Consumer Protection: A Legal Examination of Drug Counterfeiting and Adulteration in Nigeria.

ABSTRACT

In recent years, the market has been flooded with fake and adulterated drugs which are injurious to human health. It is noteworthy of the widespread use of Adulterated ‘My Pikin Teething Mixture ‘ which caused the death of many children in Middle November, 2008.

The objective of this study is to fight drug counterfeiting and adulteration at all cost, protect the consumers right to safe products and by proper sensitization of the penalties awaiting those who violate the standards prescribed would deter producers and manufacturers from manufacturing substandard drugs.

This research adopted the doctrinal method of research. It has been found that adulterated drugs have flooded the Nigerian Medical market, Imitation of drugs is on its increase, Non-enforcement of the existing laws guarding drug manufacturing. One of such factors propelling the adulteration of drugs is the high cost of standard and safe drugs.

Thus, it is recommended amongst other things that the existing laws should be enforced, price control of drugs etc. Against this backdrop, this paper tends to examine the legal effects of drug counterfeiting and adulteration in Nigeria.

INTRODUCTION

The World Health Organization (WHO) defines counterfeit drugs as those “that have been deliberately or fraudulently mislabelled with respect to identity and source”. However, Drug counterfeiting means the process of manufacturing substandard drugs with the intention of making profit.

Sale of Adulterated drugs poses a threat to the life of consumers because they may contain dangerous ingredients or lack vital ingredients. This phenomenon is a lucrative crime that has been ravaging the medical market in Nigeria. The circulation of substandard medicines in Nigeria is serious and of public health concern. Despite the severity and consequences this act may result in, it is still on the increase daily.

This concept of drug counterfeiting is under-reported in Nigeria. Hence, its rapid increase. In addition, up to 169,271 deaths are linked to falsified and substandard antibiotics used to treat severe pneumonia in children. Recent alerts from the National Agency for Food and Drug Administration and Control warn of adulterated cough syrups, antibiotics and other children’s remedies in the market.

Counterfeit drugs are a deadly and growing problem globally, particularly in developing nations where supply chain security is limited, undermining progress towards meeting the UN’s Sustainable Development Goals. Nigeria’s case is dire.

Substandard and falsified medicines have become a global problem that presents enormous public health challenges to National Medicines Regulatory Authorities, in both developed and developing countries. This cankerworm which has eaten deep into the society propels incessant deaths resulting from the consumption of these drugs. Such acts of Adulteration run contrary to consumer protection laws.

This research piece aims at tackling this age-old problem by examining drug counterfeiting in relation to consumer protection. In the course of this work we shall be analyzing laws which provide a cover and right of redress to the consumers.

What is Consumer Protection

Consumer Protection is the process of protecting consumers from the consumption of unsafe products injurious to their health. Felicia Monye[1] defined consumer protection as the act of safeguarding the interests of the consumer in matters relating to the supply of goods and services, fraudulent and hazardous practices as well as environmental degradation.

On the other hand, Consumer Protection Laws are the legal framework aimed at penalizing producers/Manufacturers, Wholesalers and Retailers who trade on unsafe products.

What is Drug counterfeiting

Drug counterfeiting is the act or process of producing fake drugs in an appearance of genuine drugs, in order to deceive consumers and to gain profit. It means the influx of substandard drugs into the drug market where the fake drugs are sold at a lower price to make profits.

In this act of counterfeiting,  people with low means of livelihood resort to the substandard drugs due to its cheapness in price not minding that it could be a substandard drug. However, this phenomenon is not only a crime but it is unethical for pharmaceutical companies to indulge in such.

What is Drug Adulteration

Drug Adulteration means when any substance other than that which the drug purports to be, is mixed with or added to or placed upon it, either to increase the bulk or weight or apparent size of the article or to give it a deceptive appearance.

Drug Adulteration may occur in different ways like the addition of some extraneous substances, the abstraction of some compositional ingredients, failure to comply with the prescribed standard or the substitution of inferior ingredients for superior ones. It is not necessary that the adulterated product should be injurious to health for an offense to be committed. it is sufficient if the product contains substances or ingredients which ought not to be there.

Adulteration also means the act of mixing a product intended for sale with any substance or ingredient, which is injurious to health or which reduces or alters the quality or character of the product so represented.

Drug Adulteration is synonymous to Drug counterfeiting in the sense that the end result is an injury to human health.

Legal Framework Against Drug Counterfeiting and Adulteration in nigeria.

In Nigeria the Principal Act prohibiting the sale of adulterated and counterfeit drugs is the Counterfeit and Fake drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Act, 2004.

