INTRODUCTION OF GENERIC MEDICINE IN HUMAN & LIVESTOCK HEALTH SECTOR & ITS ECONOMIC IMPACT IN INDIA
Compiled & Edited by-DR RAJESH KUMAR SINGH ,JAMSHEDPUR,JHARKHAND, INDIA, 9431309542,rajeshsinghvet@gmail.com
&
Ashutosh kumar singh, Chairman, SAWASTH BHARAT( NAYAS), Author “GENRICONOMICS”
A generic drug (generics) is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient. A generic must contain the same active ingredients as the original formulation. According to the US Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic propertie s. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy and intended use. In most cases, generic products are available once the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years
Introduction to generic and branded medicines—
Generic medicines are those which contain the same active ingredient(the ingredient which acts to cure the condition the medicine is used to treat) in the same quantity as a brand-name medicine. Generic medicines therefore have the same effect on the body in terms of curing disease as the brand-name medicines which they copy.
However, generic medicines are sold using a different name and may contain different inactive ingredients (ingredients that give the product its taste, shape texture, smell, et cetera, but which do not affect the body to relieve health conditions) compared with their branded counterparts. They should not be confused with counterfeit medicines, which are illegally manufactured copies that may or may not contain the same active ingredient.
The number of generic medicines being distributed in India is increasing. This is a move supported by the Modi government, who have implemented a number of strategies to encourage the use of generic medicines because they are often cheaper than brand-name medicines. Use of generic medicines may also have cost benefits for the consumer , livestock farmers and for pharmacies.
Although the use of generic medication is gradually becoming more widely accepted by Indian Allopathic doctors and consumers, many consumers in India (and overseas) have a mistrust of generic medicines. Furthermore, use of generic medication is still a controversial issue amongst doctors.
The generic pharmaceutical industry is growing, and these medicines are likely to become more common in India in the future. Increased education about generic medicines and the similarities and differences between generic and brand-name medicines is needed to allow consumers and livestock farmers to make informed choices about which medicines they use. There is also a need for education regarding the testing that is carried out to ensure generic medicines are safe and have the same effect on the body as the brand they copy (known as therapeutic bioequivalence). Consumers also need to be aware of the risks that can be associated with switching from branded to generic medicines or vice versa.
What are branded medicines?—————
A branded medicine is the original product that has been developed by a pharmaceutical company. When a company develops a new medicine, their product must undergo and pass rigorous tests and evaluations to ensure that it is both effective in curing the condition it claims to treat and safe for human use. Because pharmaceutical companies invest considerable amounts of money to develop a new medicine, they are given the sole right to manufacture and distribute the medicine for a period of time.
When a pharmaceutical company is given sole rights of manufacture and distribution, the medicine is said to have a patent on it. A patent is a technical description of what the drug is and what it is used for. For a period of time after the patent is granted, no one else can produce a drug that is the same as the patented drug; the medicine belongs exclusively to the original company. For this reason, branded medicines are the most well known and most trusted type of that particular medicine.
What are generic medicines?———–
A generic medicine is a copy of the original branded product. Once the patent for the original product has run out, the pharmaceutical company who developed the medicine no longer has the exclusive right to produce and distribute the medicine. Other pharmaceutical companies are able to create their own version of the medicine.
The type and quantity of the active ingredient in the generic product is the same as the branded version, but the inactive ingredients are slightly different. The generic medicine is sold under a different brand name and it may look different (e.g. in colour or shape) to the original.
Pseudo-generic medicines———
A pseudo-generic product is not a remake of the original; it is an exact replica of the original. It is made by the same company with exactly the same ingredients in the same way. The only difference is the name and packaging.
These medicines are usually marketed by the same manufacturer at the same price as the original. Pharmaceutical companies make pseudo-generic products to combat true generics and to discourage competitor pharmaceutical companies from entering the market for that particular medicine.
