Everybody treats a drug licence as a thing you buy once and frame. It is not quite that. It is granted for premises, but it is granted into the charge of a named, qualified person — and it only does its work for as long as that person is actually there. Start with the two Rules that decide it. Rule 64 requires the licensing authority to be satisfied that the premises are equipped with proper storage accommodation and are in charge of a person competent in its opinion to supervise and control the sale and preservation of the drugs. Rule 65(2) goes further for the counter itself: supply of any drug on the prescription of a registered medical practitioner shall be effected only by or under the personal supervision of a registered pharmacist. Put those together and you get the position almost nobody is warned about. When the pharmacist resigns, nothing cancels. The certificate stays on the wall, nobody writes to you, and the shop carries on in good faith — while the supplies that needed supervision stop being lawful ones. The defect is not in your file. It is in the gap between the name on the licence and the person at the counter. And the consequence is not a penalty notice. Section 27(b)(ii) puts a sale made without a valid licence into custody for a minimum of three years, up to five, with a fine floored at one lakh rupees or treble the confiscated value if that is greater — and the court may drop below that floor only on reasons it finds adequate and special and writes into its judgment. That is a prosecution with a statutory floor. Two things on this page are deliberately handled differently from every other page you will read on the subject. We do not print a single confident minimum-area figure, because the compiled Rules carry two provisos giving two different areas for the same wholesale forms. And we treat the 2026 recommendation that wholesale competent persons be registered pharmacists as what it is — a recommendation, not yet notified, with the three existing qualifications in Rule 64 set out as the law you are actually applying under. Our own limits, and they are drawn hard on this subject: we do not supply, arrange, lend or share a pharmacist or competent person, in any circumstances, and our own name never appears in that role. We give no advice on which drugs may be sold, stocked or dispensed — that is the pharmacist and the practitioner work, not a documentation office.
What is on this page
Begin with a distinction that is obvious once stated and almost never stated.
There are permissions that attach to a thing and permissions that attach to a person. A building approval attaches to the building. A driving licence attaches to the driver. Most business permissions sit comfortably at one end or the other, and a reader knows instinctively which kind they are dealing with.
A drug licence sits in neither place. It is granted in respect of premises, applied for by a firm, and issued as a certificate the shop hangs up — and yet the condition that keeps it working is the presence of a qualified individual. It is a premises permission with a person built into it, which is an unusual shape and the source of nearly every mistake described on this page.
Hold that shape in mind throughout: the paper is about the shop, the condition is about a person. Everything from Rule 64 to the three-year minimum in section 27 follows from it.
So what is it that the State is actually permitting?
Activity at an address. The licence permits the sale, stocking, exhibition or offer for sale, and distribution of drugs — the specific activities named in the Act — at the premises described in it, in the categories the form covers. It is not a general permission to be in the pharmacy trade, and it is not portable.
Which means three things the licence does not do. It does not travel with you to a second shop; that is a separate licence for separate premises. It does not extend to a category the form does not cover. And it does not cover anything sold at the same counter that is not a drug — food and nutrition items at a chemist counter are their own permission, dealt with under FSSAI registration.
Read your own licence for the address and the categories before you read anything else on it. Shops that expand into an adjoining unit, or start stocking a new category, routinely do so without noticing that the certificate on the wall has not moved with them.
Now the part of the licence that is a person, in the Rules own words.
Rule 64 requires that before granting a licence the authority be satisfied that the premises are equipped with proper storage accommodation for preserving the properties of the drugs, and that the premises are in charge of a person competent in the opinion of the licensing authority to supervise and control the sale and preservation of the drugs.
Drugs Rules, 1945, Rule 64 — the premises must be equipped with proper storage accommodation for preserving the properties of the drugs, and must be in the charge of a person competent in the opinion of the licensing authority to supervise and control the sale and preservation of the drugs.
Two words carry the weight. Charge — not association, not engagement, not availability. And competent in the opinion of the licensing authority — the satisfaction is that authority, which is why a name on a form is not the end of it.
With both halves on the table, look at what the certificate actually tells a visitor.
It tells them the premises are licensed, in which forms, for which period, and in whose charge the authority was satisfied the premises stood when the licence was granted. It is a record of a state of affairs at a moment. It is not a live reading of today.
Nothing on a licence updates itself. No office writes to you when the person named on it stops working there, because no office knows. The certificate will go on saying what it said on the day it was issued until somebody applies to change it.
That is a perfectly ordinary feature of documents and a dangerous one here, because the thing most likely to change — an employee — is the thing the licence depends on.
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Follow it through and you get the proposition this page exists to make.
A valid licence and an absent person is not a small clerical mismatch. It is the situation in which the certificate says the premises are in a competent person charge and they are not, and in which the supplies that required supervision were made without it. The paper is intact. The condition is broken.
And because section 18(c) forbids sale except under, and in accordance with the conditions of, a licence, a breach of the condition is inside the prohibition rather than outside it. That is the whole engine of this subject in one sentence, and the sections that follow are each a piece of it.
So the practical test for any chemist shop is not whether the licence is current. It is whether, today, at this hour, the licence is telling the truth.
Against that, here is what a first-time applicant usually believes they are purchasing, and it is worth setting out because it explains the market.
A one-off clearance. Something applied for once, granted after an inspection, renewed on a cycle, and otherwise dormant. Money spent at the start of the business, filed away, and not thought about again until renewal. On that understanding, a cheap licence and an expensive licence are the same product and only the price differs.
On that understanding, an agent who offers the licence and the pharmacist together looks like better value rather than a warning. The offer only looks like what it is once you know that the person is the condition and not a form field.
