Over-the-Counter (OTC) Medicines

OTC as a retail product and a regulated one

Over-the-counter medicines occupy an awkward position for an importer: commercially they behave like consumer packaged goods, sold on brand, pack and shelf presence, but legally they remain regulated medicinal products in most markets. Treating them as the former and forgetting the latter is how consignments get stopped. VP Global Exim sources OTC products from licensed Indian manufacturers and handles both sides: the retail presentation the channel demands and the regulatory documentation the border demands.

As with all products in this category, our role is defined and limited. We are a merchant exporter, not a manufacturer, pharmacy or regulatory consultancy. We do not advise on which remedy to sell, what it should be used for, or how it should be taken, and we make no claims about safety or efficacy. We work from a specification you provide and route it to a manufacturer that can legitimately produce it.

The categories we can source are those commonly available as non-prescription products, including analgesic and antipyretic preparations, cough and cold preparations, antacid and digestive preparations, antiseptic and first-aid topicals, oral rehydration preparations, vitamin and mineral preparations sold as medicines rather than supplements, and topical preparations for minor conditions. What is genuinely available to you depends entirely on how your destination market classifies each product, which is where any OTC project has to start.

Classification is the first question

Whether a product is over-the-counter is a decision made by each destination market, not a property of the product. The same formulation can be a general-sale item in one country, pharmacy-only in another, prescription-only in a third and unapproved in a fourth. Ingredient identity and strength both matter: a preparation may be non-prescription below a certain strength and prescription above it, and a combination product may be classified differently from its components.

We therefore confirm the classification of each product in your specific market before quoting anything, because it determines the registration pathway, the labelling requirements, the channels you may sell through and whether the product can be imported at all. An importer who assumes a product is over-the-counter because it is sold that way in India can find it prescription-only or unapproved at destination.

Classification also determines the commercial model. A general-sale product can go to grocery and convenience channels and supports consumer marketing; a pharmacy-only product is restricted to pharmacies and often to pharmacist intervention. That difference changes pack design, volume expectations and price positioning, so it is worth settling before a range is developed rather than after artwork is printed.

Where a product's classification is uncertain in your market, we say so and recommend you obtain a regulatory determination before committing. We will not offer an opinion on classification as though it were settled, because a wrong assumption in this area is expensive and can affect an importer's licence standing.

Manufacturer selection and product specification

Manufacturer selection follows the same discipline as prescription generics. We verify that the unit holds a valid manufacturing licence covering the specific dosage form and product category, that its GMP certification is current and covers the relevant facility, and that it holds any additional approvals your market recognises. Certificates are verified for number, validity, scope and facility address rather than accepted as images.

For OTC work we pay particular attention to a manufacturer's consumer-packaging capability, because it is where units differ most. A plant that produces excellent bulk oral solids may have limited capability in printed cartons, blister artwork, tamper-evident sealing, shelf-ready display packing or the pack formats a modern retail channel expects. That capability is assessed during selection rather than discovered when the first shipment looks wrong on a shelf.

Product specification is documented in writing before production: formulation and strength, dosage form, primary and secondary packaging, pack counts, artwork and labelling content, shelf life and storage conditions, and the testing and documentation to be supplied. Where you are matching an existing product, we work from its specification and packaging rather than from a photograph, and we raise any difference we cannot replicate.

Labelling, artwork and consumer information

OTC labelling carries a heavier information burden than prescription packaging because the consumer selects and uses the product without professional intervention. Requirements commonly cover the product name and active ingredients with strengths, the full excipient list where mandated, indications as approved in that market, directions for use, warnings, contraindications and precautions, age restrictions, storage instructions, batch and expiry information, manufacturer and importer details, the barcode, and the required languages.

Every element of that is market-specific and legally consequential, so we have artwork checked against the destination market's requirement list before printing rather than after. Approved indications in particular cannot be carried over from another market: text that is permitted in one jurisdiction may constitute an unapproved claim in another, and unapproved claims are a common reason for rejection or recall.

