GROUP THREE

NANNYONGA OLGA AND NGOBI FRANCIS

Classified drugs refer to drugs that are regulated and controlled by the government due to their
potential for abuse, addiction, or harm to public health. These drugs are classified into different
schedules based on their level of risk and medical value. In Uganda, the public health act
regulates the manufacture, importation, distribution and sale of drugs, including classified drugs.
The act provides provisions for the registration, licensing and inspection of drug premises and
personnel to ensure that drugs are safe, effective, and of good quality. Section 191 talks about
Classified drugs where the Minister on the advice of the authority may, by statutory instrument,
declare a drug to be a classified drug.

The public health Act also outlines penalties for the illegal manufacture, importation, distribution
and sale of classified drugs. Offenders may face fines, imprisonment, or both, depending on the
severity of the offense. The provisions aim to protect public health by ensuring that only safe and
effective drugs are available to the public and that those who engage in illegal drug activities are
held accountable.

Need for prescription for classified drugs

According to the Ugandan National Drug Authority, classified drugs are prescription-only
medicines that require a prescription from a licensed healthcare provider before they can be
dispensed or sold to patients. Examples of classified drugs include antibiotics, painkillers, and
psychotropic drugs. Section 202 provides for Need for prescription for classified drugs where a
pharmacist or licensed person shall not supply a class A or class B Group I drug unless it is
under prescription reasonably believed by the person supplying the drug to be valid.

The Public Health Act of Uganda also provides regulations on the dispensing and sale of
classified drugs.

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These regulations include maintaining accurate records of all transactions involving classified
drugs and ensuring that the drugs are stored in appropriate conditions to maintain their efficacy
and safety. In summary, a prescription from a licensed healthcare provider is required to obtain
classified drugs in Uganda, and there are regulations in place to ensure that these drugs are
dispensed and sold in a safe and controlled manner.

Actions to be taken in relation to prescription

Section 213 provides for Where a classified drug is supplied under a prescription the person
supplying the drug shall enter on the prescription in indelible writing the date on which it is
supplied and the name and address of the supplier; if the prescription is fully dispensed, it shall
be retained by the supplier and, for two years thereafter, shall be kept on the premises at which it
was dispensed in such a manner as to be readily available for inspect

 Education and awareness campaigns: The first action that can be taken is to educate
healthcare providers, patients, and the general public about the risks associated with
classified drugs. This can be done through awareness campaigns, seminars, and
workshops.
 Strengthening regulations: Uganda has regulations in place to ensure that classified drugs
are dispensed and sold in a safe and controlled manner. These regulations need to be
strengthened and enforced to ensure that healthcare providers and pharmacists comply
with them.
 Monitoring and supervision: The National Drug Authority must monitor and supervise
the dispensing and sale of classified drugs to ensure that they are not being sold illegally
or without a prescription.
 Punitive measures: Healthcare providers and pharmacists who dispense or sell classified
drugs illegally or without a prescription should be penalized. This will deter others from
engaging in such illegal practices.
 Collaboration between stakeholders: There should be collaboration between the National
Drug Authority, healthcare providers, pharmacists, and patients to ensure that classified
drugs are dispensed and sold in a safe and controlled manner.
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  Use of technology: The use of technology can help to monitor the dispensing and sale of
classified drugs. For example, the National Drug Authority can implement an electronic
system to track the movement of classified drugs from the manufacturer to the patient.

In conclusion, the prescription of classified drugs in Uganda is highly regulated to ensure that
they are dispensed and sold in a safe and controlled manner. The actions that can be taken to
further strengthen the regulation of classified drugs include education and awareness campaigns,
strengthening regulations, monitoring and supervision, punitive measures, collaboration between
stakeholders, and the use of technology. By implementing these actions, Uganda can ensure that
the prescription of classified drugs is safe and controlled.

