the procedure mention below. The renewal certificate is issued online by the authority.
- To obtain renewal certificates, one has to applied in Form 21C (for Allopathic Drugs/ Schedule X Drugs), 20E (for Homoeopathic drugs) applicant should fill Form 19, 19B, and 19C respectively and form for Additional information data.
- The applicant must pay the necessary fees via E-challan. The fee of Rs. 3000/- along with an additional fee of Rs 250/- for Homoeopathic Licence and Rs. 500/- for Schedule X license requires to be paid to Head of accounts.
- Using login ID and Password as provided, licensee has to login and create a new application by clicking on “New Inward” and upload the required documents as per the sales guidelines.
- After completing a full application, take print out of the generated applications as in Form 19/19B/19C. For future reference, save the inward ID; this is generated on the system after when the full application is completed.
- Submit the hard copy of all documents, along with an original copy of the e-challan and pay fees to the entry clerk in the inward Section within 72 hours of the submission of application.
- A hard copy of the application is received in the inward Entry section.
- Entry clerk then forwards the file to the Accounts section of the department for verification of the amount paid through challan.
- The Accounts Section once verified the amount forwards the file to concerned dealing hand.
- The dealing hand placed the application in the file of the licensee maintained in the department and also scrutinizes all the documents and put up to the Director for allotting to the Drugs Inspector/ADC.
- The Director peruses the application and gives marks to it for further online processing.
- Drugs Inspector/ADC will scrutinize all the documents and accordingly inspect the premises. The Drugs Inspector/ADC will propose for Grant of Renewal Certificate in case all relevant documents are submitted, and the premises looks satisfactory on inspection.
- On the observations at the time of inspection, Drugs Inspector/ADC will propose;
- Grant of renewal certificate.
- Issue of Show cause letter.
- Issue corrective letter.
And then forward the file to Deputy Director.
- Deputy Director will put the recommendations and forward the file to the Director.
- Then finally, Renewal Certificate is granted by the Director of the Licensing Authority. Otherwise, the licensee gives clarification. Application then handed over to the ‘Dealing Hand’ by the Entry Clerk. ‘Dealing Hand’ files the clarification and forwards the file to the Drugs Inspector.
- If licensee gives
- Satisfactory clarification, then the Drugs Inspector will propose for Grant of Renewal Licences and put up the file to concerned Assistant Drug Controller/Dy. Director, which is also recorded online.
- If clarification doest not found satisfactory, then the Drugs Inspector will propose for personal hearing by the Director and forward the file to Assistant Drugs Controller /Deputy Director.
- Assistant Drug Controller/Dy. Director will put the file for Director with his comments/report.
- The Director will grant the Renewal Certificate to the licensee, and the final certificate is issued by the Director online. Otherwise, the licensee is called for a personal hearing.
- In continuation, the e-signed license is printed and forwarded to the Dispatch clerk. Otherwise, after personal hearing, Warning/Suspension is issued to the licensee.
- The licensee shall collect the Renewal Certificate from Technical Section of Directorate of Food & Drugs Administration.
Documents to be submitted for Renewal of Wholesale Drug License
- Form-19 duly filled in by the applicant.
- Copy of the online generated receipt of the Challan for Rs. 3000 (Rupees Three Thousands) credited in Government account.
- Self-declaration/Affidavit on behalf of the applicant duly verified by the Notary Public (as per the prescribed language).
- Affidavit on behalf of the appointed qualified person duly verified by the Notary Public, where the applicant himself/herself is not a Registered Pharmacist or Competent person. (as per the prescribed language).
- Pharmacist’s Registration certificate and up to date renewal- duly issued by Pharmacy Council.
- In case of addition or alteration: Revised Site and Layout plan (to the scale floor and elevation plans including front and side) of the proposed premises clearly indicating the size of the shop, adjoining areas, details of the furniture and fixtures provided, location in the building, if any.
- In case of change in the premises: Proof of ownership/ possession of the proposed premises, i.e., Latest copy of the letter of allotment/Rent deed/agreement in case of allotted/ rented accommodation.
- Photo IDs such as Aadhaar, PAN, Voters card etc.
- Copy of the last Renewal Certificate
Drugs are very different from all other commodities due to which the Government has laid down stringent law and regulations. The drug license is provided to the wholesale business for regulating and governing the manufacturing and selling of drugs. Drug license is a permission granted by the competent authority under Drugs and Cosmetic Act, 1940 to carry out a business concerning drugs/medicines or cosmetics. To obtain the wholesale drug license, all the requisite requirements must be fulfilled.
Read our article:How to get a Manufacturing License of Drugs in India?