Tamil Nadu Drug License

Tamil Nadu Drug License

Tamil Nadu Drug License

In India, any business should possess an appropriate license to carry out its activities. Drug license is a legal permit issued by the Government to conduct businesses that deal with drugs and cosmetics. Drug license is region specific and location specific, i.e. each state requires a different license if the business operation occurs in two or more states and must acquire a separate license if sold at more than one place. The drug license includes a license for drug manufacturing and drug sale. In this article, we look at the procedure of obtaining Tamil Nadu Drug License in detail.

Drugs and Cosmetics Act, 1940

The Drugs Control Department regulates the manufacture and sales of drugs and Cosmetics under the Drugs and Cosmetic Act, 1940.  As per the act, the license covers all kinds of drug or cosmetic businesses including homoeopathic, allopathic drugs. Any person affected due to the negligence of the manufacturer or seller of the drug is considered an offence under the act.

Sales License for Tamil Nadu Drug License

The drug sale license issued covers both retail as well as the wholesale distribution of drugs in India. The issuance of a license for drug subjects to conditions attached with the competent person who deals with drugs and the premises (area of pharmacy shop and storage facility).

Pre-requisites of Area

The minimum area required for the premises are as follows.

  • Retail – 10 Sq. m
  • Wholesale – 10 Sq. m
  • Retail & Wholesale – 15 Sq. m
  • Storage facilities racks, refrigerator and A/C have to be provided.

Sale License Forms

 S.NCategorySale TypeApplication FormLicense Form
1.Drugs other than those specified in Schedule C&C (1)&XWhole Sale1920-B
Retail Sale1920
Restricted)19-A20-A
2.Drugs specified in Schedule C&C (1) but excluding those specified in Schedule ‘X’Whole Sale1921-B
Retail Sale1921
Restricted (General Store)19-A21-A
3.Drugs specified in Schedule ‘X’Whole Sale19-C20-G
Retail Sale19-C20-F
4.Homoeopathic MedicinesWhole Sale19-B20-D
Retail Sale19-B20-C

 Documents Required

  1. Covering letter to the Assistant Director of Drugs Control of the Concerned zone
  2. Form 19
  3. Authorization document signed by the authorized signatory
  4. Declaration form duly signed and filled by the applicant, pharmacist or the competent person.
  5. Details of premises
  • Ownership document of the premises
  • Rental agreement of the premises, if applicable
  • Plan of the premises signed by the licensed surveyors and the applicant.
  1. Pharmacist/ competent person’s details
  • Pharmacy council registration certificate
  • Education qualification certificate
  • Experience certificate of the competent person
  • Declaration of pharmacist/ competent person
  1. Applicant details:
  • Document relating to the constitution of concerned firm/ Company/ LLP and others.
  • If proprietor, a passport size photo , in case Partnership/ LLP- group photo (the file should not exceed 50 KB of size)
  • Applicant ID/ address proof
  • Legal tenancy affidavit
  1. Details of Storage Accommodation:
  2. In case of a change in premises or change in the constitution, enclose the following.
  • Original license
  • Documents related to change in the constitution like sale deed, reconstitution/dissolution deed,
  • Amalgamation court along with board resolution and any other document order if it is a Company.
  • Request to cancel the old license of the premises
  • If the existing license has obtained through online, then the change of premises/ change in the constitution should be applied through e-Sevai centre only.
  • If the license was issued before the launch of the online process then the application should be submitted manually in the concerned zone.
  • Purchase bills of A/C and refrigerator along with Working condition/Installation Certificate
  • Any other document or particulars to verify the correctness of the particulars submitted by the applicant if required.

For Duplicate License

  • Covering letter to the Assistant Director of Drugs Control of Tamil Nadu. The applicant should mention the intent of the application. Court fees stamp of Rs. 2/- .
  • License copy.
  • Any other document to verify the correctness of the particulars submitted by the applicant.

Fees

CategorySale TypeFees for fresh licenseFees for Duplicate License
Drugs other than those specified in Schedule C&C (1)&XWhole SaleRs.1500Rs. 150
Retail SaleRs.1500Rs. 150
RestrictedRs.500Rs. 150
Drugs specified in Schedule C&C (1) but excluding those specified in Schedule ‘X’Whole SaleRs.1500Rs. 150
Retail SaleRs.1500Rs. 150
RestrictedRs.500Rs. 150
Drugs specified in Schedule ‘X’Whole SaleRs.500Rs. 150
Retail SaleRs.500Rs. 150
Homoeopathic MedicinesWhole SaleRs.250Rs. 50
Retail SaleRs.250Rs. 50

 Renewal of License

The application forms and the fees for the renewal of license remain the same as for fresh license.

Approving Authority

The Assistant Director of Drugs Control of the Concerned zone

Processing Time

The time taken for the processing of application extends to 30 days from the date of submission.

Application Procedure for Tamil Nadu Drug License

Step 1: Visit the nearby e-Sevai Centre.

Step 2: Provide the requested details in the application form or the computer operator will fill the application on behalf of the applicant on the online system.

For Forms for respective sales or manufacturing license, click here.

Step 3: The operator at the e-Sevai centre will download the duly filled Form 19 ,and the applicant should sign and upload the same.

Step 4: On uploading the documents an application number will be generated.

Step 5: The applicant/ firm should pay the requisite fee. The confirmation will be intimated through SMS. Step 6: The applicant should send the hard copy of documents to the concerned Approving Authority through speed post or courier by quoting the application reference number

Step 7: The ADDC will scrutinise the application within three working days

If the application is complete, it will be forwarded to the Drugs Inspector for the inspection report.

In other cases, the the approving authority will request required particulars or documents from the applicant through the online system within 7 working days after which the application will be forwarded for the inspection report to the approving authority.

 Step 8:  The Drugs Inspector will upload his recommendation or remarks on the online portal after inspecting the premises.

Step 9: The applicant can download the license from e-Seva Centre after the receipt of the SMS alert.

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Post by Marlin Priya

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