Generic medicine meaning – secrets revealed

Posted On January 21, 2021November 21, 2021

Overview

This article gives complete information on generic medicine meaning in the pharmacy and pharma industry. 

Can you find anyone who has not taken any single medicine in his entire life?

Not possible!

Everyone must have taken medicine, either generic or branded. Everyone wants reasonable and affordable medicines without compromising quality.

When you visit a hospital or clinic. Your doctor prescribes branded medicines. You take the prescription and go to a drug store. The pharmacist offers you alternate brands (generic medicines) of the same branded medicine, which are inexpensive.

Now, you must be having some doubts in your mind, and several questions arise quite often –

What is generic medicine mean?

Which medicines are generic?

What is the difference between generic medicine and normal medicine?

Are they different from branded drugs?

Is generic medicine good or bad?

Do they have appropriate quality?

Are generic medicines take time to work?

There is a lot of misconception and confusion about generic medicine meaning in society. Being a pharmacist, I want to clear your doubts.

If you want to get complete information about generic medicines. Keep reading this article.

So, let’s start this fastidious topic with a simple question –

What is the meaning of generic medicine?

Generic medicines are an exact copy of innovator medicine (patented medicine or branded medicine). It is just like a copy and pastes in your computer keys –

Ctrl + C (Branded) = Ctrl + V (Generic)

However, generic medicines are supposed to be bioequivalent which they work in the body the same way as branded medicines in terms of

• safety
• efficacy
• quality
• strength
• same active ingredients
• dosage

But, generic medicines may differ in excipients (inactive ingredients), appearance, packaging, color, shape, flavor, and price.

How to identify generic drugs?

If you take medicines from great pharmaceutical companies like Cipla, sun pharma, lupin, Glenmark, etc. You will be thinking these are branded. But these are not purely branded.

Ok. Let me explain to you.

Branded medicine 

If any new medicine discover. It requires 2.9 billion dollars of investment and extensive research. So, it is not a cup of tea for everyone.

The pharmaceutical company has the right to set its own price to recover the investment. These are protected by patents for around 20 years.

During its patent time, no one could manufacture the same medicine. That is the reason these medicines are costly. So, they are known as “Branded medicine.” You may say “Innovator medicine” or “Patented medicine.”

For example – Diclofenac is a popular medicine that is used to treat pain and inflammation. It was patented by Novartis in 1965 (previously Ciba-Geigy). It was sold in the market under the brand name “Voltaren.”

Branded generic medicine 

After a long time, when the patent expires, many generic pharmaceutical companies make a copy of the same active ingredients.

They don’t require to do extensive research like preclinical or clinical trials. But they need approval from regulatory authorities like US-FDA (or other country’s regulations). These companies submit abbreviated new drug application (ANDA), which contains data.

Once US-FDA satisfies all the criteria, then they get approval and manufacture the medicines.

These medicines are known as “Branded generic medicine.” The price of these medicines may differ because many manufacturers make the same active ingredients with different trade names.

Let’s take the same example of diclofenac. Diclofenac medicine is manufactured by various pharmaceutical companies at different prices like –

• Activa 50 by Zydus cadila, Price = Rs. 69 (10 tablets)
• Dynapar EC 50 by Troikaa Pharmaceuticals Ltd, Price = Rs. 20 (10 tablets)
• Reactin 50 by Cipla Ltd, Price = Rs. 21 (10 tablets)
• Voltaflam 50 by Novartis India Ltd, Price = Rs. 22 (10 tablets)
• Vorik 50 by Glenmark Pharmaceutical Ltd, Price = Rs. 65 (10 tablets)

Non-branded generic medicine 

In India, a certain manufacturer makes essential medicines at low cost and supplies them to government hospitals, dispensaries, and generic medicine stores like “Jan Aushadhi.” 

These medicines do not have a brand name or trade name. They are known for being the active ingredients of the drug. 

For example, suppose a company sells diclofenac salt with the same name. In that case, it will be called “Non-branded generic medicine” or “Hospital generics.”

Other non-branded generic medicine examples are – 

So, there are two types of generic medicines – branded generic and unbranded generic. On the other side, we have branded medicine or patent medicine.

Hence, all three medicines (branded, branded, and non-branded generic) are safe, effective, and of good quality. They are manufactured by standard guidelines GMP (Good Manufacturing Practice).

What are the exact differences between generic medicine and standard (branded) medicine? 

The following table shows some significant differences among branded drug, branded generic medicine, and non-branded generic medicine

Lipitor (Atorvastatin) was on the market by 1996. During its patent period, the cost of 30 tablets of Lipitor (Atorvastatin 20mg) was around $183 in the US. 

