Drug manufacturers want NDA to expedite approval process

Cipla Quality Chemicals Limited

Kampala, Uganda | THE INDEPENDENT | The National Drug Authority (NDA) has started a program of retooling company chemists to eliminate unnecessary bureaucracy.

Abiaz Rwamwiri, the NDA spokesperson says that they have rejected some of the manufacturers drug prototypes many times for always misfiring on important aspects such as mixing the right chemical contents and not following the international drug manufacturing protocols.

Currently, 25 percent of the country’s drug needs are served by local manufacturers according to statistics by the NDA, whereby the majority are in the production of antibiotics and anti-malarial drugs.

Officials from NDA said on Wednesday that the number of producers is set to increase since the COVID-19 pandemic which created a major strain on imports and withheld vital antiviral treatments, opened a window for local manufacturers to innovate more.

At Cipla Quality Chemicals Limited for instance, Peter Lubega, the regulatory affairs pharmacist says their product portfolio increased from just antiretroviral therapies and antimalarial drugs to including new drugs that have been proved effective in the treatment of COVID-19.

Among the new drugs on their portfolio is remdesivir antiviral and molnupiravir, which were approved by the World Health Organization-WHO recently.

Chemists from twenty manufacturing plants attended the inaugural training that focused on analytical methods validation that involves assessing methodology for drug production in addition to precision and specificity when presenting scientific data.

However, they complained of the long time lag that their documents spend at the authority even when they tick boxes of protocols they require of them.

Dr. Aisha Bukenya who represented Mavid Pharmaceutical Company renown for the production of cough syrups said the earliest one can have their samples approved is a full year saying reviewing documents which is the simplest and earliest stage can take the authority up to four months.



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