To open and operate a community pharmacy in India, a person must follow all the rules and conditions under the Drugs and Cosmetics Act, 1940 and its rules. No pharmacy can sell medicines without a valid license issued by the licensing authority of the respective state.
A license is needed for:
- Retail sale of medicines
- Wholesale sale of medicines
- Sale through motor vehicles
- Sale of homeopathic medicines
- Sale of drugs listed under Schedule X
Different application forms and license types are used depending on the nature of the business and category of medicines.
Application Forms, License Types and Categories of Drugs
The Drugs and Cosmetics Rules provide specific forms for applying for different types of pharmacy licenses.
| S. No | Application Form No. | Category of Drugs | Qualified Person Required? | License Issued In |
|---|---|---|---|---|
| 1 | Form 19 | Wholesale/Retail sale of drugs (except Schedule X) | Yes | 20 (Retail – Cat A), 20B (Wholesale – A), 21 (Retail – B), 21B (Wholesale – B), 21C (Renewal) |
| 2 | Form 19A | Restricted license (Retail without qualified person) | No | 20A (Retail – A), 21A (Retail – B) |
| 3 | Form 19AA | Sale of drugs from motor vehicle | Yes | 20BB (Wholesale – A), 21BB (Wholesale – B) |
| 4 | Form 19B | Wholesale/Retail sale of Homeopathic medicines | Yes | 20C (Retail), 20D (Wholesale), 20E (Renewal) |
| 5 | Form 19C | Wholesale/Retail sale of Schedule X drugs | Yes | 20F (Retail), 20G (Wholesale), Renewal through 20C |
Documents Required to Obtain a Pharmacy License
To apply for a retail or wholesale pharmacy license, the applicant must submit the correct form along with the following documents:
- Layout plan of the pharmacy premises (minimum area required is 120 sq.ft.)
- Rental agreement or ownership proof of the premises
- Purchase invoice of refrigerator (for storing temperature-sensitive medicines in Schedule C and C1)
- Qualification proof of the registered pharmacist (D.Pharm/B.Pharm/Pharm.D)
Inspection and Grant of License
After submitting the application, the Drugs Control Department will inspect the premises. A license is issued only when the officer is satisfied that:
- The premises meet minimum standards
- A qualified registered pharmacist is employed
- Storage conditions for medicines are adequate
- All legal requirements are fulfilled
Once approved, the pharmacy can legally start operations.
Important Notes for Students
In the Pharm.D syllabus, the topic “Legal Requirements” is listed without detailed subtopics. Students are expected to understand the basic framework of:
- Licensing forms
- Role of licensing authority
- Minimum legal standards for a pharmacy
- Difference between pharmacy types (retail, wholesale, restricted)
Additional Information (Student-Friendly Summary)
1. Which authority issues the license?
State Drugs Control Department (also called Drugs Control Administration)
2. Qualification required?
A Registered Pharmacist with D.Pharm, B.Pharm or Pharm.D depending on the requirement.
3. Why refrigerator proof?
Some medicines need 2–8°C storage (insulin, vaccines, eye drops etc.). Refrigerator purchase bill is mandatory as evidence.
4. Minimum shop area?
120 sq.ft for a retail pharmacy as per guidelines.
5. Why is inspection important?
To ensure safe handling of medicines and to prevent misuse of drugs.
Detailed Notes:
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