The Epidemic of Adulterated Drugs in Indian Market

Adulteration is the contamination of a product with substances that alters its characteristics. It generally has a negative connotation as adulteration of a substance usually makes it lose its beneficial qualities or at least diminishes them. So, what does adulteration of drugs mean? The definition of drugs is given in s.3(a) of the Drugs and Cosmetics Act, 1940. Adulterated drug is defined in s.9A of the Act as:

Adulterated drugs.— a drug shall be deemed to be adulterated.—

• if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or

• if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health;

• if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

• if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or

• if it contains any harmful or toxic substance which may render it injurious to health; or (f) if any substance has been mixed therewith so as to reduce its quality or strength.

While adulteration of drugs is the process by which the purity of a drug is compromised, the eventual product of such adulteration is a counterfeit drug i.e. a drug that is that is claiming to be something that it is not and the industry that produces such adulterated drugs or medicines is called the counterfeit drug industry.

Adulteration or contamination of drugs can be of two major types:¹

1. Intentional Adulteration– This is the most common type of adulteration in which low standard drugs, which are morphologically and chemically similar to the crude drug, are mixed with it. It involves either contamination with superficially similar but therapeutically inferior drugs, which may not have the same effects of the original drug or mixing with synthetically produced products which resemble the original drug.²

2. Unintentional Adulteration– This might happen when drugs are produced in low-cost environments in unhygienic conditions, where air, humidity or air- borne organisms might pollute the medicines being manufactured there.³

It cannot be said that there is no general consensus that adulterated and counterfeit drugs pose a huge threat to the global health space. Yet, the counterfeit drug industry continues to grow by the day. What makes this industry to profitable?

The core answer lies in the inequalities in the access to wealth and healthcare, whether be it between the west and the global south or be it in a single nation or state itself. These drugs are produced at a much lower cost than genuine medicines, making them attractive to a huge population of people who cannot afford the expensive medicines.⁴ The resultant huge profit margins that these drugs have over the standardized ones, makes it an extremely profitable business involving minimum input costs. As a result, the developing countries have come to house huge drug counterfeiting businesses.⁵ India haemerged as the world’s 4^th largest producer of drugs by volume. Substandard or illegal drugs accounts for 20% of medicines available in major Indian markets.⁶

But, other than this core issue, there are other ancillary reasons as well, which encourages the proliferation of this industry.

Secondary Reasons for Expansion of Counterfeit Drug Industry

1. Internet commerce– The proliferation of online sites delivering medicines without the need of prescriptions and at comparatively affordable prices has been one of the causes at the forefront of the expansion of this trade.

2. Drug shortages– A high demand for drugs for the growing population creates supply Without any other alternative, people and even medical professionals look beyond the secure supply chain to obtain medicines. These supply chains are often the ones that are used by the counterfeit drug syndicates to transport their drugs all over the country as well to other countries.

3. The distribution of adulterated drugs is not just perpetrated by bad Often, well intentioned NGOs distributing drugs to the developing countries also contribute to the problem. Given their limited economic resources, they often procure copy drugs from China and India⁷. Most of these copy drugs might not be fatal and might just be copies of their more expensive foreign products, meant to bypass the patent laws. But, there have also been numerous cases where the distribution of mass drugs by philanthropic organizations have resulted in cases of mass scale deaths or side effects due to the consumption of the improperly manufactured and tested drugs.

Effects of Adulterated Drugs on Consumers and the State

1. Public heath– Drugs can kill directly if they have heavy metals, bacterial , fungal or other contamination.⁸ Drugs which have the actual active compounds in much lesser quantities than is needed to effectively treat the disease, can lead to antimicrobial resistance in the long term.⁹ As is said, “ What does not kill a microbe, only makes it stronger.”¹⁰ As many as one million people die every year from taking these fake medicines, especially in the developing countries.¹¹ Additionally, the adulterants give rise to unwanted side-effects and allergies in patients as the actual ingredients are not mentioned in the packaging, due to which the consumer does not have any idea of what they are consuming. These drugs also lead to acceleration of a condition to an incurable level, something which could have been easily prevented by using appropriate drugs at the initial stages.¹²