Supply of classified drugs

The supply of classified drugs in Uganda is regulated by the National Drug Authority (NDA),
which is responsible for ensuring that all medicines, including classified drugs, are of good
quality, safe and effective. The NDA regulates the importation, manufacture, distribution, and
sale of classified drugs in Uganda. The supply chain for classified drugs in Uganda typically
involves the following steps:

 Importation: Most classified drugs are imported into Uganda from other countries. The
importation process is regulated by the NDA, which ensures that all imported drugs meet
the required standards.
 Distribution: Once the classified drugs have been imported, they are distributed to
licensed wholesalers and distributors who are registered with the NDA. These
wholesalers and distributors are responsible for ensuring that the drugs are stored in
appropriate conditions to maintain their efficacy and safety.
 Dispensing: Healthcare providers, such as doctors and pharmacists, are authorized to
dispense classified drugs to patients. They must have a valid license from the Uganda
Medical and Dental Practitioners Council or the Allied Health Professionals Council to
dispense classified drugs.
 Patient use: Patients who have been prescribed classified drugs can obtain them from
licensed healthcare providers or pharmacies. The healthcare provider or pharmacist must
 verify the prescription and ensure that the patient understands how to use the drug safely
and effectively.

The supply of classified drugs in Uganda is strictly regulated to ensure that these drugs are
dispensed and sold in a safe and controlled manner. The NDA monitors the entire supply chain
to ensure that all parties involved comply with the regulations and that the drugs are of good
quality, safe, and effective.

Supply to conform to prescription

In Uganda, the supply of classified drugs must conform to the prescription provided by a
licensed healthcare provider. The prescription specifies the name, strength, and dosage of the
drug, as well as the duration of treatment. Section 234 provides that No person shall supply any
classified drug which does not conform to the prescription or order under which it is supplied.
The supply of classified drugs must be consistent with the prescription to ensure that patients
receive the correct medication and dosage. To conform to the prescription, the following steps
are taken:

 Verification of prescription: The healthcare provider or pharmacist must verify the

prescription to ensure that it is valid and that the medication and dosage are appropriate
for the patient's condition.
 Dispensing: The healthcare provider or pharmacist dispenses the classified drug in
accordance with the prescription. They must ensure that the medication and dosage are
correct and that the patient understands how to use the drug safely and effectively.
 Labeling: The classified drug must be labeled with the patient's name, the name of the
drug, the dosage, and the directions for use. The label must also include any warnings or
precautions.
 Record-keeping: The healthcare provider or pharmacist must maintain accurate records of
all transactions involving classified drugs. This includes the date, name of the drug,
dosage, and quantity dispensed, as well as the name and address of the patient.
 Refills: If the prescription includes refills, the healthcare provider or pharmacist must
ensure that the patient receives the correct medication and dosage each time.
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By conforming to the prescription, the supply of classified drugs in Uganda ensures that patients
receive the correct medication and dosage, which is essential for their health and well-being. The
regulations and guidelines set forth by the National Drug Authority help to ensure that the supply
of classified drugs is safe, effective, and consistent with the prescription.

Container and labels

In Uganda, the National Drug Authority (NDA) regulates the labeling and packaging of
classified drugs. The packaging and labeling of classified drugs must meet specific requirements
to ensure that they are safe and effective for use by patients. Section 255 states that No person
shall supply any classified or restricted drug unless the drug is in a container of the prescribed
description; and the container bears a label giving the prescribed particulars of its contents.

The container for classified drugs must meet the following requirements:

 The container must be made of a material that is compatible with the drug and does not
react with it.
 The container must be tamper-evident, meaning that any attempt to open or tamper with
it will be immediately noticeable.
 The container must be of a size that is appropriate for the quantity of the drug it contains.
 The container must be labeled with the name of the drug, the strength, and the dosage
form

The label for classified drugs must meet the following requirements:

 The label must be clear, legible, and in English.

 The label must include the name of the drug, the strength, and the dosage form.
 The label must include the name and address of the manufacturer, importer, or
distributor.
 The label must include the batch number and expiry date.
 The label must include any warnings or precautions that are necessary for the safe use of
the drug.

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  The label must include the storage conditions required for the drug.
 The label must include the National Drug Authority registration number.

By meeting these requirements for container and label, the supply of classified drugs in Uganda
ensures that patients receive safe, effective, and properly labeled medication. The National Drug
Authority monitors the packaging and labeling of classified drugs to ensure that they comply
with the regulations and guidelines set forth by the authority.

