Skip to main content

Best Ayurvedic Company in India

First step need to take For Starting a Pharmaceutical Company

Query: I am a veterinarian by profession. Have been going through your website from past 1 year and have planned now to give a start to my own pharma company. Please let me know what will be the first step I need to take.  Answer: First Step you need to prepare yourself for Pharmaceutical Company:  Preparation means Choose marketing type, Choose molecules want to launch, Location where you want to launch product, Choose Company, Products Name, Budget available...  Choose marketing type: As number of marketing and selling types present in pharmaceutical market. i.e. Branded Marketing , Generic Marketing , OTC Marketing, Franchise Marketing etc. You need to select any one from above.  Choose Molecule: Once you have selected which marketing type is best suitable for you then you need to select at which segment and molecules you want to work. Check out: How to choose products/service for business? Location: You can't launch your pharmaceutical company all over India or at broad area.

How to apply and renewal for Drug license (Wholesale/Retail)?

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?

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.

Comments

Register your business at

Find pharmaceutical, cosmetics, nutraceutical, ayurveda and alternative medicine's distributors, franchise, suppliers query for free.

If you want to take distribution, franchise or associates with any pharmaceutical, cosmetic or ayush company then you can find it here...

Send Your Query

Popular posts from this blog

What are the Schedules under Drug and Cosmetic Act, 1940 & Rules 1945?

Schedules are the set of provisions for classifications of drugs, forms, fees, standards, requirements and regulations related to drugs and cosmetics under Drug and Cosmetic Act, 1940 and Rules, 1945. Here drugs includes pharmaceutical, Ayurvedic (including siddha), unani and tibb system of medicines, homeopathy etc. Schedules are divided alphabetically and named also alphabetically like Schedule A, Schedule B etc till Schedule Y. Schedule Z is proposed  but not implemented yet. Schedules are important part of Drug and Cosmetic Act 1940 & Rules, 1945 . Every schedule contains specific information as discussed below. Schedule A:  Schedule A  describes application forms and licenses types. Schedule B:  Schedule B  describes Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories Schedule B1: Schedule B1 describes fees for the test or analysis by the pharmacopoeial laboratory for indian medicine (plim) or the government analyst Schedule C: 

State Pharmacy Council, Its Constitution and Composition and Functions

State Pharmacy Council: State Pharmacy Council is constituted as per the Pharmacy Act, 1948 & State Pharmacy Rules, 1951. State Pharmacy Council is an authoritative council to regulate Pharmacy Act, 1948 & State Pharmacy Rules, 1951. State Pharmacy Council means a State Council of Pharmacy constituted under section 19, and includes a Joint State Council of Pharmacy constituted in accordance with an agreement under section 20 under the Pharmacy Act, 1948 & State Pharmacy Rules, 1951. State Pharmacy Council work under Pharmacy council of india . The State Pharmacy Council consists of the following: (i) Six members, elected from amongst themselves by registered pharmacists (ii) Five members, of whom three are persons possessing a prescribed degree or diploma in pharmacy or pharmaceutical chemistry or registered pharmacist, nominated by State Government (iii) One member, elected from amongst themselves by the members o

Pharmacy Council of India, Its Constitution and Composition and Functions

Pharmacy Council of India: The Pharmacy Council of India is the statutory body of government of India also called as central council constituted under the Pharmacy Act, 1948. The Pharmacy Council of India consists of the following: (i) Six members, among whom at least one teacher of pharmaceutical chemistry, pharmacy. Pharmacology and pharmacology elected by the University Grants Commission. (ii) Six members, four of whom are persons possessing a degree or diploma in and practicing pharmacy or pharmaceutical chemistry, nominated by the Central Government. (iii) One member elected from amongst themselves by the members of the Medical Council of India. (iv) The Director General of Health Services or an authorized person by him. (v) The Drugs Controller of India or an authorized person by him (vi) The Director of Central Drugs Laboratory (vii) A representative of the University Grants Commission