Generic Medicines – Frequently Asked Questions | Trusted Generic Provider – Medkart

1. Does a generic medicine have any side effects?

Well, when one decides to switch from branded to generic medicines, the question arises on safety that does a generic drug have side effects? Will it be allergic to me? But, the answer is no.
Generic drugs are made to work like branded drugs. Drug manufacturers must show that generic medicines can be substituted for brand-name products and give the same benefits as their brand-name equivalents. After that, only the government will allow them to sell in the market. WHO-GMP and CDSCO, these firms ensure the quality, dosage, route of administration, and side effects of the generic drug are the same as its branded drug. For example, Metformin is a Glucophage’s approved generic version, a drug used for type 2 diabetes. These are prescription drugs and available in the same strengths. They are also prescribed in the same quantity and have the same instructions for taking them. So, like a branded one, generic drugs do not have any extra side effects. They both are similar in all aspects.

So, as mentioned above, generic drugs do not have any other side effects. It has the same side effects as the branded drug you take. But exceptions are always there:

These include,

1. Allergy to inactive ingredients. In generic medicines, inactive ingredients are different from branded ones, and a few people sometimes allergic to that. So they can develop unwanted effects in the body. So before you switch, you should check it.

2. When you are on the narrow therapeutic index, you are taking a drug that has particular concentration, and minor change in that concentration can create significant differences. Small variations in dosage or blood concentration can create serious problems. Well, this is also rare. 

Thyroid drugs are usually told to be specific; a minor change in it can be hazardous. So for everyone, it is advisable to ask the doctor before you switch the medicine.

2. For you did generic medications actually work better than the name brands you used?

It depends. Let me tell you why.
Generic medicines are copies of a branded one. It is cheaper just because it is a copy, not the original one. But many of us think it may not work the way branded drug works. But this is not true. Generic drugs are being made when branded drugs become successful. So when generic drug made, government ensure that generic drugs are bioequivalent, that means, generic medicine has the same effect as the branded ones.

There is barely a 5-10% difference between the development of a generic drug and the advertised one. Both types of medications have the same key ingredients, formulations, safety precautions, dosage and route of administration, power, secondary effects, and expiry date to ensure the safety and effectiveness of both medications. Packaging, color, size, and shape may differ due to the difference in an inactive ingredient and modulation. So this difference may change the absorption of the drug, but the rate is not more than 5 percent. Yet the main active ingredient is still the same. So, as they make generic medicine bioequivalent, they work equally. Whether you take branded or non-branded drugs, effectiveness will be the same. It is just a matter of price. So, yes, generic drugs work equally, not less, or more than name brands one uses.

3. Is there any risk associated with generic medicines?

Less cost of generic drugs usually raises the question that is there any risk with generic medicine? But the answer is No. generic medicines have the same quality, effectiveness, and reliability as a branded one.

A generic drug is a drug with the same active ingredient as the brand drug. Yes, this is true. Both drugs contain an exact active ingredient which is responsible for disease cure. The reason for its fewer prices is that generic drugs are copies and do not have to pass through clinical trials, research, sales, and manufacturing cost, like branded drugs. But that does not mean it makes generic drugs less effective. 

Generic medicines also have to pass through certain protocols before coming into the market, like branded ones. Once the manufacturer makes generic medicines, he has to prove that generic is bioequivalent to the branded drug. The standards of generic pharmaceutical products are assured by rigorous inspection of WHO-GMP, CDSCO (Central Drug Standard and Control Organization), and other state regulatory bodies.

So, before coming into the market, efficiency, strength, reliability, dosage, route of administration, safety, quality, and expiry date have been measured; if it is proved that it is the same as the branded drug, then only it can be sold into the market. Therefore, whatever generic medicine you buy from the market has no risk; however, one should always take care of fraud or fake pharmaceutical products.

4. What do people think about generic medicine and what the Indian government is dispending with the Jan Aushadhi initiative?

Even after providing enough knowledge, people still believe generic medicines are not as effective as the branded ones. So they do not opt for a generic one and spend money to get a branded one. Also, many doctors do not recommend or prescribe generic medicines to their patients. The government has taken the initiative to increase the usage of generic drugs and make people aware of generic medications.

This campaign is known as Jan Aushadhi Yojana or Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana Kendra (PMBJP). This campaign’s main motive is to supply generic medicine at a lower price but with the same quality and effectiveness as expensive branded drugs. The government of the Department of Pharmaceuticals has established BPPI (India’s Bureau of Pharmaceutical Public Sector Enterprises) through the Jan Aushadhi Stores, with the assistance of all CPSUs to organize purchase and supply and marketing of generic drugs. Nowadays, almost every third or a fourth person suffers from one or other diseases, be it cholesterol, cancer, or any other medical condition. Medications are so expensive that almost 50 to 60% of income is wasted into it. So to curb this problem government has initiated this program. It is claimed that this campaign saves roughly 43 percent of income per person.