Possession of classified drugs

In Uganda, the possession of classified drugs is regulated by the National Drug Authority
(NDA) and the Public Health Act. Possession of classified drugs without a prescription is illegal
and can lead to legal consequences. According to the Public Health Act, possession of classified
drugs without a prescription is a criminal offense. Section 27(1)6 provides for the following
persons may be in possession of classified drugs,
but to the extent only and subject to the limitations prescribed below any person specified in
section 14 for the purposes of that section ,a licensed person or seller of classified drugs, on
premises registered under this Act ,a wholesale dealer licensed under this Act for the purposes of
the licence and on the premises so licensed ,any person, institution or department to whom a
classified drug has been lawfully sold in accordance with this Act, for the purpose for which the
sale was made ,any person for whom the classified drug has been lawfully supplied or dispensed
by a duly qualified medical practitioner, dentist or veterinary surgeon or by an approved
institution.

Subsection (2) Any person who is in possession of a classified drug otherwise than in
accordance with this section commits an offence and is liable to a fine not exceeding two million
shillings or to imprisonment for a term not exceeding five years or to both. This means that
possession of classified drugs without a valid prescription is a criminal offense that can lead to
fines, imprisonment, or both.

The NDA regulates the possession of classified drugs to ensure that they are used safely and
effectively. Healthcare providers and pharmacists are authorized to possess and dispense
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classified drugs to patients. They must have a valid license from the Uganda Medical and Dental
Practitioners Council or the Allied Health Professionals Council to possess classified drugs.
Patients who have been prescribed classified drugs can possess them for personal use. They must
keep the drugs in their original packaging and follow the instructions provided by their
healthcare provider or pharmacist. Possession of classified drugs for any other purpose is illegal
and can lead to legal consequences.

In conclusion, possession of classified drugs in Uganda is highly regulated to ensure that they are
used safely and effectively. Possession of classified drugs without a prescription is illegal and
can lead to legal consequences. Healthcare providers and pharmacists are authorized to possess
and dispense classified drugs to patients, and patients who have been prescribed classified drugs
can possess them for personal use.

Restrictions on the supply of narcotics

In Uganda, the supply of narcotics is highly regulated due to their potential for abuse and
addiction. Narcotics are classified as controlled substances and are subject to strict regulations
and restrictions to ensure that they are used safely and effectively for medical purposes. The
National Drug Authority (NDA) regulates the supply of narcotics in Uganda under section 267
the Minister may, by statutory instrument, make regulations further restricting the persons who
may supply narcotic drugs, and otherwise controlling the supply of those drugs. No person shall
supply any narcotic drugs under international control other than for medical, dental or veterinary
purposes.

The NDA is responsible for ensuring that all medicines, including narcotics, are of good quality,
safe and effective. The regulations for the supply of narcotics are set forth in the Narcotic Drugs
and Psychotropic Substances Control Act (NDPSCA). The NDPSCA regulates the importation,
manufacture, distribution, and sale of narcotics in Uganda. The Act sets forth the following
restrictions on the supply of narcotics:

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  Prescription requirement: Narcotics can only be supplied with a valid prescription from a
licensed healthcare provider. The prescription must include the name of the drug, the
strength, the dosage form, and the quantity.
 Record-keeping: All transactions involving narcotics must be accurately recorded and
maintained. This includes the date, name of the drug, dosage, and quantity supplied, as
well as the name and address of the healthcare provider and the patient.
 Storage requirements: Narcotics must be stored in a secure and locked cabinet or safe that
is inaccessible to unauthorized personnel.
 Reporting requirements: Healthcare providers and pharmacists are required to report any
suspicious or unusual activity involving the supply of narcotics to the NDA.
 Penalties for non-compliance: Non-compliance with the regulations for the supply of
narcotics can lead to fines, imprisonment, or both.

In conclusion, the supply of narcotics in Uganda is highly regulated to ensure that they are used
safely and effectively for medical purposes. The NDA regulates the importation, manufacture,
distribution, and sale of narcotics, and sets forth restrictions on their supply. By complying with
these regulations, healthcare providers and pharmacists can help ensure that narcotics are used
safely and effectively for the benefit of patients.

Drug addicts

Drug addiction is a public health issue that is addressed by the Public Health Act. The Act
provides provisions for the treatment and rehabilitation of drug addicts In section 298 every
medical practitioner or dentist shall keep a record in the prescribed form of all persons who are
addicted to any drug specified in the First or Second Schedule to this Act and shall at least every
year make a report to the Minister specifying the names of those persons and the drugs to which
they are addicted.

Notwithstanding any other provision of this Act, no person may prescribe or supply any drug
specified in the First or Second Schedule to this Act for the use of a person whom he or she
knows or has reason to believe is addicted to any such drug, unless he or she is authorised in

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writing to do so by the Minister and in a manner and subject to conditions that may be
prescribed.

