Category: Health and Environment

 

Prof. Mojisola Adeyeye, the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), has reaffirmed the Agency’s commitment to ensuring the quality, safety, and efficacy of generic medicines in Nigeria by enforcing stringent bioequivalence.

Speaking on Thursday in Lagos, Prof. Adeyeye, said that NAFDAC initiative, aimed at boosting public confidence in generic drugs, sought to prevent the circulation of substandard medications and ensure that generics provide comparable therapeutic effects to their branded counterparts.

Bioequivalence studies are vital scientific assessments that confirm the interchangeability of generic medicines with their innovator counterparts.

 

These studies guarantee that generic drugs deliver similar clinical outcomes, ensuring their effectiveness in managing health conditions

 

She said, “By mandating bioequivalence studies, NAFDAC is strengthening its regulatory framework to safeguard public health.

“This measure not only enhances trust in the pharmaceutical industry but also encourages rational prescribing practices.”

Adeyeye said that to align stakeholders and facilitate compliance, NAFDAC had outlined a strategic roadmap that included issuing comprehensive regulations and guidelines to the pharmaceutical industry.

 

By Flowerbudnews
Rev. Fr. Michael Nwankwo, the Administrator of Mother of Mercy Hospital, Ihe in Awgu Local Government Area of Enugu State, says the newly remodelled hospital
has transformed healthcare services in Ihe and adjoining communities.

Nwankwo said this on Thursday while speaking to newmen after 90 days of official reopening of the health facility, which was done at the cost of N300 million by Ihe Development Initiative (IDI), a group composed of local entrepreneurs, academics and servicemen.

He said that the health facility, which is fully solar-powered, had provided vital medical assistance not only to the residents of Ihe community but also to nearby communities.

The administrator noted that the people of Ihe are pleased because the facility had undergone a significant transformation and “can now compete with big hospitals even in urban areas within Enugu metropolis.”

“With the upgrade, the services we provide have improved, and we are now better equipped to respond to emergency situations.

“We have acquired a ventilator — a rarity in most hospitals — and our laboratory is now better equipped to conduct a wider range of routine tests and more,” he said.

Nwankwo noted that the hospital now serves not just the people of Ihe; adding: “Residents from distant communities, such as Agbo-ogwugwu, Ugbo and Amoli, are also seeking medical care here.”

“The response has been remarkable, and we have become a healthcare provider for numerous nearby communities,” he said.

Corroborating, a resident doctor at the hospital, Dr Echem Michael, noted that following the hospital’s upgrade, both staff and patients are experiencing a transformed environment, with improved conditions for delivering healthcare.

According to Micheal, it is challenging to work here before due to poor infrastructure.

He said, “Today, the facilities here are a source of pride. We have better equipment, increased access to medications, improved beds, oxygen cylinders and their components and enhanced staffing levels, resulting in a better patient turnout and experience.

“For expectant mothers, we now offer suitable facilities for delivery, and the modern beds and equipment have made a significant difference. Today, I have my own office for consultations, unlike in the past when they were conducted in open wards.

“Previously, our living quarters were inadequate, but now we have a much-improved structure, and we’ve resolved our water issues and enjoy constant electricity, and the welcoming community makes our work seamless.”

A laboratory technician at the hospital, Ms Ijeoma Okoro, explained that the hospital had been equipped to perform tests including Packed Cell Volume (PCV), Culture Tests, Urine Microscopy, Culture and Sensitivity (MSC) and Stool Microscopy among other procedures.

Okoro also noted that, while some additional equipment is still awaited, the hospital currently possesses a microscope, microhematocrit and macrohematocrit centrifuges, an incubator and many other essential tools.

A patient, Mrs. Anastasia Nweke from Agbo-ogwugwu community, expressed her satisfaction with the services she had been receiving and was astonished by the extent of transformation in the hospital.

Another patient, Mr Hyginus Okafor, commended the care he received, noting that the doctors and nurses are diligent in their duties.

 

Okafor urged the management to maintain the current standards of care and prayed for blessings upon them and the members of IDI.

Mr Nnamdi Nwankwo, from Ihe community, said that the hospital’s achievements had greatly contributed to saving lives in Ihe community and surrounding areas.

The hospital, which was officially commissioned after remodeling on Dec. 29, 2024, was established in 1976 by the Catholic Diocese of Enugu with support from late Igwe Dennis Chukwu, the former Traditional Ruler of Ihe-Shikeaguma, and now managed by the Catholic Diocese of Awgu.

 

–  The Clinical Research Organization (CRO) is being supported by funders, led by Chief (Dr.) Dele Fajemirokun, a Nigerian businessman, entrepreneur, investor, venture capitalist, and philanthropist

 

By Biola Lawal
FLOWERBUDNEWS:   Liddie Bioequivalence (Liddie BE) Ltd (https://www.liddie.org/), an emerging world class Clinical Research Organization (CRO), is now set for a major boost of Nigeria’s health sector with local production of genetic drugs.
–
Flowerbudnews reports that the establishment of Liddie BE Limited, a consortium of pharmaceutical and drug research professionals and experts,  is expected to make available high quality and safe generic drugs at significantly reduced costs to the government and patients in Nigeria and Sub-Saharan Africa.

