Statutory Analysis
Drug License 20B & 21B Mandatory Invoicing Requirements Under Drugs and Cosmetics Act
Understanding Form 20B vs Form 21B Licenses
The State Drug Control Administration issues wholesale and retail licenses under specific statutory forms:
- Form 20B: License to sell, stock, or exhibit drugs other than those specified in Schedule C, C(1), and X.
- Form 21B: License to sell, stock, or exhibit specified biological and special products listed in Schedule C and C(1) (e.g., sera, vaccines, antibiotics, hormones).
Condition of License: Mandatory Invoice Records
Every sale of a drug must be recorded under Rule 65. The cash or credit memo must maintain consecutive serial numbers, signature of qualified person (registered pharmacist), batch numbers, and manufacturer names.
Akshay Tamrakar
akshay.tamrakar@gmail.com