For example, many cancer drugs in branded categories cost up to Rs 6500 but are available at Rs 850 in Jan Aushadhi Kendras. Almost Rs 2,000 to Rs 2,500 crore are saved by purchasing generic drugs for the ordinary man. The goal of the scheme is to minimize out-of-pocket health care expenses by offering high-quality generic medicines at rates that are affordable to the customer.

At the start, the Jan Aushadhi Kendra or outlet was dispensing only a few generic therapeutic medicines, but now it has expanded to almost all kinds of drugs and surgical equipment. Now nearly every state has JAS (Jan Aushadhi Store) to help poor people and give them medicine at a low cost. To expand this campaign, the government provides financial support up to 2.50 lakhs rupees to open Jan Aushadhi Stores; however, the condition is that one has to employ a pharma degree holder as a pharmacist.

This way, the Jan Aushadhi initiative is making people aware of generic medicines by giving at the best-tested quality and cheaper rate, especially the poor person. Besides, the government is also offering financial assistance to expand this campaign more and more.

5. What is generic medicine?

A generic drug is a replica of branded medicines that have the same active component, exact dosage, and therapeutic effect, route of administration, safety, strength, and risk as to the original drug.
In the market, two types of medicines are available: branded and non-branded/ generic. Branded medicines are made after several clinical trials, research, and approval. After several clinical trials over the years, patented drugs (branded drugs) are produced. When a company produces a new drug, a patent may be requested. Only that particular company will manufacture the drug before the expiry of the patent period. Any other company cannot replicate it. When the patent expires, other companies, along with that company, will produce the same medicine with some differences. Such drugs are called GENERIC MEDICINES.

In generic medicines, the main active or therapeutic ingredients are the same as branded ones; however, change in inactive ingredients is there, which is why only generic drugs look different from those of the branded drug. The generic drug effect is the same as the branded one because, before coming into the market, generic has to pass through the bioequivalence test done by WHO_GMP and CDCSO. By this, they check whether drugs are the same as branded one or not and also ensure its safety. This suggests that the main ingredients, applications, safety protocols, dosage, and route of administration, strength, side effects, and expiry date are the same as a branded drug that maintains the efficacy and reliability of the generic drug.

The main difference between both drugs is cost. Generic medicines are cheaper than the branded one because generic does not have to compensate for the cost of marketing and sales or clinical trials and research, like branded one. All these have already done before for the original drug.
So, Generic medicines are a bioequivalent version of branded one, available at a cheaper rate.

6. What is the difference between generic and normal medicine?

Nowadays, everywhere we listen about generic medicines, even the government also asking us to use generic drugs. But many of us don’t know what it is. So, what is the difference between generic and normal medicine? 

Pharmaceutical companies make two types of drug one is a patent branded drug, and the other is a generic drug. However, both drugs are similar in all manners except cost and external appearance. Yes, generic drugs are the same as branded ones but available at low cost and in different shapes, sizes, and colors. Otherwise, the drugs have the same active chemical component, dosage, safety, risk, side effects, expiry date, route of administration, and strength. In generic medicines, inactive ingredients and modulation are different from the branded drug, which causes differences in color, size, shape, or packaging of both products.

The difference in cost is due to its working process; the branded drugs come into the market after years of clinical trials and research followed by lots of sales and marketing that make them costly. But generic medicines are made when branded medicine’s patent expires at that time manufacturers make copies of the branded drug, keeping the main ingredient the same, and they do not have to do any research or clinical trial. 

Also, branded medicines are already established, so very little marketing needed for their generic drugs. Consequently, lots of copies are made and sold at a cheaper rate.

Thus, it can be said that there is no difference between these two drugs; generic medicine is bioequivalent to the original one only.

7. What is the working process of generic medicine?

Like non-generic or branded medicine, generic medicine has to go through several protocols. However, as they are copies of already established drugs, specific procedures are not needed in it. The difference between making a branded and generic medicine is not more than 5% to 10%.

Usually, generic drugs come into the market when the patent of its original drug expires. That means, when a company launches a new drug, the firm has already spent money on research, development, effectiveness, results, marketing, and promotion of products. After lots of clinical trials, the drug gets a patent. Drug Controller General of India (DCGI) runs under CDSCO. It has the primary responsibility of regulating clinical trials, look into matters such as product approval and standards, the introduction of new drugs, and import licenses for new medicines. Once a patent is granted, the company gets the rights to sell the drugs into the market. This can be done as long as the license is valid. 

Once the patent expires, the manufacturer again gets approval to make copies of drugs from the original, known as “generic drugs.” But in this, lengthy clinical trials are not needed as the active chemical component is the same in generic drugs. Before coming into the market, generic drugs also have to pass through specific protocols, not as extensive as branded ones. Manufacturers have to prove the bioequivalence of generic medicine. Then the quality of generic drugs is ensured by WHO-GAMP and CDSCO and state regulatory authorities via thorough inspections. 

Generic medicines can only be launched if they have the same efficiency, main active ingredients, strength, dosage, and route of administration.

So this is the working procedure of generic medicine.

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