Which is why the people who get into trouble on this subject are rarely careless. They are working from a reasonable but wrong model of what they bought.
And here is the other description of the same transaction.
A continuing permission, conditional throughout its term, to carry on a regulated activity at a stated address under the supervision of a qualified person, subject to records being maintained, to inspection, and to cancellation for breach after a hearing. Not a clearance. A standing set of obligations with a certificate attached.
Every provision discussed on the rest of this page is a term of that arrangement — the forms in Rule 61, the person in Rule 64, the counter in Rule 65, the records, the inspection cycle in Rule 65B, the cancellation machinery in Rule 66, and the offence in section 27. None of them is an optional extra.
So the first question we put to any caller on this subject is not about forms or fees.
Who is going to be in charge of the premises, by name, and have they agreed? Everything else on an application can be assembled, corrected or resubmitted. That one answer decides whether there is an application worth making at all.
If the answer is that it will be arranged, we stop there and say why. An application whose person in charge is a placeholder is an application that will succeed and then fail, which is worse than one that never went in. The rest of this page is the reasoning behind that refusal, set out provision by provision.
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Name the law properly before relying on it, because this is a field full of confident second-hand accounts.
The governing statute is the Drugs and Cosmetics Act, 1940, and the detail sits in the Drugs Rules, 1945 made under it. The Act supplies the prohibitions and the offences; the Rules supply the forms, the qualifications, the records and the machinery. A question about what you must do is nearly always a Rules question. A question about what happens if you do not is nearly always an Act question.
That division is worth knowing because it tells you where to look. Nothing in the Act tells you how many years of experience a competent person needs. Nothing in the Rules tells you the sentence for selling without a licence.
Licensing itself is administered at State level, which is the third layer and the one that decides your actual paperwork.
A question worth answering explicitly, because a good deal of recent writing on this subject implies one.
A draft Drugs, Medical Devices and Cosmetics Bill has been in circulation since 2022 and has been discussed extensively. It has not been enacted. The Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945 remain the law your licence is granted under, and every provision quoted on this page is quoted from them.
We say that plainly because we have learned to. A reader working to a Bill rather than an Act is working to requirements that do not exist, and a page that hedges about which law applies is no use to somebody filling in a form this week.
If that changes, it will change by an Act commenced and by rules notified, not by commentary. Until then, the 1940 Act is the answer.
Now the prohibition that makes the licence necessary, which has two limbs and is usually quoted with only one.
Section 18(c) provides that no person shall himself or by any other person on his behalf sell, stock or exhibit or offer for sale, or distribute any drug except under, and in accordance with the conditions of, a licence issued for the purpose under the Chapter.
Drugs and Cosmetics Act, 1940, section 18(c) — no person shall himself or by any other person on his behalf sell, stock or exhibit or offer for sale, or distribute any drug except under, and in accordance with the conditions of, a licence issued for the purpose.
Note the verbs as well. Not only selling — stocking, exhibiting, offering for sale, and distributing. A shop that is not selling today but has stock on its shelves is inside the section. And note the second limb: in accordance with the conditions of. That is where an absent pharmacist lands.
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With the prohibition in place, the next question is which licence you are applying for, and the Rules answer it by form number.
Rule 61 issues licences to sell drugs other than those specified in Schedules C, C(1) and X in Form 20, Form 20-A or Form 20-B as the case may be, with a proviso that a Form 20-A licence is valid only for the drugs specified in it; licences for Schedule C and C(1) drugs, excluding Schedule X, in Form 21, Form 21-A or Form 21-B; and licences for the sale of Schedule X drugs, by retail or wholesale, in Forms 20-F or 20-G.
Drugs Rules, 1945, Rule 61 — Form 20 / 20-A / 20-B for drugs other than those in Schedules C, C(1) and X; Form 21 / 21-A / 21-B for Schedule C and C(1) drugs excluding Schedule X; Forms 20-F and 20-G for Schedule X drugs. A Form 20-A licence is valid only for the drugs specified in it.
Two patterns are visible without any pharmacology. The plain number is the ordinary retail licence, the -A is a restricted licence limited to named drugs, and the -B is the wholesale licence. And the 20 series and 21 series exist in parallel because of which schedule the drug falls in.
So the first fork is the simplest one and the one most often got wrong by accident.
Selling to the person who will use the drug is retail. Selling to another dealer, institution or practitioner for resale or administration is wholesale. The forms differ, the person-in-charge requirement differs, and the records differ — wholesale supply has its own memo and preservation obligation that retail supply does not.
The accidental breach here is the retail shop that starts supplying a nursing home, a clinic or a neighbouring shop as a favour. That is wholesale activity, and a retail-only licence does not cover it. It is not a volume question; it is a question of who the buyer is and why they are buying.
If both are intended, both are applied for, which is the next section.
Many counters are genuinely both, and the Rules contemplate that.
The application is then for both forms in respect of the same premises — the retail licence and the wholesale licence — and the premises requirement is treated differently where both activities are carried on at one address than where only one is. The person-in-charge requirement has to be satisfied for what is being done, which for a retail counter supplying against prescriptions means a registered pharmacist regardless of what the wholesale side requires.
What this page will not do is tell you the exact minimum area for that combined case, and the reason is set out in full two sections below. It is not reticence. The compiled Rules themselves give two different figures, and the operative answer comes from your own State authority.
The second fork is which schedule the drugs fall in, and it changes the form before anything else is decided.