After the patent expiration (30 November 2011) of Atorvastatin, many generic companies manufactured Atorvastatin.

List of generic companies manufactured Atorvastatin under various brand names at different prices –

• Atorva 20 manufactured by Zydus Cadila (Price Rs. 162/- strip of 10 tabs.)
• Storvas-10 manufactured by Sun Pharma (Price Rs. 69/- strip of 15 tabs.) 
• Tonact 40 manufactured by Lupin (Price Rs. 243/- strip of 15 tabs.)
• Atchol 10 manufactured by Aristo Pharmaceutical Ltd. (Price Rs. 18/- strip of 10 tabs.)
• Lipikind 10 manufactured by Mankind Pharma Ltd. (Price Rs. 28/- strip of 15 tabs.)
• Lipvas 10 manufactured by Cipla Ltd. (Price Rs. 46/- strip of 10 tabs.)

Pfizer also makes its own generic version under the brand name Zarator.

Why are generic drugs cheaper?

There are three big reasons which make generic drugs affordable –

• Firstly, generic medicine companies are generally not required to do original research and development like preclinical trials (animal studies) and clinical trials (human studies) that are required for branded medicines.
• Secondly, they do not need to waste money on advertising because they are well-established and frequently used medications.
• Thirdly, and most importantly, there is enormous competition among pharmaceutical manufacturers, which helps lower prices. The cost may vary between 30 to 95% than branded medicines.

Do generic medicines work?

You must be having concern about the safety and efficacy of generic medicines.

But you do not need to worry.

According to the FDA, all pharmaceutical companies adhere to international standards. They manufacture medicines according to Schedule – M, i.e., GMP (Good Manufacturing Practices).

Generally, generic medicines should be bioequivalent. They need to do bioavailability (BA) and bioequivalence (BE) studies to make the medicine equivalent to branded medicine.

So, generic drugs have the same effect as branded drugs. It provides the same clinical effects and pharmacological effects.

What are the major concerns of generic medicine in the pharma industry?

India is the global powerhouse of generic medicines. They export a huge number of generic medicines in various countries like the US, Spain, Germany, Europe, Bangladesh, Nepal, etc. So, India is also known as the “Pharmacy of the World.”

India has a unique position in terms of generic medicines, which provide low-cost medication throughout the world. 

Ideally, generic medicines should be similar to the originator product (patent medicine).

• These medicines should be regulated appropriately and manufactured in a sterile environment by International Standard guidelines.
• They must be pharmaceutically interchangeable and bioequivalent to the patent product to ensure the therapeutic efficacy of generic medicines.
• They should work in the same way as patented drugs.

But in 2019, a book published, “Bottle of Lies,” was written by a famous American journalist and author Katherine Eban.

In this book, she has discussed the Ranbaxy scandal. She reveals how Ranbaxy committed fraud and potentially harmed patients on a global scale.

They supplied low-quality generic medicines in the US. They also made manipulated data that were required for filling NDA and ANDA approval for US-FDA.

Later on, they pleaded guilty to selling adulterated drugs. Eventually, they charged $500 million to US authorities.

This is not the only story of Ranbaxy pharmaceutical. Many generic pharmaceutical companies take shortcuts in the manufacturing process. They don’t follow the compliance of GMP (Good Manufacturing Practice).

That’s why sometimes we get spurious or substandard medicine.

Since 2016, there have been clear-cut guidelines for pharmaceutical companies to follow standard procedures. There should be a 90% CI (confidence interval) during bioequivalence (BE) studies.

The 90% CI is acceptance criteria in statistics. If a 90% result comes, it concludes all pharmacokinetic parameters like AUC (Area Under the Curve) and Cmax lie between 80% to 125%. It will be no difference between the two treatments (generic drug and brand drug).

Conclusion

I have provided a clear picture of generic medicines.

Now, you have clarity about branded and generic medicine meaning.

In conclusion, generic medicines are really cost-effective. They are equally safe and effective as brand medicine if manufactured under proper international guidelines.

I hope you would have found this post (generic medicine meaning) to be informative. Share it on social media to spread awareness.

References 

1. Swain et al. Pharma Regulations for Generic Drug Products in India and US. Pharmaceut Reg Affairs 2014, 3:2

2. S.S. Joshi. Generic drugs – the Indian scenario. J Postgrad Med. 2019 Apr-Jun; 65(2): 67–69.

3. Aria A. Razmaria. Generic Drugs. JAMA. 2016;315(24):2746

4. The inside story of Ranbaxy’s dirty drugs scandal. Telegraph

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