February 22, 2024

License for Sale of drugs under D & C Act

License for Sale of drugs under D & C Act

The Drugs and Cosmetics Act and Rules made thereunder provide for sale of drugs only issue of licence. State Government appoints licensing authority for a specified area to issue licences for the sale, stock or exhibit for sale or distribution of drugs.

The applicant has to make an application in a prescribed form (for sale of specified categories of drugs) for grant of licence. Granted licence required to be renewed within six months of its expiry.

Forms for applying for the grant or renewal of licence, to sell, stock or exhibition for sale or distribution: 

  1. For retail/wholesale of drugs other than those specified in schedule X – Form – 19.
  2. Restricted licence (Applicants of a town with population of 5000 or less than 5000, where services of qualified person not required and itinerant vendors. Form – 19A.
  3. Wholesale/Distribution of drugs from a motor vehicle – Form. 19AA.
  4. Schedule X Drugs – Form – 19C.     

The application forms should be accompanied by the prescribed fee. A duplicate copy of a licence can be issued on payment of the prescribed fee if the original is defaced, damaged or lost.

Application for renewal of licence should be made before the expiry of licence but not later than six months of its expiry and should be accompanied with a prescribed fee plus an additional late fee.   

The licensing authority on satisfying that the conditions of licence fulfilled as per the provisions of the Act and Rules made thereunder issues licence in the prescribed form.

Form of Licences: 

A licence to sell, stock, an exhibit for sale or distribute drugs issued in the following forms

  1. Retail sale : 
    1. For drugs other than those specified in Schedule C, C (1) and X: Form 20.   
    2. For drugs those specified in schedule C and C (1): Form – 21.  
    3. For schedule X drugs. Form 20 F.
  2. Restricted Licence : 
    1. For drugs other than those specified in schedule C, C (l) and X: Form 20-A.
    2. For drugs specified in schedule C and C (1) : Form 21-A valid for only such drug specified in licence. No licence is issued for schedule X drugs.
  3. Wholesale:
    1. For drugs other than those specified in schedule C, C (1) and X : Form . 20 B.
    2. For drugs specified in schedule C, C (1): Form .21 B. 
    3. For schedule X drugs: Form 20 G.
  4. Sale of drugs by wholesale or distribute drugs by a motor vehicle :
    1. For drugs other than those specified in schedule C and C (1) : Form – 20 – BB. 
    2. For drugs specified in schedule C und C (1) : Form 2l-BB,    

Such a licence is not required where the public carrier or a hired vehicle is used for transportation or distribution of drugs.    

For the sale or slack of drugs at more than one place, a separate application should be made for a grant of licence and a separate licence shall be issued for each place. But, this does not apply to itinerant vendors who have no specified place of business and who are licensed to conduct business in a specified area at the jurisdiction of the licensing authority, 

Duration of licence:

Original or renewed licence unless suspended or cancelled, valid up to 31st December of the year following the year in which it is granted or renewed.  

Certificate of renewal of a sale licence issued in Form 21 C

Forms in which licences are issued for the sale, stock, exhibition for sale or distribution of drugs.


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