We do not write or approve therapeutic claim text. Indication and warning wording must come from, or be approved by, your regulatory adviser or the marketing authorisation holder in your market. What we do is ensure that the wording you supply is reproduced accurately, that the mandatory structural elements are present, and that the manufacturer prints what was approved.

Private-label OTC is common and we support it: your brand, your artwork, your pack format and your barcode, produced by a licensed manufacturer. Where you are building a brand, we can coordinate a consistent packaging system across a range. The regulatory responsibility for what appears on your label sits with you as the brand owner, and we make sure that is understood rather than assumed.

Retail presentation and pack formats

Commercially, OTC lives or dies on shelf presentation. Available formats include blister strips in printed cartons, bottles with tamper-evident closures and induction seals, sachets and stick packs, tubes and applicators for topicals, single-dose and travel packs, family and value packs, and multipacks. Display and shelf-ready formats include counter display units, shelf trays and hanging packs.

Pack format choices interact with regulation. Pack size may be restricted for some products, tamper evidence may be mandatory, child-resistant closures may be required, and pack quantity may affect classification. We check these constraints against the destination market before committing to a format, since a pack that cannot legally be sold is worse than an unattractive one.

Retail-ready preparation can be applied at the factory: barcodes and SKU labels, price marking where required, promotional flashes and multipack banding, and shipper cartons designed for shelf-ready presentation. For buyers supplying multiple retail formats, we can pack to store-level allocations so cartons are cross-docked rather than re-picked.

Shelf life management is a commercial as well as a regulatory matter in retail channels. Retailers commonly require a minimum remaining shelf life at delivery, sometimes stricter than the import requirement, and short-dated stock becomes markdown. We plan production and shipping against the stricter of the two and quote remaining shelf life at arrival rather than at manufacture.

Quality documentation and testing

Every shipment carries batch-specific documentation. A Certificate of Analysis states tested parameters against the registered or agreed specification with actual measured values, covering identification and assay of actives, related substances where applicable, dissolution or disintegration on solids, uniformity of dosage units, microbiological limits, and physical parameters relevant to the dosage form. Conformance statements without values are not adequate.

Manufacturer documentation includes the manufacturing licence, current GMP certification, product specification, stability data supporting the assigned shelf life, and where the destination requires them a Certificate of Pharmaceutical Product, free sale certificate and legalised or attested copies. We confirm which of these your authority requires and assemble the pack accordingly rather than supplying a generic set.

Independent verification is available where your programme requires it: third-party laboratory testing on samples from the production batch, pre-shipment inspection by an agency you nominate, and packaging and labelling verification against approved artwork before the consignment ships. Artwork verification is worth doing on every new print run, because a single wrong element on a printed carton affects the whole batch.

Import, distribution and responsibility

Even where a product is non-prescription at retail, importing it is normally a licensed activity. Most markets require the importer to hold an import licence or wholesale dealer authorisation, require the product to be registered or notified, and impose obligations on storage, distribution, record keeping and recall capability. Those obligations rest with you as the importer, and we do not represent otherwise.

We supply only where those licences are in place. That means we will ask for evidence of your authorisation, and we will decline to supply where it does not exist or does not cover the product category. We also decline requests to ship medicinal products to private individuals, to route product to avoid a registration requirement, or to declare goods as something other than what they are.

Recall capability deserves a mention because it is easy to overlook until it is needed. Batch traceability from our documentation through your distribution to the point of sale is what makes a recall executable, and most markets require it. We maintain batch-level documentation and marking so your own traceability chain has something to attach to.

Starting an OTC enquiry

Tell us the products you want, their formulation and strength, the pack formats and quantities, your destination market, whether you hold the required import authorisation, and whether each product is already registered or notified there. If you are building a private-label range, send your brand direction and target retail price and we will propose a range and pack system against it.

We will confirm classification questions that need resolving, propose manufacturers with their approval status, quote with lead times, set out the documentation package and identify the artwork and labelling work required. Where a product's classification or registration status in your market blocks the plan, we will raise it before quoting rather than after.

A first OTC project is best run on a small number of products, with artwork approved and verified, documentation confirmed and a modest first order, before extending to a full range. Print and registration costs make late corrections expensive, so proving the process on a few lines first is genuinely cheaper.