A pharmaceutical distributor should not place sale stock in a new godown merely because invoices will continue to come from its licensed office. Drug-sale regulation covers stocking for sale as well as completing the invoice. Under the Drugs Rules, separate places where drugs are sold or stocked for sale require separate applications and licences, subject to the specific legal exceptions.
For an ordinary additional wholesale warehouse in Maharashtra, the starting position is therefore premises-specific permission. Calling the address a logistics location, overflow store or temporary godown does not by itself take it outside that rule. The business should resolve the permission, product scope, competent-person and storage arrangements before moving stock.
This article addresses ordinary wholesale drug distribution as at October 2026. Medical devices, cosmetics, homoeopathic medicines and controlled products can involve different or additional requirements and should not be forced into the same application simply because they are delivered by the same transporter.
Map the sites and activities first
Prepare a premises map covering the current sales office, existing stores, proposed warehouse, cold rooms and third-party logistics locations. For each, record the legal operator, address, products, stock ownership, receipt and dispatch activities, invoice arrangements and existing licences.
A warehouse holding sealed cartons for future sale is still relevant. The absence of a retail counter or local invoicing does not change the purpose of the stock. The rule is not limited to the place where the sales team accepts the order.
| Proposed change | Main permission question |
|---|---|
| Additional godown while the original site continues | Separate licensed premises for stocking and distribution |
| Full relocation of the wholesale operation | New premises permission and old-site transition |
| Larger space within the existing approved premises | Whether the approved layout and particulars need amendment |
| Another company becomes the distributor | Constitution or legal-operator change as well as premises questions |
| Third-party warehouse stores sale stock | Warehouse operator, activity and premises-specific licensing |
| New product category enters the warehouse | Correct licence form and any additional controls |
Give the licensing authority the actual arrangement, including whether the proposed store is physically part of the existing licensed premises or a separate place. A common owner or nearby location does not automatically make two addresses one licensed premises.
Select the forms by product scope
For ordinary wholesale dealing, Form 20B covers the relevant drugs outside Schedules C, C(1) and X, while Form 21B addresses the specified Schedule C and C(1) categories excluding Schedule X. A distributor commonly needs both forms, but the proposed product list should determine the application.
Schedule X wholesale activity requires its own Form 20G treatment and additional controls. Homoeopathic wholesale medicines use a different route. Medical-device sale or distribution requirements should be assessed under the applicable devices framework rather than presumed covered by an ordinary drug licence.
Prepare a product-category list before selecting forms. Separate cold-chain items, products with special storage instructions and regulated categories that require extra records or permissions. Do not rely on a supplier's generic description of a carton as healthcare stock.
A wholesale licence does not turn the site into a retail pharmacy or authorise manufacture, repacking or relabelling of drugs. If the operation intends to break bulk, alter labels or perform other activities, identify the relevant legal treatment before adding that work to the warehouse.
Premises suitability is more than a minimum area
For the ordinary Form 20B or 21B wholesale premises, the rules specify an area of at least ten square metres. Premises combining the relevant retail and wholesale activities generally require at least fifteen square metres. These are not guarantees that every stock volume and product range can be handled safely in that space.
The licensing authority must be satisfied about adequate premises and proper storage accommodation preserving the drugs' properties. Assess the intended inventory, shelving, circulation, receipt and dispatch zones, ventilation, pest prevention and protection from sunlight and moisture.
Separate saleable goods from damaged, returned, expired, recalled or held stock. A recommended layout should make their status unmistakable and prevent accidental dispatch. A label saying quarantine is ineffective if staff routinely pick stock from the same unsegregated rack.
For temperature-sensitive medicines, document the required range from the product's lawful storage instructions. Provide suitable refrigeration or cold-room capacity, monitoring and arrangements for power failure and temperature excursions. An air conditioner in the office does not prove that a separate warehouse maintains the conditions required by its inventory.
Temperature mapping, calibrated monitoring, alarm arrangements and a documented excursion review can be important professional controls for the actual products and scale of operation. Identify which controls follow a specific licence or product requirement and which are recommended measures supporting reliable storage; do not present every warehouse practice as a universally prescribed statutory form.
Put a competent person in charge
The ordinary wholesale rules recognise a registered pharmacist, a person with matriculation or equivalent and four years' drug-sale experience, or a recognised-university graduate with one year's experience in dealing with drugs, subject to the licensing authority's assessment.
