How are generic medicines made

1. How are generic medicines made? medbuzz.in/blogs/how-are-generic-medicines-made Introduction The increasing popularity of generic medicines in India has made everyone curious to know what generic medicines are and how they work. As a consumer, it is necessary for us to know and understand the process involved in making these generic drugs because they are the ones who will be consuming it. Before we step into how the generic medicines in India are made, first let’s have a brief outlook of what generic medicines are and how they are working as a substitute for branded medicines, and what makes them popular among doctors and patients. What are generic medicines? A generic medicine is a drug that is the same as its branded counterpart in terms of strength, dosage, quality, administration, safety, characteristics, uses, and efficiency. These medicines are equally effective as compared to the branded ones. They provide the same clinical benefits as branded ones. The generic medicines in India use the same ingredients used by branded medicines and have the same side effects and benefits as their counterpart. Benefits of generic medicines Generic medicines have many advantages for countries like India as it can considerably reduce healthcare costs and put less burden on the patients. It will help cut the medical bill much and provide patients with practical and cost-effective solutions. Some of the advantages of using generic medicines are- 1/3

2. 1. Cost-effective - the generic medicines are pocket-friendly and do not burn a hole in the pocket. They are 85% less expensive than the branded medicines as reported by the FDA. They save you a hell of a lot of money. They are more readily available than the usual branded medicines and hence your usual medical store is a generic medical store only. 2. Effectiveness- the generic medicines are equally effective as the branded ones. They have a similar composition and are safe to use. Their usage, quality, and strength are also the same as branded medicines. So, generic medicines can be opted for as an alternative to the branded ones and hence can be purchased from any generic medical store 3. Easy availability- the generic medicines are readily available over the counter. The patient need not explore and visit different stores to find it. There are a lot of alternatives available to the branded medicines in the market, which can be easily purchased from a generic medical store The process of making generic medicines in India Any company involved in the pharmaceutical business first does research and development on the product, which may or may not be successful. If the research is successful and the product comes into the market, it also simultaneously files it. Having a patent right would ensure that no other company can replicate the same drug for the next five years. This way, the company eliminates competition for some time and establishes its name and brand in the market. This means the company has a monopoly over the medicine for that period. It can sell the medicine at higher prices, which it can utilize for further R & D. The patent rules differ from country to country. In India, the patent lasts for a full of 5 to 7 years. Till this time, it can sue any company that uses its name or copies the medicine made by them. After the patent is finished, the market is open for all. The rate of the medicine goes down, and the competition becomes stiff. The generic medicines in India manufacturers make the exact copy of the branded medicine, which has been developed initially. They do not do any research and development on it. They spend the money on the promotion of the brand instead. How to test the effectiveness of generic medicines in India? The manufacturing company doesn’t involve in the R&D of generic medicines, but they are FDA approved, making it safe and quality tested to use. The FDA conducts a rigorous review and checks to ensure that the generic medicines comply with all the rules and regulations. About 3500 inspections of the manufacturing plant are conducted every year by the FDA. The staff also monitors the products regularly to ensure that the medicines are safe, effective, and sound in quality from the inception till the end. Suppose the medicine reacts negatively to any patient. In that case, FDA investigates and asks the company to alter the medicine ingredients so that it is not harmful to the consumers. FDA requires the generic drug manufacturer to show and prove the effectiveness, quality, and safety of their medicines compared to their branded version. The 2/3

3. abbreviated new drug application (ANDA) submitted by the drug companies should show that they comply with all the guidelines and rules to receive FDA approval. The following procedures to be followed - 1. The active ingredients in generic medicine should be the same as that of the branded medicine. You can have the same checked and verified at any of the generic medical stores that you purchase your medicine from. 2. The generic medicine should have the same strength, usage, administration, form, and use as the branded version. 3. The inactive ingredients of the generic medicine can be different and would be acceptable. 4. The generic drug will be manufactured to the same standards as branded medicines. 5. The container in which the generic medicine will be sold should be appropriate, and the label should be the same as the branded medicine. Conclusion The generic medicine market has expanded vastly, and it continues to grow even more as time passes by. Using generic medicines as a substitute for branded medicines doesn’t mean compromising with the product’s quality as the FDA observes strict rules for the generic medicines as the branded ones. In terms of rate and absorption, the generic product must be proven equal to the original product. Therefore, the pharmacists must understand the process of approval of generic medicines so that the consumer’s questions are answered, and a safe and potable product is delivered. At Medbuzz, we are an online generic medicine website and generic medicine app that provides cost effective and easy to home delivery services for people who want to buy generic medicines. If you choose to buy generic medicines online or otherwise, at Medbuzz, we can help you cut down your medical bills by over 70%. Do place your order on our online generic medicine website or our generic medicine app that is available for download on both iOs and Android. Also Read : Why do generic medicines not work the same 3/3