FACTS ABOUT GENERIC DRUGS

FACTS ABOUT GENERIC DRUGS

Q: What are generic drugs? 
A: A generic drug is a copy that is the same as a brand-name drug in dosage, safety, and strength, how it is taken, quality, performance, and intended use.

Q: Are generic drugs as safe as brand-name drugs? 
A: Yes. The FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.

Q: Are generic drugs as strong as brand-name drugs? 
A: Yes. The FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.

Q: Do generic drugs take longer to work in the body? 
A: No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.

Q: Why are generic drugs less expensive? 
A: Generic drugs are less expensive because generic manufacturers don't have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment--including research, development, marketing, and promotion--by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, other manufacturers can apply to the FDA to sell generic versions. Because those manufacturers don't have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, almost half of all prescriptions are filled with generic drugs.

Q: Are brand-name drugs made in more modern facilities than generic drugs? 
A: No. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices. The FDA won't permit drugs to be made in substandard facilities. The FDA conducts 3,500 inspections a year to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.

Q: If brand-name drugs and generics have the same active ingredients, why do they look different? 
A: In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.

Q: Does every brand-name drug have a generic counterpart? 
A: No. Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.

Q: What is the best source of information about generic drugs? 
A: Contact your physician, pharmacist, or insurance company for information on your generic drugs. Also, visit the FDA Web site at www.fda.gov/cder/ogd/.

LIST OF GENERICS IN INDIA

Brand name(india)	Generic name	Clinical use
Alfusin extent tab/afdura tab/fual tab	Alfuzosin	In treatment of benign prostatic hyper plasia in men with prostate enlargement
Faximab/Reopro	Abciximab	Anti thrombolytic agent
Acamprol/	Acamprosate	Anti-alcoholic agent
Rebose/ Acraz/ Glucobay/  K –Carb/ Recarb/ Acarwin	Acarbose	Anti diabetic for type-2
Acitrom Tab/ Nistrom Tab	Acenocoumarol	Anti-coagulant in thrombolytic disorders
Lorcet-HD/ Lortab/ Vicodin	Acetaminophen	Narcotic pain reliver
Codomolindon Tab/ Neofebrin Tab/ Zimalgin Tab	Acetaminophen and Codeine	Pain fever & cough
Acetamide Tab/ Acetamin Tab/  Zolamide Tab	Acetazolamide	For glaucoma & edema due to CHF & acute mountain sickness
Gluton-600/ Mucotab/ Mucomelt-A/ Lumenac	Acetylcysteine	For chronic bronchial pulmonary disease & cystic fibrosis
Aceret Cap/ Acetec Cap	Acitretin	Severe psoriasis
Acivir Dispertab/ Alovir Tab/ Clovirax Dispertab/ Psyvir Tab	Acyclovir	Herpes & chicken pox
Difra Gel/ Vandep/  Aclene/ Acneril/ Zolvee cream	Adapalene	Severe acne
Adfovir/ Adheb	Adefovir dipivoxil	Hep-b/herpis
Albex Tab/ Albazole Susp/  Zencid Tab/  Wormin-A Tab/ Zentic Tab/  Olban Tab	Albendazole	Giardiasis/tape worm infections/trichinosis
Aerotide Tab/ Alkarex-Pd Syr/ Salbusun Tab/ Ventorlin Inhaler	Albuterol (Salbutamol)	Asthma
Ados Tab/ Ralenost-10 Tab/ Zophost Tab	Alendronate	Osteoporosis in men & women & paget’s disease& for osteoporosis resulted by steroid treatment
Supracal-A/ Cad Alpha/ Calcif/ Kalcid	Alfacalcidol	Hypoparathyroidism/ osteomalacia/ renal osteodystrophy
NA	valsartan	High bp
Masse Cream	Allantoin	psoriasis
Zytol Dispertab/ Satric Tab/ Aloric Tab/ Aloriv Tab/ Alurid	Allopurinol	For gout & for to lower uric acid levels in chemotherapy
Prolin-A Tab/ Pregnol Tab/ Loestrol Tab/ Prolin-A Tab/ Gynerol Tab	Allylestrenol	To prevent recurrent pregnancy loss
Alzolam Tab/ Alprax Tab/  Eurelax Tab/ Alzopax Tab	Alprazolam	Anti anxiety
Alpostin Amp/ Bioglandin Amp	Alprostadil	For erectile disfunction
Aludrox MH Gel/ Acirid	Aluminum Hydroxide and Magnesium Hydroxide	Ulcers & for stomach indigestion
Amantral cap.	Amantadine	anti-viral and antiparkinson agent& treating certain types of flu
Zyrcof/ Pedicof-M / Ambicet/ Mucolite D	Ambroxol	Bronchiectasis/  chronic inflammatory pulmonary conditions/ bronchitis with bronchospasm asthma
Amiphos Inj	Amifostine	preventing kidney damage due to chemotherapy
Akcin Vial/ Alkanit Inj/ Nosomik Vial/	Amikacin	For serious bacterial infections
Biduret Tab	Amiloride and Hydrochlorothiazide	Diuretic prescribed for high bp & congestive heart failure
Zulpride	Amisulpride	Anti psychotic agent for schrezopenia
Hamostat Tab	Aminocaproic Acid	Antidote/prescribing for excessive bleeding caused by fibrinolytic drugs
Biofylin Amp/  Aminophylline Tab	Aminophylline	asthma, bronchitis and emphysema
Zepine/  Amlogard	Amlodipine	High bp & chest pain
Basoquin	Amoidoquine	Anti malarial agent
Blumox Cap/ Arimox-D Cap	Amoxicillin	Anti biotic
Ambisome Inj	Amphotericin B	Serious fungal infections
Sulbacin Vial/ Saltum Inj Vial	Ampicillin and Sulbactam	Skin/gynaecological/abdominal infections
NA	Inamrinone	Heart failure
Altrol Tab	Anastrozole	Breast cancer

