Minister of Health Issues Decision to Regulate Licenses for the Production and Manufacturing of Drugs Containing Narcotic or Psychotropic Substances

Abdul Karim Al-Abdullah: Minister of Health Dr. Ahmed Al-Awadi issued the ministerial decision regarding the regulation of licenses for the production and manufacture of drugs containing narcotic or psychotropic substances, as part of tightening control over the production, manufacturing, and distribution of these substances and preparations, and organizing the responsibilities of factories and pharmacists entrusted with them, in accordance with the provisions of Anti-Drugs and Psychotropic Substances Law No. (159) of 2025.

The decision was based on the provisions of Articles 32, 33, 38, and 79 of Law No. 159 of 2025, and on the Ministry of Health’s desire to regulate licenses for the production and manufacture of drugs containing narcotic or psychotropic substances. In light of operational necessities, Ministerial Decision No. 291 of 2026 was issued regarding the regulation of licenses for the production and manufacture of narcotic substances.

Production and Manufacturing

The decision stipulated that the production or manufacture of narcotic or psychotropic substances or preparations is permitted only for pharmaceutical factories and with a license from the Minister of Health. Furthermore, these factories are not allowed to use such substances except in operations authorized by the Ministry.

11 Licensing Requirements

The decision specified a set of documents and requirements that must be submitted to the Licenses Control Department for Narcotic and Psychotropic Substances and Preparations under the Ministry of Health when applying for a license to produce or manufacture substances or preparations containing narcotic or psychotropic materials. All documents must be valid.

The requirements include the following:

- A license to trade in narcotic or psychotropic substances or preparations issued by the Ministry of Health for the pharmaceutical factory.

- A license for the production of pharmaceutical preparations issued by the competent authority within the Ministry of Health.

- A Good Manufacturing Practices (GMP) certificate issued by the competent authority within the Ministry of Health.

- Approval from the competent authority within the Ministry for the manufacture of the preparation and the approval of its concentration.

- Specification of the type and quantity of the narcotic or psychotropic substance to be used in the production process.

- Designation of the pharmacist responsible for the custody of narcotic or psychotropic substances and preparations.

- Submission of professional practice licenses for the Production Director and the pharmacist responsible for custody.

- Copies of civil IDs for the Production Director and the pharmacist responsible for custody.

- Preparation of a preliminary model of the register for narcotic or psychotropic substances or preparations for approval by the Control Department.

- Preparation of a model for the material issuance register for narcotic or psychotropic substances or preparations in the pharmaceutical factory for approval by the Control Department.

- Submission of any other documents requested by the Licenses Control Department for Narcotic and Psychotropic Substances and Preparations.

14 Data Fields in Narcotic Substance Registers

The decision obliged factories to provide detailed information in the registers dedicated to the issuance of narcotic or psychotropic substances or preparations. This information must include a sequential page number for the register, the name of the department to which the register is assigned, the name of the substance or preparation, its strength, and its pharmaceutical form; the quantity received; the date and number of the receipt voucher; the source entity; the date of issuance; the quantity issued; the date and number of the issuance voucher; the requesting entity; the full three-part name of the recipient, their title, and workplace; the remaining quantity; the signature and stamp of the person responsible for custody; and any relevant notes.

Special controls for disbursement vouchers. The decision also specified the data that must be included in vouchers for the disbursement of narcotic materials or preparations or psychotropic substances. These include the serial number of the voucher book pages, the name of the material or preparation, its strength, type, and pharmaceutical form, the date of the request, the requested quantity, the date of disbursement, the recipient entity, the quantity disbursed in both figures and words, the name and signature of the recipient, and the name and signature of the deliverer. The decision mandated that the custodian retain the original order, while the requester retains a copy. The decision obliged the license holder or production manager to designate a person responsible for the custody of narcotic materials or preparations or psychotropic substances, stipulating that this person must be a licensed pharmacist authorized to practice pharmacy in the State of Kuwait.

Six main obligations for the custodian. The decision imposed on the custodian of narcotic materials or preparations or psychotropic substances a number of controls, the most prominent of which are:

- Recording narcotic materials or preparations or psychotropic substances in their dedicated register.

- Disbursing them only against a disbursement voucher.

- Retaining registers and disbursement vouchers for three years from the date of the last entry.

- Retaining purchase invoices and licenses for trading, import, export, and manufacturing for three years.

- Ensuring that requesting departments record the materials in the department’s dedicated register.

- Returning unused or expired quantities of disbursed materials to the originating entity.

The decision prohibited the destruction of registers, disbursement vouchers, purchase invoices, and import, export, and trading licenses without obtaining approval from the Monitoring of Licenses for Narcotic Materials and Preparations and Psychotropic Substances, under the Ministry of Health.

Special safes. The decision stressed that narcotic materials or preparations or psychotropic substances must be stored in secure safes with tight locks, with the custodian personally keeping the keys. It also mandated conducting an actual inventory of the balance, with the name written in full and signed clearly by both the deliverer and the recipient, along with recording the date and time of delivery in the register itself when handing over custody to another party for any reason necessitating such action. Upon transfer of custody, a final investigation must be conducted within 48 hours, and management must submit a report on the incident to the General Directorate of Legal Affairs at the Ministry of Health.

Police notification. The decision established strict procedures in the event of losing any full or empty container or any quantity of narcotic or psychotropic materials. It mandated immediate notification of the police station, in addition to informing the Pharmaceutical Inspection and Licensing Administration under the Ministry of Health. The Pharmaceutical Inspection and Licensing Administration was also obliged to submit a report on the incident to the General Directorate of Legal Affairs at the Ministry of Health within 48 hours of the occurrence, to take necessary measures in accordance with applicable systems and regulations. The decision also stipulated that in the event of loss or damage to licenses, registers, or vouchers related to materials, the Pharmaceutical Inspection and Licensing Administration under the Ministry of Health must be notified immediately, and management must submit a report on the incident to the General Directorate of Legal Affairs at the Ministry of Health within 48 hours of its occurrence. In the event that a manufacturing company closes or changes its address, the decision obliged the return of remaining quantities of materials, whether full or empty of their contents acquired from the source, before completing closure or address change procedures. The license holder or production manager must also submit a request to the Monitoring of Licenses for Narcotic Materials and Preparations and Psychotropic Substances under the Ministry of Health to cancel the license and return the materials or preparations to the source from which they were obtained.

Mandatory warnings. The decision requires licensed pharmaceutical factories producing preparations containing narcotic or psychotropic substances to include instructions on the method of use and warnings against their use in the leaflets inside the packaging, on the labels affixed to the packages, or in both, along with any other data the Ministry deems necessary to include.

Two-year license duration. The decision sets the production and manufacturing license validity at two years from the date of issuance, and obliges the license holder to submit a renewal application two months before the license expires to the Pharmaceutical Inspection and Licensing Department at the Ministry of Health. The decision grants employees of the Ministry of Health, designated by the Minister, the authority to inspect narcotic or psychotropic substances and preparations, records, disbursement vouchers, and purchase invoices, to verify compliance with the provisions of Law No. 159 of 2025. It also authorizes the Minister of Health, or his delegate, to cancel or refuse the license whenever necessary.