Drug License Registration

Drug License Registration

Licensing is mandatory to do business in Drugs & Cosmetics in India. The provisions for this has been made in Drugs & Cosmetics Act, 1940 which is applicable to whole of India. It is an Act to consolidate all the laws relating to drugs & cosmetics, which established the Drugs Control Department. In 1964, the Act was amended to include Ayurvedic & Unani drugs. However a particular business entity may require different types of drug license based on their business, you may contact us for consultancy on it.

In case a business is operating in more than two states, it has to obtain drug licence in every state in which business is being carried on. Drug licence is location specific. If drugs are sold or stocked for sale at more than one place,application shall be made, and license shall be issued, in respect of each such place except migrant vendors.

Once the licence is granted to the business, all such License must ensure that all the condition in the drug licence are complied at all the time during the course of the business. All the records /registers /Forms must be maintained in the manner specified by the licensing authorities and authorities shall be kept informed for all the changes or modification in the business activities.

 

What is Included in Our Package

 
 
 
 

Procedure for Drug License Registration

 

Additional document for Retail Sale Registered Pharmacist


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

  • Registration of Delhi Pharmacy Council

  • Appointment Letter and Bio-data
 

Additional document for Wholesale Licence Competent person


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

  • Experience Certificate

  • Appointment Letter and Bio-data
 

Conditions for obtaining Drug License

The applicant has to provide an independent shop with the adequate area for grant of retail/wholesale licences as per details given below :

For grant of a licence in Form 20 or Form 21 or both, the premises are of an area of not less than 10 square metres.

For grant of a licence in form 20-B or form 21-B or both, the premises are of an area of not less than 10 square metres.

For grant of licences :

  • In Form 20 or Form 21 or both,
  • In Form 20-B or Form 21-B or both, the premises should be of an area of not less than 15 square metres.
  • The clear height of the sales premises should be in accordance with the National Building Code of India, 2005 as amended from Time to Time.

No drug licence is granted in a premises situated on a DDA alloted residential plot/land or flat unless it meets with the requirements of MPD-2021.

 

Types of Drug License

Drug licence is classified under different categories. These are Manufacturing Licence, Sale Licence and Loan licence. Sale licence is further classified as wholesale Licence, Retail Licence and Restricted (Gen.Store) licence depending on the manner in which sales done.

 

Steps for getting the Drug license

One can file the Drug License application directly with the government. The process is long and requires 30-60 days to get completed :

Step 1 :

Applicant has to obtain user ID and Password by giving request letter in person with the details of the firm.

Step 2 :

All the documents should be scanned in 100 dpi and black and white and then should be uploaded using the said ID and Password at space provided for the purpose. All the information is filled precisely for respective application and then e-send the application. The licensing authority may ask for any other specific documents if required.

Step 3 :

You will then need to follow-up with the government department for an update on your application. In case of rejection of your application for incomplete information, the fees once paid will be forfeited by the government.

Step 4 :

The government department will take 45-60 working days to completely review your application and approve the same. Else, you can hire us for getting the Drug license for you. We get license issued in 98% of our cases and save our customers from all the government hassles.

Documents requirement for Drug License in India

Following documents are required with application form :

  • Constitution of the firm (MOA/AOA)
  • Photo ID proof of proprietor/partner/director
  • Copy of Property paper (If owned property)
  • Copy of Rent agreement (If rented property)
  • Site Plan and key plan of the premises
  • Refrigerator invoice and details
  • Affidavit regarding compliance of MPD 2021 (if premises are located on DDA residential flat/ plot/ building)

PROCESS OF OUR WORK

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