What is Pharmacovigilance, career options. job description, prospects,pay-scale,growth prospect,

What is Pharmacovigilance?

Abbreviated as PV or PhV, Pharmacovigilance is the science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines.  Generally speaking, it is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological, herbalism and traditional medicines with a view to:

• Identifying new information about hazards associated with medicines
• Preventing harm to the patients.

Why should students opt for Pharmacovigilance as their career options?

Pharmacovigilance is a great career option for life science and pharmacy graduates. It is a scientific discipline that is primarily concerned with reporting and analyzing of drug side effects. It is primarily due to the work of Pharmacovigilance professionals that the drugs in the market that we consume are mostly safe and those that are found harmful are taken off the market. Pharmacovigilance professionals continuously monitor the safety of the drugs in clinical trials as well as the drugs already being sold in the market. After a drug side effect is reported, the Pharmacovigilance professionals enter the event in relevant databases, follow up with the case to gather more information and forward these reports to regulatory authorities and other applicable bodies. The Pharmacovigilance professionals identify signals in data that may point towards a potential side effect and probe the case further.

About a career in drug safety or Pharmacovigilance

Those seeking a role in drug safety or pharmacovigilance should hold a life sciences degree or a nursing, pharmacy or medical degree. There are also postgraduate courses that could be of benefit to a candidate seeking a role in this sector, such as a Master in Pharmacovigilance.

This course covers a variety of important aspects of the career, including reporting, report writing, signal detection and risk management, as well as providing a thorough understanding of the regulatory bodies around the world.

For anyone looking to find a job in pharmacovigilance or drug safety, previous experience in the industry is of great value. Alternatively, a clinical background and first-hand experience with adverse reactions can be advantageous so nurses and pharmacists can also be attractive candidates.  

A career in drug safety and pharmacovigilance will generally start with a position as a drug safety associate, officer, scientist or coordinator. Responsibilities will then progress to senior specialist or management roles, often with an in-depth knowledge of a specialty area, such as medical writing, auditing, medical affairs or quality assurance.

Finding a pharmacovigilance job or drug safety position abroad can also be a great opportunity for those seeking a career in this sector and opportunities are prevalent, although generally in the larger companies.

How has the sector fared so far?

