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Objective of the study
The purpose of this research was:-
 To understand demand of narcotic analgesic drugs (morphine, pethidine,
fentanyl) in Ahmedabad.
 To understand supply of narcotic analgesic drugs (morphine, pethidine,
fentanyl) in Ahmedabad.
By this research I will also try to find preference level of narcotic analgesics
(opioids) over Non-narcotic analgesics (NSAIDs) by the doctors of Ahmedabad.
By this research I also tried to find hurdles faced by the doctors in using this
prohibited drugs and also the hurdles faced by the retailers in selling this drugs.
Even I tried to find out what will be preference of the doctors if new molecule
Sufentanyl (this drug is much more potent than other narcotic analgesic drugs) is
introduced.
ASSUMPTIONS AND LIMITATIONS
Assumptions
 In this study it is assumed that the entire population of anesthesiologist
and retailers selling narcotic analgesic drugs is represented by the
selected sample.
Limitations
 The selected sample may not be representing the entire population. The
results from the entire populations may be different.
 The responses given by the respondents may be biased. This may distort
the results.
 The sample is selected only from the city Ahmedabad .So the results may
not reflect the view of entire state or nation.
2
Pharmaceutical industry
The Indian Pharmaceutical Industry stands at an interesting stage today. Having
started out in a small way in 1901 India was highly dependent on U.K., France
and Germany for its requirements of drugs and medicines. In 1948 the sale of
pharmaceuticals products in the country amounted to just Rs.10 crores. By 1954
the figure had risen to Rs.54 crores and by 1960 to Rs.70 crores today the Indian
Pharmaceuticals market, with a size of USD 2.7 billion is ranked 20th
in value
terms. The market is estimated to grow at over 11.6% annually. (Source: ORG-
MARG, August 2002.)
In 1961 Senator estes Kefauer who headed an official committee to investigate
the monopolistic practices of U.S. drug firms reported: Prices of certain drugs
and antibiotics in India were among the highest in the world and that, in drugs,
India was one of the highest priced nations. Today, the situation has been
reversed with the prices of formulation in India among the lowest in the world.
The rapid development of the Indian drugs and pharmaceutical industry has
made it easier for people to access almost all-new therapies that are launched
worldwide. As a result the life expectancy has also increased substantially from
45 to 65 years.
The Indian pharmaceutical industry is highly fragmented with over 20,000
pharmaceutical companies. The leading 250 pharmaceutical companies control
70% of the market. While, the domestic companies account for the MNCs.
contributes 67% of the total market (source: ORG-MARG, Moving Annual Total,
and August 2002)
Over the years, the Indian pharmaceutical companies have used reverse
engineering capabilities to pioneer new process for products. This combined with
a strong distribution network and brand management skills have helped the
Indian pharmaceutical companies dominate the market.
Over the next five to ten years, however, the competitive dynamics of the Indian
pharmaceutical industry is all set to change .The introduction of product patents
beyond 2005 and exclusive Marketing Rights (EMRs) will change the rules of the
game. Companies will also have to focus on basic research or collaborate with
patent holders to launch new products in the market.
Globalization will become increasingly important for Indian companies in the post
GATT era. To succeed in a new competitive environment, Indian pharmaceutical
companies will have to focus on new product introductions and innovations
through Research and Development.
3
Industry analysts have been optimistic that the Indian Pharmaceutical companies
will be able to successfully meet the challenges of the competition. Indian
companies have gone ahead and R & D is emerging as a profit center. New drug
delivery systems and even drug testing or clinical trials can be a profit center in
India. This sector will never run out of fashion.
4
About Claris
Claris Lifesciences limited is an international pharmaceutical company dedicated
to the development, manufacturing and marketing of research-based products
and therapies of world-class quality for acute illness and surgical situations.
Claris is an R&D based, international pharmaceutical company offering products
and delivery systems of world – class quality, to achieve the objective of saving
lives worldwide.
The architects of Claris are a team comprising of scientists, pharmaceutical
experts and management professionals, who bring to the company a
combination of Vision, R&D capabilities, technological know how, International
exposure and manufacturing expertise. The company’s range of products and
delivery systems extends across Critical care, External and parental Nutrition,
Renal care including Transplant Therapy and medical Equipment.
