Introduction

Drug license is a license granted by the competent Government authority under Drugs and Cosmetic Act, 1940 to carry out a business in drugs / medicines / cosmetics. Put it in other words, no one can start drugs or cosmetics business in India without drugs license from the competent Government authority. All the types of drugs or cosmetics business is covered including allopathic, homeopathic, ayurvedic or unani drugs. 

In following cases too, the fresh licenses are required:

  1. In case of Change of premises (CoP).
  2. Change of Constitution (CoC).

The Drugs Control Department grants following types of Sales licence by the respective Jurisdictional delegated Licensing Authorities.

  1. Retail Drug licence.
  2. Wholesale Drug licence.
  3. Licenses to sell drugs under Schedule X.
  4. Restricted licenses.
  5. License to sell drugs from motor vehicle.

The applicants are required to submit the documents for grant of Fresh Licenses as per the Check list given below for each type of Licenses. After following the procedures mentioned in Steps 1 to 4 below, the licenses will be granted to the applicants.

In case of renewal of Licenses, applicants are required to submit respective Form, fees prescribed, additional information sheet meant for renewal along with a covering letter before the expiry of the Licenses.

If the application is made on Letter of Authority (LA) or the Power of Attorney (POA), the LA or POA original copy signed by the Director / Company Secretary / Owner supported with board resolution or by the Partner of the firm. The LA / POA Holder is required to submit his Photo & residential address proof with the application.

Checklist of documents / details

  1. A) For Retail Drug Licence:
  2. Covering letter.
  3. Form 19/Form 19C.
  4. Additional information sheet (AIS).
  5. Challan/ Payment Acknowledgement.
  6. Sketch of the premises (In duplicate).
  7. Rent agreement or lease deed.
  8. Qualified person’s proforma .
  9. KSPC Registration certificate(Original & Xerox copy).
  10. Option & approval (In duplicate)
  11.  Affidavit/s on Rs 20/- Stamp paper
  12. Registered Pharmacists affidavit.
  13. Affidavit by the applicant on Constitution, tenancy, area of premises etc.
  14. Biomedical Waste disposal Affidavit.

Note: Single affidavit can also be accepted, if the person sworn on the issue above is one and the same.

  1. Refrigerator invoice or declaration.
  2. Proprietorship declaration or Partnership deed or memorandum of articles of association.
  3. Residential address proof – document like Election ID Card / Aadhar Card / Passport / Ration Card / Driving Licence of applicants (proprietor / Partner / Managing Director / Authorized SignatoryPOA / LA ) and pharmacists & or competent persons.
  4. Passport size photographs of applicants and pharmacists/competent persons.

Notes:

  1. a)Minimum floor area required in case of retail licenses is 10 sq. Mts., in case of wholesale licences 10 sq. Mts. and in case an application is made for both wholesale and retail licences minimum floor area required is 15 sq. Mts.
  2. b) Maximum number of days to wait to get this service delivered is 30 Working Days.
  3. B) For Licenses Wholesale Drug Licence
  4. Covering letter.
  5. Form 19/ Form 19C .
  6. Additional information sheet (AIS).
  7. Challan/Payment Acknowledgement.
  8. Sketch of the premises (In duplicate).
  9. Rent agreement or lease deed.
  10. Competent person’s proforma.
  11. Competent persons experience certificate (Minimum 4 years in case of matriculate and one year in case of Recognized degree holder).
  12. Competent person’s qualification certificate.
  13. Affidavit/s on Rs 20/- Stamp paper
  14. Competent persons affidavit.
  15. Affidavit by the applicant on Constitution, tenancy, area and commercial nature of premises etc.
  16. Biomedical Waste disposal Affidavit.

Note: Single affidavit can also be accepted if the person sworn the issue above is one and the same.

  1. Refrigerator invoice or declaration.
  2. Proprietorship declaration or Partnership deed or memorandum of articles of association.

13.Residential address proof – document like Election ID Card / Aadhar Card / Passport / Ration Card / Driving Licence of applicants (proprietor / Partner / Managing Director / Authorized Signatory POA / LA ) and pharmacists & or competent persons.

