Drug License for Retail and Wholesale

Anyone who sells, stocks, exhibits or distributes drugs needs a licence from the State Drugs Control Department under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. That means retail chemists, hospital pharmacies, wholesalers, distributors and stockists. Manufacturing, import and medical device licences follow separate routes through the State authority or CDSCO, depending on the product.

Retail sale licences are issued in Forms 20 and 21 and wholesale licences in Forms 20B and 21B, with separate permission for Schedule X drugs. Most pharmacies take both 20 and 21. A retail licence needs a registered pharmacist at the counter. A wholesale licence needs a competent person with the prescribed qualification or experience.

The shop has to meet minimum area requirements and have proper storage, including a refrigerator for products that need it. You will need ownership or rent papers, a site plan showing the area, the registration and appointment letter of the pharmacist or competent person, constitution documents and affidavits from the owners. We prepare the file and get you ready for the drug inspector visit.

A change in premises, partners, directors or pharmacist needs intimation or amendment. We handle these, keep track of retention fees, and draft replies when a show cause or suspension notice arrives. Each store needs its own licence, so for pharmacy chains we keep one register across every location.

Questions clients usually ask

What is the difference between Form 20 and Form 21?

Form 20 covers drugs other than those in Schedules C, C(1) and X, and Form 21 covers Schedule C and C(1) drugs other than Schedule X. Most pharmacies hold both.

Can I get a retail drug licence without a pharmacist?

No. A retail licence needs a registered pharmacist. Wholesale needs a competent person with the prescribed qualification or experience.

Is one licence enough for several stores?

No. Each premises where drugs are sold or stocked needs its own licence.

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Drug License for Retail and Wholesale

Who Needs a Drug Licence

Retail and Wholesale Forms

Premises and Documents

Changes, Renewals and Notices

Questions clients usually ask

What is the difference between Form 20 and Form 21?

Can I get a retail drug licence without a pharmacist?

Is one licence enough for several stores?

Ready to get answers from a qualified compliance expert?

For Consultation

Call: +91 76964-26220