DRUG License (CDSCO)
Licensing is mandatory to do business in Drugs & Cosmetics in India. The provisions for this have been made in Drugs & Cosmetics Act, 1940 which is applicable to the 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 licenses based on their business, you may contact LegalRaasta for consultancy on it.
In case a business is operating in more than two states, it has to obtain a drug license in every state in which business is being carried on. Drug license is location-specific. If drugs are sold or stocked for sale at more than one place, the application shall be made, and license shall be issued, in respect of each such place except migrant vendors
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Conditions for obtaining Drug License
The applicant has to provide an independent shop with an 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 premises of the sale should be in accordance with the National Building Code of India, 2005 as amended from Time to Time.
No drug licence is granted in premises situated on a DDA allotted residential plot/land or flat unless it meets with the requirements of MPD-2021.
The applicant’s shop/premises should have an adequate area of not less than 10 sqr.mtrs., should be equipped with proper storage facilities for preserving the properties of drugs and applicant (Competent Person) must be a Registered Pharmacist with Pharmacy Council.
The applicant’s shop/premises should have an adequate area of not less than 15 sqr. meters.
The applicant’s shop/premises should have an adequate area of not less than 10 sqr.mtrs. and person in charge (Competent Person) must be a Registered Pharmacist/who has passed Matriculation or its equivalent with four year’s experience in dealing with Drugs or who holds a degree of a recognized university with one year’s experience in dealing with Drugs.