The Maharashtra guidance describes the competent-person arrangements for wholesale applications. A preference expressed in a local checklist should not be confused with removal of a route expressly recognised by the central rules. Provide the actual qualification, experience and appointment evidence for the proposed person.
A person's name appearing on another premises certificate is not proof that the person can properly supervise the proposed warehouse too. Explain working hours, duties, travel and actual availability to the authority. Do not assume that one signature on several applications establishes personal supervision at several operating sites.
Keep consent, employment or engagement evidence and accepted competent-person particulars. Plan absence and replacement arrangements before the first receipt. A warehouse cannot preserve its permission position by retaining the name of someone who has left and no longer supervises the business.
Prepare the Maharashtra application file
The current Maharashtra FDA direction requires new manufacturing and sales users to create credentials and apply through Aaple Sarkar. The department also links its drug-licensing system at fdamfg.maharashtra.gov.in. Use the official entry route for the applicant and transaction rather than an obsolete third-party login instruction.
For ordinary wholesale Forms 20B and 21B, the application framework uses Form 19. Collect the legal-entity papers, identity and authorisation, lawful possession evidence, premises plan and measurements, competent-person evidence, product categories and storage information required for the selected forms.
A tenant's file should identify the applicant and the precise leased premises. A property owner's documents should establish the relevant ownership and use arrangement. Where a third-party logistics provider offers space, the agreement should explain who controls the area, who receives and dispatches drugs and which entity applies for the relevant permission.
Use the current transaction-specific checklist and retain the originals needed for verification. If the local system uses abbreviations for a premises addition, constitution change or new application, confirm what regulatory outcome that transaction produces. The final permission should identify the actual new stocking place; the label on the portal request is secondary.
Keep the application reference, uploaded version, fee record, inspection correspondence and issued licences. Before stock arrives, compare the granted operator, address, competent person and product scope with the intended operation. A submitted application or an inspection appointment is not the issued permission.
Third-party logistics does not eliminate the premises issue
A logistics agreement can allocate commercial tasks, but it does not remove drug-law requirements. A third-party warehouse that stocks drugs for sale or distribution needs the appropriate licensing position for its actual activity and premises. Ask for its certificate and relevant conditions rather than only a GST registration and insurance policy.
Distinguish transportation from storage for sale. The rules contain specific treatment of wholesale distribution from vehicles and an exception for public carriers or hired transport vehicles. That transport provision should not be expanded into an exemption for a fixed third-party godown.
Check whether the customer distributor, warehouse operator or another entity conducts each regulated activity. Where ownership and custody differ, document both. An invoice issued from the distributor's licensed office does not itself authorise every place used by its logistics contractor.
Recommended contract controls include access to inspection records, temperature evidence, stock segregation, recalls, incident reporting and return of stock on termination. The distributor should know how to retrieve batch-level records promptly. A confidentiality clause should not be used to prevent lawful regulatory access or a necessary recall investigation.
Plan stock movement and records
Keep the existing premises compliant while its stock remains there. Do not remove critical refrigeration or supervision and continue operating merely because the old licence has not been cancelled. For relocation, coordinate the new permission, final old-site operations and the required old-record closure or surrender process.
Prepare batch-wise transfer records showing the sending and receiving premises, product, quantity and dates. Preserve the link to purchase documents and subsequent dispatches. Where the movement is not a sale, use the appropriate commercial and tax documents without allowing that classification to hide the drug-law stocking activity.
Maintain the prescribed purchase and wholesale-sale records at the appropriate business level and make them available for inspection. The Rules specify wholesale memo particulars, including the relevant purchaser, drug, batch and manufacturer information, and require the prescribed sale records to be preserved for three years. Other product-specific or applicable retention duties can require additional treatment.
Use a site-wise inventory as a recommended control. It should identify saleable, held, returned and recalled quantities and reconcile transfers between locations. A company-wide stock balance is inadequate if the business cannot tell an inspector where a particular batch is physically stored.
When a recall or quality alert arises, check every warehouse and logistics site. Do not close the matter after blocking only the invoicing office's inventory. The stock that matters may be sitting at the new godown or in a segregated return area.
Continuing validity means retention fees, not no compliance
The ordinary sale licences specified in Rule 63 continue subject to the prescribed five-yearly retention payment unless suspended or cancelled. The retention fee is equivalent to the fee for grant of the relevant licence. Replace old renewal terminology in the compliance calendar with the actual retention obligation for these forms.
If payment is late, the rule provides an additional two per cent of the licence fee for each month or part of a month up to six months, followed by deemed cancellation in the event of non-payment as prescribed. Treat the due date seriously; the ability to pay late is not a general promise that every other licence condition can be ignored.