Drugs other than those in Schedules C, C(1) and X take the 20 series. Schedule C and C(1) drugs, excluding Schedule X, take the 21 series. Schedule X drugs take Forms 20-F and 20-G and bring their own storage and record obligations, which are dealt with further down this page.
Which schedule a particular product falls in is not a question we answer, and that is a deliberate limit rather than an omission. Classification is a professional judgment for a pharmacist, and we say so again in the section on where we have no standing.
What we can do is make sure the application is for the right form once that has been established by somebody qualified to establish it.
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Put the two forks together and the answer falls out of three questions.
| What the counter does | Which schedule | Form series under Rule 61 |
|---|---|---|
| Retail, to the person who will use the drug | Other than C, C(1), X | Form 20 (or 20-A if restricted to named drugs) |
| Retail | Schedule C and C(1), not X | Form 21 (or 21-A if restricted) |
| Wholesale, to dealers, institutions or practitioners | Other than C, C(1), X | Form 20-B |
| Wholesale | Schedule C and C(1), not X | Form 21-B |
| Either, where Schedule X drugs are involved | Schedule X | Form 20-F or 20-G |
Read down the table and you will see the thing that catches people: a single counter frequently needs more than one row. It is not a choice between forms. It is a question of how many of them apply.
Given how simple that table is, it is worth asking why the question is so rarely put at the start.
Because the quotation comes first. A caller asks what a drug licence costs, and a figure can be given without knowing any of it — so the figure is given, the engagement begins, and the form question arrives later, when a correction means a fresh application rather than an amendment.
We ask it before quoting for a plain commercial reason as well as a professional one. A retail-only application and a retail-plus-wholesale application are different pieces of work, and a single price for both is a price that is wrong for one of them.
With the form settled, the rest of the application is about the premises and the person, in that order.
Rule 64 is the gate before grant, and it asks the licensing authority to be satisfied about two different things.
The premises, which must be equipped with proper storage accommodation for preserving the properties of the drugs. And the person, which is the subject of the next several sections. There is also a specific requirement where a Form 20 or Form 21 licence is sought for a pharmacy: the requirements prescribed for a pharmacy in Schedule N are to be complied with.
Storage accommodation for preserving the properties of the drugs is a functional test, not a furniture list. Refrigeration where the product needs it, protection from light and heat where that matters, and separation where separation is required. It is assessed on inspection, which is why the application should describe it and not merely assert it.
Area comes into Rule 64 as well, and that is where this page becomes unusually careful.
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Here is a finding we would rather report honestly than paper over, because it affects what a reader should do.
The compiled text of Rule 64(2) contains more than one proviso dealing with the premises area for a wholesale licence in Form 20-B or Form 21-B, and they do not agree. One requires premises of an area of not less than ten square metres. Another, addressing the same forms, requires an area of not less than fifteen square metres. Both appear in the compiled Rules as published.
That is what happens to a set of rules amended repeatedly over eighty years, and it is not an obscure corner — it is the single figure every applicant wants. We are not going to resolve a textual conflict in delegated legislation on a service page, and we are not going to pick whichever number suits a quotation.
Which leaves the practical question: whose answer governs?
The answer is the office that will actually decide your application.
Licensing under these Rules is administered by State drugs control authorities, each of which publishes its own current checklist for the grant and retention of a sale licence, with its own area requirement, document list, plan format, fee and filing mode. That checklist is the operative statement for your application, and it is obtainable before anything is drafted.
So our sequence is: get the checklist, then design the premises and the file to it. Not the reverse, and never from a figure on a commercial website. If a landlord is being chosen on the strength of a square-metre number, that number should come from the authority that will inspect the shop.
Where the premises are taken on rent, get the measured area into the rent agreement itself and have the plan drawn from a measurement rather than from the landlord description.
Now to the half of Rule 64 that this whole page is built on.
The premises must be in the charge of a person competent in the opinion of the licensing authority to supervise and control the sale and preservation of the drugs. For a wholesale licence in Form 20-B or Form 21-B, the Rule goes further and prescribes the qualifications that person must hold, which is the first point at which the law stops leaving it to opinion and says what it will accept.
Read the role rather than the title: to supervise and control the sale and preservation. That is a working function performed on the premises. It is not a licence endorsement, a signature, or a name supplied for the file.
For a wholesale licence, Rule 64 sets out three alternative qualifications, and any one of them satisfies it.
| Door | What Rule 64 requires | Experience needed |
|---|---|---|
| (a) | Is a Registered Pharmacist | None stated |
| (b) | Has passed the matriculation examination or its equivalent from a recognised Board | Four years in dealing with the sale of drugs |
| (c) | Holds a degree of a recognised University | One year in dealing with drugs |
Three doors, not a hierarchy. A graduate with a single year of relevant experience satisfies the Rule exactly as a registered pharmacist does, for the wholesale role. And a person with neither the registration nor the schooling satisfies none of them, however many years they have worked in a shop.
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Two of those three doors turn on experience, and the wording repays attention.
Door (b) asks for four years of experience in dealing with the sale of drugs. Door (c) asks for one year in dealing with drugs. In both cases the experience is specific to drugs, and in the first it is specific to their sale. General retail experience, general warehousing experience and general business experience are not what the Rule asks for.
Which has a documentary consequence worth planning for: the experience has to be capable of being shown. An appointment letter, a salary record, the name of the licensed establishment where it was gained. A person who has genuinely done the work but cannot evidence it is in a weak position before an authority that has to form an opinion.
That is one of the few places on this subject where ordinary employment documentation does real work, through an employment agreement and a proper offer letter kept on file from the start.
