Business Registrations & Compliance#090

Understanding Drug licence — retail / wholesale / manufacturing

Obtain a drug licence before operating a pharmacy, medical store, or drug manufacturing or distribution business.

At a glance

Jurisdiction

State-level — State Drugs Control Authority (SDCA) / State Drug Controller under the Drugs and Cosmetics Act, 1940 and Rules, 1945. Central Drugs Standard Control Organisation (CDSCO) regulates specific categories (new drugs, biologicals, medical devices). Applicable across India.

Who applies

Any individual, firm, company, or pharmacist intending to retail, wholesale, or manufacture drugs and pharmaceutical products in India

Typical time

Retail / Wholesale Drug Licence: 30–60 days; Manufacturing Licence: 60–90 days after inspection

Fee

Retail Drug Licence: ₹1,000 – ₹3,000 (varies by state and type — Forms 20 & 21 for retail, Forms 20B & 21B for wholesale); Manufacturing Licence: ₹3,000 – ₹15,000+ depending on scope; additional inspection fees may apply

Who should use this process

✓Retail drug licence requires the presence of a registered pharmacist (with Pharmacy Council registration) on the premises during business hours
✓Wholesale drug licence requires a person with a degree / diploma in pharmacy or medicine or 1 year experience in dealing with drugs
✓Manufacturing licence requires technically qualified personnel (manufacturing chemist with degree in pharmacy/pharma chemistry/chemistry), adequate infrastructure, and GMP compliance
✓Premises must comply with prescribed storage conditions (refrigeration for Schedule C&D drugs, secure storage for Schedule H and X drugs)

Who does NOT need to apply

✕Ayurvedic, Siddha, and Unani medicines are regulated under separate state-specific rules (not the main Drugs and Cosmetics Act) and may require separate licences
✕Homoeopathic medicines are separately regulated
✕Medical devices and diagnostics follow a separate licensing path under the Medical Devices Rules, 2017
✕Cosmetics are covered under the Drugs and Cosmetics Act but have separate application forms

Documents required

#	Document	Type needed	Purpose
1	Prescribed application form (Form 19 for retail; Form 19A for wholesale; Form 24 for manufacturing)	Download / Print	Prescribed application form under the Drugs and Cosmetics Rules, 1945
2	Proof of qualification and registration of pharmacist / technically qualified person	Self-attested Copy	Confirms that a registered pharmacist or qualified person is employed; registration certificate from the State Pharmacy Council is required for retail and wholesale
3	Proof of ownership or tenancy of premises (rent agreement / sale deed)	Self-attested Copy	Confirms the legal right to occupy the premises where drugs will be stocked and sold
4	Site plan / layout plan of the premises	Original	Shows the storage area, refrigeration facilities, and separation of Schedule X drugs storage; required for inspection purposes
5	Proof of cold-chain / refrigeration facility (for Schedule C and C1 drugs)(optional)Required for applicants who wish to stock Schedule C, C1 (biologicals, vaccines, blood products) drugs	Original	Confirms adequate refrigeration (2–8°C) for biological products, vaccines, and certain other drugs
6	Affidavit / declaration by the applicant	Original	Self-declaration that all information is correct, premises are as described, and the applicant will comply with the Drugs and Cosmetics Act
7	Identity proof of the applicant (PAN / Aadhaar / Passport)	Self-attested Copy	Identity verification of the licence applicant
8	List of drugs proposed to be stored / sold / manufactured	Original	Specifies the category of drugs (Schedule H, H1, X, G, C, etc.) to be handled; determines inspection scope
9	Manufacturing process and formula (for manufacturing licence)(optional)Required only for manufacturing licence applicants	Original	Detailed manufacturing process, formulation, and quality control procedures required for manufacturing licence application

Original documents: Carry originals only for in-person visits — do not hand them over permanently unless explicitly required.

