Pharmaceuticals and medical devices

Separate product and activity classifications

Drug manufacture, medical-device import and wholesale distribution are different activities. Identify the product’s intended use, claims, specifications and business role. Device risk classification should be checked against current CDSCO material rather than inferred from a marketing name.

CDSCO’s description of regulatory functions places drug manufacture, sale and distribution primarily with state authorities, while central responsibilities include new-drug approval and oversight of imported-drug quality. Identify the product category and activity before selecting the authority; this overview is not a complete application checklist.

Connect the dossier to operations

Keep approved product and site information aligned with manufacturing, import and distribution records. Proposed changes to intended use, specifications or premises need a regulatory assessment before implementation.

Maintain traceable evidence

• Licences and permissions with their scope and conditions.
• Supplier, manufacturing-site and quality-system records.
• Batch or serial tracking, sales and returns.
• Complaint, safety and recall documentation handled by responsible specialists.

Review the wider business

Premises, workforce, hazardous materials and waste requirements depend on the operation. Imports and exports need their own trade evidence. Financial records should distinguish inventory, samples, expiries and returns instead of treating every outward movement as an ordinary sale.

An example

A distributor starting to import a device under its own arrangement should revisit the importer role and product documentation. Its domestic distribution records do not establish that the new import pathway is covered.

Professional boundaries

Kosha can coordinate records, accounting and regulatory-document requests. Product testing, clinical evaluation, quality assurance and specialist regulatory opinions require appropriately qualified providers. No licence, safety finding or market-access outcome is guaranteed.

Keep a product-version document index

Link each product or model to the manufacturer, site, intended-use statement and document versions supplied for review. Identify missing annexures and differences between supplier documents and proposed labels so the responsible specialist can assess the actual configuration.

Drug and medical device licensing support uses that index to organise the dossier and questions. Keep technical conclusions with the professional who provides them; an administrative checklist records evidence received, not an independent finding that the product is safe or approved.

Connect returns to their original records

A returned device may have an accounting credit, a serial record and a separate quality-team decision. Retain their common reference and keep stock awaiting that decision distinguishable from ordinary saleable inventory in the working schedules.

Inventory accounting support can reconcile financial and movement records within the agreed scope. Supply the evidence for samples, expired goods, returns and adjustments, with unresolved questions assigned to the responsible operational or quality contact.