Growing a pharma business requires a strategic approach considering the specific context of your company and the pharmaceutical industry as a whole. Here are some general pointers to get you started: Market and Customer: Identify your target customer: Deeply understand the specific needs and challenges of your target audience, whether it's doctors, patients, hospitals, or other healthcare providers. This helps tailor your products, services, and marketing efforts. Focus on unmet needs: Look for gaps in the market where existing solutions are inadequate or unavailable. Addressing unmet needs can give you a competitive edge and drive innovation. Track market trends: Stay updated on regulatory changes, technological advancements, and emerging diseases to adapt your approach and anticipate future opportunities. Products and Services: Invest in R&D: Develop innovative products or differentiate existing ones through unique formulations, delivery methods, or combinations. Remember
In this article, we will discuss about how you can apply for wholesale drug license and retail drug license. In last we will also discuss, how you can renew/retain tour drug license to continue your medicine profession.
Documents, area and procedure are almost same for retail drug license and wholesale drug license, only difference in competent technical staff. For wholesale drug license, competent staff qualification and experience is either registered pharmacist or graduate in any stream with one year experience in selling of drugs at wholesale drug firm where as for retail drug license, competent person shall only be a registered pharmacist.
Check: How to be registered as pharmacist in India?
1. Requisite Application Form
2. User can pay fee Online through Net Banking/Debit Card/Credit Card and can also download the challan and can pay the fees.
3. Receipt for the fees of Rs. 3000/- paid or challan, as the case may be or their attested copies.
4. Layout plan of premises, blue print signed by owner and applicant where license is applied in 3 copies
5. Documents viz. rent receipt, purchase documents or its attested copies showing lawful possession of the premises
6. Documents relating to the constitution of the firm viz. Partnership-deed, memorandum and article of association etc. and their affidavits w.r.t. non conviction
7. Full particulars of the competent technical staff /registered pharmacist along with copies of their educational qualification, experience and registration certificates from State Pharmacy Council
8. Full name of the proprietor or the partners, as the case may be shall be provided in the application. In case of private or public limited concerns, full name of the Directors who sign the application and the authorized signatory, if any, shall be provided in the application.
9. Purchase voucher of Refrigerator/Deep freezer (For Vaccines / Sera).
10. Affidavit of authorised signatory if any
11. Copy of resolution of Board of Directors for Authorised Signatory
12. After receipt application along with required documents, the same is forwarded to DCO of the concerned District for scrutiny and inspection.
Food and Drug Administration of concern state Grants Drugs Licenses for Retail & Wholesale as per the provisions of Drugs Cosmetics Act1940 & Rules 1945 for the sale of Allopathic, Homeopathic drugs in Form 20, 21, 20B, 21B, 20A, 21A, 20C, 20D, 20F, 20G, 20BB, 21BB.
For the sale of Cosmetics no sale licence is required.
Read: How to start medicine distribution business in India?
Read: How to start pharmacy business in India?
Stage 2: The application is scrutinized and premises is inspected by DCO of the Concerned District and the report is forwarded by DCO along with his recommendation to SDCO of the Zone and during inspection DCO should verify all facilities provided and documents uploaded by the applicant.
Stage 3: Grant of Licence
If all conditions as prescribed by the Act are complied, licence is granted by SDCO-cum-Licensing Authority (Retail/wholsale) and applicant gets information through SMS /email
Read: How to start E-pharmacy business in India?
2. The license retention fee shall be equivalent to the respective fee required for the grant of such license excluding inspection fee paid for grant of license.
3. If the licensee fails to pay license retention fee on or before the due date, he shall be liable to pay license retention fee along with a late fee calculated at the rate of two percent of the license fee for every month or part there of up to six months, and in the event of non-payment of such fee, the license shall be deemed to have been cancelled.
4. Licensee at the time of submission of license retention fee should submit an undertaking that (a) there is no change in constitution (b) there is no change in premises (c) there is no change in approved technical staff (d) list of already approved items and required fee which firm intends to retain.
5. Validity certificate on receipt of license retention fee shall be issued forthwith if full fee in all respect is deposited.
Documents, area and procedure are almost same for retail drug license and wholesale drug license, only difference in competent technical staff. For wholesale drug license, competent staff qualification and experience is either registered pharmacist or graduate in any stream with one year experience in selling of drugs at wholesale drug firm where as for retail drug license, competent person shall only be a registered pharmacist.
