Drug Licence for a Medical Store in Bihar: Forms, Documents, Process

Most medical store plans in Bihar do not get stuck on money. They get stuck on the drug licence. A missing document, a shop that is a little too small, or a pharmacist who backs out at the last minute can push opening day back by weeks.

The good news is that the rules are clear once you understand them. This guide explains the forms, the documents, the inspection and the common traps, in the order you will face them. Fees and portal screens change, so use this as a map and confirm the latest details with the Drugs Control office.

Which law and which forms apply

Sale of medicines in India comes under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. For a retail medical store, these are the forms you will hear about:

• Form 19 — the application form for a licence to sell, stock or exhibit drugs.
• Form 20 — the retail sale licence for drugs other than those in Schedule C, C1 and X.
• Form 21 — the retail sale licence for drugs in Schedule C and C1 (such as certain biologicals), excluding Schedule X.

Most general medical stores apply for both Form 20 and Form 21 so they can stock the full range of common medicines. Schedule X drugs (certain habit-forming medicines) need a separate licence and very strict record-keeping, so many small stores do not deal in them at all.

If you also want to supply other shops or clinics, you will need wholesale licences too. That raises the space requirement, as explained below.

Drug license for medical store in Bihar: basic eligibility

Before you fill any form, check that you meet these conditions.

• Registered pharmacist. A pharmacist registered with the Bihar State Pharmacy Council (or the council of the state where they are registered, as accepted by the authority) must be in charge of the store during business hours. This is usually a D.Pharm or B.Pharm holder with valid registration.
• Premises area. The shop should be at least 10 sq m for retail. If you plan retail and wholesale together, plan for at least 15 sq m.
• Storage. A refrigerator for cold-chain medicines, and clean, dry storage away from direct sunlight.
• Legal possession of the shop. Ownership papers or a valid rent agreement.

The owner (proprietor, partners or directors) does not need to be a pharmacist. But the authority will look closely at who is actually running the counter.

Documents checklist

Keep self-attested copies ready in one folder, and scanned copies in PDF on your phone. The exact list can vary, but these are commonly asked for:

1. Application in Form 19, filled through the state licensing portal.
2. Covering letter on your letterhead stating the categories you want.
3. Proof of the firm's constitution — proprietorship declaration, partnership deed, or company incorporation documents.
4. ID and address proof of the proprietor, partners or directors.
5. Proof of premises — ownership document or rent agreement, plus consent of the owner if rented.
6. Site plan and layout of the shop showing dimensions.
7. Pharmacist's registration certificate, qualification certificate, ID proof and appointment or consent letter.
8. Affidavits or declarations as required (for example, that the applicant has not been convicted under the Act).
9. Proof of purchase or a declaration for the refrigerator.
10. Proof of fee payment through the prescribed method.

Do not pay any fee in cash to a middleman. Pay only through the official method shown on the portal or advised by the Drugs Control office.

The process, step by step

In Bihar, retail drug licensing is handled by the Drugs Control Administration through its online licensing system. The broad flow is:

1. Register on the portal and create your applicant login.
2. Fill Form 19 with firm, premises and pharmacist details.
3. Upload documents in the required format and size.
4. Pay the government fee online. We are not quoting amounts here because fees are revised from time to time.
5. Inspection — a Drugs Inspector visits the shop to check area, storage, refrigerator, pharmacist and documents.
6. Queries, if any — reply quickly and completely.
7. Licence issued in Form 20 and/or Form 21, which you must display at the shop.

Timelines depend on the workload of the office, the completeness of your file and inspection dates. Ask the State Drugs Control office for current timelines rather than trusting someone who promises a fixed number of days.

What the inspector looks for

The inspection is not something to fear. It is a check that your shop can store and sell medicines safely. Prepare for:

• Measurements matching your site plan.
• Racks and shelves that keep medicines off the floor.
• A working refrigerator with space for cold-chain items.
• Cleanliness, ventilation and protection from dampness and direct sun.
• The pharmacist's presence or clear proof of their appointment.
• A board or space to display the licence and pharmacist details.