In conclusion, the Public Health Act in Uganda provides provisions for the treatment and
rehabilitation of drug addicts. The Act provides for the admission of drug addicts to treatment
centers, the treatment of drug addicts, and the discharge of drug addicts from treatment centers.
These provisions are designed to ensure that drug addicts receive the care and treatment they
need to overcome their addiction and lead healthy and productive lives.

Drug quality

In Uganda, the quality of drugs is regulated by the National Drug Authority (NDA) to ensure that
all medicines, including classified drugs and narcotics, are of good quality, safe, and effective.
The NDA is responsible for regulating the importation, manufacture, distribution, and sale of
drugs in Uganda. In section 369 it states that the drug authority shall advise the Minister on
measures to be taken to ensure the quality of drugs imported into or held in stock in the country.
The execution of the measures prescribed shall be entrusted to bodies charged with the
importation and distribution of drugs. The inspection of drugs and measures prescribed may be
delegated to the chief of pharmaceuticals and health supplies or any other person properly
qualified in pharmaceuticals and health supplies. The NDA ensures that impure drugs are not
supplied by implementing quality control measures such as:

 Quality control testing: The NDA conducts quality control testing on all drugs before
they are approved for importation, manufacture, distribution, or sale in Uganda. The
testing ensures that the drugs meet the required standards for quality, safety, and efficacy.
 Inspections: The NDA conducts inspections of drug manufacturing facilities, warehouses,
and pharmacies to ensure that they comply with the regulations and guidelines set forth
by the authority. The inspections help to ensure that the drugs are stored in appropriate
conditions and that they are not contaminated.

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  Quality assurance: The NDA requires all manufacturers, importers, and distributors of
drugs to have quality assurance systems in place to ensure that the drugs they supply are
of good quality, safe, and effective.
 Reporting of adverse events: The NDA requires healthcare providers and pharmacists to
report any adverse events associated with the use of drugs. This helps the NDA to
identify any quality issues with the drugs and take appropriate action.

The Public Health Act also provides provisions for the quality of drugs. Section of the Act states
that no person shall manufacture, import, distribute, or sell any drug that is adulterated or
misbranded. Adulterated drugs are drugs that have been contaminated or do not meet the
required standards for quality, safety, and efficacy. Misbranded drugs are drugs that are labeled
incorrectly or do not contain the required information.

Proprietary drugs

Proprietary drugs are drugs that are protected by a trademark, patent, or other proprietary rights.
These drugs are manufactured and marketed by a single company, which has exclusive rights to
distribute and sell the drug. Proprietary drugs are also known as branded drugs or innovator
drugs. In Uganda, proprietary drugs are regulated by the National Drug Authority (NDA) to
ensure that they are of good quality, safe, and effective. The NDA is responsible for regulating
the importation, manufacture, distribution, and sale of proprietary drugs in Uganda. The NDA
ensures that proprietary drugs meet the required standards for quality, safety, and efficacy by
implementing the following measures:

 Quality control testing: The NDA conducts quality control testing on all proprietary drugs
before they are approved for importation, manufacture, distribution, or sale in Uganda.
The testing ensures that the drugs meet the required standards for quality, safety, and
efficacy.
 Inspections: The NDA conducts inspections of drug manufacturing facilities, warehouses,
and pharmacies to ensure that they comply with the regulations and guidelines set forth
by the authority. The inspections help to ensure that the proprietary drugs are stored in
appropriate conditions and that they are not contaminated.
  Registration: The NDA requires all manufacturers, importers, and distributors of
proprietary drugs to register their products with the authority. The registration process
ensures that the drugs meet the required standards for quality, safety, and efficacy.
 Monitoring: The NDA monitors the distribution and sale of proprietary drugs to ensure
that they are being sold in a safe and controlled manner.

