GENERIC DRUGS RAVI P. AGRAHARI (Science & Technology)
• India’s the global leader in the generic market with Indian drugs popular in Africa and other emerging markets. Some Indian pharmaceuticals have even made headway in the USA market. So what are generic drugs?• They are drugs which have the same chemical composition as branded drugs are and sold under their chemical name. For example Paracetamol , a painkiller, is the generic name for branded drugs like Crocin and Calpol. The drug market situation is a little different in India than the USA or other developed nations. In the USA, when a new drug is launched only the company that holds the FDA patent are legally allowed to sell the drug , thus giving them market monopoly. In India however there were no patent laws till 2005 which meant that anyone could replicate any drug in India without legal ramifications. This led to the trend of branded generic drugs which has 99.5% of the country’s generic drug share
• Where are they available? Generic drugs are sold everywhere including your local chemist. To buy them one simply has to ask for generic version of a branded drug though they don’t have them for all medicines. The department of pharmaceuticals of the government is responsible for promoting generic drugs but they haven’t done a very good job. To promote cheap drugs in 2008, the government had set up a scheme called Jan Ausadhi whose purpose was to set up generic drugstores around the country. Their initial plan was to set up 3000 stores but four years later only 300 of them exist. Here’s a list of all Jan Aushadhi stores in the country.
• What is the price difference between generic drugs and popular branded drugs?- Note: All prices are taken from the 2010 comparative price list- We can clearly see that in some drugs the price difference is significant. Used as Generic drug Price Branded Drug Price Painkiller Paracetamol Rs 2.45 Crocin Rs 11 Calpol Rs 10.70 Paracetamol syrup Rs 9.00 Crocin (syrup) Rs 15 Febrex Rs 20.50 Diclofenac sodium + Rs 4.4 Diclogesic Rs 19.40 paracetamol Antibiotic Amoxycilin Rs 13.2 LMX Rs 40 Remox Rs 38.7 Azithromycin Rs 41.8 Azee Rs 107 Azithral Rs 128.55
Is there a difference in quality between generic drugs and branded ones?This is a question which is hard to answer and polarises theentire medical fraternity – doctors, chemists, pharmaceuticalreps, etc. Some of them say that they are as good as brandedones while others feel that they are of poorer quality. Doctorsand chemists have the impression that they are less effective.In fact some doctors avoid prescribing generic drugs as far aspossible and even go to the extent of handing out freesamples of branded drugs to patients who can’t affordbranded medicines. Doctors also aren’t aware about theiravailability due to lack of advertising and marketing. On theother hand a pharma rep we talked to was of the opinion thatthere is no difference in quality and a generic drug was asgood as a branded one.
Why aren’t generic drugs more popular?• There are various reasons for their unpopularity. There is a distinct lack of awareness about them. Before the Satyamev Jayate episode only a handful of people knew them. Also since they are cheap, people who can afford branded drugs don’t buy them believing them to be of inferior quality. Chemists have to hand out exactly what’s written on the prescription and most doctors except in government hospitals don’t hand out generic drugs.• An insider felt that private doctors would never hand out generic drugs because there are no kickbacks or incentives involved from pharma companies. According to a highly placed source in the MCI, the body has very little say in the doctor-pharma relationship. Most guidelines are blatantly ignored. The government or specifically the government’s Department of Pharmaceuticals is also to blame for the lack of awareness. The DoP has failed to do a good enough job of promoting generic drugs and the aforementioned failure to implement the Jan Ausadhi scheme reinforces that.
How to promote generic drugsGeneric drugs are the answer to better healthcare for all.India has one the highest out-of-pocket healthcareexpenditure in the world and despite providing very cheapservices (compared to rates of the countries like USA and UK)it’s still inaccessible to many due to poor purchasing power.The only way to promote generic drugs is to curb illicitmedical practices. Though the MCI guidelines dictate thatdoctors should prescribe generic medicines as far as possible,very few private practitioners actually do it. There’s a need tostrengthen the Jan Ausadhi scheme and break down thedoctor-big pharma nexus. Moreover the MCI needs toprovide more practical guidelines rather than an archaic set ofrules which simply can’t be followed in the real world.
Whats the difference between brand-name and generic prescription drugs ?A brand-name drug product is originally discovered and developedby a pharmaceutical company. In order for the company to marketand sell their product they must first gain approval from the Foodand Drug Administration (FDA) by submitting a New DrugApplication. In this documentation the company submits data toestablish a drugs clinical safety and efficacy. Other studiesdetermine the characteristics of the drug dosage form, includingthe manufacturing process, drug stability, purity, strength, andhow it dissolves. Once the drug receives FDA approval, theinnovator company can then exclusively market and sell thisbrand-name product for as long as the company has patentprotection. A 2000 study published in the Journal of HealthEconomics estimated that bringing a new drug to market costs theinnovator on average $802 million over a period of 10 to 15 years.A patent allows the innovator to sell its product exclusively inorder to recoup money spent during development and to generatea profit.
The difference between a brand-name product and a generic one isdesigned to be transparent. Once the patent life expires on abrand-name drug product, it is eligible to be made into a "genericdrug." To do this, the generic drug manufacturer must ensure thatthe drug they are producing contains the same active ingredient(s)as the brand-name product, in the same dosage form, at the samedose or concentration, and for the same route of administration(for example, amoxicillin 500 milligram (oral) capsule). The drugmay differ in color, shape, taste, inactive ingredients, preservativesand packaging, however. Because of these differences, the genericdrug manufacturers are required to submit additional paperworkto the FDA to prove that their product is manufactured inaccordance with good manufacturing practices (GMPs), and is aspure and stable as the brand-name product. Additionally, thegeneric needs to meet pharmacokinetic parameters in the body,which means it must dissolve (in a beaker) at the same rate and tothe same extent as the original. This process ensures that the twoproducts are bioequivalent because if product A and product Bdissolve in a virtually identical manner, then they should behavethe same in the body.
Thus, a drug that contains the same active ingredient, in the same amount, in the same form, dissolving at the same rate in equal amounts may be granted acceptance for substitution for a brand-name product. If it is accepted, the drug can be prescribed no differently than the brand-name product. Once all the equivalency tests have been conducted, the generic drug is considered a therapeutic equivalent. This means that the drug will do the same thing via the same mechanism, and will also follow the same distribution, metabolism and elimination pathways in the body. One publication that lists this sort of information is called the Orange Book. This publication rates generic drugs in accordance with their respective brand-name products and gives the FDA substitution recommendations. The FDA website (www.fda.gov) is also a very good source