Saturday, 27 June 2020

Pharmaceuticals:- Stats and Facts

Pharmaceuticals:- Stats and Facts




India is currently the largest producer of generics drugs in the world.

India contributes to 40% of the United States’ generic demand and over 50% of global demand for various vaccines.

Share of generic drugs in India’s pharmaceutical market revenue is 70%.

China is the largest API-producing country in the world. 

Gujarat is considered the “pharma capital” of India (Gujarat absorbs up to 18% of investment in pharmaceuticals).

Hyderabad is considered as the "Bulk Drug Capital of India" 

Top AIDs drugs manufacturer worldwide is GlaxoSmithKline.

AbbVie’s Humira "(adalimumab)" is currently the world's top-selling drug (19.2 billion US dollars sales worldwide in 2019). Humira is a branded biologic medication (Tumor necrosis factor (TNF) blocker) used to treat rheumatoid arthritis and other conditions.  

The Most Expensive Prescription Drugs in the World is Zolgensma (by Novartis). Zolgensma is approved by USFDA in 2019 to treat spinal muscular atrophy (SMA).The drug is Priced $2.1 million per dose.

The richest pharmaceutical company in the world is  Pfizer (2019 revenues $51.75 bn).

Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

Serum Institute of India Pvt. Ltd. is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses each year). Serum Institute of India is ranked as India's No. 1 biotechnology company. About 65% of the children in the world receive at least one vaccine manufactured by Serum Institute.

TAPI (Teva Active Pharmaceutical Ingredients) is the leading manufacturer of APIs in the world.

Germany exported the highest dollar value worth of drugs and medicines during 2019 (US$56.9 billion).

 


Serum Institute - Pride of India




 

Serum Institute - Pride of India

 

Ø Serum Institute of India Pvt. Ltd. is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses each year)

Ø Serum Institute of India is ranked as India's No. 1 biotechnology company.

Ø About 65% of the children in the world receive at least one vaccine manufactured by Serum Institute.

Ø Vaccines manufactured by the Serum Institute are being used in around 170 countries across the globe in their national immunization programs.

Ø Serum Institute of India was founded in 1966 by Dr. Cyrus Poonawalla.

 


Saturday, 20 June 2020

USFDA’s Inspections Program for Human Drugs

USFDA’s Inspections Program for Human Drugs

 

The Office of Regulatory Affairs (ORA) is the lead office for all field activities at the FDA. They are responsible for conducting the inspections.

FDA prioritizes inspections by risk and gives higher risk situations a higher priority.

 Generally FDA conducts 4 types Audits

Pre-Approval Facility Evaluations And Inspections

Pre-Approval Facility Evaluations and Inspections directly support the assessment of marketing applications by assuring that any manufacturing facility named in the application is capable of manufacturing the drug in conformance to Current Good Manufacturing Practice (CGMP) requirements and that the data submitted in the application are accurate and complete.

Post-Approval Facility Inspections

Post-Approval Facility Inspections are similar to Pre-Approval Facility Inspections in that they are product specific, but are conducted after applications have been approved. This type of inspection focuses largely on the process validation lifecycle and any manufacturing changes that may have occurred following approval. Changes in perceived risk may also initiate such an inspection, even in cases where a Pre-Approval Inspection was not deemed necessary.

Surveillance Facility Inspections

This type of inspection is meant to monitor the conformance to CGMP requirements and is not necessarily an assessment of a specific product. Rather, it is a system-based inspection. The purpose of this type of inspection is to identify quality problems and adverse trends at facilities so that the FDA can develop strategies to mitigate them.

For-Cause Facility Inspections

This type of inspection is meant to gather additional information to determine the quality of marketed product and to determine whether enforcement actions are warranted.

 

Criteria for USFDA’s Pre Approval Inspections

First time facility is named in an application

First application by the applicant

First ANDA for an approved drug

New molecular entity

Narrow therapeutic range drugs

New manufacturing process or dosage form for facility

High – risk API

Numerous applications or site, process or product changes

OAI status or no recent inspections

More General Criteria

Difficult to manufacture drug

Site compliance Record

Corporate compliance Record

Recent inspections

Supply chain risks

 

Criteria for FDA Surveillance Inspections

Compliance history of the establishment

Record, history and nature of recalls linked to the establishment.

Inherent risks of drugs manufactured, prepared, propagated, compounded or processed at the establishment.

Inspection frequency and history of the establishment.

Inspections by foreign regulators

Patient exposure

Hazard signals (e.g., FARs, adverse events)

Inherent product risks

 

 



Narrow Therapeutic Index (NTI) Drugs

Narrow Therapeutic Index (NTI) Drugs

 

Therapeutic Index : A ratio that compares the blood concentration at which a drug becomes toxic and the concentration at which the drug is effective. The larger the therapeutic index (TI), the safer the drug is.

