Branded vs generic drugs: Does affordability make them less effective?

Most people falsely believe that generic medicines are less effective than their branded counterparts. However, India’s first private drug quality audit conducted by MESH (Mission for Ethics and Science in Healthcare), an NGO based in Kerala, dismisses this common myth. The crowdfunding study was one of the largest such studies conducted in India, with public participation. The medicines were tested in high-security labs that are certified by the central government and the US FDA.

The lab test proved that the branded medicines of the prominent pharmaceutical companies as well as the medicines supplied by the government via Jan Oushadhi and Kerala Medical Services Corporation (KMSCL) are all equally effective and are of the same quality. Meanwhile, the affordable drugs supplied by the government fared better in the drug content, dissolution and purity categories. Moreover, these drugs are around 49 per cent cheaper than the branded drugs. 

Noted hepatologist Dr Cyriac Abby Philips, who is popularly known as the LiverDoc on social media, speaks to Manorama Online about the study. 

Why was the study conducted?
Most of my patients have been taking medicines for a long time, and they often can’t afford the price of many drugs. So, those who have been seeking treatment for liver-related diseases tend to discontinue their treatment or stop taking medicines, solely because of the cost factor. But this eventually worsens their health condition, and they are likely to be admitted to the ICU. I started noticing that the number of ICU admissions has increased lately, and their charges are skyrocketing. It was then that I decided to study more about generic drugs. I wanted to know whether these generic drugs distributed at our government hospitals are as good as the branded ones. Most patients and even healthcare experts do not know that good-quality generic drugs are available in the market. 

People are generally unaware of the quality of the generic drugs. They are sceptical whether they would actually get better by taking these drugs. My patients often ask me whether it is ok to have these medicines. We do not see the underlying facts when a diabetic patient claims his sugar levels do not go down despite taking the cheaper drugs. He may be eating rice three times a day, or may be someone who doesn’t indulge in exercise at all. We hardly have any idea about these additional facts. But, we just proclaim that our condition doesn’t improve because of taking the generic drugs. This study was conducted to determine whether these generic medicines actually meet pharmaceutical quality standards.

We do not discourage people from buying branded drugs. It’s just a reminder that good quality generic drugs are available for those who do not have the financial ability to buy these expensive drugs. 

Mystery shopping and crowdfunding
Conducting this study wasn’t easy at all. It took over a year to develop the study's structure. 131 types of tablets and capsules, including 8 medication categories and 22 drugs, were tested under this project. This is, in fact, one of the biggest such studies in the world. This study was fully crowd-funded, with no external influence. Twitter and Instagram were used to raise public awareness and collect funds for testing. Rs 27 lakh was collected within a week for this project. 

Forty samples are required to test a drug. So, 131 x 40 samples of the same batch were purchased. For example, if you are testing azithromycin, then you need 40 tablets of the same batch produced by the same company. The drugs for testing were procured via mystery shopping. Antibiotics for ten days were purchased from the medical stores using the hospital prescription. Another person would then make the purchase later.

That is how 40 drugs of the same batch were procured. Drugs that didn’t belong to the same batch weren’t tested. It took about 6–9 months to procure all the medicines for testing. It was a very difficult task as you need a government sample and a private sample for testing. Collecting samples from government institutions weren’t easy. So, the crowdfunding was started only after this.

Same quality
Pharmaceutical equivalence (Drugs that contain the same active ingredient, in the same dosage form and strength, and meet the same quality standards) was done to compare the quality of the drugs. Some were curious why bioequivalence (Two medicines that work the same way in the body and give the same effect) wasn’t done. Drugs that are used by people for a long time have been used here. Medicines that are generally prescribed for diabetes, heart disease, cholesterol and antibiotics were procured for testing. There is no need to do the bioequivalence in this scenario. If the pharmaceutical equivalence confirms the drugs are of good quality, then it naturally means that they have bioequivalence. After testing 131 drugs, it has been proven that the generic, branded generic, and the local generic medicines are of the same quality. They are all perfectly fine. 

