Generic medicines work just as well: The 'Liver Doctor' explains how
Two years ago, the Mission for Ethics and Science in Health Care (MESH) decided to scientifically examine the quality of generic and branded medicines. Here's what they found.
Two years ago, the Mission for Ethics and Science in Health Care (MESH) decided to scientifically examine the quality of generic and branded medicines. Here's what they found.
Two years ago, the Mission for Ethics and Science in Health Care (MESH) decided to scientifically examine the quality of generic and branded medicines. Here's what they found.
There is a deeply rooted perception that low-cost generic medicines are inferior in quality, and doctors, too, have played no small part in reinforcing this belief. I, myself, once assumed that the generics supplied through government hospitals were substandard. As a result, I routinely prescribed expensive branded drugs for patients with cirrhosis. Even when patients, strained by the high costs, asked whether they could instead purchase generics from outlets like Janaushadhi, my instinct was to discourage them.
The reality, however, is that many patients simply cannot afford costly medicines. Influenced by repeated claims about poor quality, they too avoided generics altogether. The result is tragic. Medicines are taken irregularly, treatment suffers, and the disease progresses to more severe stages.
It was against this backdrop that, two years ago, we decided to scientifically examine the quality of generic and branded medicines. The initiative was led by the Mission for Ethics and Science in Health Care (MESH), a collaborative platform that brings together doctors, scientists, and ordinary citizens. The testing was carried out at a cost of Rs. 27 lakh raised from the public, making it the first initiative of its kind in the country to be undertaken with broad community participation.
Medicines selected for evaluation
Patients with conditions such as heart disease, diabetes, infections, gastrointestinal disorders and cholesterol often depend on medicines for years, sometimes for life. 22 categories of these essential, long-term medications were selected for evaluation. In total, 40 samples from 131 different tablet batches were subjected to detailed testing.
The medicines examined included widely used drugs such as paracetamol and ibuprofen; the steroid prednisolone; antibiotics such as azithromycin and amoxicillin; rifaximin used in liver disease; ranitidine, omeprazole and pantoprazole for gastrointestinal ailments; atorvastatin for cholesterol control; telmisartan and amlodipine for hypertension; and aspirin used to prevent blood clotting. Nutritional supplements, including folic acid, vitamin D and calcium tablets, were also subjected to testing.
The analysis
The analysis was carried out at the Haryana facility of a laboratory approved by the United States Food and Drug Administration (USFDA). Multiple quality parameters were assessed, including ingredient quantity, dissolution capacity, purity, and dosage accuracy, before arriving at the final evaluation.
The results challenged all prevailing assumptions. Generic medicines available through outlets such as Jan Aushadhi, as well as those supplied to government health centres through the Kerala Medical Services Corporation, were found to match branded medicines in quality.
Any risks?
Even though minor variations can occur, all the generic medicines tested fully met the quality standards set by the Central Drugs Standard Control Organisation (CDSCO). Rare quality issues may arise. That risk, however, is the same for both generic and branded medicines.
But what about cost? Branded medicines can be up to 14 times more expensive than their generic counterparts, and many require long-term use. Just imagine the financial relief for patients who switch to generics. Consider a simple example: if a person needs calcium and vitamin D supplements for six months, the branded version costs around Rs. 1,903, while the generic equivalent is just Rs. 139. In this case, the savings come around to a staggering 93%.
The key takeaway
For those on long-term treatment, generics are clearly the more economical choice. Insisting on branded medicines reflects perception rather than necessity, especially when generics provide the same quality. This is a key takeaway that the public must understand.
Avoid confusion
It is also important not to confuse generics with counterfeit drugs. Fake medicines exist in both branded and generic categories, but the study confirms that generics available through Jan Aushadhi stores and government hospitals match the quality of medicines produced by major pharmaceutical brands.
The production processes and quality assurance systems for branded and generic medicines are essentially the same. The higher price of branded drugs largely reflects additional costs for marketing, packaging, and promotion, rather than any difference in quality.
This study is expected to help dispel public misconceptions about generic medicines. The medical community must also acknowledge and embrace these findings. The National Medical Council recommends that prescriptions should use the generic names of medicines, yet in practice, this guideline is hardly adhered to.
(The author is a liver disease specialist at Rajagiri Hospital and the president of MESH, the organisation that conducted the medicine quality study. His Instagram Page 'Theliverdr' is quite popular. )
Frequently Asked Questions
1. What are generic medicines?
It is a generic version of a brand-name drug already sold in the market. For example, the same tablet that is available in the market as paracetamol is sold as Crocin. Such medicines have the same dose, quality, strength and safety as the branded variant.
2. How are generic medicines different from counterfeit medicines?
While generic medicines are legally manufactured and approved by drug regulators, counterfeit medicines are fake. Generic medicines contain the same active ingredient, while counterfeit medicines contain the wrong ingredients or none at all. Generic medicines are safe for health, and counterfeit drugs are dangerous and unsafe.
3. Who regulates the quality of medicines in India?
It is done by the Central Drugs Standard Control Organisation (CDSCO), which is under the Ministry of Health and Family Welfare. Drugs need to be approved by the CDSCO before they are sold in domestic and international markets. Find details here.