(Chief (Dr.) Dele Fajemirokun, a Nigerian businessman, entrepreneur, investor, venture capitalist, and philanthropist)

The company is already investing heavily in a Bioequivalence/Clinical Trial Centre for a tremendous impact on the nation’s healthcare delivery.

The groundbreaking ceremony for Liddie BE’s state-of-the-art facility in Ibadan, Nigeria, which includes a dedicated 24-bed clinical trial unit and a bioanalytical laboratory (positioned for ISO 17025 certification), will take place by Q2 2025 and will be commissioned in Q3 2026, Flowerbudnews learnt.

The Nigeria-based Clinical Research Organization (CRO), is the first of its kind in sub-Saharan Africa and in collaborative operation with the prestigious Obafemi Awolowo University (OAU), Ile Ife, Nigeria.  The CRO is being supported by funders, led by Chief (Dr.) Dele Fajemirokun, a Nigerian businessman, entrepreneur, investor, venture capitalist, and philanthropist, Flowerbudnews reports.

Flowerbudnews learnt that Liddie BE, which  is already registered with the Corporate Affairs Commission (RC 1575041) has a Corporate Social Responsibility (CSR) commitment to strengthen the pharmaceutical industry in Nigeria in the assessment of the bioequivalence of generic medicines (drugs).

For effective operations, Liddie BE has signed a comprehensive memorandum of understanding (MOU) with the Obafemi Awolowo University (OAU), which covers collaboration in the design and conduct of bioequivalence and clinical research projects for the pharmaceutical industry and building capacity of academic staff and young scientists, Flowerbudnews reports.

A statement on the unique pharmaceutical project made available to Flowerbudnews disclosed that
currently, Liddie BE Ltd bioanalytical laboratory (Bioequivalence and Biopharmaceutics Laboratory, Faculty of Pharmacy, OAU) under the leadership of Prof. Oluseye Bolaji, is equipped with state-of-the-art analytical equipment (including LC-MS and HPLC) that are currently domiciled at OAU.

A clinical site is also now located at the newly built Jennifer Etuh Medical Center, Ifewara, Osun State (with in-house modern laboratories), a few kilometers from OAU, Flowerbudnews reports.

”The Centre will obtain WHO prequalification/FDA certification by Q4 2026 and will work closely with the National Agency for Food and Drug Administration and Control (NAFDAC) to ensure that all the expected clinical and laboratory operations compliances are met and consistent with international best practices,” the statement stressed

The statement further disclosed that ”the Liddie BE company is driven by a strong management team of US-based Nigerian pharmaceutical scientists in partnership with Nigeria-based pharmaceutical and clinical professionals (https://www.liddie.org/team/).

”The company is being built on a quality-driven foundation, staffed with a competent diaspora-sourced clinical pharmacologist with over 30 years combined US FDA/pharmaceutical industry regulatory work experience.”

Flowerbudnews learnt that the ”in-country scientists are composed of university professors with greater than 90 years of combined clinical/pharmaceutical research experience, and regulators with over 60 years of NAFDAC regulatory careers.”

The brief on LIDDIE BE also disclosed that the CRO’s top pharmaceutical scientists and administrators are operating with strategic direction, under a seasoned advisory board to provide oversight. It also has Dr Olawale Salami, an international clinical trials expert, as an advisor, who supports the company with his expertise in the design and management of Phase 1 to 4 clinical trials.

”Dr. Salami has overseen over 40 clinical trials, including complex trials, across several therapeutic areas (oncology, infectious diseases, cardiovascular and gynecological diseases),” the brief stated.

It disclosed further:
One component of healthcare that can be reduced substantially is the cost of medicines and this can be achieved by using cheaper, locally produced, and quality generic substitutes of the often more expensive innovator (or brand-named) medicines.

To serve as substitutes, generic products should be bioequivalent or therapeutically equivalent to the commercially available brand (innovator, originator, comparator) product.

The US FDA defines a generic drug as a “medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.”

Flowerbudnews learnt that the African market is dominated by the presence of generic drugs (>80%). Nigeria also controls more than 60% of pharmaceutical manufacturing in the ECOWAS sub-region, serving 300 million people.

Yet, a vast majority of the generic drugs in the Nigerian market do not have BE data. From Nigeria’s NAFDAC sources, at least 50% of drug products registered that are supposed to have BE data do not come with such data.

Specifically, 80% of antivirals, 75% antibiotics and 96% antimalarials are registered without BE data.

Flowerbudnews also learnt that, with the Maturity Level 3 status of NAFDAC and the goal for Maturity Level 4, the Director General had given a directive that BE data has become mandatory for the registration of products that need such data.

The establishment of Liddie BE Limited will play a significant role in achieving the laudable NAFDAC goal and will make available, high quality and safe generic drugs at significantly reduced costs to the government and patients in Nigeria and Sub-Saharan Africa, the statement assured.