Not against private companies
Although doctors are often urged to prescribe generic medicines, there is no conclusive evidence to prove their efficacy. Both those who prescribe medicines and those who take them should know that generic drugs are of the same quality as their branded counterparts. The evidence for that has been revealed through this study. So, we have taken a significant step that the government ought to take. The aim of this study was not to discredit or discourage patients from buying branded medicines. Instead, it is just a reminder that those who are not able to buy the expensive drugs have access to good-quality generic drugs too.

The study is not against any private pharma companies; this has been done for the people. Now, the government should take up the initiative to conduct such studies and share the findings with the public to make this sector more transparent. For instance, when a doctor prescribes an expensive antibiotic, the patient may not be able to buy it. If there is reliable government data, the patient can make an informed decision. The patient also gets a chance to make a choice in this. 

The money saved this way could be used by the patient for other things that improve his/her standard of living. Such a small step could, in fact, bring about a significant change in society. 

Study's benefits
Dr Rajeev Jayadevan, the Convenor of the State IMA Research Cell, also reacted to Manorama Online about the study report. The study that proved that generic drugs are as effective as branded drugs should be seen positively. However, India is a huge country where hundreds of pharma companies produce more than 60,000 varieties of drugs. Low-quality and fake drugs have also been identified among them. In the regular tests and raids conducted by the Central Drugs Standard Control Organisation, poor-quality drugs are often found in all sorts of categories. Besides, fake medicines are also identified in these tests and raids. Fake medicines have been seized from various places, including Kerala. 

India's generic drugs
New reports have appeared showing how poor-quality drugs are produced even in the government sector. These incidents, too, should be considered while analysing the findings of the new study. The study that was conducted last year by John Gray of the Ohio State University, US had found that the generic drugs manufactured in India are more likely to have side effects compared to the generic drugs made in the US. They discovered that some of the drugs had caused health problems in the patients. “Using exact matching analyses based on the equivalency criteria established by the US Food and Drug Administration, we find that generic drugs manufactured in India, where a majority of emerging economy generic drugs are made, are associated with significant higher instances of serious adverse events than equivalent drugs made in the US, where a majority of advanced economy generic drugs are made,” the study report stated. 

The 131 samples tested by researchers in Kerala show that the drug content is the same in both generic and branded drugs. The next step must be to collect generic and branded drugs from all over the country, test them in official laboratories, and conduct extensive follow-up studies. 

Besides finding a solution to the question, ‘whether the drugs contain the stipulated amount of drug content’, they should also see, just like the Americans have done, whether these drugs perform in the desired way in the patients’ bodies. This method is called bioequivalence. The current study has only tested, according to the pharmacopoeia, whether the drugs contain the stipulated amount of drug content. Now, other factors, including manufacturing methods, storage, packaging, and the drug's effect on the human body, should be studied.

These are crucial in the case of life-saving drugs that are prescribed for seizures, heart disease and kidney disease. There may or may not be any difference when a patient consumes two different tablets that have the same amount of drug content. This means the absorption rate may fluctuate when a patient takes two different formulations of the same drug. So, bioequivalence studies are conducted to test this factor. The current study is not based on bioequivalence. Nevertheless, it is highly commendable that this study highlights the message that generic drugs are not fake. 

Not all generic medicines...
The findings of the current study could be validated if extensive research based on the above-mentioned factors is done. Moreover, it would be helpful to alleviate doubts among medical practitioners and the public about generic drugs while reducing treatment costs. 

Unlike what most people think, generic doesn’t mean these drugs are manufactured by a low-standard company. Be it generic or branded, all these drugs are manufactured by some company. Among them are reputable companies known for their credibility and quality. World-class companies that make expensive branded drugs also produce generic drugs in the same quality. These generic drugs are of high quality, even though they do not have the fancy packaging of the expensive drugs. It means that not all generic medicines are manufactured by small companies that do not meet the quality standards. The drugs that were tested in the study may have been manufactured by these excellent companies.

It is not possible to conclude that all generic medicines that are manufactured here are of high quality. This study should surely be seen in a positive light. Besides, the guideline that all companies should strictly follow the Indian Pharmaceutical Good Manufacturing Process may be implemented this year. Although a few smaller manufacturers have opposed this move, the central government is likely to insist that Good Manufacturing Practice guidelines be followed and that companies adopt a system that ensures high-quality drugs. High quality and efficacy would be ensured for all drugs manufactured and sold in India once this guideline is implemented.