A live development, reported this year, which readers are already being told is the law. It is not.
The Drugs Technical Advisory Board recommended in 2026 that the competent person for a wholesale licence in Form 20-B or Form 21-B be required to be a Registered Pharmacist, and asked that the Drugs Rules be amended accordingly. In other words, doors (b) and (c) described above would close, leaving only door (a).
The Board had earlier considered a wider option, allowing a science graduate with two years of experience together with a short certificate course, and returned to requiring a registered pharmacist. That history is worth knowing because it tells you the direction of travel even while the present Rule stands.
And the distinction that matters more than the recommendation itself.
A recommendation of the Board is not an amendment to the Rules. Delegated legislation changes when the amendment is made and published, and until that happens the three qualifications set out above are what Rule 64 contains and what your licensing authority applies.
So a reader must not be told, today, that their graduate competent person no longer qualifies — and must not be sold a service on that basis. We state the proposal as a proposal and the Rule as the Rule, and anybody quoting you for work made necessary by an unnotified amendment is quoting for work that does not exist yet.
Two practical consequences, pulling in slightly different directions, and a reader is entitled to both.
For compliance today: apply the Rule as it stands. A competent person qualifying under door (b) or (c) is lawfully in charge of your wholesale premises and no amendment has changed that. For planning: if you are recruiting now for a role you expect to hold for years, a registered pharmacist is the appointment that survives the change if it is made.
That is the honest shape of the advice — comply with the present Rule, hire with the proposal in view. If you want the position checked against the Rules as they stand on the day you are reading this, an online legal consultation or a video consultation is the cheap way to do it, and far cheaper than acting on a headline.
With the person settled, the next part of this page moves from obtaining the licence to operating under it, which is where the Rules become most specific.
Rule 64 is the gate. Rule 65 is the shop, open, trading, every day.
It is the longest and most practical rule in this part, and it sets out the conditions of the licence itself — who may supply what, against what, recorded how, kept for how long, stored in what manner, and produced to whom. Almost everything an inspector asks about is in it.
So the licence does not end at grant; Rule 65 is what the licence actually says. A shop that has read Rule 64 carefully and never read Rule 65 has prepared for the application and not for the business.
The sub-rules that follow are the ones a retail or wholesale counter meets daily.
Start with the sub-rule that decides the lawfulness of the ordinary transaction.
Rule 65(2) provides that the supply, otherwise than by way of wholesale dealing, of any drug supplied on the prescription of a Registered Medical Practitioner shall be effected only by or under the personal supervision of a registered pharmacist. The expression registered pharmacist is tied, by the Explanation to Rule 65(15), to clause (i) of section 2 of the Pharmacy Act, 1948.
Drugs Rules, 1945, Rule 65(2) — the supply, otherwise than by way of wholesale dealing, of any drug supplied on the prescription of a Registered Medical Practitioner shall be effected only by or under the personal supervision of a registered pharmacist.
Read the three words the Rule chose. Not under the general oversight of. Not under arrangements made by. Personal supervision — which means the person is there while it happens, or it is happening without what the Rule requires.
And which supplies that applies to is itself set by the Rules rather than by practice.
Rule 65(9) restricts the retail sale of drugs specified in Schedules H, H1 and X to sale on and in accordance with the prescription of a Registered Medical Practitioner. For Schedule X, the prescriptions are to be in duplicate, one copy being retained by the licensee. And supplies to practitioners and hospitals are to be made only against a signed order in writing, preserved by the licensee.
Three distinct categories, three distinct paper trails. Which product sits in which schedule is a professional classification question and not one we answer — but which record each category needs is a Rules question, and that is squarely documentation work.
The practical point is that the records are not one register. They are a set, and the next sections set them out.
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The central record first, and note when it has to be written.
Rule 65(3) requires that the supply of a drug on a prescription, other than a Schedule X drug, be recorded at the time of supply in a prescription register specially maintained for the purpose, with the entries the sub-rule specifies — including, for the drugs it names, the manufacturer of the drug, its batch number and the date of expiry of potency. Supplies of Schedule H1 drugs are to be recorded in a separate register at the time of supply, and those records are to be maintained for three years and kept open for inspection.
Drugs Rules, 1945, Rule 65(3) — supply on prescription is to be recorded at the time of supply in a prescription register, with manufacturer, batch number and date of expiry entered for the specified drugs; Schedule H1 supplies are recorded in a separate register at the time of supply, maintained for three years and open to inspection.
At the time of supply is the part that is breached most often and most innocently. A register written up at the end of the week is not a register kept as the Rule requires, and the entries that matter most — batch and expiry — are the ones memory cannot reconstruct.
Now the part that catches tidy shops, because the periods are not uniform.
Rule 65(7) requires records to be preserved for not less than two years from the date of the last entry. But the Schedule H1 register is to be maintained for three years; the carbon copies of wholesale cash or credit memos are preserved for three years from the date of the sale; and the Schedule X duplicate prescription and the signed orders from practitioners and hospitals are retained for two years.
So a shop applying a single two-year rule across the whole shelf will destroy a record a year before its own sub-rule allowed. That is a contravention created by housekeeping, and it is entirely avoidable by writing the retention date on each register when it is opened.
The table below is the one worth photocopying and keeping inside the file itself.