Retail sale of proprietary drugs

In Uganda, the retail sale of proprietary drugs is regulated by the National Drug Authority
(NDA) and the Pharmacy and Drugs Act. The Pharmacy and Drugs Act provides regulations for
the retail sale of proprietary drugs in Uganda. The Act requires that all pharmacies and drug
shops be licensed by the NDA to sell proprietary drugs.in section 3210 Power to prohibit retail
sale of proprietary drugs where The authority may prohibit the sale by retail of a proprietary drug
if, in the opinion of the authority claims are made for the drug, whether or not in a statement
furnished under section 31, which are unjustified; the use of the drug may endanger the health of
the user or there may be other undesirable effects in the use of the drug; details of the
composition of the drug furnished under section 31 differ substantially from those disclosed on
an analysis of samples of the drug obtained from retail suppliers; or descriptive matter published
in relation to the drug differs substantially from that, whether or not in the same language,
contained in copies furnished to the authority in relation to the drug under section 31 The Act
also provides for the following regulations:

Dispensing by licensed pharmacists: Proprietary drugs can only be dispensed by licensed

pharmacists or licensed pharmacy technicians under the supervision of a licensed pharmacist.

Prescription requirements: Proprietary drugs can only be dispensed with a valid prescription
from a licensed healthcare provider. The prescription must include the name of the drug, the
strength, the dosage form, and the quantity.

Record-keeping: All transactions involving proprietary drugs must be accurately recorded and
maintained. This includes the date, name of the drug, dosage, and quantity dispensed, as well as
the name and address of the healthcare provider and the patient.

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Storage requirements: Proprietary drugs must be stored in a secure and locked cabinet or safe
that is inaccessible

Control of publication of descriptive matter

In Uganda, the publication of descriptive matter about drugs and related products is tightly
controlled by the National Drug Authority (NDA) under the National Drug Policy and Authority
Act, 1993.in section 33(1)11 Subject to this section, no person shall, by way of advertisement,
publish, in whatever manner, in relation to any drug, descriptive matter calculated to lead to the
use of that drug for prevention or treatment of any disease specified in the Fifth Schedule to this
Act; for the purpose of termination or influencing the course of human pregnancy; or for any
purpose relating to enhancing human potency.
subsection (2) Subject to this section, the authority may, with the approval of the Minister, serve
on any person a notice prohibiting him or her from publishing in relation to any drug descriptive
matter referred to in the notice.

Descriptive matter includes any information published in any form about a drug or related
product, including advertisements, promotional materials, and product labeling. The following
are some of the provisions for the control of publication of descriptive matter in Uganda:

 Approval: All descriptive matter related to drugs and related products must be approved
by the NDA before publication. This includes advertisements, promotional materials, and
product labeling. The NDA evaluates the descriptive matter to ensure that it is accurate,
not misleading, and does not make false claims about the product.
 Registration: Any person or company intending to publish descriptive matter about drugs
and related products must register with the NDA. The registration process involves
submitting an application to the NDA, which includes information about the person or
company, the product being advertised, and the proposed descriptive matter.
 Prohibited Claims: The NDA prohibits the publication of descriptive matter that makes
false or misleading claims about the product, or that promotes the product for uses that
are not approved by the NDA. The NDA may also require that certain warnings or

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 precautions be included in the descriptive matter to ensure that the product is used safely
and effectively.
 Penalties: The National Drug Policy and Authority Act, 1993 provides for penalties for
non-compliance with the control of publication of descriptive matter. Offenses such as
publishing false or misleading claims about a product may result in fines, imprisonment,
and other penalties.

Drug regulation and registration of specialties

The National Drug Authority (NDA) is responsible for regulating drugs and related products in
Uganda. The NDA is mandated to ensure that all drugs and related products meet the required
standards of safety, efficacy, and quality before they are registered and allowed to be sold in
Uganda. To register a drug or related product in Uganda, a company or individual must submit
an application to the NDA. The application should include details of the drug or product, its
composition, manufacturing process, and clinical data to support its efficacy and safety. The
NDA then evaluates the application and conducts inspections of the manufacturing facility
before granting or denying registration. Section 35(1)12 The drug authority may scientifically
examine any drug for the purposes of ascertaining efficacy, safety and quality of that drug; shall
institute a system for the approval of drugs or drug combinations not included in the national list
of essential drugs.

(2) The drug authority shall keep a register of specialties in the prescribed form.

(3) If, on application made in the prescribed manner and on payment of the prescribed fee, the
authority is satisfied that the drug or preparation in respect of which the application is made has
not previously been registered; and that the use of the drug or preparation is likely to prove
beneficial, the authority shall register the name and description of that drug or preparation.

Where, on application so made, the authority is not satisfied as aforesaid, it shall notify the
applicant that the application is dismissed on the grounds which shall be specified. The authority
may direct at any time for the deletion of any drug or preparation from the register. The register

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shall, at all reasonable times, be open for public inspection on payment of such fee as may be
prescribed.