Step-by-step guide

1
Determine the type of drug licence required
Offline
Identify whether you need a Retail Drug Licence (Form 20 & 21), Wholesale Drug Licence (Form 20B & 21B), or Manufacturing Licence (Form 25 & 28 for allopathic). Also determine whether Schedule H, H1, or X drugs will be stocked, as these require additional compliance. For manufacturing, identify whether GMP (Good Manufacturing Practices) certificate under Schedule M is required.
1–2 days
2
Register on the state Drugs Control portal or SUGAM portal
Online
Many states now use the central SUGAM portal (cdscoonline.gov.in) for drug licence applications. Some states have their own portals (e.g., Maharashtra, Karnataka). Create an account, enter applicant details, and select the type of licence. For central approvals (new drugs, clinical trials, imports), use the CDSCO SUGAM portal.
30–60 minuteshttps://cdscoonline.gov.in
3
Fill application form and upload documents
Online
Fill the prescribed application form online. Enter premises details, pharmacist/qualified person details (Pharmacy Council registration number), list of drugs to be handled, premises area, refrigeration facilities, and storage arrangements. Upload all supporting documents.
1–2 hourshttps://cdscoonline.gov.in
4
Pay prescribed licence fee
Online
Pay the applicable licence fee online via the portal's payment gateway. For retail or wholesale, the fee covers a 5-year licence. For manufacturing, fees vary by the number of product groups and dosage forms.
30 minutes
5
Physical inspection of premises
Offline
A Drug Inspector from the State Drugs Control Authority visits the premises to verify: premises area and layout, storage facilities, refrigeration (if applicable), Schedule H/X drug storage (separate lock-and-key), presence of a registered pharmacist, and overall compliance with Drugs and Cosmetics Rules. For manufacturing licences, the inspection is comprehensive (GMP audit) and may take 1–2 days.
7–30 days after applicationDrug Inspector (State Drugs Control Authority)
6
Reply to inspection queries (if any)
Both
If the Drug Inspector raises deficiencies (e.g., storage area too small, missing refrigeration, pharmacist's documents incomplete), submit a compliance report with evidence of rectification within the prescribed time. Failure to comply results in rejection of the application.
15–30 days
7
Drug licence issuance
Online
Upon satisfactory inspection and compliance, the State Drug Controller issues the drug licence (retail, wholesale, or manufacturing). The licence is issued for 5 years (for retail and wholesale) and must be renewed before expiry. Display the licence at the premises.
30–90 days from applicationState Drug Controller

Government officers involved

Drug Inspector

State Drugs Control Authority (SDCA) / State Drug Department

Step 5

Conducts physical inspection of the premises, verifies pharmacist qualifications and storage compliance, and submits inspection report to Drug Controller

State Drug Controller / Drugs Control Authority

State Health / Drugs Department

Step 7

Reviews inspection reports, approves or rejects licence applications, and issues the drug licence certificate

Government portals

SUGAM — CDSCO Online Portal

https://cdscoonline.gov.in

Online drug licence application for both state licences (accessed through SUGAM) and central approvals (new drugs, import licences, clinical trial approvals)

CDSCO Official Website

https://cdsco.gov.in

Reference for drug regulations, Schedule H / H1 / X drug lists, GMP guidelines, and regulatory guidance documents

Things to watch out for

Registered pharmacist must be present during all business hours

For a retail drug licence, a registered pharmacist (registered with the State Pharmacy Council) must be physically present at the pharmacy premises during all hours of operation. Absence of the pharmacist during business hours is a violation and can result in suspension or cancellation of the drug licence.

Schedule H, H1, and X drugs have stringent record-keeping requirements

Drugs under Schedule H, H1 (antibiotics, habit-forming), and Schedule X (psychotropics, narcotics) must be sold only on a valid prescription and detailed records must be maintained. Purchases and sales registers for Schedule X drugs must be submitted to the Drug Inspector periodically. Non-maintenance of registers is a serious offence.

Licence is premises-specific — relocate requires fresh application

A drug licence is granted for a specific premises and a specific pharmacist. Any change of premises, change of pharmacist, or change of ownership requires a fresh application or an amendment to the existing licence. Operating from an unlicensed premises is a cognizable offence.

Renewal must be done 30 days before expiry

Drug licences are typically valid for 5 years. Renewal applications must be filed at least 30 days before the expiry date. Operating after the expiry of a drug licence is equivalent to operating without a licence and is a criminal offence attracting prosecution.

Cold-chain requirements for vaccines and biologicals

If you intend to stock Schedule C and C1 drugs (vaccines, biological products, blood and blood products, sera), a validated cold chain with continuous temperature monitoring (2–8°C refrigerators) is mandatory. The Drug Inspector will verify this during inspection. Inadequate cold-chain leads to licence refusal.