 Narrow therapeutic index drugs are drugs where small differences in dose or blood concentration may lead to serious therapeutic failures and/or adverse drug reactions that are life-threatening or result in persistent or significant disability or incapacity.

Examples of NTI drugs includes, aminoglycosides, ciclosporin, carbamazepine, digoxin, digitoxin, flecainide, lithium, phenytoin, phenobarbital, rifampicin, theophylline and warfarin


Saturday, 13 June 2020

What is Insulin Glargine


 

 

What is Insulin Glargine

 

 


Insulin Glargine is a long-acting, man made version of human insulin(insulin analogue) used for the treatment of hyperglycemia caused by Type 1 and Type 2 Diabetes. Insulin glargine works by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy.It also stops the liver from producing more sugar.

Insulin Glargine offers better glucose control with the convenience of once daily injection versus the discomfort of multiple daily injections and reduces the possibility of developing hypoglycemia (low blood sugar). It is prescribed for adults with Type 2 diabetes as well as adults and pediatric patients (children 2 years and older) with Type 1 diabetes.

Insulin glargine is produced by recombinant DNA technology using a non-pathogenic laboratory strain of Escherichia coli (K12) or yeast cell,Pichia pastories,which is genetically engineered to express the human Insulin Glargine protein,when grown in culture,which is then purified and formulated. 


Monday, 8 June 2020

Drugs and their Classifications




Analgesics:

Drugs that relieve pain. There are two main types: non-narcotic analgesics for mild pain, and narcotic analgesics for severe pain.

Antacids:

 

Drugs that relieve indigestion and heartburn by neutralizing stomach acid.

Antianxiety Drugs:

 

Drugs that suppress anxiety and relax muscles (sometimes called anxiolytics, sedatives, or minor tranquilizers).

Antiarrhythmics:

Drugs used to control irregularities of heartbeat.

Antibacterials:

Drugs used to treat infections.

Antibiotics:

 

Drugs made from naturally occurring and synthetic substances that combat bacterial infection. Some antibiotics are effective only against limited types of bacteria. Others, known as broad spectrum antibiotics, are effective against a wide range of bacteria.

Anticoagulants and Thrombolytics:

 

Anticoagulants prevent blood from clotting. Thrombolytics help dissolve and disperse blood clots and may be prescribed for patients with recent arterial or venous thrombosis.

Anticonvulsants:

Drugs that prevent epileptic seizures

Antidepressants:

There are three main groups of mood-lifting antidepressants: tricyclics, monoamine oxidase inhibitors, and selective serotonin reuptake inhibitors (SSRIs).

Antidiarrheals:

Drugs used for the relief of diarrhea. Two main types of antidiarrheal preparations are simple adsorbent substances and drugs that slow down the contractions of the bowel muscles so that the contents are propelled more slowly.

Antiemetics:

Drugs used to treat nausea and vomiting.

Antifungals:

Drugs used to treat fungal infections, the most common of which affect the hair, skin, nails, or mucous membranes.

Antihistamines:

Drugs used primarily to counteract the effects of histamine, one of the chemicals involved in allergic reactions.

Antihypertensives:

Drugs that lower blood pressure. The types of antihypertensives currently marketed include diuretics, beta-blockers, calcium channel blocker, ACE (angiotensin- converting enzyme) inhibitors, centrally acting antihypertensives and sympatholytics.

Anti-Inflammatories:

Drugs used to reduce inflammation - the redness, heat, swelling, and increased blood flow found in infections and in many chronic noninfective diseases such as rheumatoid arthritis and gout.

Antineoplastics:

Drugs used to treat cancer.

Antipsychotics:

Drugs used to treat symptoms of severe psychiatric disorders. These drugs are sometimes called major tranquilizers.

Antipyretics:

Drugs that reduce fever.

Antivirals:

Drugs used to treat viral infections or to provide temporary protection against infections such as influenza.

Barbiturates:

See "sleeping drugs."

Beta-Blockers:

Beta-adrenergic blocking agents, or beta-blockers for short, reduce the oxygen needs of the heart by reducing heartbeat rate.

Bronchodilators:

Drugs that open up the bronchial tubes within the lungs when the tubes have become narrowed by muscle spasm. Bronchodilators ease breathing in diseases such as asthma.

Cold Cures:

Although there is no drug that can cure a cold, the aches, pains, and fever that accompany a cold can be relieved by aspirin or acetaminophen often accompanied by a decongestant, antihistamine, and sometimes caffeine.