Each record against its own sub-rule and its own period.
| Record | Rule | Keep for | Runs from |
|---|---|---|---|
| Records generally | 65(7) | Not less than two years | Date of the last entry |
| Schedule H1 separate register | 65(3) | Three years, open to inspection | Maintenance of the register |
| Wholesale cash or credit memo carbons | 65(5) | Three years | Date of the sale |
| Schedule X prescription, duplicate copy | 65(9) | Two years | Retention by the licensee |
| Signed orders from practitioners and hospitals | 65(9) | Two years | Preservation by the licensee |
Read the fourth column as carefully as the third. Two years from the last entry in a register is not two years from the transaction; a register in use for three years carries its whole contents forward. Where you would rather not be the custodian of all this, legal file management exists for exactly this kind of dated bundle.
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The wholesale side has one obligation of its own that retail-only shops never think about.
Rule 65(5) requires that supply by wholesale be made against a cash or credit memo, and that the carbon copies be preserved as records for a period of three years from the date of the sale of the drug.
Drugs Rules, 1945, Rule 65(5) — wholesale supply is to be made against a cash or credit memo, the carbon copies of which are preserved as records for three years from the date of the sale.
This is the sub-rule that converts the informal favour into a documented breach. A retail shop that supplies a neighbouring clinic has not only acted outside its form of licence; it has made a wholesale supply with no memo and no carbon to preserve, and the absence of the record is itself visible on inspection.
Schedule X carries the heaviest handling obligations and they are physical as well as documentary.
Rule 65(12) requires drugs specified in Schedule X to be stored under lock and key in a cupboard or drawer reserved solely for the storage of those substances, or in a part of the premises separated from the remainder of the premises. Rule 65(21) requires the supply of Schedule X drugs to be recorded at the time of supply in a register, and the prescriptions, as noted above, are in duplicate with one copy retained.
Reserved solely is the operative phrase in the storage requirement. A shared cupboard with a lock on it is not a cupboard reserved solely for those substances, and the distinction is visible to anybody who opens it.
If Schedule X is intended at all, say so at the application stage — it changes the form under Rule 61 and it changes what the inspection will look at.
Which raises the question of when all this is actually looked at, and the Rules answer it.
Rule 65B provides that the licensing authority shall cause inspection, by an Inspector appointed under the Act, of each premises licensed under this Part, to verify compliance with the conditions of the licence, not less than once in three years or as needed on a risk-based approach. And Rule 65(6) requires the licensee to produce the registers and records for inspection on demand.
So inspection is scheduled with a floor, not left to chance, with discretion to come sooner where the risk indicates it. That reframes record-keeping entirely: you are not keeping records in case somebody asks, you are keeping them for an event with a known maximum interval.
Keep every inspection report and your dated reply to it, because those documents become the evidence of diligence discussed later on this page.
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Now the situation this page was written for, which arrives in an ordinary way.
A pharmacist resigns, retires, moves city, falls ill, or simply stops coming. Nothing dramatic happens. No notice arrives, no shutter comes down, no system flags anything, because no system knows. The shop opens the next morning and trades.
And the owner, reasonably, concludes that there is time to deal with it — at renewal, or when a replacement turns up, or when somebody from the department mentions it. That conclusion is where the damage is done, and the next two sections explain why.
Take the first half of the position, which is true and is the part people rely on.
The licence does not lapse because the person named in it has left. It runs for its term. Nothing in the Rules makes a resignation a cancellation, and the licensing authority has taken no step and may know nothing about it. If you ask whether your licence is valid, the answer is yes.
That is why the mistake is made by careful people rather than careless ones. They ask the right question and get a true answer. The trouble is that validity of the licence was never the whole of what the law required.
And here is the other half, which is the one that matters.
Rule 65(2) conditions the supply itself, not the certificate: prescription supply only by or under the personal supervision of a registered pharmacist. Section 18(c) forbids sale except under, and in accordance with the conditions of, a licence. So each prescription supply made with no pharmacist supervising is a supply outside the condition, while the licence on the wall remains perfectly valid.
The licence is valid and the sales are not. Both statements are true at once, and only the second one carries a penalty. That is the whole of this page in two sentences, and it is the thing no agent selling a licence will tell a first-time owner.
Which is why the advice when a pharmacist leaves is immediate and practical: stop the supplies that need supervision, appoint a replacement, and write to the authority yourself with the dates.
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So what can the authority actually do about a breach? Rule 66, and it is more protective of the licensee than people expect.
The licensing authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons, cancel a licence issued under this Part or suspend it for such period as it thinks fit, either wholly or in respect of some of the substances to which it relates, if in its opinion the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or rules.
Drugs Rules, 1945, Rule 66(1) — cancellation or suspension, wholly or in respect of some substances, only after an opportunity to show cause and by an order in writing stating the reasons, for failure to comply with a condition of the licence or a provision of the Act or rules.
Note the middle option. Suspension in respect of some of the substances is available, which matters where a defect concerns one category and not the whole business.
Two procedural protections sit in that sub-rule and both are worth knowing before you ever need them.
First, an opportunity to show cause why such an order should not be passed. The authority forms its opinion after hearing you, not before. Second, an order in writing stating the reasons. A cancellation is not an instruction conveyed on a visit; it is a reasoned written order, and the reasons in it are what any challenge is built on.
So the reply to a show-cause notice is the most important document in the whole sequence, and it is not drafting work. It is where the defences in the proviso are actually deployed, and it belongs with an advocate from the day the notice arrives.
Keep the envelope and date-stamp the notice. Both the reply period and the later appeal period run from dates.
