Understanding How The Indian Pharmaceutical Industry Works

The Indian Pharmaceutical Industry is around $ 17 billion in industry (2016) with as many as 20,000 registered companies (including MNCs and small scale units) directly or indirectly involved in the drug sales business. India is different as the lowest cost drug producer in the world. India also has the fur as the largest exporter of generic drugs in the world, we have some great franchises like Lupine, Sun Pharma etc.

Terminology

API-Active Pharmaceutical Ingredients

• These are the basic drugs themselves with the desired pharmaceutical properties of drugs, also known as mass drugs.

Intermediate - Most chemical reactions are wise steps, namely they take more than one basic step to complete and intermediaries are formed in the process of making an API called an intermediary.

Dose or Formulation Completed - This is the form where the medicine is consumed by us. The drug dosage form usually consists of two things: API, which is the drug itself; and excipients, which are substance tablets, or liquids suspended by the API.

Oncology - Oncology related to cancer prevention, diagnosis and treatment.

Tentative Agreement - A tentative agreement was given before the expiration of patent exclusivity for blockbuster drugs, but companies that received tentative approval were unable to market drugs in the US until they received final approval.

Blockbuster Drug - Blockbuster drugs are very popular drugs that generate annual sales of at least $ 1 billion for companies that sell them. Blockbuster drugs are generally used to treat general medical problems such as high cholesterol, diabetes, high blood pressure, asthma and cancer.

DMF - Master Drug File - API manufacturers need to submit a document known as a drug master file (DMF) with a regulatory body. The Drug Master File (DMF) is a submission to the FDA that can be used to provide confidential detailed information about facilities, processes or articles used in the manufacture, processing, packaging and storage of one or more human drugs.

New Drug Applications - The final step officially taken by drug sponsors, which applies to the Food and Drug Administration (FDA) for the approval needed to market new drugs in the US. The NDA is a comprehensive document with 15 sections covering data and analysis on animal and human studies, drug pharmacology, toxicology and dosage, and the manufacturing process. When the NDA is submitted, the FDA has 60 days to decide whether to submit it for review, or reject it because some of the information needed is lost. The aim of the FDA Drug Evaluation and Research Center (CDER) is to review and act on at least 90% of NDA for standard medicines within 10 months after application is received, and six months for priority medicines.

YOU (New Drug Abbreviations Application) - New Drug Applications Abbreviation is "abbreviated" because they do not require applicants to conduct clinical trials and require less information than the New Drug Application. If YOU are approved, generic drugs will be listed in the Orange Book, which lists all drugs that are FDA-safe and effective. YOU contains all the information that needs to be evaluated about how safe and effective the proposed generic drug is compared to its brand name. The FDA will not approve generic drugs unless they are equally safe and effective.

Bio Similars - Bio similar is an approved drug that is very similar to a biological product that is FDA approved, and does not have clinically meaningful differences in the safety or effectiveness of products that were originally approved. However, similar bio chemically is not identical to the drug they are referring to, and may include a slight difference. Medical practitioners or pharmacists do not have the freedom to give drugs that are similar to their biology.

PARA 1 - Submission of Para 1 was made at the time of the launch of generic drugs when innovators had not provided the necessary information in the orange book.

PARA 2 - The 2 submissions are made when the drug is not patent.

PARA 3 - Submission of Para 3 is done when the applicant has no plans to sell generic drugs until the original drug is not patent.

PARA 4 - Submission of Para IV for the launch of generic drugs is carried out when the applicant believes the product or use of the product does not violate the innovator's patent or if the applicant believes such a patent is invalid or cannot be enforced.

Chronic Disease - A chronic condition is a condition of human health or a persistent disease or its effects last long. The chronic term is usually applied when the course of the disease lasts for more than three months.

CRAMS - Research Contracts and Manufacturing - One of the fastest growing segments in the pharmaceutical and biotech industries. This is related to outsourcing research services / manufactured products to low-cost providers with world-class standards.

Generic drugs - Generic drugs are drugs that are not branded but are similar to branded drugs or references in terms of dosage, administration and performance.

505 (b) (2) - The 505 (b) (2) new drug application (NDA) is one of the three drug approval lines of the US Food and Drug Administration (FDA) and is a regulatory strategy that is attractive to many clients. 505 (b) (2) The NDA contains a full security and effectiveness report but allows at least some of the information needed for NDA approval, such as information on safety and efficacy on active ingredients, can come from studies not carried out by or for the applicant.

Biology - Biology produced in living systems such as microorganisms, or plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules. Many biologics are produced using recombinant DNA technology.

Exclusivity Period - Period of exclusivity refers to certain delays and prohibitions on the approval of competing drugs available under the law attached to the approval of certain drugs or supplements. The period of exclusivity is designed to promote a balance between new drug innovations and greater public access to drugs resulting from generic drug competition.

