Last updated: September 16th, 2024 6:10 PM

Arunachal Pradesh Drug License

Drug license is a legal document/ certificate which is required to do businesses related to the pharmaceutical industry, drugs & cosmetics. Arunachal Pradesh drug license is issued by the Food Safety and Drug Administration Department of the Arunachal Pradesh State Government. The Drugs Control Administration regulates the manufacture, sale and distribution of drugs in the state of Arunachal Pradesh by implementing relevant central Drug and Pharmaceutical legislation in the state. In this article, we look at the procedure for obtaining Arunachal Pradesh drug license.

Drugs and Cosmetics Act, 1940

This Act governs and regulates the import/ export, manufacture, distribution and sale of drugs and cosmetics, and clinical Research of Drugs and Cosmetics through licensing in India. It also assures that the drugs and cosmetics that are sold in India is safe, conforms and effective to state quality measures. This Act aims to set Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC) for allied and Allopathic drugs and cosmetics.

Eligibility Criteria

Any individual, partnership firm, group of persons or company willing to open a wholesale medical or retail medical store outlets, has to get a drug license from the Inspector of drugs within its jurisdiction. The person will have to live with an independent shop with an adequate value of the area to get permission for wholesale or retail Drug License.

Conditions for Granting Drug License

There are 2 kinds of drug license, the wholesale license and retail license for drug sale or distribution in India. For obtaining a new drug license, there are specific conditions that the applicant will have to follow.

• The area in premises of which a wholesale or retail license is to be granted must not be less than 10 sq meters.
• In respect of the application form for the grant of drug license in Form 19 individually or both, the licensing authority will satisfy itself that the premises of an area of not less than 10 meters.
• In respect of the application form for the grant of drug license n Form 19 individually or both, the licensing authority will satisfy itself that the premises of an area of not less than 15 meters.

Documents Required

The below listed are the records/ documents to be submitted by the applicant along with the application for grant of new Retail/ Wholesale License.

• Covering letter mentioning the details of the documents submitted.
• Application in respective Form- 19, 19B, and Form 19C dully filled and signed.
• Additional information data form duly filled and signed.
• Court fee stamps to be fixed on each application.
• e-Challan for Rs. 3000/- along with the details specified on the list attached, an additional fee of Rs. 250/- for homoeopathic license and Rs. 500/- for schedule X license (if requested).
• Blue Print plans of the premises drawn to scale
• Site plan of the premises on a blueprint.
• Certified copy of Lease Deed (if rented)
• Ownership Documents (if owned)
• Certificate copy of partnership deed (if in partnership firm)
• Description of the premises, with all details.
• Occupancy certificate (attested)
• House tax receipt (attested)
• NOC from the Municipality/ Panchayat (attested)
• Certificate copy of qualification certificates of registered pharmacist/ Competent person
• Certificate copy of Registration Certificate of the registered pharmacist issued by GSPC.
• Experience certificates of the registered pharmacist/ Competent person
• Appointment letter by the registered pharmacist/ Competent person
• Self-declaration from regarding sale of drugs
• Bio-data of the applicant mentioning the details of DOB, experience and details of occupation for the previous five years.
• Certified copy of power of attorney of the applicant (if applicable)
• Copy of refrigerator invoice
• Identity card copy of Proprietor/ Partners/ Directors/ Registered Pharmacists/ Competent persons.

Note: The carpet area required for the wholesale/ retail premises minimum is 15sqmts. The height required is 2.5 sq. meters. The applicant must obtain a book from the directorate by paying the necessary fees of Rs. 50/- on the grant of the license at the time of issuance of the license. These are the documents to be submitted for the manufacturing Pharmaceutical Products.

• Covering Letter
• Application Form with a non-judiciary stamp of Rs. 2/-
• For Non-Biological Products
• Form 27/ 27A/ 27B/ 27D
• Site Master File
• Challan in original, indicating the paid license fee.
• Two copies of the site plan.
• List of machinery, instruments/equipment in quality control.
• Names of the competent technical staff
• NOC from Pollution Control Board
• List of Directors/ Partners of the firm
• Clearance from Drug Controller General
• Label text of the identical product available in the market.
• Copy of the documents indicating ownership, rental, lease title of the plot.

Renewal of Drug License

• Online deposition of fees via treasury portal.
• Tenancy or house rent agreement document by notary/ NOC for a further period of minimum 5 years.
• Resolution of Board of Directors
• Declaration of the firm regarding the changes
• Additional Requirement in Case of Loan License
• Consent letter from the Principal manufacturing unit
• Self-declaration of a competent individual in a prescribed format with signature and date.
• A valid drug license record of manufacturing unit
• The Drug production capacity for which applied for loan drug license
• Copy of GMP if any

Application Procedure for Drug License – Offline Mode

The applicants have to follow the given steps to obtain a Manufacturing Drug Licences by submitting the application form offline.

Approach the District Head Office

Step 1: The applicant can visit the respective district offices/ head office to apply for the Drug license.

Get Application Form

Step 2: You have to get only the prescribed application form according to your License Category from the concerned officials. You must get the Form 24 respectively along with additional information data. Note: You may also download the application form in the official web portal of FDA Arunachal Pradesh. The copy of the application Form 19 of manufacturing drug license is given below for your ready reference:

Fill in the Right Credentials

Step 3: You need to fill in the application form with all the mandatory details. Step 4: Now you have to attach the duly filled additional forms to your License Category for which you have applied.

Attach Required Documents

Step 5: After that, you have to attach all the necessary documents as prescribed in the above checklist. Step 6: Once all the documents are attached, you must verify the certificates/ documents from area Drugs Inspector or any Drugs Inspector of Food & Drugs Administration.

Make Payment

Step 7: Now you have to pay the prescribed fee (challan) in the office as per the fee structure tabulated above. Step 8: To generate e-Challan you need to fill the challan form available with the department for requisite fees and get it verified from Drugs Inspector.

Submit the Application Form

Step 9: Now you need to submit the application along with requisite documents and original copy of challan to the Assistant Drug Controller (ADC) at the relevant District Drugs Control Office of your area. Step 10: After submitting the application form, collect the acknowledgement receipt that can be used later to check the status of the application form.

Renewal of License

You can apply for the renewal of drug license in the concerned authority. You have to submit the renewal form along with the requested documents. Then the process of renewal will be completed upon the payment.

Validity of Licence

Drug Licenses are valid up to 5 years from the issue of licence subject to the conditions specified in the licence and to the provisions of the Drugs & Cosmetics Act.