Fillers, binders and lubricants———
The inactive ingredients in a medicine can include substances such as lactose, dyes and gluten. For the majority of people, making changes to these ingredients does not change the effectiveness or safety of the medicine. The differences in formulation and production will, however, change the appearance of the medicine, for example the shape, colour, taste or texture. Changing the appearance of a medicine does not change the effect it has on the body, although it may affect the ease with which a person takes the medicine (e.g. how easy it is to swallow).
Differences between generic and branded medicines are important for people who have allergies and intolerances to some of the inactive ingredients used to make the medicine. Therefore it is very important to discuss any allergies you may have with your doctor and pharmacist before you take any medication, and before you switch from using a brand-name medicine to a generic medicine or vice versa.But this is not so important in case of large animals particularly ruminants ,of course in case of pets this point is taken in to consideration.
Medicine labeling————
All prescription medication will have the brand name on the label. This is the name with the registered or copyright sign attached to it. Underneath the brand name will be the name of the active ingredient in the product. In the case of a branded and generic medicine that copies it, the label for each medicine will have a different brand name, but the same active ingredient.
What is therapeutic bioequivalence?
In order for a generic medicine to successfully enter the pharmaceutical market, it must be bioequivalent to the branded medicine. That is, the effect the generic medicine has in the body must be statistically the same as the effect the original medicine has in the body.
To determine whether two medicines are bioequivalent, a pharmaceutical company needs to scientifically show that its generic medicine has the same bioavailability as the branded medicine. That is, the medicines need to have similar absorption, distribution, metabolism and excretion.
Differences in the formulation of the generic medicine can influence these pharmacokinetic properties, and therefore can potentially affect a medicine’s safety and efficacy. For most generic medicines, the property differences from the original medicine are subtle and do not alter its overall bioavailability or its effectiveness in treating the condition it is intended for.
However, subtle changes in formulation and inactive ingredients may have significant effects in medicines with narrow therapeutic windows (the dose range in which the medicine is effective and safe). If a medicine with a small therapeutic window becomes even slightly better absorbed, a small proportion of the medicine will become more accessible in the circulation. As a result, the medicine plasma concentration (concentration of the medicine which enters the blood) could exceed the maximum therapeutic limit and potentially be unsafe.
On the other hand, if changes to the manufacturing of a medicine reduce its bioavailability, there may not be enough of the active ingredient absorbed into the body to have the desired effect. The medicine may not work as well to cure the condition it is intended for.
For these reasons, the generic medicine must undergo rigorous bioequivalence testing in order for the Therapeutic Goods Administration (TGA) to approve them for sale as generic medicines. Once a pharmaceutical company has successfully demonstrated to the TGA that the generic product is bioequivalent to the original, it can produce and market the generic. The generic medicine can also be considered for listing on the pharmaceutical benefits scheme (PBS).
Bioequivalence testing———
Bioequivalence trials are not as time-consuming, costly or large-scale as clinical trials, which companies that develop new medicines must conduct to prove the safety and effectiveness of their product. However, bioequivalence trials are still considered to be rigorous evaluations of the generic medicine.
What do bioequivalence tests assess?——
The aim of the trials is to compare the bioavailability of the generic medicine in question to that of the branded medicine. The bioavailabilities of the medicines are determined by:
• Peak plasma concentration: This is the maximum concentration the active ingredient reaches in the person’s blood, measured by testing a blood sample. The concentration varies based on the time since the medicine was taken. Before taking the medicine, a person will not have any active ingredient in their blood. After taking the medicine, the concentration will increase as the active ingredient is absorbed, until it reaches the peak concentration. It will then reduce until all the medicine has left the person’s bloodstream (unless more medicine is taken);
• Time taken to reach peak plasma concentration: Measured by taking a series of blood samples and recording the amount of time between the person taking the medicine and the blood sample with the peak plasma concentration being drawn.
How is bioequivalence testing conducted?———
Usually, 20–40 healthy participants/ livestocks are used to assess the bioequivalence of two medicines. Each participant takes a dose of the branded medicine and a dose of the generic medicine, on separate occasions. It is important to leave a sufficient period of time between taking the two medicines to ensure that the first medicine has been completely eliminated from the person’s body (there is no active ingredient in their bloodstream).
