Real medicine

Is Your Medicine Safe? A Guide to Testing and Quality Checks

When Laxman was injured during the battle against Ravana, Lord Rama was informed that the Sanjeevani herb from the Himalayas could cure him. Lord Hanuman could not find the herb, so after fighting off Kalanemi, who had been sent by Ravana, he famously brought the whole mountain. Had Ravana changed his strategy and planted a poisonous/do-nothing look-alike herb in a visible place, then Hanuman and Laxman would be no different from the millions of Indians today who purchase/consume fake/substandard/adulterated medication.  

Even though Ravana is long gone, some pharmaceutical companies still follow in his greedy footsteps. We hear about fake and counterfeit medicines daily, yet when you Google how to protect yourself from them, you’re often led to blogs written by big pharma companies. The irony? Their medicines too fail to pass the rigorous tests of the Central Drugs Standard Control Organization (CDSCO). You won’t see their names in the headlines because, with the power to hire Bollywood celebrities for endorsements worth crores, it’s far easier for them to manipulate the media. 

To keep your name out of the list of people killed by fake medications, keep reading this site to find out what to look for in a medicine before you take it, so you can be sure that each pill is helping you.

What is a medicine test? 

A medicine test is like a school exam. Just as passing a school exam helps us grasp the concepts for the next grade, when a medicine passes its test, it ensures it is safe and fit for consumption. 

While the term “medicine testing” may seem new, the practice dates back to 1938 in the US, when a cough syrup manufacturing company added diethylene glycol to enhance palatability without proper testing. This negligence resulted in the deaths of 100 children, and the incident became known as the “Taste of Death.”  

After this tragedy, every country became alert and made it mandatory for pharmaceutical companies to conduct quality and safety tests before marketing their products. This is why many pharmaceutical companies now have laboratories on their premises. 

Now that we understand what medicine testing is, this takes us to… 

How can I get a medicine test report? 

If you believe that passing a law mandating quality and safety testing for medicines will ensure 100% compliance by pharmaceutical companies, then we wouldn’t be seeing headlines about the loss of countless lives due to the consumption of fake medicines. 

Relying solely on regulatory authorities is not enough when we know they are easily bribed and hide reports in their files. As consumers, don’t we have the right to know the quality of what we are putting into our bodies? 

When you question the quality of everything, why not do the same for medicines—something directly linked to your health and survival?  

You can ensure your medicine’s safety by sending it to an NABL lab for testing, but this involves wasting some medicine and incurring additional costs. Sayacare simplifies this for you by testing all medicines at no extra charge, ensuring they are safe for consumption. 

Now, this takes us to…… 

Check for these tests to ensure your medicine is fit. 

Just as school exams assess your knowledge and abilities, medicines must also pass certain tests to prove their quality and safety. Here are the key tests to check if your medicine is truly fit for use. 

(A) Identification test

We know there are fake medicines in the market, made by adding cheap/substandard ingredients to maximize profit—putting your health and life at serious risk. If you want to protect yourself from these dangerous counterfeits, ask for identification test reports to ensure your medication is genuine and effective. Here are some simple ways to verify the authenticity of your medicine… 

(i) Chemical test- Just like using face recognition or fingerprint security to lock your phone, ensuring it won’t unlock with anyone else’s face or fingerprint, a chemical test can identify whether the right compounds are present in medicine based on their distinctive characteristics.

(ii) Spectroscopy: When sunlight falls in the pond you can clearly identify whether the water is clear or filled with impurities; similarly, scientists use different waves to identify the correct salt in medicine. Some spectroscopy tests are High-Performance Liquid Chromatography (HPLC) and Ultraviolet (UV).

(iii) Chromatography: Imagine a group of children running in a field. Each child runs at a different speed—the faster kids move farther ahead, while the slower kids lag behind. By the end, the children are spread out at different distances. Similarly, in chromatography, medicines are made to run on a field of paper, and based on their ability to cover a distance, the medicines are identified.

(iv) Physical test like melting point: Just like pure gold melts at a temperature of 1,064 degrees Celsius, any deviation from this temperature indicates adulteration. Similarly, every active ingredient has its own melting point. If it melts above or below its standard temperature, it indicates adulteration. Like a fingerprint, this melting point test is a reliable way to verify a medicine’s purity.

(B) Uniformity

Uniformity in medicine is an indicator of its effectiveness. A difference in the weight of tablets across a strip indicates a variation in the amount of active ingredient, leading to inconsistency. This means one tablet might contain too much medication (causing an overdose), while another might contain too little (resulting in an underdose). Such variations can severely impact your treatment and overall health. To protect yourself from underdosing or overdosing, look for the following tests to ensure the uniformity of medicine… 

(i) Uniformity of content: Just as salt evenly distributed throughout a dish enhances its flavor uniformly, an active ingredient must be present consistently across every tablet in a strip or throughout a syrup to ensure proper effectiveness. 