  1. Passport size photographs of applicants and pharmacists/competent persons.

Notes:

  1. a)Minimum floor area of premises required in case of wholesale licences 15 Mts.
  2. b)The applicants are required to produce supportive documents to show that the proposed premise is of commercial in nature.
  3. c)Maximum number of days to wait to get this service delivered is 30 Working Days.

 

  1. C)  For Grant of Licences To Sell Drugs Under Schedule X
  2. Covering letter.
  1. Form 19C.
  2. Additional information sheet (AIS).
  3. Challan/Payment Acknowledgement.
  4. Photocopy of licenses in Form 20, 21 and /or 20B and 21B.
  5. Undertaking that schedule X drugs shall be kept under lock and key, to which only responsible persons have access;

As a policy licenses in Form 20F is granted only to such persons possessing valid licenses in Form 20, 21 and similarly 20G licenses to such persons possessing valid licenses in Form 20B and 21B.

 

  1. D) For Grant of Restricted Licenses in Form 20A And Form 21 A
  2. Covering letter.
  3. Form 19A.
  4. Additional information sheet (AIS).
  5. Challan/Payment Acknowledgement.
  6. List of drugs permitted to be sold [ separate for list for 20A and 21 A] (Refer formatgiven).
  7. Sketch of the premises (In duplicate).
  8. Rent agreement or lease deed.
  9. Proprietorship declaration or Partnership deed or memorandum of articles of association.
  10. Photo copies of address proof and photo I. D’s of applicants.

10.Residential address proof – document like Election ID Card / Aadhar Card / Passport / Ration Card / Driving Licence of applicants (proprietor / Partner / Managing Director / Authorized Signatory POA / LA).

  1. Passport size photographs of applicants.

Note:

  1. a) Maximum number of days to wait to get this service delivered is 30 Working Days.
  2. E) For License to Sell Drugs from Motor Vehicle
  3. Covering letter.
  4. Form 19AA.
  5. Challan/Payment Acknowledgement.
  6. Attested photocopy of Registration certificate (RC book) of the vehicle- [licensee must be owner of the vehicle.  Should be possessing licenses in Form 20B and 21B. Licence shall not be granted to hired vehicle and /or public carriers.]
  7. Vehicle should have well equipped for preserving the properties of drugs – such as cold storage facility, where ever required.
  8. Photocopy of license in Form 20B and/or 21B licenses.
  9. Photo I.D. and address proof.

Steps in Granting Licence

The following steps are followed from the receipt of application of applicants till the grant of licenses.

Step-I

The applicants are required to submit the required statutory application in the prescribed Form, Fees, and other documents listed in the Check list for grant of Fresh Licenses. The applicants are instructed to use the suitable on line Form/s available in the website.

In case of additional grant of Licenses also the same procedure, document and fees are required from the licensees.

The Licensing Authority may call for any additional documents to ascertain the correctness of information furnished by the applicants.

 Step-II

The application is verified by the section for the correctness of the list of documents submitted and is then processed and submitted to concerned Assistant Drugs Controller who in turn either scrutinize himself or forward to Drugs inspector working under him / her for scrutiny and inspection of proposed premises.

If the submitted application is not in order or requires any clarifications / information a compliance letter will be served to the applicant.

Step-III

If the submitted documents, area of premises and the facility for storage are found in order, after inspection based on recommendation the concerned Assistant Drugs Controller and delegated Licensing Authority will Grant the License.

Step-IV

The applicants will get computerized SMS alert to the provided mobile number in their application. The Granted licenses along with the original documents like KSPC Certificate will be delivered by post.

**Source / support / courtesy: Internet.

For more information / clarification please keep in touch with following/s:

  1. http://naco.gov.in/sites/default/files/Drug%20%26%20Cosmetic%20Act%201940_1.pdf
  2. http://drugs.kar.nic.in
  3. https://cdsco.gov.in
  4. For license, please apply here: https://dcd.kar.nic.in/onlinesales/