Check: How to be registered as pharmacist in India?
Checklist of documents required for drug license:
Documents to be uploaded or submitted along with the application form:
Scanned documents are to be uploaded and hard copies of documents are to be handed over to Inspecting Officer/Drug Control Officer during the Inspection:1. Requisite Application Form
2. User can pay fee Online through Net Banking/Debit Card/Credit Card and can also download the challan and can pay the fees.
3. Receipt for the fees of Rs. 3000/- paid or challan, as the case may be or their attested copies.
4. Layout plan of premises, blue print signed by owner and applicant where license is applied in 3 copies
5. Documents viz. rent receipt, purchase documents or its attested copies showing lawful possession of the premises
6. Documents relating to the constitution of the firm viz. Partnership-deed, memorandum and article of association etc. and their affidavits w.r.t. non conviction
7. Full particulars of the competent technical staff /registered pharmacist along with copies of their educational qualification, experience and registration certificates from State Pharmacy Council
8. Full name of the proprietor or the partners, as the case may be shall be provided in the application. In case of private or public limited concerns, full name of the Directors who sign the application and the authorized signatory, if any, shall be provided in the application.
9. Purchase voucher of Refrigerator/Deep freezer (For Vaccines / Sera).
10. Affidavit of authorised signatory if any
11. Copy of resolution of Board of Directors for Authorised Signatory
12. After receipt application along with required documents, the same is forwarded to DCO of the concerned District for scrutiny and inspection.
Food and Drug Administration of concern state Grants Drugs Licenses for Retail & Wholesale as per the provisions of Drugs Cosmetics Act1940 & Rules 1945 for the sale of Allopathic, Homeopathic drugs in Form 20, 21, 20B, 21B, 20A, 21A, 20C, 20D, 20F, 20G, 20BB, 21BB.
For the sale of Cosmetics no sale licence is required.
Read: How to start medicine distribution business in India?
The Requirements of Sales premises for drug license:
Minimum carpet area
- For Retail sale: 10 square meter
- For Wholesale: 10 square meter
- For Retail - Wholesale together: 15 square meter
Storage Facilities
Adequate storage facilities including cupboards with glass doors, racks refrigerator is required.Read: How to start pharmacy business in India?
Procedure to obtain Retail & Wholesale Drug License (Fresh)
Stage1:The Applicant has to apply online to the Senior Drug Control Officer cum Licensing Authority of the Zone & the following documents to be uploaded Online to the SDCO. Fee the user can pay fee Online through Net Banking/Debit Card/Credit Card and can also download the challan and can pay the Fee. The applicant has to make application in the requisite Form viz 19, 19A,19B, 19AA. The details of Forms and fees are given in fee chart in Appendix A. The fee can also be paid through challan at Government Treasury, under Head of Account- ----- - Medical and Public Health. ------- Public Health. ------- - Fees and Fines, etc.Stage 2: The application is scrutinized and premises is inspected by DCO of the Concerned District and the report is forwarded by DCO along with his recommendation to SDCO of the Zone and during inspection DCO should verify all facilities provided and documents uploaded by the applicant.
Stage 3: Grant of Licence
If all conditions as prescribed by the Act are complied, licence is granted by SDCO-cum-Licensing Authority (Retail/wholsale) and applicant gets information through SMS /email
Read: How to start E-pharmacy business in India?
Procedure for Retention of Drug Selling Licence:
1. Govt. of India vide its notification no. GSR-1337 dated 27.10.2017 has omitted the word "Renewal" and instead of renewal procedure of license retention by the licensee, “ïf the licensee deposits a license retention fee before the expiry of a period of every succeeding five years from the date of its issue, unless, it is suspended or cancelled by the Licensing Authority”.2. The license retention fee shall be equivalent to the respective fee required for the grant of such license excluding inspection fee paid for grant of license.
3. If the licensee fails to pay license retention fee on or before the due date, he shall be liable to pay license retention fee along with a late fee calculated at the rate of two percent of the license fee for every month or part there of up to six months, and in the event of non-payment of such fee, the license shall be deemed to have been cancelled.
4. Licensee at the time of submission of license retention fee should submit an undertaking that (a) there is no change in constitution (b) there is no change in premises (c) there is no change in approved technical staff (d) list of already approved items and required fee which firm intends to retain.
5. Validity certificate on receipt of license retention fee shall be issued forthwith if full fee in all respect is deposited.
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