 The Drugs and Cosmetics Act 1940 and Rules
1945 have been enacted with the objective of
regulating the import,manufacture,distribution
and sale of drugs and cosmetics.
 SCHEDULE W:
 • List of drugs marketed under generic names.
 • Its label contain the name and quantities of
active ingredients.
 • If vitamins are present, the following words
must be written,
 “ For therapeutic use”
 “For prophylactic use”
 “For paediatric use” and age of child/infant

 This includes only five drugs that shall be
marketed under generic names only :
 1. Analgin
 2. Aspirin and its salt
 3. Chlorpromazine and its salt
 4. Ferrous sulfate
 5. Piperazine and its salt
 • (Schedule W ) - Inserted as per G.O.I
Notification No. GSR 27 ( E) dt 17.1.1981 and
deleted as per G.O.I Notification No. GSR 94 ( E)
dt 8.2.2000

 A generic drug is a medication created to be
same as an existing approved brand name,
drug in dosage form,safety,strength,route of
administration,quality and performance
characteristics.
 A generic drug is a medication that has
exactly the same active ingredient as the
brand name drug and yields the same
therapeutic effect.
 It is the same in dosing , quality , strength ,
safety , the way it works , the way it is taken ,
and the way it should be used.

 However when a generic drug is first approved and
marketed , cost may remain high(although less
than the brand name drug)for 6 months because
the FDA will give the first generic manufacturer a
“180-day exclusivity period”.
 The”180-day exclusivity ” is assigned to the
generic manufacturer who is the first to file an
ANDA and has done the additional work to get the
generic drug to market.

 Both look different in size , shape and color
 Might have inactive ingredients(drugs are
made up of active and inactive ingredients .
Some people may be sensitive to inactive
ingredients.)
 Generic drugs may vary by manufacture ,
which means you could receive different
versions based on where you purchase your
medication and what type of generic may
dispense
 Generic cost less than the brand name drug

BRANDED DRUGS GENERIC DRUGS
Strict quality control Strict quality control
High manufacturing cost Low manufacturing cost
High retailer margin Low retailer margin
High marketing investment Low marketing investment

 An example of generic drug ;
 Drug used for Diabetes is METFORMIN its
Brand name is GLUCOPHAGE
 Drug used for Hypertension is METAPROLOL
its Brand name is LOPRESSOR

Name of Salt Dosage Pack
Average Market
Price of
Branded
Medicines(Rs.)
Prices of Generic
Medicines (Rs.)
Tablet
Ciprofloxacin
250 mg 10 55.00 11.10
Tablet
Ciprofloxacin
500 mg 10 97.00 21.50
Tablet
Diclofenac SR
100 mg 10 51.91 3.35
Tablet
Cetrizine
10 mg 10 37.50 2.75
Tablet
Paracetamol
500 mg 10 13.56 2.45
Tablet
Nimesulide
100 mg 10 38.66 2.70
Cough Syrup 110 ml
bottle
33.00 13.30

Product Company
Price
(Rs.)
Ramipro 5mg Cap Emcure Pharma 30.00
Ziram 5mg Capsule 10s FDC 46.65
Proace 5mg Capsule 10s Alembic Pharma 47.50
Bpace-5 Cap Claris 62.40
Servace 5mg Capsule 10s Bal Pharma 67.00
RAMIPRIL 5MG BRANDS IN INDIA :

Product Company
Price
(Rs.)
Quinobid
200mg Tablet
10s
Micro Labs 38.42
Olfi-200 Tab Ipca Labs 40.00
Entof 200 Mg
Tablet 10s
Deys 44.00
Oflomil-200
Tab
Glenmark 44.60
Otox-200Tab Franklin Labs 45.00
OFLOXACIN 200MG BRANDS IN INDIA :

Product Company
Price
(Rs.)
Cefiglen 200mg
Tablet 10s
Glenmark 55.00
Mahacef-200
DT
Mankind
Pharma
65.00
Milixim 200mg
Tab
Glenmark 67.18
Ceftas 200 Mg
Tablet 10s
Intas 78.48
Hifen-200 DT Lyka 79.00
Extacef-200
Tab
Blue Cross 79.00
Raxim-O-
200mg Tab
Zydus Cadila 8
CEFIXIME 200MG BRANDS IN INDIA :

Product Company
Price
(Rs.)
Algina 650mg Tablet 10s Geno Pharma 9.70
Febrinil 650mg Tablet 10s SVIZERA HEALTHCARE 17.05
Paracip 650 Mg Tablet 10s Cipla 19.50
Lanol ER 650 Cap Lyka 19.90
Doliza-ER 650mg Tab Ranbaxy 19.96
Parafizz 650 Mg Tablet 4s Cipla 21.48
Dolopar 650mg Tablet 15s Micro Labs 28.05
PARACETAMOL 650MG BRANDS IN INDIA :

Product Company
Price
(Rs.)
Blumox-500 DT Blue Cross 8.00
Symoxyl 500
Mg Capsule 6s
Abbott India 40.78
Blumox-500
Cap
Blue Cross 62.35
Moxipal 500mg
Capsule 10s
Jagsonpal
Pharma
63.51
Moxywil 500mg
Capsule 10s
Zeelab 63.90
Erox 500mg
Tablet 10s
Micro Labs 65.63
AMOXYCILLIN 500MG BRANDS IN INDIA :

 WHY DO GENERIC DRUGS COST LESS?
 As per the study conducted by Journal of Drug Delivery
and Therapeutics, about 62% of healthcare providers
want to substitute generic drugs but not for all the
cases they treat, thus indicates the perception of the
efficacy of the two classes of medicines.
 With the escalating cost of healthcare facilities, many
people in India started to opt for generic medicines.
The solution of generic medicines is way cheaper than
branded drugs and is backed by the Government of
India which made it mandatory for the physicians to
prescribe the generic names. Generic medicines are
affordable versions of the branded drugs which are
introduced once the patent acquired by the drug
manufacturer expires. These drugs are dispensed
either by a brand or salt name.

 Generic drugs are only cheaper because the
manufacturers have not had the expenses of
developing and marketing a new drug. When a
company brings a new drug onto the market, the
firm has already spent substantial money on
research, development, marketing and promotion
of the drug. A patent is granted that gives the
company that developed the drug an exclusive
right to sell the drug as long as the patent is in
effect.

 Generic medicines are usually identical as a
proprietary drug that has a brand name because
of which the chemical composition of the
medicine is sold as. Without any difference, the
generic drug is the same in potency, dose, and
method of intake, quality, and implications and
works the same as the branded medicine. As per
Indian household, the term ‘generic’ implies the
drug is a cheaper, less effective and duplicate
version of the brand name product. In reality,
generic drugs are of the same quality and as
effective as of the branded medicine. These
medicines might contain Inactive Pharmaceutical
ingredients like suspending agents, demulcents
etc which do not disturb the body for curing
illness.