What is a retail drug licence?
It's the legal authorisation under the Drugs & Cosmetics Act, 1940 that allows a
pharmacy, chemist or store to sell medicines directly to consumers. It's commonly issued as Form
20 together with Form 21 by the State Drug Control Department.
What's the difference between Form 20 and Form 21?
Form 20 covers retail sale of drugs other than Schedule C, C(1) and X, while Form
21 covers Schedule C and C(1) drugs (such as biologicals). Most retail pharmacies are issued
both together.
Do I need a registered pharmacist?
Yes. For a retail licence under Forms 20 and 21, a registered pharmacist must be
available to dispense medicines. (A wholesale licence instead needs a qualified "competent
person" rather than a pharmacist.)
What are the premises requirements?
A retail pharmacy generally needs a minimum of about 10 square metres of dedicated
floor area, with proper shelving, ventilation and refrigeration for drugs that need cold
storage. State minimums can vary.
Is the licence state-specific?
Yes. Retail and wholesale drug licences are issued by the State Drug Licensing
Authority, filed online via the state portal / ONDLS. Manufacturing and import licences involve
the central CDSCO. India is moving toward a "One Nation, One Drug Licensing" model.
How long does it take?
A retail drug licence usually takes between 15 and 30 working days, depending on
the completeness of your documents and the timing of the Drug Inspector's premises inspection.
How long is the licence valid?
Under the amended rules, the licence runs in perpetuity but is subject to a
licence-retention fee payable every five years from the date of issue, rather than a full
re-application.
What happens if I sell without a licence?
Selling drugs without a valid licence is a criminal offence. Under Section 27 of
the Act, it can attract imprisonment and a significant fine, besides seizure of stock.
Do I need FSSAI as well?
If your pharmacy also sells health drinks, dietary supplements or baby food — as
most do — you'll typically need an FSSAI registration in addition to your drug licence. We can
arrange both.
Can I sell cosmetics on the same licence?
Cosmetics are regulated under the same Drugs & Cosmetics Act. Retail sale of
cosmetics must comply with the Act's labelling and sale provisions; we advise on what your
specific product mix requires.