This Act is clear in its provisions in Section 1 which provides;

Any Person who

a) produces, imports, manufactures, sells, distributes or is in possession of, or

b) sells or display for the purpose of sale,  or

c) aids or abets any person to produce, import, manufacture, sell, distribute or display for the purpose of sale, any counterfeit, adulterated, banned or fake, substandard or expired drug or unwholesome processed food, in any form whatsoever, commits an offense under this Act and shall, accordingly, be punished as specified in this Act.

Thus, Section 3 of the above act provides for penalty of fine not exceeding #500,000 or imprisonment for a term not less than five years or more than fifteen years or to both such fine and imprisonment.

This concept is however not without a judicial authority as the court in the case of Eromosele v. FRN where the Court of Appeal reaffirmed the conviction of the Appellant for having sold dangerous drug with name “My Pikin Baby Teething Mixture” to Roca Pharmacy contrary to section 1(18)(a) of the Miscellaneous Offences Act, Cap. M17, Laws of the Federation of Nigeria,2004 and punishable under section 1(18) (a)(ii); 1(18),(b)(ii) and 3 of the same Act.

The facts of the case are below;

Sometime in the middle of November, 2008, some children died after taking a syrup called “My Pikin” manufactured by Barewa Pharmaceutical Industries Ltd. Preliminary investigation by NAFDAC officials revealed that the drug that was common to all the children that died was “My Pikin” syrup.

All the children had the same symptom of renal failure characterized by the inability to pass urine. NAFDAC officials purchased random samples of “My Pikin” syrup off the shelf which were sent to the laboratory for analysis. With the first result from the laboratory, they went to Barewa Pharmaceutical Industries Ltd and sealed it up.

NAFDAC officers nationwide had to mop up all “My Pikin” syrup irrespective of batch, even though the laboratory result was for batch No.02008. The laboratory result indicated contamination with a deadly chemical called Diethylene Glycol (antifreeze). Barewa Pharmaceutical Industries Ltd was directed to mandate their distributors to withdraw all batches of the syrup in their possession.

A team of inspectors went to Barewa Pharmaceutical Industries Ltd. It was at this visit that NAFDAC officers established some facts. First the contaminated batch 02008 was produced around the time that a school certificate holder purchased for the company a keg of that Diethylene Glycol wrongly labeled propylene Glycol.

It was also established that the Quality Control Officer did not carry out the mandatory identification test for all the raw materials before production as required by law. It was discovered that the Production Manager went ahead to produce batch 02008 with only a verbal clearance from the Quality Control Officer. Several other violations were documented in their final report.

Consequently, the appellant and two others, including the Barewa Pharmaceuticals Ltd, were charged to court for the offenses of manufacturing, distributing, selling and adulterating a drug known as “My Pikin Baby Teething Mixture”and for conspiracy under the provisions of the Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous provisions) Act, Cap. C34, Laws of the Federation of Nigeria,2004.

In its judgment delivered on 17/05/13, the trial court discharged and acquitted the appellant and the two other accused persons on counts 1, 2, 5 and 6 but convicted them on counts 3 and 4. They were sentenced to seven years imprisonment on each of counts 3 and 4, with the terms to run concurrently. The court also ordered that the assets of the 3rd accused Barewa Pharmaceuticals Ltd be wound up and forfeited to the Federal Government of Nigeria.

S.1(18)(a)(ii) of the Miscellaneous Offences Act for which the appellants were convicted states as follows:

“Any person who –

deals in, sells, offers for sale or otherwise exposes for sale any petroleum product, food, drink, drug, medical preparation or manufactured product which is not of the quality, substance, nature or efficacy expected of the product, or is not of the quality, substance, nature or efficacy which the seller represents it to be, or has in any way been rendered or has become noxious, dangerous or unfit,shall be guilty of an offense and liable on conviction to imprisonment for a term not exceeding ten years”

It is imperative to note the ingredients of this offense to which the appellant was charged.

1. Proof that the drug was contaminated

2. Proof that the appellant sold the adulterated drug

3. Proof that the product is not of the quality, expected of the product or is not of the quality, substance, nature or efficacy which the seller represents it to be, or has in any way been rendered or has become noxious,dangerous or unfit.

The Federal High Court has the exclusive jurisdiction to try offenses bordering on Counterfeit and Fake drug offenses.

How Counterfeit and ADULTERATED Drugs Enter the market.

Manufacturers

The first link in the drug supply chain is the manufacturer. Here is the most common place for a counterfeit drug or ingredient to enter circulation, as there are many different ways for drugs to be counterfeit. The ingredients could be wrong, in the wrong dosage, or just completely missing. Sometimes the wrong drug ends up in bottles, and sometimes placebos are sold instead of actual medicines.