In terms of specialty drugs, the NDA has specific guidelines for the registration of biological and
biosimilar products. These guidelines outline the requirements for clinical trials,
pharmacovigilance, and post-marketing surveillance for these products. Additionally, the NDA
has established a specialized unit, the Traditional and Complementary Medicines (TCM) Unit, to
regulate traditional and complementary medicines in Uganda. The TCM Unit has developed
guidelines for the registration and regulation of these products, which include herbal medicines,
traditional medicines, and homeopathic medicines.

License required for wholesale supply of restricted drugs

In Uganda, a wholesale dealer's license is required for the wholesale supply of restricted drugs.
The license is issued by the National Drug Authority (NDA) under the National Drug Policy and
Authority Act, 1993. The wholesale dealer's license allows the licensee to import, export, store,
supply, and distribute restricted drugs. According to Section 37 of the National Drug Policy and
Authority Act, 1993, No person shall carry on a business of supplying restricted drugs by
wholesale unless he or she is authorised to carry on that business by a licence granted under this
section.

The authority may, on application made in the prescribed form and upon payment of the
prescribed fee, grant a licence for the carrying out of a business of supplying restricted drugs by
wholesale, if the authority is satisfied that the applicant is a person to whom the licence can
properly be granted; that the business will be carried on in separate premises apart from any
other business; that the business will be carried on in premises under the immediate supervision
of a pharmacist; in the case of a company, that at least one of the directors is a pharmacist
resident in Uganda; and in the case of a partnership, that at least one of the partners is a
pharmacist resident in Uganda. A licence granted under this section may include a condition
prohibiting or limiting the supply of restricted drugs of a description specified in the condition,
and shall be deemed to include a condition prohibiting the supply of any prepared opium or
Indian hemp which is prepared for smoking. A licence granted under this section shall be valid
for a period specified in the licence; but the authority may revoke the licence if, at any time, it is
satisfied that the holder of the licence has contravened any provision of this Act or any condition
contained in the licence or has ceased to be fit to carry on the business.

The NDA requires that an applicant for a wholesale dealer's license must meet certain
requirements, including having a suitable premise for storage and distribution of drugs, having
qualified personnel to handle and dispense drugs, and having a quality management system in
place. The NDA may also conduct inspections of the premises and request additional information
before issuing a wholesale dealer's license. It is important to note that restricted drugs are subject
to strict regulation in Uganda, and the wholesale supply of these drugs must comply with the
relevant laws and regulations. Failure to comply with the licensing requirements and other
regulations may result in penalties, including fines and imprisonment, as outlined in the National
Drug Policy and Authority Act, 1993.

Control of manufacture and storage of drugs

In Uganda, the manufacture of classified drugs is tightly controlled by the National Drug
Authority (NDA) under the National Drug Policy and Authority Act, 1993. Classified drugs are
drugs that are classified as prescription-only medicines, over-the-counter medicines, and
veterinary medicines. According to Section 27 of the National Drug Policy and Authority Act,
1993, no person shall manufacture, import, export, distribute, or sell any classified drug unless
they have been registered by the NDA. The registration process involves submitting an
application to the NDA, which includes information about the drug's composition, manufacturing
process, labeling, and packaging. The NDA evaluates the application and conducts inspections of
the manufacturing facility before granting or denying registration.

The NDA also has the power to inspect and monitor the production and distribution of classified
drugs to ensure that they meet the required standards of safety, efficacy, and quality. The NDA
may conduct regular inspections of manufacturing facilities to ensure compliance with Good
Manufacturing Practices (GMP) and may also test samples of drugs to ensure that they meet the
required specifications. Additionally, the National Drug Policy and Authority Act, 1993 provides
for penalties for non-compliance with the manufacturing and distribution of classified drugs.
Section 38 of the Act provides for fines, imprisonment, and other penalties for offenses such as
manufacturing, importing, or distributing unregistered drugs, selling drugs without a license, and
other related offenses.

Restrictions on the manufacture of classified drugs

The manufacture of classified drugs is subject to strict restrictions under the National Drug
Policy and Authority Act, 1993. Classified drugs include prescription-only medicines, over-the-
counter medicines, and veterinary medicines. Section 3813 provides that no person shall
manufacture any drug or preparation which is not included on the national formulary unless the
drug or preparation is approved by the authority. No person, unless approved by the authority in
that behalf, shall manufacture a speciality. No person shall manufacture any classified drug
unless the processes of manufacture are carried out or supervised by a pharmacist.

