Manipur Drugs Control Administration DCA - Directorate of Health Services

The Drugs Control Administration has been functioning under the provisions of Drugs and Cosmetics Act 1940, Drugs and Cosmetics Rules 1945 and Medical Devices Rules 2017 under Health Department, Government of Manipur at the Directorate of Health Services.

OBJECTIVES

1. Maintain quality, safety and efficacy of drugs, cosmetics and medical devices moving in the state. 2. Regulate manufacturing, sale, storage and distribution of drugs, cosmetics and medical devices. 3. Enforce the provisions of the said Act and Rules in any matters relating to drugs, cosmetics and medical devices in the State of Manipur.

DRUGS LICENCE

Drugs Licence is a permission granted by the competent authority / licensing authority under the provisions of Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules 1945 to carry out business concerning drugs/medicines, cosmetics and other related items. In other words, no person can start or continue a business dealing with drugs and related items in India, unless an appropriate licence is obtained for the conduct of such activity.

Checklist for Issue of Retail or Whole Sale Drugs License

Competent Person/ Pharmacist

The medicines need to be handled with by a specialist, and for that matter, there is a requirement of a qualified pharmacist in case of retail drug license and in case of wholesale a graduate with 3 years experience or undergraduate having 5 years experience is must.

Area of Pharmacy Shop

For opening a pharmacy business, the carpet area of the pharmacy must be a minimum of 10 square meters, and in case the application is for both retail and wholesale pharmacy the minimum area prescribed in 15 square meters. The premises must be adequately ventilated.

Storage Facility of Drugs

Medicines need to be stored at a clean, ventilated and cool storage facility, since some drugs, in particular, the vaccines need to be stored in a low-temperature freezing zone. Hence, facility of a refrigerator and air conditioner is essential for grant of a drug license in India.

Inspection by Drug Inspector

Before the grant of a drug license, the drug inspector having jurisdiction of the area visits the premises where drug license is required and verify the particulars furnished with the application and if required take measurement of the premises and also interview the competent person.

CHECK LIST FOR DRUGS LICENCE

Wholesale Drugs Licence

(In Form 20-B, 21-B, 20-G)

1. Prescribed Form 19 , as per Drugs & Cosmetics Rules,1945.
2. Recent Passport size photograph of proprietor.
3. Uppermost Qualification Certificate (Atleast XII passed).
4. Residential Certificate [From concerned SDC / Domicile Certificate (From concern DC)] or Aadhaar card.
5. Unemployment Certificate (From Employment Exchange).
6. Affidavit of proprietor or partner before Oath Commissioner.
7. Site / Location map of the sales premises (Rough sketch or Google Map).
8. Ownership Jamabandi or lease agreement deed of premises.
9.Experience Certificate from a licensed wholeseller / retailer.
10. Certificates of Registration and Licensing of Shop from Municipal Councils.
11. PAN Card.
12. Bank account details for proprietor (Passbook showing name, account no, upto date balance in xerox copy).
13. Detail report and recommendation of the concerned Drugs Inspectors /Chief Medical Officer of the districts in Form 35 as per Drugs & Cosmetics Rules 1945 [After submission].
14. Licence registration fee of Rs. 6000/- for five years.

Retail Drugs License

(In Form 20, 21, 20-F)
(Proprietor + Regd. Pharmacist)

1. Prescribed Form 19 , as per Drugs & Cosmetics Rules,1945.

Other requirements for both A. Proprietor and B. Qualified Person

2. Recent Passport size photograph of proprietor.
3. Uppermost Qualification Certificate (Atleast XII passed) for A and Diploma/Degree certificate for B.
4. Residential Certificate [From concerned SDC / Domicile Certificate (From concern DC)] or Aadhaar card both for A and B.
5. Unemployment Certificate (From Employment Exchange) both for A and B.
6. Affidavit of proprietor or partner before Oath Commissioner for A only.
7. Site / Location map of the sales premises (Rough sketch or Google Map).
8. Ownership Jamabandi or lease agreement deed of premises.
9. Experience Certificate from a licensed wholeseller / retailer.
10. Latest copy of registration certificate for pharmacist for B only.
11. Certificates of Registration and Licensing of Shop from Municipal Councils.
12. PAN Card for both A and B.
13. Bank account details for proprietor (Passbook showing name, account no, upto date balance in xerox copy).
14. Detail report and recommendation of the concerned Drugs Inspectors /Chief Medical Officer of the districts in Form 35 as per Drugs & Cosmetics Rules 1945 [After submission].
15. Licence registration fee of Rs. 6000/- for five years.

Note: All Documents in PDF format scanned in GRAY scale.

After the documents are submitted the inspection is carried by the local drug authority for the accuracy and correctness of detail submitted with the application

Our Location

Directorate of Health, Lamphelpat
Imphal West, Manipur - 795 001

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Opening hour

Mon-Fri (10.00-04.00)
Sat-Sun (Closed)

Drop a message

controller@manipurdrugscontrol.in
0385-2410338

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