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Licensing Services
 

Drug License

Food and Drug Administration grant Drug license, and ensure following points.

To ensure safety, efficacy, purity and quality of Drugs.
To prevent consumers from self-medication.
To ensure availability of drugs at authorised prices.
To create an awareness about the importance of proper storage
  of drugs.
To eliminate irrational combinations /banned drugs.
To study the problems and suggestions made by the stakeholder.
To collect the information in general about the drug trade and
  take necessary steps.
To prepare policy regarding drug matter.
To prevent misuse of Narcotics drugs.

Drug includes –

All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes
Such substances (other than food ) intended to affect the structure or any function of the human body or intended to be used for the destruction of [vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette

• All substances intended for use as components of a drug including empty gelatin capsules.
• Drugs regulated
• Allopathic Drugs
• Ayurvedic Drugs
• Homeopathic Drugs
• Unani , Siddha Medicines
• Blood, Blood components, Blood Products
• For the sale of Ayurvedic Drugs and Cosmetics no sale license is required.

Following Documents
Are required for allopathic drugs in form 20B & 21 B

Application in Form No: 19.

Additional information form (With Competent Person’s present photograph)
T.R. Challan No: 7 showing Licence fees of Rs. 3000/- (For Biological & Non – Biological Licences) deposited at R.B.I. / S.B.I. Main branch.
XEROX COPY OF HOUSE RENT BILL (In case of rented shop premises), with full signature of House owner.
Xerox copy of House Tax Receipt (Issued by local Municipality / Government Tax
Receipt issued by B.L.R.O.) in case of Panchayat area
Xerox copy of Purchase record of Refrigerator in the name of the proposed firm, with full address.
Appointment letter of competent person (as per format affixed on Notice Board)
Xerox copy of experience certificate issued by Drug Licenced firm with attestation of the signature of experienced salesman by the proprietor of the said licensed firm.
If the candidate is Graduate with minimum 1 (One) year experience after passing the last examination as salesman is required and in case of under graduate but Madhyamik passed persons 4 years experience (joining date & release dates are to be mentioned) after passing the Madhyamik examination is required.
Academic qualification Certificate (Xerox Copy).
Date of birth certificate / Affidavit of experienced person (competent person)
Affidavit of competent person (format affixed in Notice Board)
Partnership deed (copy) in case of partnership firm (if registered no other papers are required)
Copy of receipt of Registration of firms (In case of Partnership firm)
List of Directors ( In case of Limited, or Private Limited, Company)
Memorandum of Article of Association ( In case of Limited or Private Limited, Firm).
Copy of extract of resolution taken in the meeting of Board of Directors of the company regarding start of business in drugs & to appoint authorized Signatory
(In case of Limited or Private Limited, Company.)
Affidavit of Proprietor / Partner / Director (as per format affixed on Notice Board)
Sketch plan with actual dimensions, surroundings and signature of Proprietor / Partner / Director of the proposed firm. Any other relevant paper which will be required during inspection. An affidavit as stating that applicant will be liable for any false, misleading or counter fit paper if detected during processing or after granting license.

The Requirements of Sales premises are as follows:

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
following is the requirement for Wholesale drug license.
Required area of the proposed business premises – 108 Sq. Ft. (Carpet Area)
Required ceiling height – 8`2” minimum.
The premises shall be brick built, plastered floor cemented with R.C.C. roofing.
The proposed premises should be completely separated with completely separate and identical entrance (No residential common passage will be allowed)
House owner of the proposed premises should sign himself in full, in the rent bill.
Address of the firm must be same as in House Tax Receipt in all related papers.
Items No: 9,10 & 11 are to be verified by the P.R.O. / Head Assistant of this office before submitting the application.
Mob : +91-9022060498 E-mail : info@legalbabu.com
 
 
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