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If you are considering purchasing medication from outside the U.S., be aware that, in most circumstances, it is technically not legal for individuals to import prescription drugs; however, U.S. government officials have stated that individuals who order non-controlled prescription drugs from Canada or other foreign sources (up to a three-month supply) for their own use are not being pursued or prosecuted.
Are generic drugs as effective as the brand? How about in Canada and other countries?
For the most part, generic drugs are as effective as the brand version. Unfortunately, not all generic drugs are created equal, both within the U.S. and internationally. Sometimes a generic drug does not work the same as the brand, or even as well as another generic. This is mainly due to poor regulatory oversight and/or neglect by a drug company.
Generic Medication Quality Around the World
Generics manufactured in accordance with U.S. Food and Drug Administration Good Manufacturing Practices and countries and regions with similarly strict standards— including Australia, Canada, the European Union, New Zealand and the UK—have very high-quality generic medication.
India is the world’s largest manufacturer and exporter of generic drugs. Its highest quality products, particularly those manufactured in plants registered with the U.S. FDA and other similarly strong drug regulatory authorities, are of excellent quality. Generic drugs made in India, however, especially those made by small companies and exported to lower-income countries can be of high quality but tend to have more quality problems than those sold in the U.S.
Generic vs. Brand-name Medications
Generally, properly manufactured generics will be equal to their brand-name counterparts because they have the same:
Generic drugs can and usually do have different inactive ingredients and excipients from their brand counterparts.
Also, they may look different than brand-name medications. The differences in size, shape, and color do not affect how well generics work compared to the brand.
When it comes to price, generic drugs are usually much cheaper than brands. What is less known is that generic drugs sold in U.S. pharmacies are often cheaper, sometimes by a lot, than those sold in Canada or other countries.
Facts about Generic Drugs in the U.S.
All new drugs in the U.S. must go through a rigorous process of scientific and clinical review to make sure that they are safe and effective. For new drugs under patent, companies apply for what is called a New Drug Application (NDA). The applicant must prove to the FDA that the drug will be safe and effective, labeled properly to best inform medical professionals and patients, and manufactured in accordance with FDA’s standards. The NDA application requires: 1) testing in animals to determine safety; 2) testing in a small number of humans to further determine safety and show efficacy; and 3) testing a much larger number of humans to prove more definitively the safety and efficacy of the drug.
Companies that apply to the FDA to sell a generic version of a brand already approved under an NDA, submit what is called an Abbreviated New Drug Application (ANDA). The application is “abbreviated” because companies don’t have to go through the same protocols for testing since the drug has already been proven safe and effective under the NDA. However, through the ANDA, the drug company applicant must show that the generic copy will be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics. This “sameness” is referred to as bioequivalence.
Why are generic drugs cheaper than the brand version?
In the U.S., generic medicines often cost about 85% less than the brand.
Generic drugs cost less for two reasons.
One, there are several companies making generics that compete on price.
Two, generic medicine manufacturers do not have to repeat the animal and clinical (human) studies and trials that were required of the manufacturing company applying to sell the innovator, brand-name drug to ensure safety and effectiveness of the medication.
Facts about Generic Drugs in Canada
The process for approving all drugs in Canada is similar to that in the United States.
According to Health Canada’s Therapeutic Products Directorate, Canada’s counterpart to the FDA, a generic drug is pharmaceutically equivalent to the brand-name drug if it contains the identical medicinal ingredients, in the same amounts and in a similar dosage form. Like in the U.S., generic medications may have different non-medicinal – inactive – ingredients than the brand, but the manufacturer must demonstrate that these do not affect the safety, efficacy, or quality of the drug compared to the brand-name drug.
There can be many generic versions of the same brand-name drug, and these are usually available at a lower cost to consumers.
Health Canada regulates medications to ensure they are safe, effective, and of high quality. Manufacturers must submit information to Health Canada before the medication can be sold. The information required depends on the type of product and its level of risk. Once a medication is approved for sale, Health Canada continues to monitor its safety, effectiveness, and quality.
Facts about Generic Drugs in the European Union (EU) and the United Kingdom
The process for approving drugs in the EU is similar to the process in the United States, with some differences. In the EU, a drug company can apply to the European Medicines Agency to market and sell a drug in any member-state of the EU (e.g., France, Germany, Italy, Poland). Additionally, a drug company can apply to a national regulatory authority, such as the UK Medicines and Healthcare Products Regulatory Agency.
