Drug withdrawal

Drug withdrawal from the market: How and Why?

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I hope, recently you may have heard the news about drug withdrawal from the Indian market.

If you do a deep research, then you will find that these medicines were so harmful for us. Withdrawn medicines were having more adverse events/side effects than its benefit.

But, the big question is, why Drug withdrawal needed and on which basis authorities analyse it?

In this article we will discuss how government and authorities analyzes it, how they collect various data and why these medicines need to be withdrawn from the market?

First in this article, I will give you a brief idea about end to end process of a drug. Most important, I will let you know that how you can play a very important role in this whole cycle.

Research and development of a drug:

Withdrawal of any medicine costs a lot to the Pharmaceutical companies. Companies spend a lot of money and efforts in research and development to develop a medicine or a combination of ingredients or generics.

There are different steps involved in the development of a drug. Mainly these are-

  • Pre-clinical trial phase
  • Clinical trial phase
  • Post marketing phase

The total procedure takes around 8 – 12 years of long time after which drug start making profit for the company.

Timeline for drug development process:

Process of development of a drug can be differ in different countries. However, here is an example showing all the steps involved into that process-


Image: Graph created based on information provided in Scientific American article, “Faster Evaluation of Vital Drugs” by Kernsters at Wikipedia

Side effects of a drug:

In post marketing phase a drug comes under real conditions and may not show the expected results. Sometimes, it shows unusual reactions and severity, which is popularly known as side effects of a drug.

However, in medical terms it is known as Adverse Drug Reaction (ADR). ADRs are undesirable effects of medicines that lead to morbidity and mortality.

There are many classifications of medicines. As per a research, most of the drugs withdrawn in the last decade are from below mentioned classes

  • Nonsteroidal anti-inflammatory drugs (28%)
  • Antidiabetics (14.28%)
  • Antiobesity (14.28%)
  • Antihistamines (14.28%)
  • Gastroprokinetic drugs (7.14%)
  • Breast cancer and infertility drugs (7.14%)
  • Irritable bowel syndrome and constipation drugs (7.14%)
  • antibiotics (7.14%)

Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%).

It was found out that 75% of laymen, 40% of the doctors and pharmacists, and 60% of science students were not aware of ban. Click here to know in detail.

Why drug withdrawal is required?

Adverse drug reporting is as important as the treatment we are taking. First, I will explain you why it’s needed?

Reporting of any adverse effect will give a data to the drug regulatory authorities and the respective company. Now, they will analyze this data from different procedures which helps to identify the Risk/Benefit analysis of the drug.

Benefit Risk ratio

If an authority finds the risk is higher than benefit then they will ask company to check or modify the drug again and provide a genuine reason. If company fails to take proper action then authority decides to withdraw that medicine from the market.

You can check list of drugs withdrawn from the market in different countries on this link

Recently, in India more than 300 Fixed Dose Combination (FDC) has been withdrawn from the market. The list includes many popular medicines also like painkiller Saridon, Antibiotic Taxim AZ and many more.

These are a perfect examples that why you should be aware about medicines you consuming.

A patient should inform any reaction of a drug to the Doctor, Pharmacist or other health care professionals.

Adverse event reporting:

You may wonder why the reporting of any reaction is needed and who should do this?

It is known as Adverse Event Reporting. When any side effect of any drug is reported, it gives a signal to the companies and authorities to take action or keep an eye on it. So, the less number of reporting leads to generate less number of signals.

Suppose a drug gives some side effects but it has not been reported and so the company and authorities will not get the signal data. So, they may assume that the drug is doing well in the real time conditions and no action will be performed because data will show benefit is more than risk.

Now, the question is who should report the events?

The answer is “EVERYONE”

Yes, everyone should report the adverse reaction which comes under their knowledge. However, there are many ways to report an adverse reaction.

  • Inform to your doctor or Health Care Professional (HCP)
  • Report directly to company or manufacturer via call or e-mail
  • Report directly to respective authority of your country

Apart from this Adverse events should be reported from clinical trials also by investigators.

I will write a detailed article also regarding how to report an adverse event by common people and how it will help to improve the health of our country.

Let me know if you have any question in you mind.

Vinay Dubey

A Health care professional and Pharmacologist with an aim of sharing my knowledge about health and lifestyle to everyone. Specially, I want to empower people from non medical background, with the knowledge that how daily lifestyle and medicines can affects their health. Also, to let them know how they can play an important role in the life cycle of a medicine.

1 Comment

  1. Hi there! Such a wonderful short article,
    thank you!

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