A counterfeit manufacturer can be a small lab or a huge factory operation. Often, they produce and package fake medicines to look like real ones, and to most people they are indistinguishable. Quality control is incredibly important here, as it protects patients later on down the line. While legitimate manufacturers will have their own QA divisions, counterfeit operations will lie about their credentials to distributors.

Distributors

Now, it doesn’t help the counterfeiters if they make the medicine and can’t sell it. In many countries, the manufacturer does not sell to anyone but a distribution company (and a few other entities, such as government programs and labs), so distribution networks need to be set up to ensure that the fake goods take the place of real ones.

Sometimes, these operations are incredibly sophisticated, using tracking technologies to infiltrate existing legitimate networks in places where security isn’t as tight or barcode scams that take advantage of delays in mass scans. Sometimes, these operations are incredibly simple, on the level of just shipping the drugs to a pharmacy and getting paid for them, regardless of what the product is or where it came from. There are many ways that drugs can enter between the manufacturer and the distributor, or the distributor and the pharmacy.

Pharmacies

The pharmacy is the crux of the problem. Chances are if you go to a local pharmacy or a large retail chain, and buy name brand (or even store brand) drugs, you’ll be getting the real deal. However, patients are increasingly turning to online pharmacies to buy medicine, as the prices can be vastly lower than the list price. Often, the drugs bought from online pharmacies will come from different countries, with promises that the label might look strange, but the medicine is the same. And sometimes it is! But most of the time it isn’t.

Thanks to the rising cost of pharmaceutical products around the world, patients will risk buying counterfeit medicines because they often can’t afford required drugs. Online pharmacies, especially ones based in countries with loose regulations, have every incentive to sell an inferior or counterfeit product, as the profit is still immense. Governments shut down online pharmacies all the time, but they keep springing up, as there is a worldwide demand for cheaper drugs.

Methods of detecting counterfeit and Adulterated Drugs.

It is thought-provoking on how to identify substandard drugs by an average consumer and also how to ascertain the genuineness of a drug. In some cases, fake and adulterated drugs may present striking resemblance with genuine brands to the extent that the most cautious consumer may be deceived. However, some suggestions have been proffered by some experts.

Osibo  writes that if the label or package of a drug does not contain information such as batch number, name and address of the manufacturer, the drug should be shunned because if the need arises for its production history, the manufacturer may not be traced. Such omissions are clear evidence of the doubtful integrity of the manufacturer.

Thus, any discrepancy in the label should put the consumer on the alert. For instance, if the drug is in tablet form and the word capsule is used on the label, the consumer should not purchase it as the discrepancy portrays the fake manufacturer’s ignorance.

Obi and Okoro observe that the packaging of fake drugs may be poor and of low quality. The pack may not close firmly and may allow contents to slip off. It is also observed that genuine drugs have their batch numbers and expiry dates printed on the packets or labels. Other modes identified by the authors include taste, nature of packs (e.g, blister packs), texture as well as inadequate, unprofessional, inconsistent or misleading information on the label and inserts.

CONCLUSION AND RECOMMENDATIONS

This thought-provoking phenomenon has considerably been dealt with in this research piece. On the same vein Drug counterfeiting and adulteration in the midst of the economic hardship in the country is fast increasing, despite the extant laws aimed at fighting it.

It is worthwhile stating that standard and genuine drugs are getting more costly day by day as average citizens and consumers become tempted to purchase substandard drugs due to its low price not minding the quality and its standardization.

It is recommended inter alia that the silent extant laws be activated to fight this cankerworm, the price control act should be resurrected for the control of the prices tagged on products/drugs, there should be adequate quality control of product in manufacturing companies to be supervised by the quality control officer.

Before the purchase and consumption of drugs by the consumers, there should be a proper scrutiny of the label to ensure that the drug meets up with the requirements of a standard product.

REFERENCES

1. F. Monye, Law of Consumer Protection(Ibadan: Spectrum Books Ltd; 2005), pp.15-20.

2.ibid

3.  [2017]1 NWLR (Pt. 1545 )55

4. D. Osibo, Spurious Drugs: Reading Between the Lines (Lagos: Lanpharm Laboratories and Scientific Service Ltd; 1990), pp.5-24

5. C.C. Obi, and R. Okoro, Current Guide to Good Pharmaceutical Wholesaling in Nigeria, (Lagos: Chris & Robins Nigeria 1992), pp. 54-55.

About the Author 

Okeke Chukwuemeka C

Law Student of Chukwuemeka Odumegwu Ojukwu, University Igbariam. Anambra State

Law enthusiast , Avid writer and a Legal researcher.