Both the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), assess quality, safety and efficacy and approve every medicine before it can be sold in the UK.
To gain MHRA and EMA approval, generic medicines must prove to be bioequivalent to their brand-name versions. That means generic and brand name medicines are essentially the same in the following ways:
Maximum amount of medicine in the blood at any given time
Total amount of medicine in the blood from the time it is taken until the body eliminates it
Strength and dosage
Route of administration – orally, intravenously etc.
Expected safety and efficacy
MHRA and EMA evaluation of manufacturing facilities
Facts about Generic Drugs in Turkey
The process for approving drugs in Turkey is similar to the United States, but there are some differences. Tukey’s counterpart to the FDA is called the Medicines and Medical Devices Agency of Turkey (TMMDA).
In Turkey, the price of the drug is set during the regulatory approval process and the TMMDA Health must complete its regulatory review of the drug application file within 210 days.
According to the TMMDA, generic medications have the same qualitative and quantitative composition and the same pharmaceutical form as the original medicine in terms of active substances. A generic drug’s bioequivalence with the original medicinal product must be proven with appropriate bioavailability studies.
The TMMDA evaluates and closely monitors the clinical trials of all human medicinal products in compliance with international legislation. Pharmaceutical wholesalers, exporter/importer pharmaceutical warehouses and where necessary the pharmacies are inspected in order to ensure that the quality, efficacy and safety of medicines are maintained throughout the supply chain.
Facts about Generic Drugs in India
The process for approving drugs in India is also similar to that of the United States. There are some differences and potentially more safety issues related to lack of regulatory enforcement.
What are the differences and what are the potentially greater risks?
The differences from the US are bioequivalence data is required to be established only by those applicants who seek approvals within the first 4 years of the launch of a new drug in India. No bioequivalence study is required for generics, where the ‘reference formulations’ have been in the Indian market for more than 4 years. CDSCO has a much smaller staff size than the U.S. FDA making regulatory enforcement for all cases difficult.
The potential greater risks are problems with drug quality in India, but mostly these issues are with products sold to poorer Indian communities and countries. Lawfully-manufactured, Indian versions of medications sold online by international pharmacies, even if they are of high quality, are not necessarily and often not FDA-approved.
India is the largest producer and exporter of generic drugs in the world. Its largest multinational drug companies provide excellent quality products to high-income countries, like those manufactured in plants registered with the U.S. FDA. Problems are more likely to come from medicines made by lesser-known companies and plants that are not registered with top drug regulatory authorities.
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and serves parallel functions to the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.
The CDSCO ensures safety and efficacy of drugs before the drug product can be approved for manufacture and marketing in the country.
When a company in India wants to manufacture or import a new drug, it must prove to the CDSCO that the drug will be safe and effective, labeled properly to best inform medical professionals and patients, and manufactured according to CDSCO standards. The application requires: 1) testing in animals to determine safety; 2) testing on healthy human volunteers to determine maximum tolerated dose and adverse reactions; 3) testing in a small number of human patients to determine effective doses; 4) testing a much larger number of humans to confirm the safety and efficacy claims of the drug.
Companies that want to sell a generic version of brand name medication already approved by CDSCO, will have to submit the same application as a new drug but don’t have to go through the same protocols for testing since the drug has already been proven safe and effective under the initial approval. However, for the generic version, the company must submit testing that demonstrate bioequivalence based on bioavailability studies.
The CDSCO exercises quality control of imported medicines through the port offices and maintains drugs testing laboratories for testing of samples.
See our Ask PharmacyChecker answer: Are Indian pharmacies really safe? The prices are so much lower!
Ordering Generic Medications Online
Patients in the U.S. and worldwide that are looking to buy medications online should know that properly-manufactured, safe and effective generic medicines are available at PharmacyChecker-verified international online pharmacies.
There are sometimes lower-quality and poorly made generic drugs sold in lower-income countries, and dangerous rogue online pharmacies may sell these lower-quality drugs. This is one of the reasons why we caution consumers to stick to ordering through websites that are properly credentialed and verified, such as those online pharmacies verified by PharmacyChecker.