Have the original documents with you on the day.

After you get the licence

The licence is the start of compliance, not the end. Keep these habits from day one.

• Sell Schedule H and H1 medicines only against a valid prescription. Maintain the H1 register with patient, prescriber, drug and quantity details.
• Keep purchase invoices from licensed distributors for every batch.
• Store cold-chain items correctly and keep a simple temperature log.
• Inform the Drugs Control office if your pharmacist changes, and do not run the counter without one.
• Renew or retain the licence as per the current rules before it lapses.

Good billing software helps a lot here. It records batch numbers, expiry and prescription details automatically.

Mistakes to avoid

• Renting before measuring. A 9 sq m shop will not pass a 10 sq m requirement.
• Using a pharmacist's certificate without them working. This is a serious violation and can lead to suspension.
• Uploading unclear scans. Blurry documents bring queries and delay.
• Missing the refrigerator. It is a basic requirement for most stores.
• Trusting "setting" agents. Use the official process. Shortcuts often cost more later.

FAQs

Can I apply for Form 20 and Form 21 together?

Yes. Most retail stores apply for both in one application so they can stock general medicines and Schedule C/C1 items.

Can the pharmacist work at two stores?

Generally, a pharmacist must be in charge of one premises during its working hours. Confirm the rules with your Drugs Control office.

What is the government fee?

Fees are revised from time to time. Check the current amount on the Bihar licensing portal or with the State Drugs Control office.

Do I need a separate licence for wholesale?

Yes. Wholesale needs its own licences, and the combined premises should be at least 15 sq m.

Does Griomed Global apply for the licence for me?

Griomed Global provides licence filing support for all its franchise formats. The licence is still issued in your name after the official inspection.

Get help with your licence file

Licensing becomes simple when your shop, pharmacist and documents are ready together. Griomed Global helps franchise partners prepare their file, plan the layout to meet area rules and get the shop ready for inspection. Explore the formats on our franchise page, learn about us, or contact our team. Call or WhatsApp +91 90316 00721, Monday to Saturday, 10 AM to 7 PM.

हिंदी में सारांश

मेडिकल स्टोर के लिए ड्रग लाइसेंस औषधि एवं प्रसाधन सामग्री नियम, 1945 के तहत मिलता है। आवेदन फॉर्म 19 में होता है। रिटेल लाइसेंस फॉर्म 20 और फॉर्म 21 में जारी होते हैं। ज़्यादातर दुकानदार दोनों के लिए एक साथ आवेदन करते हैं।

सबसे ज़रूरी शर्तें तीन हैं। पहली, स्टेट फार्मेसी काउंसिल में रजिस्टर्ड फार्मासिस्ट दुकान पर मौजूद रहना चाहिए। दूसरी, रिटेल के लिए कम से कम 10 वर्ग मीटर जगह चाहिए, और होलसेल साथ में हो तो 15 वर्ग मीटर। तीसरी, ठंडी दवाओं के लिए फ्रिज होना चाहिए।

दस्तावेज़ों में पहचान पत्र, दुकान का किराया या मालिकाना कागज़, नक्शा, फार्मासिस्ट का सर्टिफिकेट और सहमति पत्र, और ज़रूरी शपथ पत्र रखें। बिहार में आवेदन ड्रग्स कंट्रोल एडमिनिस्ट्रेशन के ऑनलाइन पोर्टल से होता है। फीस और समय-सीमा बदलती रहती है, इसलिए राज्य औषधि नियंत्रण कार्यालय से पुष्टि ज़रूर करें। किसी बिचौलिए को नकद पैसा न दें।

निरीक्षण में ड्रग इंस्पेक्टर दुकान का माप, रैक, फ्रिज, सफ़ाई और फार्मासिस्ट की मौजूदगी देखते हैं। लाइसेंस मिलने के बाद शेड्यूल H1 रजिस्टर रखें और हर खरीद का बिल संभाल कर रखें। Griomed Global अपने फ्रैंचाइज़ी पार्टनर्स को लाइसेंस फाइल तैयार करने में मदद करता है।

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