2. Health inequality between the Global North and the Global South– The developing world or the Global South is both the region of production of adulterated drugs as well as the main consumer base for these. Since this region is marred with extreme poverty, people depend on these adulterated drugs as a replacement for the more costlier originals¹³. This leads to a vicious circle of them falling sick due to the consumption of spurious drugs and then relying on another set of adulterated drugs to treat the symptoms, thus hindering the process of development of modern medicines and pharmaceutical industries in the South due to minimal demand and therefore their further alienation from access to proper modern medicines.¹⁴

3. Search for replacements in the developing countries– The undesirable side effects and no therapeutic value of the counterfeit drugs causes a loss in confidence of the developing countries in modern medicines, guiding them back to traditional and herbal alternatives¹⁵, like ayurveda in India. But, where is the guarantee that these traditional medicines would be free from any kind of adulteration?

To take a case, most of the ayurvedic medicines have their references to old scripts written in a language which is not determinantly understood today and has various regional interpretations.¹⁶ This causes a confusion as to which product does the script actually refers to, giving rise to the use of wrong products for the production of the ayurvedic medicines. Adding to these, due to the loss of substantive biodiversity over the years, many of the plant species mentioned in the manuscripts have been lost. To make up for these losses, many manufacturers use substitute products which either do not have any therapeutic value or gives rise of symptoms not considered.¹⁷ Also, the problem of heavy metal pesticides being used for farming , which eventually causes soil and water pollution, thus affecting the metal composition of various herba and plants cannot be ignored while talking about the safety and efficacy of herbal medicines.¹⁸

4. Squandered health resources– This consequence arises because the counterfeiting business today is not just restricted to dingy slums and small shady In fact, even well-known pharmaceutical companies are involved in adulteration of drugs¹⁹, to make them more competitive. These corporations receive a hefty portion of the health budget to spend on research and development of new drugs and for manufacturing drugs to meet the growing demand. By using that money to create profits while also producing spurious medicines , they steal scarce resources of the health sector of the country while also reducing access to efficacious treatments and legitimate drug supplies.²⁰

5. Burden on the Public Exchequer– Economic burden due to counterfeiting of drugs takes primarily three forms: Firstly, the loss of tax revenues from the companies producing the counterfeits²¹. The difference between the cost of manufacturing of counterfeits and original drugs is not taxed. Loss of revenue also comes from the citizens who suffer after consuming the adulterated They get out of the workforce and consequently their income falls below the taxable slab. Secondly, as the fear of counterfeit drugs polluting the market spreads, additional regulatory mechanisms are set up by the government, leading to additional expenditure.²² The increased expenditure on healthcare to mitigate the effects produced by the adulterated drugs is the third pillar of expenditure for the government.²³

There is another aspect of cost that the government has to bear as a result of the proliferation of the counterfeit drug industry. This damage, the damage to the reputation of drugs²⁴ produced by certain companied registered in a particular company might not have any immediate economic ramifications, but in the long run, it might affect the export of drugs from the country, thus affecting the revenue income from such exports.

Laws Dealing With Adulterated Drugs in India

1. Section 274 IPC, 1860 states that, Whoever adulterates any drug or medical preparation in such a manner as to lessen the efficacy or change the operation of such drug or medical preparation

, or to make it noxious, intending that it shall be sold or used for , or knowing it to be likely that it will be sold or used for , any medical purpose, as if it had not undergone such adulteration, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both.

2. The Drugs and cosmetics Act, 1940 deals with the prohibition of manufacture and sale of certain drugs. The whole act in itself is very comprehensive. It contains chapters relating to manufacture and import of adulterated drugs involving ayurvedic medicines, provides a list of the regulatory authorities along with a chapter on offences and penalties under the act.

3. Drugs and Cosmetics Rules, 1945 is a derivation of the Drugs and Cosmetics Act, 1940. It provides for storage, labelling, display, sale and prescription of medicines.

4. Drugs Control Act, 1950 provides for the sale, supply and distribution of drugs. It also gives the dealers and manufacturers instructions on determination of maximum price for drugs.

