In short: In India a pharmaceutical wholesaler needs a licence from the state drug control authority for each category it sells: Form 20B for drugs other than those in Schedules C, C(1) and X; Form 21B for Schedule C and C(1) products such as biologicals, vaccines and sera; and Form 20G for Schedule X drugs. The licences stay valid as long as a retention fee is paid every five years, and each premises needs a qualified competent person.
Which form covers what
Under the Drugs Rules, 1945, the common wholesale licences are:
- Form 20B: wholesale of drugs other than those in Schedules C, C(1) and X — most tablets, capsules and injections.
- Form 21B: wholesale of drugs in Schedules C and C(1), which include biological products such as vaccines, sera and many injectables that need a cold chain.
- Form 20G: wholesale of Schedule X drugs, applied for separately.
- Forms 20BB and 21BB: wholesale from a motor vehicle.
Why it matters to buyers and manufacturers
A distributor supplying cancer biologics, insulins or vaccines without a Form 21B licence is outside the law, however good its prices. Hospitals and pharma companies should ask to see copies of every licence, check that they name the premises the stock actually ships from, and confirm the categories match the products being supplied.
Validity and the competent person
Wholesale licences no longer need periodic renewal: they remain valid as long as the holder pays a retention fee before each five-year period ends. Each licensed premises must be run under a competent person — a registered pharmacist, a graduate with one year’s experience in dealing in drugs, or a matriculate with four years’ experience.
RS Surgipharm’s licences
RS Surgipharm holds wholesale drug licences in Form 20B and Form 21B issued by the Food & Drugs Control Administration, Gujarat, covering biologicals and vaccines as well as other drugs. Copies are available to hospitals and manufacturers on request.
Quick answers
- Does a wholesale drug licence need a pharmacist?
- Not necessarily. The competent person for a wholesale licence can be a registered pharmacist, a graduate with one year’s experience in dealing in drugs, or a matriculate with four years’ experience.
- Which licence covers vaccines?
- Vaccines are Schedule C and C(1) products, so a wholesaler needs a Form 21B licence to sell them.
Sources
This guide is general information for healthcare professionals, procurement teams and patients, not medical, legal or regulatory advice. Rules change; confirm with the relevant authority.