The proviso to Rule 66(1) then does something unusual and useful: it sets out, in terms, what saves a licensee whose employee caused the breach.
| Defence | What the licensee must prove | How it is proved |
|---|---|---|
| (a) | The act or omission was not instigated or connived at by him, or by a partner of the firm or a director of the company | Standing written instructions; absence of any contrary direction |
| (b) | Neither he nor his agent or employee had been guilty of any similar act or omission within twelve months before | Inspection history and the shop own corrective record |
| (c) | For a continuing act or omission, he had not and could not reasonably have had knowledge of the earlier one | Supervision and review records showing what was and was not visible |
| (d) | He had used due diligence to ensure that the conditions of the licence and the provisions of the Act and rules were observed | The whole compliance system, documented and dated |
Read the third column, because it is the point. Every one of the four is proved by records made before the event, not by an explanation offered after it.
Door (d) deserves its own section, because it is the only one of the four a shop can build on purpose.
Due diligence here is not an attitude; it is a file. A written appointment of the person in charge. An attendance record for that person. Standing written instructions on what may not be supplied in their absence. Registers actually maintained at the time of supply. Dated action on every earlier inspection remark. A documented check that the person registration is current.
A shop that can produce those six things is arguing from paper about a day it was not watching. A shop that cannot is asking an authority to accept its recollection of an event at a counter it was not standing behind. The Rule leaves room for the first argument and very little for the second.
Build it at the start. Every item on that list costs nothing while the shop is being set up, and cannot be created afterwards.
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Everything so far has been licensing. There is a second track running alongside it and it is not administrative at all.
Cancellation and suspension under Rule 66 are the licensing consequence. The Act carries its own offences, prosecuted in the ordinary way, and they are not alternatives to each other — a shop can lose a licence and be prosecuted for the same facts. Rule 66(2) allows an appeal to the State Government within three months of an order of suspension or cancellation; a prosecution follows a different road entirely.
This is the point at which a documentation question stops being one. A notice, a summons, a sample reported not of standard quality, a seizure or an appeal are all matters for an advocate, and the handover is listed again near the end of this page.
The section below is the one every shop owner should read once and remember.
And here is the consequence that makes the difference between this page and a checklist.
Section 27(b)(ii) attaches to a sale made without the valid licence that section 18(c) requires. The custodial term it fixes has a floor of three years and a ceiling of five. The fine has a floor too: one lakh rupees, or three times the value of the drugs confiscated if that figure is the larger of the two. And the court may go beneath the floor only on reasons that are both adequate and special and that it records in its judgment.
Drugs and Cosmetics Act, 1940, section 27(b)(ii) — sale without the licence section 18(c) requires. Custody: floor three years, ceiling five. Fine: floor one lakh rupees, or treble the confiscated value if greater. Below the floor only on adequate and special reasons, recorded.
So an unlicensed sale is not an application running late and it is not a penalty. It is an offence with a statutory minimum term, and nothing in the Act makes a pending application a defence to it. That is why, where a shop is trading on nothing valid, the honest advice is to stop selling rather than to file faster — and we give it even though it costs us the quicker engagement.
Alongside this licence, the ordinary business permissions still have to be in place and sequenced — the municipal trade licence, shop and establishment registration, GST registration, MSME registration, professional tax where the State levies it, a fire NOC where the premises require one, an import export code if anything is imported, and a trademark registration for the shop own name. The constitution of the business, whether a proprietorship or a partnership deed, is an attachment to the application rather than an afterthought, and a document verification run before filing catches the mismatches that cause most refusals. Where an authority asks for an assurance in a particular form, that is an undertaking, an indemnity bond or an NOC rather than an informal letter; keep a certified true copy of anything you hand over; and where a properly made application simply sits unanswered, a legal notice is the step that exists for it.
This last stretch is ours: our side of the file, and the one thing we will not supply at any price.
Four kinds of enquiry. A chemist shop opening for the first time, where nothing has been applied for yet. An existing shop whose pharmacist has resigned. A distributor adding wholesale to a retail counter, or the reverse. And a shop that has received a notice and wants the paperwork put straight before answering it.
The second and fourth are the urgent ones and they arrive in the same week more often than you would expect, because a resignation and a notice tend to be connected. Both are dealt with in the order set out above: establish the position, then the paper.
Five questions, asked before a single form is filled or a figure named.
Which State, because the licensing authority and its own checklist are State-level. Retail, wholesale, or both at one address. Whether any scheduled drug is intended to be stocked. Who the registered pharmacist or competent person is, by name, and whether that person has agreed. And whether anything is already being sold on the premises today.
The fourth question is the one we will not move past. A name is not an answer; an agreement from the person named is. The fifth question we ask plainly, and the answer changes what we advise rather than whether we help.
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Set out as documents, because an application of this kind is an assembly job and most refusals are assembly failures.
The application in the form the State prescribes, with the correct form of licence identified. Proof of the premises, by ownership or tenancy. The constitution of the firm. The qualification and registration papers of the pharmacist or competent person, with that person’s own declaration. A site plan with the measured area. The storage and refrigeration particulars. And an index, so that the file can be read by somebody who has never met you.
We prepare it as a file to be inspected rather than a form to be submitted, because that is what it becomes. An inspector reading a numbered, indexed bundle asks fewer questions than one reading a folder of loose photocopies, and that difference is most of the time saved.
Stated first and without qualification, because it is the standard offer in this market.
We do not supply, arrange, introduce, lend or share a registered pharmacist or a competent person. Not for a fee, not as a favour, not as part of a package, and not for the few weeks until you find your own. We will not let our name, or any of our people’s names, appear in that role on any application.
A pharmacist whose registration is on your licence and whose person is not behind your counter is the central abuse in this trade, and it is not a paperwork shortcut — it puts the registration of a real professional and the liberty of the licensee in the same place. Anybody offering you a pharmacist along with a licence is offering you the part of this that goes wrong.
