Mrs. Oge Ikeakanam is the Group Head of Regulatory Affairs at KCH. In this interview with PharmaTimes, she stated that Pharmamax, a member of the KCH group has declared war on cardiovascular diseases through efforts geared towards formulating high quality combination therapy for prevention and management of cardiovascular risks. She also spoke on the issue pertaining to drug counterfeiting among others.
It is popular knowledge that cardiovascular diseases have become an alarming health concern both for the healthcare providers and the citizenry. What is your company’s contribution towards the prevention and management of cardiovascular risks in the country?
You are correct on that notion. Basically, we are concerned about the rising incidence of Cardiovascular Diseases – professionally called CVD’s among different age groups in Nigeria, and the rate is alarming. As is usual with us, we are going to do our best to play a part in the efforts aimed at ensuring that the greatest majority of Nigerians have access to cardiovascular medicines. In view of the development and in fulfilment of our promises to our numerous customers we have decided to declare war on CVD’s in two ways. Firstly, Pharmamax, a member of the KCH group have launched Pharmamax Amlodipine and Lisinopril which are our own generics formulated for the purpose of facilitating primary preventive and management care to lower heart related diseases. We have also gone a step further to commence the process of formulating a combination therapy for effective management and prevention of the secondary category of cardiovascular risks.
The idea is to make sure that various classes of patients with CVD cases are accommodated in the prevention and management plan we have laid out. As I speak the registration of the combination therapies are at the final stages and in a matter of weeks we will conclude on them. However, I must tell you that we are emboldened by complimentary reports we get from operators of drugstores, healthcare personnel and end users from across the country testifying to the efficacy of Pharmamax Amlodipine and Lisinopril in the prevention and management of hypertension. CVD’s as you may have heard are considered by global health authorities as the world’s leading cause of death. In fact it has become a global issue that compelled the World Health Organisation to launch a new initiative titled ‘Global Hearts’ on September 22, 2016 – on the resolve of the United Nations General Assembly to seek ways of beating back the global threat of cardiovascular disease. It is a serious disease ravaging humanity that an estimated 17 million people die annually from it – going by WHO reports.
As head of regulatory affairs your job among other things brings you closer to the operations of NAFDAC. With the benefit of hindsight what would you consider the biggest challenge being faced by the agency in registering drugs?
From my own observation and experience, rather than say that NAFDAC is facing any major challenge as it relates to registration of drugs, I would say that the agency has introduced new strategies to enhance its delivery time and also strengthen its overall operations. For instance, the agency has streamlined the registration process in such a way that you now have drugs of Chinese or Indian origin being treated separately during registration process. Again, the agency has also started implementing a policy whereby its officials must visit the company manufacturing the drug products you are registering irrespective of their locations before putting a final seal on the registration certificate. The idea by my understanding is primarily to ensure that NAFDAC carry out due diligence on the company to establish the GMP status and other relevant requirements before giving its nod. It’s a welcome development because that is the standard practice everywhere in the world. At least the policy would help curb the excesses of counterfeiters in the industry.
Counterfeit drugs have been a big issue in the pharmaceutical world. Could you enlighten the public on what counterfeit drug connotes?
Health experts define counterfeit drugs as those sold under a product name without proper authorisation. Counterfeiting can apply to both brand name and generic products, where the identity of the source is mislabelled in a way that suggests that it is the authentic approved product. Counterfeit products may include – products without the active ingredient, with an insufficient or excessive quantity of counterfeit medication or the active ingredient, with the wrong active ingredient, or with fake packaging. In a nutshell a counterfeit drug is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. In fact the challenge of counterfeit drugs is so huge that it is estimated that 10 per cent of the world’s medicines are counterfeit while up to 30 per cent of medicines circulating in developing countries are counterfeit.
What risks are involved with taking counterfeit drugs?
An individual who receives a counterfeit drug may be at risk for a number of dangerous health consequences. Patients may experience unexpected side effects, allergic reactions, or a worsening of their medical condition. A number of counterfeit products do not contain any active ingredients, and instead contain inert substances, which do not provide the patient any treatment benefit. Counterfeit drugs may also contain incorrect ingredients, improper dosages of the correct ingredients, or they may contain hazardous ingredient.
How are KCH products protected from the threats posed by counterfeiters?
We embraced the policy of affixing MAS labels on our products quite early. When NAFDAC came up with the policy of MAS and mandated pharmaceutical companies to comply for anti-malarial products – and that was at the pilot phase, we were among the first pharmaceutical marketing companies in the country to comply, and the first to extend the MAS service to our numerous products. That action has paid off handsomely because we have never encountered any issues with counterfeiting.
A number of commentators believe that NAFDAC is not doing enough in terms of curbing the proliferation of counterfeit medicines. What is your take on this?
I disagree with that kind of comment because it does not reflect the true picture of what is going on in NAFDAC for quite some time now. I would like to say that kudos must be given to authorities in the agency for mounting unrelenting war on counterfeiters resulting to a significant reduction in their activities. From the tenure of late Prof. Dora Akunyili, as NAFDAC Director-General till date, the agency has been able to win a number of battles with the unscrupulous merchants of unwholesome pharmaceutical products. I think the implementation of technological devices in detecting counterfeit drugs nailed the coffin of counterfeiters. It is true that there are still pockets of incidence of counterfeiting yet to be surmounted but NAFDAC to a large extent is on top of the situation.