The company enjoys Market Leadership position in several product categories in
India and significant presence globally. Claris has marketing operations in more
than 30 countries, through its subsidiaries, offices and distributors, with a
customer profile including institutions, major corporate hospitals and international
aid agencies.
IT ENABLING
The company invested in IT infrastructure by getting the latest PCs, having lease
lines at its corporate headquarters, and going in for state-of-the-art hosting facility
with one of the top 5 hosting service providers in the U.S.A. It is strengthening its
IT infrastructure backbone by investing in high technology servers and high-
speed networks.
Claris has plans to link our new manufacturing campus with the corporate office
so as to enable exchange of data, voice and video in a more sophisticated and
economic manner.
Claris is further investing in a customized ERP package, which will integrate all
its business process tightly .It is going in for CRM (Customer Relationship
Management), SCM (Supply Chain Management) and KM (Knowledge
Management) packages which will extend to customers, doctors, suppliers , and
partners like distributors and C&F agents.
TECHNOLOGY
The company has laid emphasis on Quality and Technology from its early stages
of growth. Its modern manufacturing facility uses sophisticated state of the art
5
technology, sourced from world leaders. The facility is designed to produce
aqueous and oil based products in glass containers and bags. Apart from
manufacturing for Claris, this facility also caters to the needs of companies in
India and abroad for international markets of toll manufacturing.
PROPRIETARY TECHNOLOGY CAPABILITIES
The Company has capabilities in bringing laboratory batches to full production
scale successfully, through it process-engineering competence. This
technological excellence also goes beyond process and it has executed several
projects with its technology platforms including:
o Non PVC bag manufacturing technology
o Dialysis bags and accessories
o Fat emulsion based products
o Micro emulsion technology
o Integrating of clinical needs and medical devices via custom made
software for its delivery systems.
o Biomedical equipment development and manufacturing for operation
rooms and ICUs.
EMOTIONAL PHARMACOPOEIA
The quality philosophy of Claris is the commitment to achieve a level of
perfection that surpasses every pharmacopoeial standard. It’s final test for quality
is a very simple question that they ask themselves without fail, “Would we use it
to treat our dearest ones?”
If the answer is an unhesitant ‘Yes’ the product has passed final quality test. At
Claris this is called ‘Emotional Pharmacopoeia”.
Manufacturing processes and systems are oriented for consistent batch quality.
This focus on quality begins with the housing of the central laboratory facilities
within clean rooms from Clestra, France – a world leader in the industry.
Claris has an advanced laboratory set up equipped with facilities for chemical
and instrumental analysis. The laboratory is capable of undertaking the most
comprehensive tests for various pharmacopoeia parameters.
Claris believes in building quality through every step of production. This is done
by having a separate team for in process quality checks (QA) and finished
products’ testing (QC) at the end. Separate managers head both these functions.
This total commitment to quality, coupled with international exposure to
technology, aids them in their efforts to help save human lives worldwide.
6
Business Profile
Critical care
The Claris product basket in Critical Care includes Anesthesia, Blood and
Plasma products, I.V. fluids and advanced Antiinfectives/Antibacterials.The
company’s expertise in lipid based technology has made it one of the few
companies in the world to manufacture propofol. The entry of this advanced
anesthetic revolutionized the way anesthesia was given in the
country.Today,proviveTM i
is an internationally accepted brand while profolTM
is the
no.1 brand of propofol in India and one of the best selling success stories.
Claris is the first Indian and one amongst the first few companies of the globe to
have manufactured profol Intravenous Injection.
Claris is the first Indian and one amongst the first few companies of the globe to
have manufactured Profol Intravenous Injection.
Nutrition
The link between malnutrition and increased risk of complications in patients is a
proven one. Good nutrition practice makes a vital difference in quality and time of
recovery of such patients.