Setting up of stringent laws by regulatory bodies (e.g. US-FDA, DCGI, EMEA etc.) has led to the adoption of a systematic Pharmacovigilance framework worldwide. This in turn had led to the creation of large number of jobs pertaining to this field.

Worth of Pharmacovigilance market worldwide was US $186 million in 2008 and is estimated to reach US $ 2,253 by the year 2015.

At present, India is the fourth largest producer of pharmaceuticals in the world and therefore is a surfeit of drug brands with more than 6,000 licensed drug manufacturers and over 60,000 branded formulations. India offers unique advantages for the growth of Pharmacovigilance that include:

• Rapid induction of New Chemical Entities (NCEs) and high technology pharmaceutical products in market
• Abundance of patients with genetic diversity
• Presence of Lakhs of formulation in domestic market
• Presence of large number of licensed drug manufacturers in India
• Potentially large world scale Adverse Drug Reaction (ADR) database

Job description:

A Pharmacovigilance professional does the following:

• Track all adverse event reports received and completed;
• Review and assess all source documents, and compile data in an adverse event report;
• Data enter report into the safety database;
• Code adverse events in the safety database;
• Perform labeling assessment of adverse events, comparing adverse event to adverse events previously reported and contained in the product label;
• Release report to safety database

Job prospects:

Starting salaries for freshers are substantially a function of their educational background, varying from year to year as well as across organizations and domains.

The following represents the typical work place hierarchy.

• The Entry level job for life science graduate is DSA (Drug Safety Associate). DSAs are mainly involved in case creation, checking for MSI ( Minimum safety information – a patient, a reporter, a suspect drug and a adverse event ), reconciliation and follow-up process, data entry of all information available in the document and medical coding
• Once an individual acquires an experience of 2-3 years in that position and builds the required skill sets (Medical coding, narrative and scientific writing, good understanding of medical terms and basic understanding of regulatory affairs, ICH-GCP and compliance etc) he can go on to become a DSS (Drug Safety Scientist).
• Individuals  once having acquired a good narrative writing experience can pursue it on a larger frame, moving from individual cases like writing for PSUR(Periodic Safety Update Report) and PADER(Periodic Adverse Drug Experience Reports) and as well as becoming a Aggregate report scientist.
• With an overall of 7-10 years experience in this position individual can easily become a Team lead or Team manager based on the company.
• Lastly, individuals end up acquiring the position of a Director or Vice-President with an experience of 9-10 years.

Pay-scale:

• Fresher:  Rs 15,000-20,000
• After 5 years: Rs 50,000-60,000
• After 10 years: More than Rs 80,000-90,000

Growth prospect:

Individuals trained in Pharmacovigilance will find good job options in the following sectors:

• Pharmaceutical Companies (MNCs & Indian) & Biotech companies.
• Clinical Research Organizations.
• KPOs like Accenture & Quintiles.
• Regulatory Agencies like DCG (I) & CDSCO
• Pharmacovigilance units in Medical colleges & Hospitals

Besides this, students might land up in companies like:

Asian clinical trials serene, Bioserve, Clin invent, Clintec international, Clinigene, Dr Reddy’s lab, Elly Lilly,  Glaxo smithkline, IGATE clinical research, Intass biopharmaceuticals, Johnson & Johnson, Lambda therapeutic research, Lupin limited, Matrix laboratories ltd., Merck, Novartis, Novo Nordisk, Pfizer, Pharmanet, Quintiles, Ranbaxy, Roche India, Sristek, Siro Clinpharma, Synchron, Sanofi Aventis, Torrent pharma, Vimta labs, Zydus,  Reliance life science,  Amed,  Accutest, Actimus, Adroit insights, Alembic, Asian Clinical Trials.

Some of the best institutes to study Pharmacovigilance

·         ICRI (Indian Institute of Clinical Research - India)

·         Catalyst Clinical Services are

Courses can be pursued to become a Pharmacovigilance professional

·         ICRI’s Post Graduate Diploma in Clinical Research and Pharmacovigilance

·         Catalyst's Professional Certificate in Pharmacovigilance