India Pharmaceutical Licensing

This record covers the retail sale, wholesale and manufacture of non-homoeopathic drugs under Part VI of the Drugs Rules, 1945. Licences for business premises, individual pharmacist registration, product/new drug approvals and import licences must be considered separately.

Company formation, taxation, local business registration and foreign investment are not themselves pharmaceutical licences. The Drugs Rules reviewed do not specify a uniform company form, capital requirement or foreign ownership ratio applicable to all applicants. Traditional medicines, homoeopathic medicines, devices and cosmetics must first be classified.

— Do not apply Hong Kong ASP/LSP, two-pharmacist or “two-thirds” pharmacist coverage, pCM or capital requirements.

— Schedule X, vaccines, blood products and other specialised products require separate route verification.

The Ministry of Health and Family Welfare’s 2024 parliamentary reply states that manufacture, sale and distribution are regulated by the State Licensing Authorities (SLAs) under the Drugs Act and Rules; CDSCO coordinates State drug control authorities and, together with the Ministry of Health, is responsible for central drug regulation.

This record does not describe CDSCO as the sole licensing authority for all ordinary business licences. Apply to the SLA of the target State for sale/general manufacturing; imports, registration and new drugs follow separate central procedures.

— State level: licensing and on-site enforcement for sale, distribution and general manufacture.

— Central level: imports/registration, new drugs and regulatory coordination.

— Individuals: verify registration with the relevant State Pharmacy Council.

Rule 61 classifies retail sale of drugs other than those in Schedules C, C(1) and X under Form 20; drugs in Schedules C and C(1), but not Schedule X, under Form 21; and Schedule X drugs under Form 20F. Forms 20A/21A are restricted licences, authorising only the drugs specified in the licence, which may be sold without the supervision of a qualified person.

Rule 62 requires separate applications for multiple sales or stocking locations. Rule 65 provides that compounding at the premises or supplying drugs on the prescription of a registered medical practitioner must be carried out by a registered pharmacist personally or under their personal supervision; records of purchases, prescriptions and sales must be maintained.

— Confirm the Schedule classification and any special storage requirements for each item.

— Pharmacies must also meet the requirements of Schedule N and the premises conditions imposed by the SLA.

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Wholesale means transactions for resale and also includes sales to hospitals, clinics, and medical educational or research institutions. Form 20B applies to general drugs; Form 21B to drugs in Schedules C and C(1), excluding Schedule X; and Form 20G to Schedule X drugs. Wholesale/distribution by motor vehicle follows separate routes under Forms 19AA, 20BB/21BB.

Form 20B requires drugs to be sourced from a licensed dealer or manufacturer; sales to persons who do not hold the required licence are generally prohibited, subject to statutory exceptions that should be verified against the original text. Rule 65 requires transaction records containing details of the buyer’s licence, batch, manufacturer and competent person.

— State whether the business will deal in Schedule C, C(1) or X drugs, or distribute by motor vehicle.

— Verify suppliers’ and customers’ licences, and retain batch and handover records.

Manufacturing applications are submitted to the State-level SLA. Form 24→25 generally applies to drugs other than those in Schedules C and C(1); Form 24F→25F applies to Schedule X drugs; and products in Schedules C and C(1), vaccines, etc. follow routes such as 27/28, 27B/28B and 27D/28D. Form 25 cannot be used as a catch-all for all pharmaceutical products.

Rules 71/76 require competent technical staff, premises, equipment, testing and storage, and link pharmaceutical products to Schedule M GMP. Rule 73AA requires a joint inspection by Central and State inspectors before a licence is issued; licensed premises must undergo joint inspection at least once every 3 years or as required according to risk.

— New drug formulations must have the applicable written approval.

— Contract manufacturing may constitute a loan licence; assess whether routes such as 24A/25A apply.

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Under the Pharmacy Act, a “registered pharmacist” is an individual whose name is entered in the register of the State in which they reside or practise/carry on the profession or business of pharmacy; this is not a business or premises licence.

Retail compounding and supply on prescription require the supervision of a registered pharmacist. Wholesale operations must be handled by a competent person approved by the SLA; the Rules provide for pharmacists and alternative qualification/experience routes. Manufacture requires full-time competent technical staff; these roles must not be conflated.

— Verify the individual’s registration in the relevant State and their actual functions.

— A pharmacist’s registration does not replace a premises licence.