Other than these statutory provisions, the Central Drug Standard Control Organization is the apex regulatory body that controls the licensing of medical products and vaccines, the approval of new drugs and clinical trials , test of new drugs being introduced in the market as well as the oversight and market surveillance with the help of the appropriate state authorities.

So, the question remains, despite having such comprehensive provisions in multiple statutes dealing with standards of medicines, procurement of licenses and offences and penalties associated with the production of drugs, why is India one of the major markets of adulterated drugs? Why is counterfeit drug production so difficult to regulate despite having a centralized regulatory body in place?

To start off, the first stage of reaching a solution to a problem is the acknowledgment that the problem actually exists. The Indian government strongly denies that adulterated drugs are a problem in this country.²⁵ Government figures claim that counterfeit medicines account for only 0.4% of the drug market. This value is largely understated. WHO says that the rate of fake drugs in the Indian market is close to 20%²⁶.

Alleging corruption in the supply networks and wilful government ignorance²⁷ as the reasons behind these inefficiencies might seem like over simplifying, but these are the foremost reasons behind the inefficiencies of the regulatory authorities in the application of the law. The other reason would be the abysmal state of public health systems in this country. Marred with chronologically low funds, public health institutions often either do not have the required medicines needed to treat the patients, thus recommending them to get them from elsewhere. It is not difficult to understand, that the people depending on public health institutions often do not have the resources to access expensive medicines from private pharmacies and so, have to depend on the less expensive fakes or substitutes available in the market. There is another possibility, that the shortage of funds may force these hospitals to avail cheaper alternatives from alternate supply chains.

The availability of drugs online has exacerbated this problem. Medicines are available without the need of a prescription from a doctor. Additionally, the supply chain of these online platforms cannot always be verified, making them the preferred method for distribution of adulterated drugs nowadays.

Added to all the above reasons, the fundamental lack of technologies to guarantee product standards in developing countries like India,²⁸ hinders product safety and their traceability.

Recommendations

1. There is an urgent need for consumer education²⁹. Most people do not have enough idea about the prevalence of fake drugs in the Also, there is a need to inculcate the habit of reading the ingredients on the back of the medicines before buying them. Ingredients

must be printed in English as well as local languages so as to make them more accessible to a wide range of the consumer base.

2. Clearly defined supply chains involving legitimate pharmaceutical companies, NGOs and qualified local distributors are essential to ensure that poor populations have access to affordable and quality medicines³⁰.

3. There is also a need to provide the public health institutions with an increased budget, so that they do not have to turn down patients due to unavailability of medicines or take the help of alternate supply chains to procure medicines at cheaper rates.

4. The government should also set up strong and efficient audit mechanisms for all the pharmaceutical companies which receive money from the government for development of drugs. The knowledge that they would be held accountable for the government resources that they are spending on development of drugs would act as a deterrent against the use of the precious resources for making profits by manufacturing low-quality or contaminated

Conclusion

Adulteration of drugs is a public health emergency of the highest order and must be curtailed before it can claim more lives than it already has. Every country, be it a developed or a developing one, has a responsibility towards the consumers of the world to ensure that they put in mechanisms to nip the industry while it continues to spread its tentacles. A collaborative effort is needed to overcome this problem, but the initial steps have to be taken on home ground itself.

India’s capacity to develop low-cost drugs have been misappropriated to produce adulterated and spurious medicines, thus posing a huge health risk to its huge consumer base, both at home and abroad. What has to be kept in mind is that, the capabilities that India has shown in producing affordable drugs has been appreciated by many developing countries as it has made available drugs to treat diseases prevalent in the developing world, which would otherwise be very expensive to procure from the developed countries. India is the hub of producing medicines which are patented under TRIPS, but have been exempted from being otherwise manufactured for better access to the third-world countries.

As the world has trusted us with giving them access to affordable medicines without any compromise to its efficiency, it is our responsibility to ensure that our drugs pass every standard test and that out capabilities are not exploited for monetary gain by the counterfeit drug industry.