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Which means a positive obligation sits with you, and we would rather say so than let it be discovered later.
The person in charge is your appointment, on your terms, present on your premises during the hours you sell. We can tell you what the Rules require of that person’s qualification and what the Rules require of their presence. We cannot be that person, provide that person, or confirm to anybody that the person is there.
Treat the appointment as the first business decision of the shop rather than the last compliance item. Everything else on the application is paper that can be corrected. This one is a person who either turns up or does not, and the whole licence stands on it.
And the boundary around our own competence, which on this subject is narrower than on most.
We do not advise on which drugs may be stocked, sold or dispensed, on what may be supplied against which prescription, on substitution, on storage temperatures, or on anything else that is the professional judgment of a pharmacist or a medical practitioner. We are a documentation office. Those questions are not ours and we will not answer them even when asked directly.
Our part is the licence file and the records the Rules require. The practice of pharmacy is the pharmacist’s. A consultant who answers both is answering one of them without the training to.
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Three refusals in drafting, each one a document somebody has asked us for.
We will not draft a declaration for a pharmacist or competent person who has not signed it in front of us or sent it to us themselves. We will not prepare a site plan or an area statement from a figure given to us over the phone; it is measured or it is not stated. And we will not draft an answer to a notice that says records exist where we have not seen them.
Each of those three is a statement made to a licensing authority about a fact, and an office that manufactures one is manufacturing evidence. If a file cannot be put together honestly, we say that instead of putting it together.
One procedural insistence, and it is the one that saves readers the most money.
Before anything is drafted we obtain the current checklist of your own State’s drugs control authority and work to that document rather than to a general description of the Rules. Area, documents, plan format, fee, mode of filing and the sequence of inspection are all set by that office, and they do not all say the same thing.
We will not substitute a figure from any commercial website for that checklist, and you should not accept one either. For the specific reason that applies to the premises area on this subject, see the two sections below — it is not caution, it is that the compiled Rules themselves do not read consistently on the point.
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Some things on this subject are not documentation and the handover should happen early, not after an answer has been filed.
A show-cause notice proposing cancellation or suspension. A prosecution, or a summons. A sample taken and reported not of standard quality. A seizure. An appeal to the State Government against a cancellation. Any allegation that a drug was spurious or adulterated. And any question about a pharmacist’s own registration before the Pharmacy Council.
Court work is for your advocate, whose fee is engaged and paid by you directly; we do not quote, collect or share it.
The sample report deserves naming twice. It is the point at which a documentation question becomes a defence, and the time to instruct somebody is when the report arrives, not when the summons does.
A short word on what to keep, since this is a trade where the records are the compliance.
Keep the licence, the pharmacist’s appointment and registration papers, the prescription register, the separate scheduled-drug registers, the purchase bills, the wholesale memo carbons, the cold-chain log and every inspection report and reply, in one place, in date order, each with its retention date written on it.
The retention periods are not uniform and that is where shops come unstuck — a register thrown out at two years when its own rule said three is a contravention created by tidying up. The table earlier on this page sets each period against its rule; keep a copy of it inside the folder.
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Here is the number, and then the longer list of what it is not.
We charge ₹14,999 and the listed time against it is 30 – 90 days. That is the assembly of the application file, the qualification and premises documentation, the records framework the Rules require, and the drafting of the registers and formats you will have to maintain from the first day of trading.
The spread in that time is not padding. An application for a shop whose premises and pharmacist are both settled moves at one speed; one waiting on a tenancy, a measured plan or a person who has not yet agreed moves at another, and no part of the difference is in our hands.
And the list of things that are not in it, written out so nothing arrives as a surprise.
The State licence fee, paid where it is charged. The pharmacist’s or competent person’s salary, which is an employment cost and never ours. The cost of a measured site plan if a draughtsman is needed. Refrigeration, storage furniture and any premises work. Notarisation. Any fee for a professional opinion on a product question. And an advocate’s fee if the matter reaches any of the situations listed two sections above.
None of those is marked up by us and none passes through our account. If a quotation for this work is a single number with nothing excluded, the exclusions have not gone away — they have just not been mentioned yet.
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One omission, and unusually it is the Rules rather than us that make it necessary.
You will have noticed that the minimum premises area is discussed above without this page committing to one number for wholesale. That is because the compiled Rules carry two provisos giving two different areas for the same forms, and we are not willing to print one of them as though the question were closed. What settles it in practice is the State authority’s own current checklist, which is why obtaining that comes before drafting.
Every commercial page on this subject prints one figure with complete confidence. Read two of them and you will find both numbers in circulation, which is the clearest possible sign that neither author went to the text. We would rather tell you the position is unsettled and tell you who settles it.
A different reader, and the commonest one after the notice.
If drugs are already being sold, the first question is not what to apply for but what is being relied on today. A licence in the wrong form, a licence whose named person has left, an expired licence, or no licence at all are four quite different positions with four different urgencies, and only one of them is an application.
Where the answer is that nothing is being relied on, the honest advice is to stop selling rather than to apply quickly, and we give it. The reason is in the section on the criminal side of this: an unlicensed sale is not an application that is running late.
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If you do nothing else after reading this page, do this.
Look at your licence and read the name of the person in charge on it. Then establish whether that person works on those premises, during the hours you sell, today. If the two answers do not match, you have the single fault that this whole page is about, and it is fixable this week by hiring rather than by filing.
