Suspending importation of Indian poor quality medicines is necessary but not sufficient

 

On June 25, 2012, National Drug Authority suspended medicines manufactured by Flamingo Pharmaceuticals Limited India from importation and use in Uganda. The justification was that this company did not comply with GMP (Good Manufacturing Practice) standards. Failure to comply with GMP means that the manufacturing process cannot guarantee that the final medicines manufactured are of the required good quality.

 

NDA, therefore, suspended the importation and use of these medicines because the required quality of these medicines could not be assured or guaranteed. By implication, therefore, I can, with very high levels of confidence, state that medicines that were being imported from this Indian medicine manufacturer into Uganda are of poor quality. 

 

For example, let us look at antibiotics. Antibiotics are medicines used in treatment of bacterial infections. On the list of the 67 medicines from Flamingo that were suspended from use in Uganda, over 50% are antibiotics. Compared to other antibiotics from other manufacturing companies, these were relatively cheap.

 

This means that on a generic prescription to be dispensed at either a public or private pharmacy, the client is more likely to receive the cheaper version, the poor quality version in this case. Administering poor quality medicine means that the patient takes a dose less than what the prescriber intended.

 

This is automatic under-dosing. Under-dosing with antibiotics means a number of things. The patient is not likely to cure from the infection. If the patient is to cure, it takes longer durations of medicines administration than the normal. And finally, under-dosing exposes bacteria to suboptimal medicines concentrations leading to bacterial resistance.

 

This resistance shall not discriminate between manufacturers but affect all antibiotics in that class. The medicines that used to be very effective gradually cease to work, necessitating the prescription of very expensive alternatives which are many not available, leading to increased infectious disease burden in terms of increased morbidity and mortality due to lack of effective antibiotics to certain bacterial infections.

 

After understanding the effect of poor quality medicines on the health of persons using these medicines, we can now pose some questions to help us understand who is responsible and who is to blame for the poor quality medicines available on the Ugandan medicines market.

 

1. NDA inspectors are mandated to routinely carry out overseas inspection for GMP compliance of medicine manufacturing facilities whose medicines are imported and used in Uganda. Who finances the foreign plant inspections? Does NDA really carry out the routine foreign plant inspections?

 

If yes, is the inspection upon notification of the plant managers or not? Are NDA inspectors empowered to give results of their independent assessment of GMP compliance without any external interference? Can NDA confirm without reasonable doubt that the facilities it inspects are actually the facilities from which the medicines imported into Uganda are manufactured?

 

Is suspension of these medicines the best NDA can do? Or aren’t we just aware of the further steps that NDA took? What became of routine market sampling for chemical analysis? Is foreign plant GMP compliance the only way of assuring quality of medicines used in Uganda?

 

2. Does Flamingo in India have only one medicines manufacturing plant? Does Flamingo manufacture medicines for Uganda only? If no, are the Flamingo medicines in other countries of the same quality and from the same plant as those in Uganda? Does Flamingo use the same quality standards for its different markets? Is this acceptable in medicine manufacturing standards? Can’t the quality of the final medicines be altered on the request of the bulk buyer to reduce on the cost to pay?

3. To whom is the medicine importation license issued? The LTR (Local Technical Representative) or the manufacturer? What are the advantages of issuing the importation license to the LTR over to the manufacturer? What are the responsibilities of the LTR to NDA?

 

What are the responsibilities of the LTR to the manufacturer and vice versa? Who should NDA really blame, the LTR or the manufacturer or NDA themselves? Is it possible that the LTR was aware that the quality of the medicines being imported was poor? Even if the LTR was not aware that the manufacturing process was not according to GMP, would this ignorance be defense? Who does the suspension from the register affect?

 

Bacterial antibiotic resistance should be looked as a public health emergency of international concern. The two competing causes of increased bacterial resistance are irrational antibiotic use and availability of poor quality antibiotics. It is the mandate of NDA to ensure quality of medicines plus their rational use. Whether NDA has exercised its mandate to achieve these two objectives can be the topic of our next discussion.