We live in a drug oriented society!!

Headache? Take a painkiller

Stomach ache? Antacids
Tired? Grab a cofee
Want to relax? Grab a beer
What is a drug?
A substance that causes a physical or emotional change in a
person.
Types of Drugs
Over the counter:
Tobacco :
Alcohol : Illegal Drugs :
Unrecognized Drugs
:
Natural remedy:
Prescription drugs:
Why need of drug categorization?
Because of potential misuse and/or abuse of drugs and drug substances
Drug Misuse: improper use of a drug (not taking prescribed drugs as directed)
Drug Abuse: intentional improper use of a drug (legal drug not as prescribed/illegal drug for any reason)
Drug Act 19!
To prevent misuse and abuse of drugs" they have been classified into three
categories according to their constituents" efficacy and use as per Drug
#tandard $egulation %ith the provision of #ection 1 of the Drug Act&

'roup ()a* + ,arcotics and potent therapeutic agents&

'roup ()ha* + Antibiotics" hormones and general therapeutic agents&

'roup ('a* + -ther common drugs %hich are safer&

Drugs in group ()a* and ( )ha* are prescriptive drugs %hile those in group (
'a* are over the counter ones&

Drug Act Amendment ./0 1.//.2 has made provision to allocate the
prescriptive drugs for physician" integrated physician or health %or3er&

A pharmacist" pharmacist assistant or recogni4ed drug seller %ith 5ualification/

training as prescribed by Drug Advisory 6ommittee and recogni4ed by it" is
only authori4ed for sale and distribution of drugs&
7nade5uacy

The ma8imum percentage" 5uantity of potent and abuse9

prone drugs to be prescribed by the physician and dispensed
by the pharmacist or pharmacy professional and also the time
interval for the ne8t prescription of such drugs are to be
mentioned for each drug&

Widely used drugs li3e aspirin" cough medicines" la8atives"

diet pills" nasal sprays" and numerous other medications can
be abused or misused that are available %ithout a prescription
1-T6s2&

#ome hormonal drugs have high potential of abuse %hich

should be 3ept in a separate category but in drug act all
hormonal drugs are 3ept under schedule 3ha together %ith
antibiotics" e&g&" anabolic steroids&
7nade5uacy in drug categori4ation

:nder the category 3a" #ub category 1 mentions about

narcotic drugs and sub category . on poisonous drugs but they
are not clearly defined& ,o clear e8planation on difference
bet%een poison and narcotic drug&

According to Drugs 6ategory $ules" ./;<119!=2"

categori4ation %ould be according to ,epalese
>harmacopoeia but it is still not published to our 3no%ledge&
?o%ever" it has mentioned other pharmacopoeia such as 7>"
@> etc& as %ell until ,epalese >harmacopoeia is published&

Aac3 of evaluation of the systems designed to monitor and

mitigate the impacts of prescription drug misuse
#uggested categori4ation

Schedule 1: the substances with highest potential of

abuse which is prohibited for the use of human or
animals but restricted to certain institutions research
centre and national health authorities for research
acti!ity only e.g. Heroine "S# hydroxypethidine etc.

Schedule $: the substances with high potential to

cause harm e!en in negligible doses which should be
restricted to speci%c personals who ha!e speci%c
&nowledge of manufacturing handling using and storing
such substances e.g. arsenic cyanides mercury etc

Schedule ': the substances which ha!e moderate

potential to harm which need specialized pac&aging
strong warning and directions for safe use. (or example
acetic acid in pure form carbon disulphide copper
sulphate etc.
#uggested categori4ation

#chedule ;: The substances %ith lo% potential to cause harm

%hich should contain appropriate pac3aging and simple %arnings
and directions for safe use& Bor e8ample" boric acid1not in salt
form2" carbaryl" chlornidine" etc&

#chedule 0: these include drugs for therapeutic purposes& 7t is

divided into follo%ing sub9schedules:
o
sub9schedule a
o
sub9schedule b and
o
sub9 schedule c
o
sub9schedule d
o
sub9schedule e
#uggested categori4ation
1& #ub schedule a: substances %hich should be available for human
use but certain restrictions on manufacture" distribution"
possession and use to prevent the misuse" abuse and
psychological and physical dependence& These are controlled
drugs& These drugs should be prescribed by e8perienced
physicians %ho have special license to prescribe these substances
and also dispensed by pharmacists* only %ith strict medical
counseling& Bor e8ample" acetyl methadone" acetylmorphines"
amphetamine" cocaine" butorphanol" fentanyl" etc&
.& #ub schedule b: these include substances %ith moderate abuse
potential such as hormonal drugs e&g&" anabolic steroids& These
are prescription only medicines but any registered physicians can
prescribe but under the medical counseling and dispensing of a
registered pharmacist only& Bor e8ample" androstanolone"
androstenediol" androiso8a4ole" etc&
#uggested categori4ation
'. sub9schedule c: these are drug substances %ith lo%er abuse
potential than sub9schedule b but need to be restricted due to
strong therapeutic potential and associated side effects& These
are also prescription only drugs %hich should be prescribed by
registered physicians and dispensed by registered pharmacists
%ith proper counseling& Antibiotics fall under this sub9schedule&
;& sub9schedule d: these are pharmacist only medicines& These are
-ver the counter1-T62 drugs %hich can be dispensed %ithout
prescription but patient counseling by the pharmacist is
obligatory& Cery lo% abuse potential drugs li3e la8atives"
aspirin etc& fall under this category" e&g&" cyproheptadine"
cycli4ine1oral2" diclofenac etc&
#uggested categori4ation
0& sub9schedule e: these drugs are to be received from
pharmacy %ith counseling of pharmacist for the safe use but if
the pharmacist is not available a licensed pharmacy
professional can also dispense these drugs" e&g&" acetic acid"
acetylcysteine" econa4ole etc&
)*(*)*+,*S
1. http:--www.tga.go!.au-industry-sched
uling.decisions.%nal.html
$. www.lawcommission.1 go!.np
'. http:--www.ehow.com-about/0121'2'/
drug.misuse.!s.drug.abuse.html