Nutrition solutions from Claris include Enternal and Parental Nutritional products
and delivery systems. Claris is the market leader in Parental Nutrition, with a
product range encompassing amino acid solutions, fat emulsions, trace elements
and advanced delivery systems like PNATM and CelemixTM
, which come with
the convenience of multiple nutrients and the flexibility to add other nutrients for a
tailor made preparation .Products individually or as a combination, are designed
to meet specific and unique nutritional needs of different patients suffering from
malnutrition.
Claris is the first Indian company to manufacture parental fat emulsion.
The product range of Claris comprises of Total Parental Nutrition , Blood and
Plasma , Anesthetic Range and organ preservation solution
RENAL CARE
Kidney failure is one of the most debilitating diseases to occur to a human
being .Its incurable nature makes it critical diseases like cancer or AIDS.
7
In the Renal Care, segment, Claris offers a range across systems, solutions,
medicines, disposables and equipment.
The company is the first in India and one of the few in the world to manufacture
perfusolTM
– cold organ preservation system for transplant, and RenografTM
–
multi organ perfusion system.
Today , RenografTM
is used in one out of every three transplants in India.
PHARMACEUTICAL GENERICS
Claris offers injectables and oral dosage forms across various therapeutic groups
with focus on antibiotics , antibacterials , antinfectives ,etc.Medical devices and
disposables .The company’s range of products in medical devices and
disposables includes blood bags, two piece syringes , needles , I.V. infusion sets
and disposables for haemodynamics.
MEDICAL EQUIPMENT
As in all spheres of life, technology is adding convenience to medicine also.
Claris has a broad spectrum of medical equipment including the Protiva 2000TM
–
anesthesia pump, Infulife SPTM – syringe pump, oxylifeTM
– oxygen concentrator
and Invocare HDTM
– state of the art dialysis chairs and beds .All designed to
offer convenience, comfort and ease of use.
INTERNATIONAL OPERATIONS
The company has a presence in more than 30 countries including Latin America,
Europe, CIS, Asia Pacific and Africa through its own sales force and local teams
in various countries. This presence is slated to go up to 70 countries and plans
for the U.S.A., Australia, and U.K., is in place.
Subsidiaries and its own offices in various countries are involved in grass root
marketing products. Almost 70% of the Company’s revenues come from
international operations, and several major brands like proviveTM
(Propofol) are
widely recognized and accepted globally.
The teams in international markets include sales, marketing and support people,
ably complemented by a strong network of distribution partners. This level of
infrastructure in international markets helps Claris meet the demands of its
international customers including aid agencies, large corporate hospitals and
institutions.
HOSPITAL CARE
8
This division of Claris is recently launched to cater the needs of the hospital. Its
product range comprises common IV fluids, antibiotics and antiamoebic drugs.
PROPOSED ONCO DIVISION
Claris is planning to launch a new division that is Onco division to save the lives
of the patients suffering from various types of cancers. This division will be
launched in the near future.
RESEARCH AND DEVELOPMENT
The company is actively involved in the area of Research and Development
through Claris research Foundation.The Foundation’s is in the area of
development of critical products and new drug delivery system.
CRF has developed some pioneering technologies in the last few years and has
built its expertise in such fields. One example of this is parenteral fat emulsions
(Lipid Drug Delivery System). Claris used this platform to manufacture Propofol,
which was introduced in 1998 in India.Since then this product is sold in many
countries world wide, and is benchmarked against international products in a
large number of countries.
CRF has now developed expertise in Liposomal drug delivery systems. In both of
these DDS, there are several drugs in the pipeline, which have reached a
threshold for the next stage in development.
The research pipeline of Drug Delivery Systems for the next three years has
been chalked out. The foundation has filed for respective patents. Its IPR Cell
has the infrastructure to handle the short term and long term plans.
CRF has initiated its research program in the field of Biotechnology with a focus
on R&D of Monoclonal Antibodies technology platform and to develop drugs for
therapeutic application. CRF’s vision to do advanced research in Oncology fits in
well with its Biotech vision.
Another area, in which CRF is working, is the recombinant Technology platform.
Some specific, rare bulk drugs (API) have also been developed, which makes
Claris one of the few manufactures of such drugs in the world today. Several
more APIs are in the pipeline.