(ii) Uniformity of weight: Weight uniformity in medicines is crucial because it ensures that every tablet or capsule contains exactly the same amount of active ingredient, regardless of which batch it comes from. After all, if I took two spoons of sugar, but one weighed more than the other – then the sugar levels would not be considered the same.

(iii) Average weight and Average fill weight: Just like in a math multiple-choice test, you do your calculations and get an answer. If the answer matches one of the four options, you know you’ve used the correct steps; if not, you correct your approach. Similarly, in this method, the average weight of the medicine is taken, and if it falls within the range stated in the pharmacopeia, it is considered uniform.

(C) Purity/Impurities

Just as air pollution damages your lungs and reduces life expectancy, impure medicines can severely harm your health and even cause death. While it’s nearly impossible to avoid breathing polluted air, you can protect yourself from consuming counterfeit or substandard medicines by checking these test reports before taking any medication: 

(i) Heavy Metal Test: Heavy metals in medicines are dangerous because they can accumulate in your body over time, causing serious health problems like memory disorders and kidney dysfunction. Checking that your medicine has passed heavy metal testing ensures it’s free from these harmful contaminants. 

(ii) Microbial Test: This test verifies that your medicine is free from harmful microorganisms (like bacteria and fungi) that could make you sick. A passed microbial test confirms the medicine is sterile and safe for consumption. 

(D) Potency/ Efficiency

Potency or efficacy refers to a medicine’s ability to produce the intended healing effect at the prescribed dose. To achieve the desired effect after taking a medicine, check for the following tests that define its potency: 

(i) Assay: The active ingredient in a medicine must be present in exactly the amount stated on the label—no more, no less. If there is more or less than stated, the medicine may cause an overdose or underdose, respectively. Therefore, this test protects you from unwanted effects.

(ii) Dissolution: Dissolution can be understood by comparing it to dissolving sugar in water, which is easy, versus dissolving it in oil, which is more difficult. Similarly, our body contains fluids of different natures, and medicines need to dissolve in these fluids to work effectively. This test ensures that the medicine breaks down properly in the body’s environment to produce the desired effect.

(iii) Disintegration: We chew food to break it into smaller pieces, allowing our body to digest it more easily. Similarly, although we cannot chew tablets, we expect them to disintegrate as soon as they meet body fluids, just like a biscuit dissolves when dipped in hot tea.

(E) Pharmacokinetic and Performance test

Our body follows a principle: after eating food, it absorbs, utilizes, and eliminates medicines. To ensure that medication is properly processed by your body, rather than accumulating harmfully or failing to work effectively, specific tests are conducted. These tests verify that the medicine will be absorbed correctly, produce its intended effect, and be safely eliminated from your body without causing toxic effects. Here are the essential tests to look for: 

(i) Bioavailability (BA): Our body excretes waste material only after absorbing essential nutrients into the bloodstream. Similarly, after taking 500 mg of paracetamol for a headache, a certain amount is absorbed into the bloodstream, while the rest is excreted as waste. This process is studied in a bioavailability study, which examines how much of a medicine is absorbed and how much is excreted.

(ii) Bioequivalence (BE): A bioequivalence test is a comparative study done between generic medicine and branded medicine to determine if the rate and extent of absorption are the same for both. 

Bioequivalence studies are mandatory for newly discovered medicines in every country, but the same is not true for generic medicines in India. While India has laws requiring pharmaceutical companies to conduct BA/BE studies and submit data to the government within four years for generic medicines, no company has submitted BA/BE study data so far. Instead, they bribe the officers and the truth remains hidden. 

Conclusion 

After the sulfanilamide tragedy, every country made it mandatory for pharmaceutical companies to conduct medicine tests to ensure safety before marketing. However, if the test is conducted by the government, and the medicine fails, it shows that the law is merely on paper, and full compliance is lacking. The government body, CDSCO, also takes a lot of time to deliver quality reports, and by the time the report is out, the medicine may already be available on the market, causing harm or loss of countless lives. 

Even after passing a law that mandates pharmaceutical companies to test medicines before marketing, these companies often conduct superficial tests and inaccurately claim their medicines are safe, prioritizing profit over safety. However, the blame isn’t solely on the manufacturers. The government also operates like a sewing machine, delivering monthly standard quality test reports with significant delays, sometimes as late as the next month- by which time the medicine is already in the market, making it difficult to trace and address the harm caused. 

When the process is so tedious, we cannot rely solely on the government. But don’t worry, SayaCare is here to help and educate you, just like the physician Sushena guided Hanuman to bring the Sanjeevani herb. If Hanuman had made a mistake, Sushena would have corrected him. Similarly, we provide you with a medicine test report for every medicine before distributing it to customers, ensuring that every medicine you consume proves to be as effective as Sanjeevani for you. 

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