Drug License

Introduction

No person can start or continue a business of drugs or cosmetics in India without an appropriate license is obtained for the conduct of such activity. This license in India is granted by the competent authority under the drug and cosmetic act 1940. The provision related to drug licenses in drug and cosmetic act 1940 is extended all over India.

To carry out a business dealing with drug or cosmetic under the purview of drug & cosmetic act 1940 all type of drug or cosmetic business is covered including Allopathic, Homeopathic, Ayurvedic or Unani drugs. Maintaining the quality of Drugs and cosmetics is the responsibility of all persons dealing with it. Any harm or damage occurred after consuming drug or cosmetic and it's proved that the damage was due to the negligence of the manufacturer or seller, it is categorized as the offense, which is tribal as an offense of grievous hurt under IPC.

To start a business of drugs and cosmetics in India it is mandatory to obtain a drug license.  The basic feature of drug license:

• Mandatory for drugs & cosmetic business
• Commercial premises shall also obtain a drug license for the sale of drugs.
• The pharmacy business needs to comply with the condition of the license.
• The obtained license must be visible at a prominent place of premises.

There are different types of drug license and it depends on the kind of business activity. For obtaining the drug license, an application is required to be submitted by the applicant to the drug controller.  The application must contain correct information along with the necessary documents as per the guidelines of the drug & cosmetic rule. Prior to applying for obtaining a drug license, the applicant should contact the duty officer at the mail receipt counter of the Drug Control Department for any guidance or information.

Drug control organization issues two types of license, out of which one is Retail Drug License (RDL) to run a chemist shop. It is issued to only those persons who possess a degree or diploma in pharmacy from a recognized university. And other is Wholesale Drug License (WDL) which is issued to a person who is engaged in the business of wholesale drugs and medicines.

Drug license is classified as follows:

1. Manufacturing License-To produces allopathic or homeopathic drugs and cosmetics can be granted only in recognized industrial areas.

2. Selling License- further, it is categorized into:

a. Retail Drug License

b. Wholesale Drug license

General Instructions

1. Obtain user ID and Password by giving a request letter in person with the details of the firm.

 2. All the documents should be scanned in 100 dpi & black and white, and then should be uploaded using the said ID and Password at space provided for the purpose.

3. Please show all the original documents to the inspector at the time of inspection.

4. Please be sure that, all the information is filled precisely for the respective application mentioned below and only then re-send the application. Due to incomplete information application got rejected then application paid fees will be forfeited.

5. Authority may ask for further clarification or other specific documents as per requirement.

6. These guidelines are subject to change as and when required and will be notified from time to time.

7.  Application need to be digitally signed by the applicant

8. If the proprietor/ partner is changed, it will be treated as a ‘change in the constitution’ and the applicant will have to obtain a fresh license.

9. After the grant or rejection of your application, you will receive an SMS about the same. Take a print out of the fresh license and renewal approval/rejection option from 'Print License' and click 'MISC approvals' for further approvals within 3 days. With the valid e-signature and official seal, you will obtain licenses/approvals.

10. Registered Pharmacists are also required to update their details by obtaining a separate password.

Here are the following requirements for obtaining drug license:

• Area

The minimum area to set up a medical shop or pharmacy is 10 square meters. In case store business combination with the retail & wholesale then the minimum area of 15 square meters is required.

• Storage

It is required to have a refrigerator and air conditioner on the premises because some drugs such as vaccines, insulin injections, etc. are needed to be stored in the fridge.

• Technical Staff 

1. Offline Selling of a drug: can only be carried in the presence of a department licensed registered pharmacist who is needed in the retail shop during the working hours.
2. Wholesale: Sales can be made by either a licensed pharmacist or another qualified person who must be a graduate with one year of experience in drugs or in the presence of someone who has passed S.S.L.C with four years of experience in drugs, specifically approved by the Department of Drug Control.

Documents

Documents required Fresh Application of Retail/Wholesale license :

1. Online fee deposit receipts.

2. Application Form No. 19/19A/19B/19C as applicable (System Generated)

3. Layout plan and key plan of the premises.

4. Constitution of the firm viz: Memorandum and articles of association and Copy of resolution Passed, in case of the company. Deed of partnership, duly attested by Notary Public, in case of the partnership firm. Trust deed, in case of trust/society.

5. Photo ID proof of proprietor/partner/director of the firm.

6. Affidavit regarding non-conviction of Prop./Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.

7. Affidavit regarding the compliance of MPD 2021.

8. Registration / Conversion charge /Parking charge receipt issued by MCD with relevant documents in support of commercial use as per MPD 2021 viz; document indicating the Name of notified commercial / mixed-use road/street.

9. The affidavit from the Regd. pharmacist/competent person (System Generated)

For Retail Sale Registered Pharmacist should be:

a. Qualification Proof that is Degree certificate / provisional certificate with mark sheets.

b. Registration Pharmacy Council,

c. Appointment Letter and Bio-data

​For Wholesale Licence Pharmacist person:

a. Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets

b. Experience Certificate,

c. Appointment Letter, and Bio-data.

For Manufacturing License

Application for grant or renewal of Drug Manufacturing license. ( application should be made in form 24/ 27)

Required Documents are:

1. Covering letter along with payment of application fee

2. Self-assessed checklist of documents

3. Form 24 & 27

4. Product list

5. List of excipients

6. Similar product

7. Draft label

8. Methods of analysis

9. Additional information form

10. Copy of memorandum of articles

11. List of directors with their address

Import of drug

Under chapter III of drug and cosmetics act 1940 & Part IV of Drug & Cosmetics rule, 1945 regulated the import of drugs in India. As per the requirement of rule 24, A & 24 of drug and cosmetics rule 1945 the application is processed.

The applicant needs to get registered first through form-40 and registration will remain valid for 3 years and after obtaining registration applicant needs to apply for import license in form 8.

Documents required:

1. Cover Letter clearly stating the intent of application duly signed by the applicant

2. As per Rule 37, whether the Drug is patent and propriety medicine (if Yes provide related detail)

3. A copy of Valid Registration Certificate for import of drug in Bulk quantity

4. A copy of Valid Form 10 License for import of drug in Bulk quantity

5. A copy of Valid Manufacturing License for the activity performed, viz., Filling/Packing/Labelling

6. Original labels for Bulk Container

7. Original labels for an innermost and outer carton of the finished formulation

8. S.O.P employed for assigning the Shelf Life to the product

9. Hold Time Stability data to justify the hold time period/transport duration/temperature excursions