Generic Medicine Quality: Breaking Down The Myths With Industry Facts

When healthcare industry stakeholders are offered generic drugs that cost much less than the innovator, they immediately have quality concerns. The market has widespread misbelief that original or innovative drugs are always better. However, safety data and research do not show that. Generics are, at least, as good as innovators, or even better, yet they cost multiple times less.

This belief that generic may be inferior in some respect is ill-founded, based on insufficient information and even wrongly held belief systems. The truth is that generic medicine producers often must undergo extreme regulatory processes before they can produce their medications.

What are generic medicines?

Generics are medications produced once the patent that belongs to the company that first commercialized the drug has expired. Generic medicines need to be of the same dosage and quality as the original drug. Hence, when generics apply for registration in the manufacturing country, they are tested against the innovator drugs.

As a rule, generics must be either be similar to the innovator in almost all aspects. This also includes the level of impurities, stability,  and so on. Furthermore, since generics might use slightly different kinds of excipients, they often have to undergo pharmacological equivalence testing and provide bioequivalence data.

This ensures that generics are not just chemically similar to the innovators but also biologically the same. Hence, generics are not inferior to innovators in any conceivable aspect except despite the lower cost.

Generics might be sold as branded generics, or manufacturers may use International Nonproprietary Names (INN). Thus, for example, omeprazole was first launched as Losec in Sweden. However, drugs like Omez by Dr. Reddy are an example of branded generics. Whereas many other manufacturers sell it under the INN, that is, omeprazole. Generally, non-branded generics are slightly cheaper than branded ones, as branding often means additional investments.

Top 3 Myths about Generic Medicines

Before we look deeper into how the quality of generics is ensured in one of the largest generics-producing nations in the world, that is India, let us look at some of the common myths surrounding Generics and Innovators.

Myth 1: Generics are always of inferior quality

The quality of medicine depends on how it is produced and how extensively it is tested. Terms generics or innovator are rather legal terms and not representative of the product quality. Moreover, once the patent is over, most manufacturers source APIs from the same handful of companies.

In fact, after the patent is over, many multinationals stop in-house manufacturing their products altogether for cost savings. Since once the patent is over, the secrecy surrounding the technology is not a concern anymore.

Hence, when it comes to the quality of products, deciding factors are COA, EU GMP, US FDA approvals, WHO GMP, and so on.

Myth 2: The innovator is the company that invented or first made the product

It is one of the biggest secrets of innovators. They rarely take part in creating the product. In fact, most of the innovators or companies holding the patent have also sourced the technology from other smaller firms specializing in R&D.

Thus, for example, Nycomed (now part of Takeda) often describes itself as an innovator of Pantoprazole. However, this is far from true. A small German company, Altana, first created Pantoprazole, and Nycomed acquired the rights to sell the product first. This is often true for most products. It just confirms that the terms like innovator or generics are just legal terms and do not necessarily indicate innovation or product quality.

Myth 3: Generics are not as extensively tested

Basically, just the opposite is true. Generics are generally more extensively tested. Moreover, it is worth understanding that generics are also supported by post-marketing data. Generics are only introduced in the market once there is sufficient proof of the safety and efficacy of any given product.

Factors Ensuring Quality of Generics

Below are a few factors ensuring that generics are of the highest possible quality.

Regulatory oversight

India is not merely a generics manufacturing hub but also among the most well-regulated pharmaceutical markets. Apart from Central Drugs Standard Control Organization (CDSCO), many generics producers in India have US FDA and EU GMP approvals.

In fact, India has the largest number of US FDA-approved facilities outside the US and the largest number of EU GMP-approved facilities outside the EU! These numbers themselves speak of the quality. India has so many US FDA-approved drugs that US FDA even opened its representative office in India in 2008.

Bioequivalence to ensure the highest quality

Many generics in India are tested for pharma equivalence and bioequivalence. It means that these drugs are not just shown to be good in lab tests. Instead, bioequivalence studies ensure that generics act in the human body similarly to original drugs, thus having similar safety and efficacy.

Cost-Efficiency Doesn’t Mean Lower Quality

The primary reason for buying generics remains their lower cost. But, these lower costs do not suggest lower quality. These costs are lower since generics producers spend much less on R&D. However, more importantly, the lower cost of generics is explained by the falling price of APIs over time. Once the patent is over, APIs become much more affordable, resulting in a steep decline in drug manufacturing costs.

Even developed markets are increasingly relying on generics as they realize their benefits. Thus, in 2005, one-third of drugs in Japan were generics. However, in 2021, almost 80% of all medications in Japan were generics.

The picture is no different in EU member states, where, in any given country, 40%-70% of all medications are generics now. So, yes, generics dominate even developed markets, too.

Transparency in production

Most reputable generics manufacturers are quite transparent and are always ready to share information about quality management, various documents confirming the quality of products from COA to information about various approvals. Not only that, many manufacturers even welcome visitors and are happy to show their manufacturing facilities to the regulatory bodies, representatives of the nations, and even the managers of commercial organizations.

Bottom line

Outsourcing high-quality generics that do not compromise on quality and are by no means inferior to innovator drugs is not challenging. These drugs are safe, effective, and cost-effective alternatives to the more popular, costly innovator drugs. However, when procuring generics, it is always good to ask the suppliers for specific documents confirming the quality of the products. It is vital to differentiate high-quality and well-tested generics from those not essentially produced by following the highest standards.

If you have any concerns or questions regarding the quality of generics supplied by our company, please do not hesitate to contact us.