The dose for both will be the same because the generic medicine must contain the same amount of active ingredient as the branded medicine. Because different bodies absorb, metabolise and eliminate medicines differently (e.g. absorption may be different in two people with different body weights), the same people take both types of medicine. Any differences between their bodies will therefore be the same for both the generic and the branded medicine tests.
What conditions must be satisfied for medicines to be considered bioequivalent?
For two medicines to be considered bioequivalent, the results of bioequivalence testing must be statistically equal in terms of peak plasma concentration and time to reach peak plasma concentration. However statistical equivalence does not mean that the two medicines are exactly the same.
Two medicines are considered bioequivalent when the values obtained from the tests are within the 80–125% range. This means that the average peak plasma concentration and time to reach peak plasma concentration for the generic medicine cannot be more than 20% below or 25% above the average values for the branded medicine.
Advantages of generic drugs————
The major advantage of generic medicine use is the cost benefit. Generic medicine cannot be marketed at a price higher than the branded medicine, so it is often a cheaper option, both for the consumer and the government who pays for part of the cost of the medicine under the Pharmaceutical Benefits Scheme. This may help people to take their medications as prescribed by the doctor.
More expensive medicines can sometimes affect people’s/ livestock farmers ability to strictly adhere to the dosage schedule prescribed by the doctor, especially when there are many repeats and the medicine has to be purchased on multiple occasions. In many cases, not finishing all repeats will have negative health effects: the medication will not treat the intended condition as well as it should – for example, a person’s infection may not be completely eliminated if they stop taking antibiotic medicines too early (although they will often feel fine when they stop taking the medicine). Having cheaper medication available makes it financially easier to continue with the medication for the whole duration of the prescription.
However, over two-thirds (68%) of generic medicines are the same price as the original in human and in case of animal health sector the cost are almost same as the branded medicines. Despite this, research shows that over half of people (55%) don’t ask their pharmacist if the generic is any cheaper before purchasing it. If cost is the same, most Indian (95%) would prefer the original medicine their doctor prescribed over the generic their pharmacist is offering.But reverse is the case in animal health sector, here farmers has very little knowledge about branded & un branded due to low level of education and they used to take the medicine as advised by their vets or pharmacists and paying the same cost for un branded generic medicines.
Disadvantages of generic medicines———
Consumer confusion
Without properly understanding the similarities and differences between generic and branded medicines, it is easy to become confused and anxious about taking a new medicine. This is particularly the case when someone is used to taking a certain medicine and is introduced to a new medicine that has a different name and appearance but is ‘the same’. But this confusion is almost nil in case of livestock farmers of India because majority of them don’t know the difference.
There are two main points that you need to understand if you are considering the switch to generic medication in human and to some extent in pets:
- Even though a generic medicine may taste, look and be packaged differently, it has the same active ingredient as the branded medicine you are used to taking. Therefore, the two medicines cannot be taken together. This will lead to an overdose of that particular medicine. Always remember that one replaces or is substituted for another.
- The generic medicine has been thoroughly tested by the pharmaceutical company and the TGA. The generic medicine is interchangeable with the branded medicine. This means that it will have the same actions in the body as the original medicine. The only differences exist in the inactive ingredients, which will not have any negative effect unless you have an allergy or intolerance. However, when treating certain critical conditions such as epilepsy, the normally acceptable equivalence range is too large. In these cases, your doctor will include instructions on the prescription that substitutes should not be used and the pharmacist must not offer you a substitute.
Not understanding that the new medicine is substituting a medicine already being taken can lead to:
• Decrease in medicine adherence due to confusion and anxiety about taking the new medicine; or
• Overdose toxicity due to taking both the branded and generic forms.
If you are not comfortable with the concept of generic substitution, do not switch medicines.
