Introduction
No person can start or continue a business of drugs or cosmetics in India without an appropriate license being obtained for the conduct of such activity. This license in India is granted by the competent authority under the Drug and Cosmetics Act 1940. The provision related to drug licenses in the Drug and Cosmetics Act 1940 is extended all over India.
To carry out a business dealing with drugs or cosmetics under the purview of the Drug & Cosmetics Act 1940, all types of drug or cosmetic business are covered, including allopathic, homeopathic, Ayurvedic, or Unani drugs. Maintaining the quality of drugs and cosmetics is the responsibility of all persons dealing with them. Any harm or damage occurred after consuming a 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 a drug license:
Commercial premises shall also obtain a drug license for the sale of drugs
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Mandatory for drug & cosmetic businesses
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The pharmacy business needs to comply with the condition of the license.
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The obtained license must be visible at a prominent place on the premises.
There are different types of drug licenses, 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 organizations issue two types of licenses, out of which one is the 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 another is a Wholesale Drug License (WDL), which is issued to a person who is engaged in the business of wholesale drugs and medicines.
Drug licenses are classified as follows:
1. Manufacturing License
To produce 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 the 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 resend the application. Due to incomplete information, the application got rejected, and 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. The application needs 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 printout 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 a drug license:
The minimum area to set up a medical shop or pharmacy is 10 square meters. In case the store business combines with retail & wholesale, then a minimum area of 15 square meters is required.
It is required to have a refrigerator and air conditioner on the premises because some drugs, such as vaccines, insulin injections, etc., need to be stored in the fridge.
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Technical Staff for drug license
- Offline selling of a drug: can only be carried out in the presence of a department licensed registered pharmacist who is needed in the retail shop during the working hours.
- 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 for 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 a notary public, in the 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 the 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., a document indicating the name of the notified commercial/mixed-use road/street.
9. The affidavit from the registered pharmacist/competent person (system generated)
For retail sale, a registered pharmacist should be:
a. Qualification proof that is a degree certificate/provisional certificate with mark sheets.
b. Registration Pharmacy Council,
c. Appointment Letter and Bio-data
For Wholesale License 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. (The 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. Forms 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 the Drug and Cosmetics Act 1940 & Part IV of the Drug & Cosmetics Rule, 1945, the import of drugs in India was regulated. As per the requirement of rule 24, A & 24 of the 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, the applicant needs to apply for an 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 proper medicine (if yes, provide related detail)
3. A copy of the Valid Registration Certificate for the import of a drug in bulk quantity
4. A copy of the Valid Form 10 License for the import of drugs in bulk quantity
5. A copy of the 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. SOP employed for assigning the shelf life to the product
9. Hold Time Stability data to justify the hold time period/transport duration/temperature excursions