Keep separate retention dates for each premises and form. Adding a warehouse does not reset the original site's payment cycle, and a company's incorporation date is not necessarily the licence's retention reference date. Verify the issued record and accepted payment history.
A CA can keep the premises and fee calendar alongside financial administration using assureOffice. Storage suitability, product classification and drug-licensing submissions remain specialist responsibilities. Information at assureoffice.in should not be understood as certification of a pharmaceutical warehouse or a direct FDA filing service.
Frequently asked questions
1. Can an unlisted godown hold drugs invoiced elsewhere?
Do not assume it can. Stocking for sale is itself regulated, and separate stocking places ordinarily require separate applications and licences. The invoice location does not remove the warehouse issue.
2. Does an additional warehouse always mean the original licence is cancelled?
No. The original site may continue if it remains compliant. Assess the new premises separately and distinguish expansion from complete relocation of the existing operation.
3. Which forms commonly cover wholesale medicines?
Forms 20B and 21B address different ordinary wholesale drug categories. Select them from the actual product range; Schedule X, homoeopathic medicines and devices need their separate applicable assessment.
4. Is ten square metres enough for every wholesale warehouse?
It is the ordinary minimum-area condition for the relevant wholesale forms, not proof of adequate storage for every inventory. Product conditions, capacity, layout and supervision must also be satisfactory.
5. What if retail and wholesale operate together?
The relevant combined premises generally require at least fifteen square metres and the appropriate permissions for both activities. A wholesale certificate should not be treated as a retail pharmacy licence.
6. Must the competent person always be a pharmacist?
The ordinary wholesale rules recognise other specified qualification-and-experience routes. Provide evidence for the applicable route and obtain the licensing authority's acceptance rather than assuming a job title proves eligibility.
7. Can the same person supervise two sites automatically?
No automatic assumption is safe. Explain actual duties, hours and availability and obtain the appropriate acceptance. A name on two forms does not demonstrate effective personal supervision.
8. What happens when the competent person leaves?
Address the departure, replacement and required authority update promptly. Reassess operations dependent on supervision rather than leaving the departed person's name on the records as a paper arrangement.
9. Does a third-party warehouse need review?
Yes. Obtain its relevant premises permission and assess who conducts stocking and distribution. A logistics contract or GST registration alone does not establish drug-law authorisation.
10. Is transportation the same as warehousing?
No. Specific vehicle and carrier provisions do not create a blanket exemption for a fixed godown holding sale stock. Describe the actual custody and activity before relying on any exception.
11. Does air conditioning establish cold-chain compliance?
Not by itself. Follow the product's required storage conditions and provide suitable equipment, monitoring and contingency arrangements for the actual area and stock volume.
12. Can sale stock move while the new application is pending?
Do not treat filing as grant. Resolve the required permission and site readiness before using the address for regulated stocking and distribution.
13. Which portal should a new Maharashtra sales user use?
The current FDA direction sends new manufacturing and sales users through Aaple Sarkar. Follow the official service routing and the linked drug-licensing system for the transaction.
14. Does a new company inherit the old operator's licence?
Do not assume so. Assess the constitution and operator change separately from the premises. The application and issued permission should identify the entity actually carrying on the business.
15. Can the warehouse repackage medicines under its wholesale licence?
Wholesale permission does not automatically authorise manufacturing or repacking. Examine the proposed physical activity and obtain the required permission before changing labels or packs.
16. Must stock transfers be traceable by batch?
Keep records sufficient to trace the regulated stock and reconcile its location. A recommended batch-wise transfer record connects the sending site, receiving site, quantity and subsequent dispatch history.
17. Are the ordinary sale licences renewed every five years?
The current framework uses continuing validity with five-yearly retention fees for the specified forms. Track that payment duty rather than relying on obsolete renewal descriptions or assuming payment is no longer required.
18. What is the late retention-fee consequence?
The rule provides two per cent per month or part of a month up to six months, with deemed cancellation for the prescribed non-payment default. Confirm the actual record and resolve the status promptly.
19. Does a warehouse addition restart all retention dates?
No general reset follows. Keep the original and new premises' grant and retention records separately, including each relevant licence form and payment acknowledgement.
20. What should be resolved before the first stock receipt?
Confirm the legal operator, premises licence, product forms, competent person and storage conditions. Ensure purchase, transfer, segregation and recall records can identify the batch and its actual physical location.