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Shruti Gupta
| Updated: 03 Apr, 2020 | Category: Drug License, Government Registration

Drug License in India – Basic Requirements, Types & Procedure

Types of Drug Licenses

Drug license has to be attained by those who are engaged in the import, manufacture, and distribution of drugs in India under the Drugs and Cosmetics act, 1940[1].

The drug includes all medicines and devices which are made for internal or external use for diagnosis, treatment, mitigation, destruction, or prevention of any disease in human beings or animals.

This act was amended in the year 1964[Drug (Amendment) Act 1964] to include AYURVEDIC AND UNANI DRUGS.

What is a Basic Requirement for Drug License?

Following are the requirements for obtaining a Drug License in India:

Area  – The minimum area required is

  • In wholesale and Retail -minimum 15 square meters
  • In other cases -minimum 10 square meter

Storage facility – It is mandatory to have a refrigerator and air conditioner on the premises in order to store those drugs which require the cold storage area.

Technical Staff

Wholesale –There must be a registered/competent pharmacist or graduate with one year experience in dealing with drugs or a person who has passed S.S.L.C. with four years experience in dealing with drugs, specially approved by the department of drug control.

Retail – There must be a registered/competent pharmacist approved by the department, and that registered pharmacist is required throughout the working hours.

How to apply for a Drug License?

Following steps have to be followed to apply for drug license:-

  • Valid and active email id and mobile number of the applicant should be there for the process of applying for drug license.
  • Register on Online Drug Store Registration & Licensing System.
  • The spelling of the name of the applicant should be spelled correctly in the application as it appears in the license.
  • After successful registration, the system will generate a unique Registration Number for each and every application, which will be used for further processing and reference.
  • The printout of the “Forms” will be taken out and attach the fee challan and supported documents (which will differ from case to case) required as part of the application and submit the application in the District Licensing Authority Office, within 15 days from the date of submission of online application.

Types of Drug Licenses

There are five types of drug licenses:-

  • Manufacturing Drug License    
  • Sale Drug License       
  1. Retail Drug License
  2. Wholesale Drug License
  3. Restricted Drug License                                                   
  • Import Drug License  
  • Loan Drug License   
  • Multi-Drug License

Manufacturing Drug License in India

Manufacturing Drug Licence is to be attained by the manufacturers of Allopathic/Homeopathic medicines, cosmetics, and to repack the drugs.

Documents required for grant or renewal of Manufacturing Drug Licence

  • Covering letter along with payment of application fee.-1 copy
  •  Self Assessed checklist of documents –1 copy
  •  Form 24 & 27 (Maximum 10 Products should apply under each form)- 1 copy (http://fsdaup.gov.in/manufacturing-licence.htm)
  •  Product List.  –2 copies
  •  List of Excipients-1 copy
  •  Similar Product-1 copy
  •  Draft Label- 1 copy
  •  Method of Analysis. – 1 copy
  •  Additional Information Form. – 1 copy
  • Certificate of Incorporation, Memorandum of Association and Article of Association(in case of the company, partnership deed(in case of the partnership firm), LLP agreement (in case of the Limited Liability Partnership Firm)-1 copy
  •  List of Directors with address- 1 copy
  •  Copy of Power of attorney to sign the documents.- 1 copy
  •  Copy of Plan approval –1 copy
  •   Non- Objection Certificate/Consent from SSI, Pollution-1 copy

Documents required for grant or renewal of Ayurvedic Manufacturing Licence

  • Covering letter along with payment of application fee. – 1 copy
  • Self Assessed checklist of documents – 1 copy
  • Form 24-D (Maximum 10 Products should apply under each form) – 1 copy
  • Product List. – 2 copies
  • List of Excipients – 1 copy
  • Similar Product.   – 1 copy
  • Draft Label. – 1 copy
  • Method of Analysis.  –1 copy
  • Copy of Memorandum of Articles- 1 copy
  • List of Directors with address –1 copy
  • Copy of Power of attorney to sign the document.-  1 copy
  • Copy of Plan approval –1 copy
  • Noc/Consent from SSI, Pollution.- 1 copy

Sale Drug License

Sale Drug License is availed by those who are engaged in the business of selling the drugs, whether in wholesale or retail.

Read our article: How to Obtain Drug License in India?

What is the process of a department to Issue a Sale Drug Licence?           