Rule 64 requires suitable sales premises, storage conditions that preserve the properties of medicines, and a competent person in charge; pharmacies must also comply with Schedule N. The minimum area under the rules for applications for retail licences 20/21 or wholesale licences 20B/21B alone is 10 square metres; for combined retail and wholesale operations, it is 15 square metres. Rules provide an exception for certain existing historical licences.

Retail-area figures do not apply to manufacturing premises; space, equipment, testing and storage must be provided in accordance with Rules 71/76 and Schedule M. Special temperature, segregation or security requirements depend on the product classification and licence conditions.

— Verify each shop, warehouse, combined-operation site and factory individually.

— Map product storage requirements to the plans and equipment documentation.

First determine the business activity, products, premises and competent authority; then select the forms by Schedule classification, prepare premises, storage, personnel and quality documentation, and apply to the target State Licensing Authority (SLA) for sale/manufacturing. Manufacturing is subject to a joint inspection. State portals and documentation vary; this record does not invent a single national application portal.

Imports are handled through the central CDSCO pathway: the guidance document specifies an application on Form 40, a registration certificate on Form 41, an import licence on Form 8 and, for Schedule X, Form 8A. It also requires verification of documents such as the Indian agent’s wholesale/manufacturing licence. Import or manufacture of a new drug for sale/distribution requires a separate application for central authorisation under the NDCTR 2019.

— Sale: Forms 19/19A/19C and the corresponding licence category.

— Manufacture: Form 24, 24F or product-specific forms.

— Import/new drugs: Forms 41, 8/8A and CT-18 to 23, as determined by the product.

No uniform approval timeline or total government fee is promised. The rules and forms provide for application, inspection and retention fees, but amounts, payment, requests for additional information and scheduling should be verified against the version confirmed by the target State SLA or CDSCO at the time of application, the product category and portal notices.

Rule 63 requires retention fees for sales licences in the 20/21 series to be paid before the end of each consecutive five-year period. Manufacturing licences such as Forms 25/25F and 28 also have a five-year mechanism. The forms additionally refer to continuing validity and inspection at least every three years or on a risk basis; this should not be interpreted as eliminating the need for maintenance.

— Set reminders for five-year retention fees and inspections.

— Budget separately for official fees, inspections, corrective actions and supplementary submissions.

A sale licence holder should procure from licensed dealers or manufacturers, maintain purchase, prescription and sales records and make them available for inspection; copies of wholesale cash/credit sale invoices must be kept for three years.

Manufacturers must maintain personnel, premises, equipment and GMP, test batches of raw materials and finished products, and retain manufacturing and testing records; relevant records under Rule 74 are generally retained for five years. Manufacturing premises are jointly inspected periodically or on a risk basis.

— Records should align with the scope of the licence and batch traceability.

— Assess regulatory triggers before adding products, cold-chain operations, contract manufacturing or new drugs.

Forms 20 and 20B require written notification of a change in the constitution of the business; the old licence is deemed valid for a maximum of three months from the date of the change, unless a new licence has already been obtained in the name of the business after the change. Form 20 also requires changes in the responsible person to be reported within one month.

The import guidance also requires updates or re-obtainment in the event of a change to the manufacturer, Indian agent or address. Whether a particular share transaction constitutes a change in constitution and triggers company-, investment- or product-level filings should be confirmed with the SLA, CDSCO and local professionals on the basis of the transaction documents.

— Before a change, verify the named holder, location, responsible person, products, agent and facilities.

— Without written confirmation, do not rely on an old licence to cover a new entity or relocated premises.

For imported medicines, the registration certificate is applied for using Form 40 and issued as Form 41; the import licence uses Form 8, or Form 8A for Schedule X, and Form 41 is generally required as an attachment. A State-level sale/wholesale licence does not automatically exempt the holder from the central import pathway.

For import of a new drug for sale/distribution, apply using CT-18 and obtain CT-19/20; for manufacture, apply using CT-21 and obtain CT-22/23, depending on whether the product is an API or formulation, among other circumstances. An ordinary sale or manufacturing licence cannot replace a new-drug authorisation.

The original text of the controlled-drug provisions in the Indian Code could not be reliably extracted for this review; accordingly, no uniform national conclusion is made about narcotic drugs, psychotropic substances or other controlled substances. Verify requirements with the competent authority in addition to ordinary licences. Traditional medicines and homeopathic products also require confirmation under their separate regimes.

— Imports: Verify Forms 41 and 8/8A separately.

— New drugs: First determine whether NDCTR 2019 applies.

— Controlled and traditional-medicine products: Do not assume automatic coverage.