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Deregistration with the Department of Drug Administration (DDA) is a mandatory legal requirement for any pharmacy, wholesaler, or pharmaceutical industry ceasing operations. This process involves the formal surrender of the drug sale/manufacturing license to ensure the owner is no longer held liable for drug compliance and to prevent the illegal trade of scheduled medicines.
₨ 100,000.00
Under the Drugs Act, 2035 (1978) and the Drug Registration Regulation, 2038, no individual or entity can sell, distribute, or manufacture drugs without a valid certificate from the DDA. When a business decides to close, a formal “Deregistration” (Khareji) is required. This is not just a business exit but a public health safeguard; it ensures that controlled substances, narcotic drugs, and sensitive medical inventories are accounted for and that the license is not misused by third parties.
Pursuant to Section 10 and 11 of the Drugs Act, 2035, the right to sell or distribute drugs is contingent upon maintaining an active registration. When an entity ceases operation, it must formally notify the DDA to revoke the name and shop registration initially granted under these sections. Furthermore, under the Drug Sales and Distribution Codes, 2080, a pharmacy must ensure that the registered (Professional) or Pharmacist is legally withdrawn from the records. This is critical because, under Section 28 of the Act, operating (or appearing to operate) without the required technical human resources can lead to severe liability for both the proprietor and the pharmacist.
If a business stops functioning but remains “Active” in DDA records, the proprietor remains liable for any “Pharmaceutical Crimes” associated with that license, including the potential misuse of the premises for selling unregistered or date-expired drugs (prohibited under Section 30). Penalties for such non-compliance can include imprisonment for up to three years or heavy fines. Additionally, the Inland Revenue Department (IRD) requires a formal cancellation recommendation from the DDA to finalize the business tax closure for a clean financial exit.