It is noteworthy that Liddie BE recently initiated the first bioequivalence study from a local manufacturer sponsor and a Principal Investigator who is a professor of medicine at OAU, Ile Ife.(Flowerbudnews)

 

 

– as Agency Uncovers More Massive Fake Drug Warehouses, Depots in Aba, Onitsha, etc

– 3000 Shops Screened, Sealed In Idumota, 14 truckloads of fake drugs seized in Aba, 10 across Anambra, and more in Onitsha

 

 

By Biola Lawal

FLOWERBUDNEWS: The Director General of the National Agency for Food and Drug Administration and Control, NAFDAC, Prof. Mojisola Adeyeye has declared total war against fake drug peddlers across the country, warning – enough is enough.

Prof. Adeyeye, who gave the charge while speaking on the ongoing NAFDAC Enforcement Operations, disclosed that two more massive warehouses full of fake and expired medicines were uncovered over the weekend in Aba, truckloads in Idumota and Onitsha.

”The goal is to stop the sale of counterfeit, substandard, expired, and rebranded drugs that pose significant health risks to Nigerians with a continued goal to safeguarding the health of Nigerians,” the NAFDAC Boss stated, statement by Sayo Akintola, Resident Media Consultant disclosed.

(NAFDAC Boss, Prof. Adeyeye, herself leading a combined team of NAFDAC Operatives and Security agents on the enforcement operation)

Prof. Adeyeye gave details of the recent NAFDAC successful operations saying:

Last week, the Agency uncovered a major operation depot dealing in expired and falsified drugs at Umumeje village, Osisioma Ngwa area of Abia State where the illegal operation was being run from multiple buildings near the Ariaria International Market.

The expired medicines were repackaged and revalidated for resale, posing a significant health risk to consumers.

Seized items consisted of expired potassium chloride, allergy medications, immune boosters, and cholesterol treatments. Machines used to rebrand and alter expiry dates were also discovered on-site.

The depot was discovered when NAFDAC operatives raided the facility in collaboration with a joint security team as part of the Agency’s intensified crackdown on counterfeit medicines which commenced on Monday.

During the raid, some individuals were arrested, but the prime suspect remains at large. Despite efforts to reach him, he showed no concern for his detained family members.

Later in the week, the NAFDAC enforcement officers and security forces from NSA uncovered another drugs depot at 269 Faulks road, Aba.

During the raids, NAFDAC operatives discovered machines used to rebrand and alter the expiry dates of medications, along with a large quantity of rebagged containers and fraudulent packaging materials.

This operation followed extensive data collection and intelligence gathering, which revealed large-scale repackaging of counterfeit drugs in the market,

At Onitsha, the Agency uncovered and seized fake, expired and falsified drugs (14 trucks loaded) at the Ogbo-Ogwu Bridge Head Market in Onitsha, Anambra State.

The operation, which commenced on Monday, February 10, 2025, has already led to many shop raids, revealing a disturbing volume of adulterated and substandard medications worth billions of naira.

NAFDAC’s investigation highlighted the market as a hub for repackaging and revalidating expired medicines, which are often sold to unsuspecting consumers with fraudulent claims of authenticity.

Also commenting, the Director of NAFDAC’s Southeast Zone, Mr. Martins Iluyomade, said that several containers bearing fake NAFDAC approvals were among the seized drugs.

So far, we have confiscated no fewer than 14 trucks, each carrying a 40-foot container filled with fake, substandard, and adulterated drugs from the market. Some of these drugs even bear fraudulent NAFDAC approval claims, he stated.

‘We detected these fraudulent claims using our scanning and detection machines.’ The seized drugs include expired, banned, substandard, defective, repackaged, and recalled products.’ Iluyomade disclosed

The continued enforcement operation in Lagos, targeted major distributors suspected of supplying counterfeit drugs to pharmacies and hospitals across the state.

In the first week of the enforcement operation, NAFDAC screened and sealed over 3000 shops inside Open Drug Market Idumota in Lagos. Items discovered were vaccines in dilapidated, unventilated rooms sealed with Iron sheets in very filthy environment.

Others were banned products like large consignment of banned Analgin Injections, diverted Free HIV and Retroviral Drugs, expired drugs kept for revalidation, unregistered drugs, etc.

The Agency was able to evacuate illicit Pharmaceuticals of equivalent of 12 trucks.

Furthermore, empty packs of cartons of expired unregistered antimalarial injections were discovered inside a packing shop with the vials removed. Various brands of Codeine Cough Syrup and Tramadol 225 were discovered in a warehouse within the market, away from the pharmaceutical section where other products are sold.

The Director General, Prof Mojisola Adeyeye, however, insisted that the Agency would not rest on its oars until the market is completely sanitised.

She said, ‘enough is enough’, we shall not look away while a few disgruntled elements in society continue to kill unsuspecting consumers through substandard and falsified medicines.

The NAFDAC boss further explained that the extended enforcement operation targets the three major markets simultaneously in Idumota, Onitsha and Aba, which distribute significant percent of medicines in the country.

‘The goal is to stop the sale of counterfeit, substandard, expired, and rebranded drugs that pose significant health risks to Nigerians with a continued goal to safeguarding the health of Nigerians’ (Flowerbudnews)