Checklist at a glance

You need one set of papers in your own name and a second set that your franchise company should hand over. Here is the first set.

The next four sections go through the important ones in detail.

Wholesale drug licence: what the inspector actually looks at

The wholesale drug licence is the one document you cannot skip, and it is where most first-time applicants lose weeks. You apply on Form 19, usually through your state’s online portal (many states now use the Online National Drugs Licensing System, ONDLS), and the licence is issued on Form 20B for general allopathic drugs. If you will also deal in products listed under Schedule C or C(1), such as certain biologicals, you need Form 21B as well.

Here is what goes into the application:

• Form 19 and the system-generated fee receipt (the fee is small, around ₹1,500 per licence in many states, but state fee schedules differ)
• Self-declaration or affidavit from the proprietor, partners or directors
• Proof of the firm’s constitution, plus ID and address proof of the owner
• Premises papers: ownership documents or a rent agreement with the landlord’s ownership proof, site plan, key plan, and a recent electricity or tax receipt
• Papers for your competent person: qualification certificate, experience certificate, appointment letter, photograph and a self-declaration

The competent person is where applications get stuck. A wholesale licence does not need a registered pharmacist, but it does need a competent person. That means a science graduate with one year of experience in handling drugs, or a non-graduate with four years. The experience certificate should show the previous employer’s drug licence number. A certificate without it is not treated as valid.

Premises matter more than people expect. Storage space of around 10 square metres is the usual minimum for a standalone wholesale set-up, and some states, Delhi for one, do not grant drug licences on premises located on residential plots. Check your state’s rule before you sign a rent agreement, not after.

What changed in 2026. The Drugs (Amendment) Rules, 2026 (G.S.R. 135(E), 16 February 2026) updated the conditions attached to wholesale licences. Sales must happen under the personal supervision of a named competent person, and you must inform the licensing authority within one month if that person changes. If your competent person resigns and you only find a replacement three months later, you are out of compliance. Keep a standby name ready.

Once issued, the licence stays valid indefinitely, subject to paying a retention fee every five years.

GST registration, and why the 2025 changes matter to you

GST registration is quicker and the tax on most medicines is lower than it was two years ago, and both changes affect how you plan your first few months.

On 22 September 2025, GST on most medicines fell from 12% to 5%, and a list of life-saving drugs went to nil. The National Pharmaceutical Pricing Authority told manufacturers and marketers to revise MRPs from that date and issue fresh price lists to dealers. For you, that means two things. Check that the price list you receive from the company is the post-September 2025 one. And if a product is nil-rated, input tax credit on it has to be reversed in proportion, so ask your accountant how the mix of 5% and nil-rated items will sit in your books.

Since 1 November 2025, small and low-risk applicants can get GST registration within three working days, provided Aadhaar authentication goes through and the system raises no risk flag. The scheme is meant for applicants whose output tax on supplies to registered persons will stay under ₹2.5 lakh a month. A new PCD distributor will usually qualify, but that is not a promise. Applications flagged as high risk still go through the normal process.

Documents for GST are the usual ones: PAN, Aadhaar, photograph, proof of business constitution, address proof for the place of business (a recent utility bill works) and bank details. One practical point: apply for GST using the same address as your drug licence. A mismatch between the two is one of the easiest ways to invite questions later.

The documents your franchise company should give you

This is the part almost no blog covers, and it is the part that protects you. You are the one whose name is on the invoice and whose stock the drug inspector can pick up, so you should be able to see who made what you are selling.

Before you sign, ask the company for:

• A copy of the manufacturing licence of the plant making your products (or of the loan licence, if the company outsources). Check that the licence is current and covers the dosage forms you are being offered.
• Written proof that the plant meets revised Schedule M. It has applied to every pharma manufacturing unit in India since 1 January 2026, and the regulator has told states to begin risk-based inspections. A plant that is still “upgrading” is a risk for you too.
• The product list with composition, strength, pack size and MRP, and the current NPPA price list for any product under price control.
• Product permissions or approvals for anything that is a new drug or a fixed-dose combination.
• Certificate of analysis for the batches you will receive, and a recall and returns policy in writing.
• Your franchise agreement, with the territory, the exclusivity (monopoly) terms, minimum order if any, and the term and exit conditions.
• Proof the brand name is cleared, such as the trademark registration or application receipt.

One more reason to ask: the Central Drugs Standard Control Organisation (CDSCO) publishes a monthly list of drug samples declared Not of Standard Quality. In May 2026 it flagged 46. A stockist cannot inspect a batch, but you can check the manufacturer’s name against that list every month.

Gynae-specific points most blogs skip

A gynae range is not a generic range, and a few paperwork questions come up only in this segment.

Drug or supplement? A typical gynae catalogue mixes prescription drugs (hormonal products, antifungal pessaries, antibiotics, tranexamic acid) with iron, folic acid, calcium, vitamin D and inositol products. Some of these are licensed as drugs. Others are sold as nutraceuticals and sit under FSSAI. Ask the company to tell you, product by product, which licence each one is sold under. If any come under FSSAI, you will need your own FSSAI registration to store and sell them.

Cosmetic or medicine? Intimate washes, wipes and similar care products can be classified as cosmetics rather than medicines. Since September 2025 that is a big gap in GST: most medicines attract 5%, cosmetics 18%. Get the classification in writing, with the HSN code the company is using on its invoices.

Prescription-only products. Many gynae products are Schedule H drugs. Your wholesale licence conditions say you may sell only to people who hold the right licence, so every invoice for these goes to a licensed chemist, hospital or nursing home, never to an individual. Keep your purchase and sales records in order, because this is the first thing an inspector asks for.

Pregnancy-related and abortion-related medicines. Some products in this area carry tighter sale conditions. Ask the company which items in your list are affected, and get your state drug controller’s view if you are unsure. This is one area where guessing is a bad idea.

Folic acid labels. In June 2026 the Drugs (Fourth Amendment) Rules corrected the unit for folic acid in Schedule V from mg to mcg. If your range includes folic acid, check that the company’s labels and specifications match the corrected unit.

What Changes in 2027, and What Paperwork You Need

Some new rules will affect pharma franchise businesses in 2027 and later. These rules do not require a separate licence, but you must follow them and maintain proper records.

Data protection is the one most people will miss. If your team keeps a list of gynaecologists with phone numbers, or a WhatsApp group of chemists, you are handling personal data. From 13 May 2027 you will need to tell people what you collect and why, take their consent, secure the data and report breaches. Build a simple consent record now, a one-page privacy notice and a rule that nobody forwards doctor lists to outsiders. The earlier transition period for the older IT rules ends on the same date.

QR codes will reach gynae quietly. The Drugs (Seventh Amendment) Rules, 2026 (G.S.R. 506(E), 22 June 2026) extended the QR rule from a list of 300 brands to whole therapeutic classes, with a phased roll-out. Anti-cancer drugs, vaccines and narcotics are reported to be due by July 2027, and antimicrobials by July 2028. The code carries the batch, manufacturer, manufacturing licence number and expiry date. As a distributor, you should be able to scan a pack and see that it matches the invoice.

The advertising draft is still a draft. If it is notified as proposed, a stockist who advertises a Schedule H product to the public would be in breach of the licence conditions. Keep your social media to company and awareness content, and keep brand promotion for the doctors who prescribe.