How to minimise confusion———
Doctors be it MBBS or VETERINARIANS ,play a very important role in reducing confusion about generic medicines because their patients take advice about medicine from them and trust their doctor to prescribe effective medicines. Your doctor can assess any potential risks and help with any questions you may have about the new medication.
Make sure you have gathered all the information you need in order to understand and feel comfortable with generic medicines by following some simple guidelines:
• Education: Take the time to ask your doctor to explain the basic principles of generic medication. Ensure you understand the concept of active and inactive ingredients. Become very familiar with the active ingredient in the medication you are taking. The active ingredient is always printed on the label of every medication. By knowing what active ingredient you need to take, you will not be confused by different brand names.
• Consistency: Being consistent with your brand decision is very important. If you have switched to generic medication once, it is recommended that you continue with that brand. Multiple medicine switches will increase confusion.
• Medicine review: Make appointments to review your medications with your doctor. This will help you feel in control of the medication requirements and give you the opportunity to ask any questions you may have.
• Instructions/labels: Basic labels and instructions can be attached to medicine packaging that state clearly the dosing requirements. You can ask your pharmacist to add Label 15 to the new medication: “This medicine replaces […]. Do not use both.”
Why choose the branded medicine rather than the generic medicine?
WHY WE SHOULD USE GENERIC DRUGS???
Health care costs continue to rise. Therefore, consumers, providers and policymakers need to assess the best way to keep health care affordable. Without adversely affecting access to quality care, with prescription drug (branded drug) costs serving as a major contributor to cost escalations, generic drugs offer an important tool for reducing the rate of growth in overall health expenditure. As more and more patents expire, the generic portion of the pharmaceutical market is expected to continue for increased sales. While brand name drugs certainly play an important role in medicine, generic drugs are a cost effective alternative. Pharmaceutical costs are increasing faster than any other portion of the health care expense. Not only are generic drugs cost effective, but they are safe. Generic drugs are bioequivalent to their brand name twins. As generics tend to be older, they are generally less risky than new drug therapies. Generic drugs offer sound treatment options for patients. So patients should be told about the generic drugs and myths should be solved that “costlier will be effective.” If all these things go hand in hand generic drugs may make the medical costs cheap and a relief for the people living in economic struck nations.
For many people, substituting a generic copy for a brand name medicine is safe. However, you should not substitute the brand of medication you are taking if any of the following situations apply to you:
- You do not understand the change and feel anxious;
- Your doctor specifically tells you that substitution for your condition is associated with risks;
- You are allergic or intolerant to an ingredient in the substitute;
Five reasons to prescribe medicines using generic rather than brand name———
Generic prescribing is promoted in many countries as a way of reducing pharmaceutical costs. In the India , Modi govt. has launched the schemes the PRADHANMANTRI JAN AUSHADHI PARIYOJNA to encourage generic medicine besides it many non government organizations like SAWASTH BHARAT (TRUST) is also running pan India awareness programme. The Chairman of this trust SAWASTH BHARAT (NAYAS)Mr Ashutosh kumar singh has recently published his book GENRICONOMICS on this topic . This is the unique book of its kind in India.
You don’t have to remember different brand names
- You don’t have to remember which brand is currently subsided
- There is less potential for confusion and error, especially when brand names are similar
- Less expensive medication brands can be used more often, allowing other medicines to be funded
- Pharmacists can dispense the medication in stock without having to consult the prescriber
- The generic name provides a guide to the drug’s pharmacology and chemical class
WHY GENERIC DRUGS ARE INTRODUCED———
The principal reason for the relatively low price of generic medicines is
? Competition increases among producers when drugs no longer are protected by patents. Companies incur fewer costs in creating the generic drug, and are therefore able to maintain profitability at a lower cost to consumers. The costs of these generic drugs are so low that many developing countries can easily afford them.
? Generic manufacturers do not incur the cost of drug discovery and instead are able to reverseengineer known drug compounds to allow them to manufacture bioequivalent versions.
? Generic manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company.