Claris has networking with German and Japanese laboratories for technical
alliances are an outcome of the same. Claris continues to add up innovative
research projects in its pipeline that have the potential to save human lives
across the globe.
9
PIPELINE
In the pipeline are several innovative research projects in the area of critical care
and drug delivery systems. Our world class R&D center undertakes pioneering
work in the development of recombinant products for critical care e.g.
Erythropoietin, Heparen, Interferon, and Interlukins etc.
Liposomal systems are being developed with drugs in various therapeutic
segments such an anticancer, anti-fungal agents and antibiotics.
Biotechnology is an area of key interest, as one of the major platforms available
for producing lead compounds with preselected properties.
CLARION
CLARION is a bimonthly news magazine of Claris, featuring issues and events at
CLARIS.
10
Research Design
Sample design
This design will consist of two different sample .One will be to understand
demand pattern of narcotic analgesic drugs and the other one to understand the
supply pattern.
11
Sample to understand the demand pattern of narcotic analgesic drugs
 Population:- All anesthesiologists of Ahmedabad city.
 Sample type:-Convenient sample
 Sample size:-15
(The anesthesiologist doctors will be selected randomly from private
hospitals like Sterling, SAL, Medisurg and the government hospitals like
Vadilal Sarabhai , Shardaben , Rajasthan and LG.
Sample to understand the supply pattern of narcotic analgesic drugs
 Population:-All retailers having the permit to sell narcotic analgesic
drugs.
 Sample type:- Probability sample
 Type of the probability sample:-Random sample
 Sample size:-2
Scheduling:-
The research is completed within the time span of eight weeks starting from 19th
May .The schedule is presented here week wise.
Weeks Starting date Work done
1st
19th
May Preparing research methodology
2nd
26th
May Designing the questionnaire
3rd
2nd
June Revising the questionnaire
4th
9th
June Revising the questionnaire
5th
16th
June Survey
6th
23rd
June Survey
7th
30th
June Analysis of the data
8th
7th
July Presenting the results
Research instrument:-
The instrument for the research will be a self administered questionnare.There
will be two different questionnares for the two different samples. One
questionnaire will be for the sample of anesthesiologist (to understand the
demand of narcotic analgesic drugs) and the other questionnaire will for the
sample of retailers( to understand the supply pattern of narcotic analgesic drugs).
The two different questionnaires for two samples were:-
o Questionnaire for the sample of anesthesiologist
o Questionnaire for the sample of retailers
12
Data Analysis
First of all I will present the analysis of the sample of anesthesiologist.
 Preference of narcotic analgesics (opioids) over non narcotic
analgesics (NSAIDs)
In the sample of anesthesiologist that was selected 94% of the doctors prefer
narcotic analgesics (opioids) while only 6% of the doctors prefer non-narcotic
analgesic drugs.
PREFERENCE OF NARCOTIC
ANALGESICS OVER NON NARCOTIC
ANALGESICS
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Narcotic analgesics Non narcotic
analgesics
PERCENTAGE
13
• The number of surgeries in which doctors use narcotic analgesic drug
Percentage of surgeries No.of doctors using narcotic analgesics
0% to 20% 6.6%
21% to 40% 0%
41% to 60% 13.3%
61% to 80% 46.7%
81% to 100% 26.6%
14
Percentage of surgeries in which doctors
use narcotic analgesic drugs
0.00%
5.00%
10.00%
15.00%
20.00%
25.00%
30.00%
35.00%
40.00%
45.00%
50.00%
0%
to
20%21%
to
40%41%
to
60%61%
to
80%
81%
to
100%
Percentage of surgeries
Percentageofdoctors
usingnarcoticanalgesic
drugs
No.of
doctors
using
narcotic
analgesics
 Preference of following narcotic analgesic drugs .
o Morphine
o Fentanyl
o Pethidine
In preference level for morphine, fentanyl and pethidine
o Rank 1
100% doctors gave rank1 to fentanyl in preference.
o Rank 2
87% of doctors gave rank2 to pethidine in preference.
