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FDA trains importers, manufacturers of controlled substances

The Food and Drugs Authority (FDA) has held a two-day training program for importers and manufacturers of Controlled Substances (CS).


The two-day training was held on the 11th and 12th October 2023 in Accra.

 

The program was organized to educate representatives from 49 pharmaceutical companies, comprising both local manufacturers and importers of Controlled Substances on Regulatory Requirements for Controlled Substances and raise awareness about emerging trends and threats associated with New Psychoactive Substances.

 

An unregulated trade in controlled substances, they were told could lead to an increase in drug abuse which can lead to issues such as reduced productivity in the workplace due to absenteeism, impaired cognitive function, overall decreased work efficiency.


This, as explained could also have an adverse impact on a country's economy and increase the cost of healthcare and the strain on healthcare systems.


Other health implications of substance abuse include mental health problems and infectious diseases like HIV/AIDS and Hepatitis C.


Another negative effect of unregulated trade in controlled substances is the increase in illicit trade and organized crime.


Illegal drug trade often fuels organized crime, leading to violence and instability.


These activities coulddeter economic development in affected regions. 


The FDA as mandated by the Public Health Act, 2012 (ACT 851) Section 126 revealed that it has been mandated to oversee the legal, scientific, and medical use of narcotic drugs, psychotropic substances, and precursor chemicals, aligning with international drug conventions as well as subscribed guidelines.


These UN drug conventions include the 1961 Single Convention on Narcotic Drugs (amended by the 1972 Protocol), the 1971 Convention on Psychotropic Substances (adopted in 1988), and the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.


The pursuit of a safe and legitimate drug supply chain is bridled by some challenges.  


These challenges include issues related to document submissions such as late responses from controlled drug importers, inaccuracies/ erroneous documentations and errors in the processes involved in controlled substance permit applications.


The FDA in accordance with the provisions of the law and allied international drug commitments has developed two essential documents, namely, "Guidelines for the Importation of Controlled Substances" and "Guidelines for the Sale, Supply, and Use of Controlled Substances” to provide guidance to stakeholders.

Thus, the training of manufacturers and importers of controlled substances was intended to provide improved knowledge gap and capacities in the use of these guidelines and the reporting system which includes submission of proper documentations such as Advice of receipts, Returns (Utilization/distribution records) and processes involved in the Controlled Substances Import Permit applications). 


The training was also expected to equip manufacturers and importers of controlled substances with the requisite skills in effective standard storage practices for controlled substances, raise awareness about emerging trends and threats associated with New Psychoactive Substances as well as other relevant aspects concerning controlled drug management.


Speaking at the training, DCEO in charge of health products and technology, Seth Seaneke expressed his immense gratitude towards the participants for availing themselves for this all-important training.


He admonished them to take the session serious to properly apply the lessons.  


On her part, Director for the Tobacco and Substances of Abuse Department, Dr. Olivia Boateng indicated that it had become imperative that the FDA brings manufacturers, importers, and dealers in Controlled substances up to speed on the advent of NPS (New Psychoactive Substances).


She stated during her presentation that these substances are either analogues of existing controlled drugs or newly synthesized chemicals, created to mimic the actions and psychoactive effects of licensed medicines and other controlled substances.


“NPS are clandestinely produced and have no industrial or medicinal use” she stated.


She also pointed out that the dangers of NPS are far reaching hence the need to find ways to curb its proliferation.


Participants of the training engaged in meaningful discussions regarding emerging threats posed by New Psychotropic Substances and pledged their support to the FDA in ensuring that stakeholders are well-informed and prepared to address these evolving challenges.


They further committed to comply with the relevant guidelines to ensure an efficient supply chain management of the controlled drugs to curb any form of illicit diversion which could further escalate the drug abuse situation in the country


Story by: Joshua Kwabena Smith

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