? A brand name company enjoys a period of “market exclusivity” or monopoly, in which the company is able to set the price of the drug at a level which maximizes profitability. This price often greatly exceeds the production costs of the drug, which can enable the drug company to make a significant profit on their investment in research and development, thus enabling them to fund the research and development of new medicines which most generic companies doesn’t undergo all these things.
? Introduction of competition, which prevents any single company from dictating the overall market price of the drug. Competition is also seen between generic and name-brand drugs with similar therapeutic uses when physicians or health plans adopt policies of preferentially prescribing generic drugs as in step therapy.
? Multiple firms producing the generic version of a drug the profit-maximizing price generally falls to the ongoing cost of producing the drug, which is usually much lower than the monopoly price.5
MYTHS ABOUT GENRIC DRUGS————-
? Misbranded drugs: Generally people think that generic drugs are misbranded because of change in the color, taste, appearance than original (ethical drug). But alterations of the color, taste, appearance is the part of the generic formulations and they are not misbranded.
? Duplicate drugs: Due to their change is the brand name or shape of the of dosage shape packing, some may think the drugs are duplicate.
? Rejected drugs and fake drugs: Due to cheap price of the generic drugs, it is generally thought that generic drugs are rejected form the company that is why they are selling for the low price.
? Drugs manufactured at third party manufacturing unit: This myth is in the mind of the wholesaler or the retailer that the drugs which are manufactured at some other plant which is not company’s own plant. Generally this true because generic drugs are generally manufactured at small scale industry but it is not applicable in all the cases.
? Ineffective drugs: People also have a mindset that “costlier will be effective”. They think that there is surely something wrong with the medicine because it is too cheap
Pharmaceutical Regulations in India——-
A generic drug can be defined as “a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.” A generic drugshould essentially contain the same active ingredients as in the original formulation. A generic drug is similar or bioequivalent to a brand drug in dosage form, route of administration, strength, quality, performance characteristics, safety, and intended use. In spite being chemically identical to generic drugs they are sold at considerable discount from the branded price.
Generic Drug Approval Process in India—————-
The following documents are required for the approval of generic drugs in India:
1.
Form 44.
2.
Treasury Challan of INR 15,000 is required, provided all the active ingredients have been approved in India for >1 year, or INR 50,000 if any of the active ingredients is approved for <1 year.
3.
Source of bulk drugs/raw materials: For the ingredients which are approved and treated as new drugs. In case the applicant has a manufacturing license for bulk drugs, he needs to submit a copy of the same. Alternatively, the consent letter from the approved source is to be provided concerning the supply of material.
INDIAN SCENARIO———
In India, the pharmaceutical sector is regulated by the bodies and acts mentioned in the Table . The regulation of manufacture, sale and distribution of drugs is primarily the concern of state authorities while central authorities are responsible for approval of new drugs and clinical trials, laying down the standards for drugs, control over the quality of imported drugs, coordination of the activities of State Drug Control Organizations providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. Central Drugs Standard Control Organization (CDSCO) under Ministry of Health and Family Welfare is the pivotal agency dealing with all drug related issues. This organization deals with all new drug approvals, review of new safety information regarding approved drugs, approval and safety review of fixed-dose combinations, medical devices, and implants. All endocrine and metabolic drugs are covered by these organizations and acts. Food supplements (including many herbal products) are regulated by separate laws since they are legally not considered drugs.
Table
Drug regulatory apparatus in India
In India, drug testing laboratories are located at central and regional levels which are entrusted with the job of ensuring production and availability of quality medicines. Besides all this India needs a proper policy guideline for price controlling, efficacy and distribution channel for generic medicine to common people not only for human but also for animals ,pets and livestock then only the dream of our PM could be fulfill .By providing low rate generic medicine to our livestock farmers we can reduce the cost of productions of agriculture/ livestock produce drastically which will ultimately help in their income increament.
Till now under the Pradhan mantari janausadhi pariyojana more than 4500 janausadhi store has been opened throughout India.