Subsection (3) shall not apply to the manufacture of preparations mentioned in the Sixth
Schedule to this Act if the processes of manufacture
are carried out or supervised by a medical practitioner.

Section 3914 states that the Minister may, by statutory instrument, make regulations further
limiting the persons who may manufacture any drug or preparation and the premises in which
they may be manufactured, and otherwise controlling their manufacture. No person shall
manufacture any narcotic drug or psychotropic substances under international control for
purposes other than for medical, dental or veterinary use.

The following are some of the restrictions on the manufacture of classified drugs in Uganda:

 Registration: No person shall manufacture, import, export, distribute or sell any classified
drug unless it has been registered by the National Drug Authority (NDA). The
registration process involves submitting an application to the NDA, which includes
information about the drug's composition, manufacturing process, labeling, and
packaging. The NDA evaluates the application and conducts inspections of the
manufacturing facility before granting or denying registration.

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  Good Manufacturing Practices (GMP): Manufacturers of classified drugs are required to
comply with Good Manufacturing Practices (GMP) to ensure that the drugs are of high
quality, safe, and effective. The NDA conducts regular inspections of manufacturing
facilities to ensure compliance with GMP.
 Quality Control: Manufacturers of classified drugs are required to have a quality control
system in place to ensure that the drugs meet the required specifications. The NDA may
also test samples of drugs to ensure that they meet the required specifications.
 Labeling and Packaging: Manufacturers of classified drugs are required to label and
package the drugs in accordance with the relevant laws and regulations. The labeling
must include information about the drug's composition, dosage, warnings, and
precautions.
 Adverse Drug Reaction (ADR) Reporting: Manufacturers of classified drugs are required
to report any adverse drug reactions to the NDA. This helps the NDA to monitor the
safety of the drugs and take appropriate action if necessary.
 Penalties: The National Drug Policy and Authority Act, 1993 provides for penalties for
non-compliance with the manufacturing and distribution of classified drugs. Offenses
such as manufacturing, importing, or distributing unregistered drugs, selling drugs
without a license, and other related offenses may result in fines, imprisonment, and other
penalties.

Local research and production of drugs(storage)

In Uganda, local research and production of drugs is encouraged to promote access to affordable
and quality medicines. The National Drug Authority (NDA) is responsible for regulating the
storage, distribution, and sale of locally produced drugs under the National Drug Policy and
Authority Act, 1993. Section 4115 the National Drug Authority shall encourage research by
persons carrying on research and development in herbal and other medicines and where
appropriate take such medicines into production as a component of the drug supply.

The following are some of the provisions for local research and production of drugs in Uganda:

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 Licensing: Any person or company intending to engage in the production of drugs must
obtain a license from the NDA. The license is issued after the NDA has conducted an
inspection of the production facility and confirmed that it meets the required standards.
 Good Manufacturing Practices (GMP): Local drug manufacturers must comply with
Good Manufacturing Practices (GMP) to ensure that the drugs are of high quality, safe,
and effective. The NDA conducts regular inspections of manufacturing facilities to
ensure compliance with GMP.
 Quality Control: Local drug manufacturers must have a quality control system in place to
ensure that the drugs meet the required specifications. The NDA may also test samples of
drugs to ensure that they meet the required specifications.
 Storage: Locally produced drugs must be stored in accordance with the relevant laws and
regulations. The storage facilities must be suitable for storing drugs and must be equipped
with appropriate temperature and humidity control systems.
 Labeling and Packaging: Locally produced drugs must be labeled and packaged in
accordance with the relevant laws and regulations. The labeling must include information
about the drug's composition, dosage, warnings, and precautions.
 Adverse Drug Reaction (ADR) Reporting: Local drug manufacturers are required to
report any adverse drug reactions to the NDA. This helps the NDA to monitor the safety
of the drugs and take appropriate action if necessary.
 Penalties: The National Drug Policy and Authority Act, 1993 provides for penalties for
non-compliance with the production and distribution of drugs. Offenses such as
producing and selling substandard drugs, selling drugs without a license, and other
related offenses may result in fines, imprisonment, and other penalties.