It costs nothing to check and it is the first thing an inspector establishes. Every other defect on a drugs file can be cured by producing a document. This one can only be cured by a person being present.
One sentence to carry away, and it is not about the application at all.
The State licenses premises, but it licenses them into the charge of a named, qualified person — so the licence is only doing its work for as long as that person is actually standing behind the counter. A certificate on the wall and an empty counter is the one combination the law treats as no licence at all.
Send us the State, whether the counter is retail, wholesale or both, the premises papers and your pharmacist’s or competent person’s own registration details — and we will tell you which form of licence applies and exactly what your own licensing authority’s current checklist asks for.
Where each sentence above came from, rule by rule. The governing statute is the Drugs and Cosmetics Act, 1940, which remains in force; a draft Drugs, Medical Devices and Cosmetics Bill has been in circulation since 2022 but has not been enacted, and nothing on this page assumes otherwise. Section 18(c) provides that no person shall himself or by any other person on his behalf sell, stock or exhibit or offer for sale, or distribute any drug except under, and in accordance with the conditions of, a licence issued for the purpose under the Chapter. The forms of licence are set by the Drugs Rules, 1945: Rule 61 issues licences to sell drugs other than those in Schedules C, C(1) and X in Form 20, Form 20-A or Form 20-B as the case may be, with a proviso that a Form 20-A licence is valid only for the drugs specified in it; licences for Schedule C and C(1) drugs, excluding Schedule X, in Form 21, Form 21-A or Form 21-B; and licences for Schedule X drugs in Forms 20-F or 20-G.
On the person in charge, which is the subject of this page, Rule 64 requires the licensing authority to be satisfied that the premises are equipped with proper storage accommodation for preserving the properties of the drugs and are in charge of a person competent in the opinion of the licensing authority to supervise and control the sale and preservation of the drugs, with a further requirement that where a Form 20 or Form 21 licence is sought for a pharmacy the requirements prescribed for a pharmacy in Schedule N are complied with. For a wholesale licence in Form 20-B or Form 21-B, the proviso to Rule 64(2) requires that the premises be in the charge of a competent person who (a) is a Registered Pharmacist, or (b) has passed the matriculation examination or its equivalent examination from a recognised Board with four years’ experience in dealing with the sale of drugs, or (c) holds a degree of a recognised University with one year’s experience in dealing with drugs. On the counter itself, Rule 65(2) provides that the supply, otherwise than by way of wholesale dealing, of any drug supplied on the prescription of a Registered Medical Practitioner shall be effected only by or under the personal supervision of a registered pharmacist; the expression is tied by the Explanation to Rule 65(15) to clause (i) of section 2 of the Pharmacy Act, 1948.
On records and inspection, again from the Rules themselves: Rule 65(3) requires supply against a prescription to be recorded at the time of supply in a prescription register, with the manufacturer, batch number and date of expiry entered for the drugs it specifies, and requires Schedule H1 supplies to be recorded in a separate register maintained for three years and open to inspection; Rule 65(5) requires wholesale supply to be made against a cash or credit memo whose carbon copies are preserved for three years from the date of sale; Rule 65(7) requires records to be preserved for not less than two years from the date of the last entry; Rule 65(9) restricts retail sale of drugs in Schedules H, H1 and X to sale on and in accordance with the prescription of a Registered Medical Practitioner, requires Schedule X prescriptions to be in duplicate with one copy retained for two years, and requires supplies to practitioners and hospitals to be made against a signed written order preserved for two years; Rule 65(12) requires Schedule X substances to be stored under lock and key in a cupboard or drawer reserved solely for them or in a separated part of the premises; and Rule 65B provides for inspection of each licensed premises to verify compliance not less than once in three years or as needed on a risk-based approach.
On losing a licence and on the criminal side, Rule 66(1) allows the licensing authority, after giving the licensee an opportunity to show cause, by an order in writing stating the reasons, to cancel or suspend a licence wholly or in respect of some of the substances if in its opinion the licensee has failed to comply with any condition of the licence or any provision of the Act or rules; the proviso protects the licensee where the failure was the act or omission of an agent or employee and the licensee proves that it was not instigated or connived at by him or by a partner or director, or that there had been no similar act or omission within twelve months, or that he had no and could not reasonably have had knowledge of a previous continuing act, or that he had used due diligence to ensure compliance; Rule 66(2) allows an appeal to the State Government within three months. Under section 27(b)(ii) of the Act a sale made without the valid licence section 18(c) requires carries a custodial floor of three years and a ceiling of five, with a fine floored at one lakh rupees or at treble the confiscated value where that is greater, the court being able to go beneath the floor only on reasons it finds adequate and special and records in its judgment. One matter is deliberately left as a proposal rather than a rule: the Drugs Technical Advisory Board recommended in 2026 that the competent person for a wholesale licence in Form 20-B or 21-B be required to be a Registered Pharmacist, and asked that the Rules be amended accordingly. That recommendation has not been notified and the three qualifications set out above are what Rule 64 presently contains. And one figure is left open on purpose: the compiled Rules carry two provisos stating two different minimum areas for wholesale premises, so this page states the position as unsettled and directs the reader to the current checklist of the State drugs control authority rather than printing a number.
Related work on this site. The licence that sits beside this one for most shops is the municipal trade licence, which is a different permission from a different authority and is dealt with on its own page. Where food is also sold from the same counter, see FSSAI registration. The premises paperwork behind an application — the tenancy, the ownership proof and the constitution of the firm — is covered on rent agreement and partnership deed, and the employment side of appointing your pharmacist on employment agreement and offer letter drafting.
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