Custom Chemical Synthesis CCS - Custom Chemical Synthesis is the implementation of chemical reactions that aim to obtain a product, or several products. This occurs by physical and chemical manipulation which usually involves one or more reactions. In the use of modern laboratories, this tends to imply that the process can be reproduced, reliable, and established to work in several laboratories.

FTF (First to File) - First to file is another category where even before the first five years after a company can challenge the drug if it is agreed that the company gets 180 days of exclusive approval to market the generic version of the Innovator drug. This can prove very beneficial for challengers if given. On the other hand there is a Litigation Risk in which Innovators try to prove that the challenger has violated his patent / process when developing a generic version.

Innovator drugs - Generic drugs are bio-equivalents with drugs that have brand names, also called drug innovators. It will have a different name and will look different from its fellow innovators, but the active ingredients will be the same.

Expenditures - Sell properly with halal recipes. Recipes can only be filled out by pharmacists, veterinarians, dentists or registered medical profession members. The law requires that prescriptions be written only for patients who are in doctor's care.

CFA (Clearing and Forwarding Agent) - These organizations are mainly responsible for maintaining the stock of the company's products and forwarding SKUs to stockists on request. Most companies save 1-3 CFA in each Indian state. On average, a company can work with a total of 25-35 CFA. CFA is paid by the company every year, once or twice, based on a percentage of total product turnover.

Stockist - He is a distributor, who can simultaneously handle more than one company (usually, 5-15 depending on the area of??the city), and can reach even 30-50 different. They pay for the product directly on behalf of the pharmaceutical company after 30 to 45 days.

Bio-equivalence - Bio-equivalence is the similarity between two drugs which basically means both have the same effect on patients. Bio equality means that two drugs release their active ingredients into the bloodstream in the same amount and at the same level. When assessing how well generic drugs work, scientists evaluate bio equivalence with name-brand versions.

CGMP - Current Good Manufacturing Practices, CGMP must follow current guidelines to produce the best quality pharmaceutical products.

Children's exclusivity - another 6 months added to the existing patent exclusivity.

Orphan Drug Exclusivity - To treat diseases that affect fewer than 200,000 people in the United States. The law on drugs offers tax breaks and a seven-year monopoly on drug sales to encourage companies to develop and manufacture these drugs, which in turn might not be profitable because of the small potential market.

Type of medicine

There are two types of medicine:

Drug innovator

Generic drugs

Drug innovator

Narcotics were formed from the start, so a very strict and even patent process was fulfilled which caused a huge price of drugs in the life of his patent because there were no competitors. And when a drug goes out patent at that time the price falls around 70%. Usually players who get a 180-day exclusivity angle of 60% of this market as their brand are established.

Drug Development Life Cycle

Development of the Drug Life Cycle is a complex and very long process that lasts 10-15 years. 1000 tests carried out on drugs throughout the country. The team of researchers from various laboratories worked hard day and night to analyze the disease. When a new drug is launched there is a clinical trial conducted by first submitting it. We have a drug development phase regulated by authorities such as the FDA, this phase is phase 1, phase 2, phase 3 etc.

iscovery

Is the first stage. This is the process by which the drug is found and / or designed. We identify cellular and genetic factors that play a role in certain diseases and need 10-15 years for drug approval.

Development

This is the phase where promising compounds are converted into marketable products. This is the process of taking new chemicals through the various stages needed to enable them to be tested in human clinical trials.

Pre-clinical test

The beginning of the drug approval process. To see the potential effects on humans, tests were carried out on: Isolated tissue, cell and animal cultures. The company decides whether to enter drugs into the human testing process, based on the selling power of the product and their financial situation. On average, only one compound in a thousand can really be tested by humans

Submission of NDA

After the desired results from Phase III, a New Drug Application (NDA) will be submitted. The NDA contains data that supports drug efficacy and safety. Approval can take 2 months to several years, but on average it takes around 18 to 24 months. Medications must be reviewed continuously, ensuring that no side effects arise. After FDA approval, this drug can be marketed and distributed.

Patent

Generally it lasts for 20 years. Because most companies file patents during pre-clinical trials, patents are usually only good for 10 years or more after FDA approval. What can be patented - products, methods and uses.

2. Generic drugs

Generic drugs are drugs that are made the same as trademark drugs that have been marketed in dosage forms, security, strength, route of delivery, quality, performance characteristics and intended use. This similarity helps to show bio equality, which means that generic drugs work in the same way and provide the same clinical benefits as the brand name version. In other words, it can be treated as an equivalent substitute for its brand name partners.pharmaceutical drug intermediate