The process followed by the department is:-           

  • Online User Registration and Submission of Form
  • Application Received in Drug Inspector Office 
  • Application Scrutiny by Drug Inspector
  • Discrepancies in application
  • Application is correct
  • Premises inspection by Drug Inspector & Reporting  
  • Application forwarded to DLA
  • Application Documents correct and Premises complies norms as per Rule
  • Discrepancies found and resolved
  • A license granted by DLA
  • Signed Copy Uploaded 
  • The license received by user
  • If discrepancies found in the application and not resolved by the user, then the application will be Rejected

There are three types of sale drug licenses in India:-         

  • Wholesale Drug License

This type of license is issued only to those entities where there is the presence of registered/competent pharmacist or graduate with one year experience in dealing in drugs or a person who has passed S.S.L.C with four years experience in dealing in drugs, specially approved by the department of drug control.

Following documents are required for obtaining the wholesale drug licenses:-

  • Form-19  (http://fsdaup.gov.in/sales-licence.htm)
  • Copy of Plan of Premises/Layout of location.
  • Self Assessed checklist of documents
  • Challan of the prescribed fees-Amount of fees to be deposited in Government Treasury or Government Branch of State Bank of India of the district where a license is required and an original copy of the treasury challan is to be submitted with the application
  • Proof of possession
  • Covering letter stating the purpose of the application
  • Certificate of Incorporation, Memorandum of Association and Article of Association(in case of the company, partnership deed(in case of the partnership firm), LLP agreement (in case of the Limited Liability Partnership Firm)
  • Board Resolution  signed by the directors (in case of private/public company)
  • List of directors/partners
  • Certificates of Competent Person/ Super wiser in charge.
  1. Copy of Offer of Appointment.
  2. Copy of Consent/Acceptance Letter.
  3.  Copy of Experience Certificate.
  4. Copy of Degree Certificate. 
  5. Copy of Marks Statement.
  6.  Affidavit of pharmacist  
  • Stamp as per the stamp act
  • Copy of Power of attorney to sign the documents
  • 13. Photo Identity proof
  • Retail Drug License

Retail Drug license shall be issued only to those entities where there must be a registered/competent pharmacist approved by the department, and that registered pharmacist is required throughout the working hours.

Documents required in the case of retail drug licenses shall be the same as the wholesale drug license.

  • Restricted License for General Store in India

Such a license is issued to those who are involved in the sale without the support of registered/competent pharmacists.

This license is issued under Forms 20A and 21A

Import Drug License

This kind of license is taken by those who are engaged in the process of manufacturing, distribution, sale of imported drugs in India. In the case of import of more than one drug manufactured by the same manufacturer, the single license may be issued. Whereas in case the only manufacturer has two or more factories manufacturing drugs in different places, then a separate license shall be required in respect of each factory.

Loan Drug License in India

Loan drug license means a license which is issued to an applicant who does not have any arrangement for manufacture and avail the manufacturing facilities owned by another licensee.

In the case of pharmacy business is operating its business in more than two states, then it is required to obtain a drug license in each state where the business is carried on. A separate license shall be issued in case drugs are sold at more than one place. After the license is granted to the business, the licensee must ensure that all the conditions of the drug license must be complied with during business. In the case of any changes or modification in business activity authority must be informed and all the registers, records, and forms must be maintained in a specified manner

Documents are required for obtaining the Loan Drug License

  • Covering letter along with payment of application fee –1 copy
  • Self Assessed checklist of documents –1 copy
  • Form 24-A & 27-A (Maximum 10 Products should apply under each form) –1 copy
  • Manufacturing Loan no. 1, 2 & 3. (Original)- 1 copy
  • Copy of selling license – 1 copy
  • Product List.  –2 copies
  • List of Excipients. –1 copy
  • Similar Product. –  1 copy
  • Draft Label- 1 copy
  • Method of Analysis. –  1 copy
  • Additional Information Form- 1 copy
  • Copy of Memorandum of Articles –1 copy
  • List of Directors with address- 1 copy
  • Copy of Power of attorney to sign the documents. – 1 copy

Multi License for Drugs

Multi-license for drugs is obtained by those who are operating in two or more states with the same name having one registered office.

Conclusion

Therefore, Types of Drug licenses, as per the activity, are issued:-

  • To promote the public health.
  • To regulate the manufacture, distribution, sale, and import of drugs.
  • To control the level of drugs.
  • To ensure the compliance of rules and regulations framed under the act.
  • To make sure a genuine organization will obtain the license.

Read our article: Punishment for Selling of Medicines Without a Drug License

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Shruti Gupta

Shruti Gupta is an experienced Company Secretary. Apart from that she did her graduation (B.com hons), post graduation (M.com) from Delhi University and LLB.

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