Corticosteroids:

These hormonal preparations are used primarily as anti-inflammatories in arthritis or asthma or as immunosuppressives, but they are also useful for treating some malignancies or compensating for a deficiency of natural hormones in disorders such as Addison's disease.

Cough Suppressants:

Simple cough medicines, which contain substances such as honey, glycerine, or menthol, soothe throat irritation but do not actually suppress coughing. They are most soothing when taken as lozenges and dissolved in the mouth. As liquids they are probably swallowed too quickly to be effective. A few drugs are actually cough suppressants. There are two groups of cough suppressants: those that alter the consistency or production of phlegm such as mucolytics and expectorants; and those that suppress the coughing reflex such as codeine (narcotic cough suppressants), antihistamines, dextromethorphan and isoproterenol (non-narcotic cough suppressants).

Cytotoxics:

Drugs that kill or damage cells. Cytotoxics are used as antineoplastics (drugs used to treat cancer) and also as immunosuppressives.

Decongestants:

Drugs that reduce swelling of the mucous membranes that line the nose by constricting blood vessels, thus relieving nasal stuffiness.

Diuretics:

Drugs that increase the quantity of urine produced by the kidneys and passed out of the body, thus ridding the body of excess fluid. Diuretics reduce water logging of the tissues caused by fluid retention in disorders of the heart, kidneys, and liver. They are useful in treating mild cases of high blood pressure.

Expectorant:

A drug that stimulates the flow of saliva and promotes coughing to eliminate phlegm from the respiratory tract.

Hormones:

Chemicals produced naturally by the endocrine glands (thyroid, adrenal, ovary, testis, pancreas, parathyroid). In some disorders, for example, diabetes mellitus, in which too little of a particular hormone is produced, synthetic equivalents or natural hormone extracts are prescribed to restore the deficiency. Such treatment is known as hormone replacement therapy.

Hypoglycemics (Oral):

Drugs that lower the level of glucose in the blood. Oral hypoglycemic drugs are used in diabetes mellitus if it cannot be controlled by diet alone, but does require treatment with injections of insulin.

Immunosuppressives:

Drugs that prevent or reduce the body's normal reaction to invasion by disease or by foreign tissues. Immunosuppressives are used to treat autoimmune diseases (in which the body's defenses work abnormally and attack its own tissues) and to help prevent rejection of organ transplants.

Laxatives:

Drugs that increase the frequency and ease of bowel movements, either by stimulating the bowel wall (stimulant laxative), by increasing the bulk of bowel contents (bulk laxative), or by lubricating them (stool-softeners, or bowel movement-softeners). Laxatives may be taken by mouth or directly into the lower bowel as suppositories or enemas. If laxatives are taken regularly, the bowels may ultimately become unable to work properly without them.

Muscle Relaxants:

Drugs that relieve muscle spasm in disorders such as backache. Antianxiety drugs (minor tranquilizers) that also have a muscle-relaxant action are used most commonly.

Sedatives:

Same as Antianxiety drugs.

Sex Hormones (Female):

There are two groups of these hormones (estrogens and progesterone), which are responsible for development of female secondary sexual characteristics. Small quantities are also produced in males. As drugs, female sex hormones are used to treat menstrual and menopausal disorders and are also used as oral contraceptives. Estrogens may be used to treat cancer of the breast or prostate, progestins (synthetic progesterone to treat endometriosis).

Sex Hormones (Male):

Androgenic hormones, of which the most powerful is testosterone, are responsible for development of male secondary sexual characteristics. Small quantities are also produced in females. As drugs, male sex hormones are given to compensate for hormonal deficiency in hypopituitarism or disorders of the testes. They may be used to treat breast cancer in women, but either synthetic derivatives called anabolic steroids, which have less marked side- effects, or specific anti-estrogens are often preferred. Anabolic steroids also have a "body building" effect that has led to their (usually nonsanctioned) use in competitive sports, for both men and women.

Sleeping Drugs:

The two main groups of drugs that are used to induce sleep are benzodiazepines and barbiturates. All such drugs have a sedative effect in low doses and are effective sleeping medications in higher doses. Benzodiazepines drugs are used more widely than barbiturates because they are safer, the side-effects are less marked, and there is less risk of eventual physical dependence.

Tranquilizer:

This is a term commonly used to describe any drug that has a calming or sedative effect. However, the drugs that are sometimes called minor tranquilizers should be called antianxiety drugs, and the drugs that are sometimes called major tranquilizers should be called antipsychotics. 

Vitamins:

Chemicals essential in small quantities for good health. Some vitamins are not manufactured by the body, but adequate quantities are present in a normal diet. People whose diets are inadequate or who have digestive tract or liver disorders may need to take supplementary vitamins.