The question about Branded (original) and generic medicines has always been very hard to patients and some medical practitioners. When a pharmacist tells a patient about original brand what hits the patient’s mind is that the other generics are fake and it may take quite some energy to convince the patient. The physicians know a bit about generics and branded medicines but the difference between them is very unclear to them and most of them end up prescribing the original brand.
The price of the medicines most of the times is usually very different with some original costing about ten times the generics. For example the price of a tablet of ciprobay 500mg(ciprofloxacin) is ksh400 while that of generic ciprofloxacin 500mg is between ksh10-20. The price of a tablet of voltaren 100mg(diclofenac) is ksh100 while that of generic diclofenac is ksh5-10. Such differences in price makes most people including physicians doubt the quality of generic medicines. Only pharmacists fully understand the differences in price.
All medicines used in any country must be approved and registered for use in that country. In the United States, the Food and Drugs Administration is the government body that regulates foods and medicines. In Kenya, it’s the Pharmacy and Poisons Board, which also regulates the training of pharmacists and pharmaceutical technologist, manufacturing, importation and exportation of medicines and the business of pharmacy.
The role and powers of the Pharmacy and Poisons board is described in CAP 244, Pharmacy and poisons act, Laws of Kenya
For any medicine to be approved for use any given country it must meet it must meet the set standards by the country’s regulatory body. In Kenya, these are the set standards;
- For highly potent drugs, the amount of active pharmaceutical ingredient(s) (API) should not be less than (NLT) 98% and not more than (NMT) 102% of the stated amount.
- For the other drugs, the amount of Active pharmaceutical ingredients should be between 95-105% of the stated amounts.
In relation to the Branded (original) medicine, the generic must meet the following;
- Bioavailability, the percentage of drug that gets into the blood must be equal that of the Brand(original).
- The generic must perform as the original that is the therapeutic effects.
- All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs, and the generic products must meet the same exacting specifications as any brand name product. In fact, many generic drugs are made in the same manufacturing plants as brand name drug products.
There maybe some differences in amounts of API but as long as is within the set standards, the medicine is okey. As a matter of fact, there are usually variations in different batches of the branded product.
Therefore there is no difference in quality of generic drugs and that of originals. Then why the astronomical differences in prices?
The original companies are the inventors of the drug. Companies do not just wake up one day and they have a wonder drug. It is a rigorous process of research which requires a lot of resources both in personnel and equipment.
During drug development, many compounds with similar chemical structures are introduced and studied. These compounds maybe selected using computer software.
The effects of the compounds are studied on animals until the best compound is picked, which can then be tested on humans which we call clinical trials. Clinical trials is one long process that has three phases, I, II, III, and the last one that takes all drug use life, pharmacovigilance. That is to say the drugs is always under study and can be withdrawn from the market if very undesired effects occur.
Over 50% of drugs fail before even reaching clinical trials.
After a company develops a drug, it is allowed to sell the drug for a specified number of years after which the other companies can come in and start producing.
Therefore the major reason why original drugs are expensive is to cater for the cost of Research and Development (R&D). Research and development may even require use of equipment that never existed which at the end will be put in the price of medicine. The other very minor reason is the target group.
Generic companies can afford to sell their drugs very cheaply since everything had been set and they only took the formula.
To prevent the confusion, prescribers are required to prescribe by the International Nonproprietary Name(INN). For example Paracetamol instead of Panadol, Sildenafil instead of Viagra, Chlorpheniramine instead of piriton and so on.
The public should also be aware that medicines have two names-the brand name example Panadol and the International Nonproprietary Name(INN) which is paracetamol in our examples.
Patients should always take the brand they can afford and public hospitals are encouraged to buy generic drugs since they are cheaper and will deliver as originals. The cost that passed down to the patient is small an everybody is happy and healthy.
FACT: Cheaper does not mean lower quality.