Retail Drug Licence Checklist (India)

About the Retail Drug Licence Checklist (India)

A checklist for a sale licence for medicines in India — a retail chemist or pharmacy, a wholesaler, or both — built from the Drugs Rules, 1945. Tell it what you will sell and how, the area and height of the premises, your registered pharmacists and, for a wholesale licence, the competent person in charge, and it lists the licences to apply for (Forms 20 and 21 for retail, 20B and 21B for wholesale, 20F and 20G for Schedule X), the application form and fee (Form 19 with ₹1,500, Form 19C with ₹500), and checks your plan against rule 64 and Schedule N.

You also get the documents that prove what the rules ask for, the particulars Form 19 needs filled in, what the shop may display, and the licensing authority of your State from CDSCO’s list. Everything you type stays in this browser as a draft. The application pack — the checks, Form 19’s particulars and the document and Schedule N lists with tick boxes — is a free preview without a pass: its pages show marked “not for use”, and its PDF and printing unlock with a Premium pass. It is a checklist, not legal advice: the State licensing authority decides.

Common uses

• A pharmacist opening a new chemist shop who wants to know, before signing a lease, whether the premises are big and tall enough.
• A distributor adding a wholesale licence and checking who can be the competent person in charge.
• A pharmacy adding Schedule X drugs, with the second form and fee it needs.
• Preparing the papers before visiting or applying to the State drugs control department.

The licences and the application

Rule 61 issues the sale licences in these forms: Form 20 for the retail sale of drugs other than those of Schedules C, C(1) and X; Form 21 for the retail sale of drugs of Schedules C and C(1) (except Schedule X); Form 20B and Form 21B for the same by wholesale; Form 20F and Form 20G for Schedule X by retail and by wholesale. Rule 59(2) asks for the application in Form 19 with a fee of ₹1,500, or for Schedule X in Form 19C with ₹500; your State’s portal shows the amount to pay for the licences you apply for. Every place where drugs are sold or stocked needs its own application and licence (rule 62). A licence stays valid while a retention fee equal to the licence fee is paid before every fifth year from its issue, with a late fee of 2% of the licence fee a month for up to six months (rule 63).

Premises and the people in charge (rule 64)

• The premises must be adequate, with proper storage for the drugs, and in the charge of a person the licensing authority finds competent to supervise their sale, distribution and preservation.
• Area: at least 10 m² for a retail licence (Forms 20 and 21) or a wholesale licence (Forms 20B and 21B), and 15 m² for retail and wholesale together. Premises licensed before the Drugs and Cosmetics (1st Amendment) Rules, 1997 are not held to these figures.
• Wholesale: the premises must be in the charge of a registered pharmacist, or of someone who passed the matriculation examination with four years’ experience in dealing with the sale of drugs, or who holds a university degree with one year’s experience in dealing with drugs.
• Retail: a drug supplied on a doctor’s prescription is supplied by or under the personal supervision of a registered pharmacist (rule 65(2)); Form 19 names the pharmacists and their qualifications.
• In granting a licence the authority has regard to the average number of licences granted in the three years before and to the applicant’s trade or business, and may refuse an applicant convicted under the Act or whose licence was cancelled.

Schedule N: the pharmacy

A licence in Form 20 or 21 for a pharmacy — a shop where drugs are dispensed, prescriptions compounded or drugs prepared, or one that calls itself a pharmacy — is granted only when Schedule N is met: the inscription “Pharmacy” at the front; premises apart from private rooms, well built, dry, lit and ventilated; a dispensing area of at least 6 m² for one pharmacist and 2 m² more for each other one; a height of at least 2.5 m; a smooth, washable floor and washable walls; ample good water; a barrier keeping the public out of the dispensing department; a dispensing bench with an impervious top; a locked poison cupboard marked “POISON” in red on white; tightly closing, labelled containers; the listed apparatus and books; and the continuous personal supervision of a registered pharmacist whose name is displayed. The licensing authority may relax or add requirements in a particular case.

What the shop may display (rule 65(15))

• “Drugstore”: a licensee who does not need a registered pharmacist.
• “Chemists and Druggists”: with a registered pharmacist, but no pharmacy for compounding against prescriptions.
• “Pharmacy”, “Pharmacist”, “Dispensing Chemist” or “Pharmaceutical Chemist”: with a registered pharmacist and a pharmacy for compounding against prescriptions.

Schedule X

A retail licence in Form 20F is granted only to a pharmacy — or to a chemist and druggist where no pharmacy is operating (rule 64(1)). Schedule X drugs are kept under lock and key in a cupboard or drawer reserved for them, or in a part of the premises only responsible persons can enter (rule 65(12)), and every supply goes into a bound Schedule X register (rule 65(21)).

Documents

The rules themselves ask for the application and the fee (rule 59(2)), the names and qualifications of the pharmacists (Form 19), particulars of any special storage (Form 19), and — on demand — documentary evidence of the ownership or tenancy of the premises and of the constitution of the firm (rule 65A). A plan of the premises with its measurements shows the areas and height rule 64 and Schedule N ask for. Each State’s licensing authority publishes its own checklist and may ask for more: follow it.

Limitations

• It follows the Drugs Rules, 1945 as published by CDSCO. States run their own portals, fees for each licence form, checklists and inspections, and the licensing authority decides — it may relax or add Schedule N requirements.
• It does not file the application or fill in your State’s online form; it prepares what the form and the inspection ask for.
• Homoeopathic medicines (Forms 20C and 20D), restricted licences (Forms 20A and 21A) and sale from a motor vehicle (Forms 20BB and 21BB) are not covered.
• The licensing authorities’ addresses come from CDSCO’s list. CDSCO’s Online National Drugs Licensing System lists online applications for sale licences among its services; whether your State takes them there or on a portal of its own is for its office to say.

Privacy

Your plan, the applicant’s details and the pharmacists’ names stay in this browser on your device (kept as a draft until you clear the form). The pack is made on the device; nothing is uploaded.