13% of doctors gave rank2 to morphine in preference.
o Rank 3
87% of doctors gave rank3 to morphine in preference.
13% of doctors gave rank3 to pethidine in preference.
Morphine Fentanyl Pethidine
Rank 1 0% 100% 0%
Rank 2 13% 0% 87%
Rank 3 87% 0% 13%
15
• Preference of Sufentanyl
(In the selected sample 67% of the anesthesiologists replied that they would
prefer Sufentanyl even if the cost is high while 33% of the doctors gave negative
answer)
16
Preference level of Sufetanyl
Would prefer
sufentanyl
Would not prefer
sufentanyl
• How many doctors use narcotic analgesics in pre-surgery, peri-
surgery, post-surgery.
Do prefer
narcotic
analgesics
Do not prefer
narcotic analgesics
Pre surgery 46% 54% 100%
Peri surgery 94% 6% 100%
Post surgery 26% 74% 100%
When the drug is used
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Pre
surgery
Peri
surgery
Post
surgery
Do prefer narcotic
analgesics
Do not prefer
narcotic
analgesics
17
• Hurdles faced in using narcotic analgesic drugs
o 53% felt legal formalities is a hurdle.
o Avaibility is not a hurdle.
o 13% felt that cost is a hurdle.
o 34% felt that they don’t face any hurdles in using these drugs.
18
HURDLES FACED IN USING NARCOTIC
ANALGESIC DRUGS
0%
10%
20%
30%
40%
50%
60%
Legalform
alities
Avaibility
Cost
No
hurdle
HURDLES
PERCENTAGE
Series1
• Short supply of this drugs
The sample was asked that how frequently they face short supply of these drugs
and the options given to them were very frequently, frequently, sometimes,
rarely, never. The results are as under.
Very frequent Frequent Sometimes Rarely Never
0% 0% 46% 27% 27%
19
Short supply of Narcotic analgesic drugs
Very frequently
Frequently
Sometimes
Rarely
Never
• Comparison between narcotic analgesics and non narcotic analgesic
According to the doctors the benefits of narcotic analgesics over non-narcotic
analgesic were as follows:-
o They are potent analgesic.
o They decrease the volume of the anesthetic agent required.
o Drugs like fentanyl have shorter duration of action .So they can be
used for short duration surgeries.
o They prevent much variation in haemodynamic changes.
o These drugs can easily be used on the patient having bleeding
tendencies.
o Provides better pain control
o Cardiovascular stability
Thus overall Narcotic analgesic (opioids) are potent analgesic,have short
duration of action.,provide haemodynamic stability and cardiovascular
stability, decrease the requirement of anesthetic agents compared to non
narcotic analgesic drugs(NSAIDs).
20
• Data analysis of sample retailers (to understand the supply of
narcotic analgesic drugs).
As morphine, fentanyl and pethidine are the prohibited drugs the retailers
need to get permit from narcotic department to sell this drugs. Also they need
permit to transport this drugs .The retailers having the permit to sell this drugs
are needed to maintain a record of prescriptions, record of person to whom
they have sold this drugs. Due to all this legal formalities involved in selling
this drugs there are few retailer who have license to sell the drugs in
Ahmedabad.I could meet two retailers who keep this drugs.
Here is the analysis of the data, which I could get from the two retailers
through the questionnaire.
o Which narcotic analgesic drugs do they keep?
The three main narcotic analgesic drugs are morphine, fentanyl, pethidine
and as can be seen from the analysis of the sample of anesthesiologist
fetanyl is widely used and most preferred narcotic analgesic drug. Out of two
retailers I met:-
 One of the retailers kept two drugs fentanyl and pethidine.
 The other retailer kept only fentanyl.
21
o Amount of morphine , fentanyl and pethidine kept by the retailers
in units
Out of the two retailers one retailer kept only fetanyl while the other kept
fetanyl and pethidine. The amount in which they kept these drugs is as
follows.
Morphine Fentanyl Pethidine
Retailer 1 Does not keep this
drug.
2ml x 5000 amp
and 10ml x 100
amp
1ml x 500 amp
Retailer 2 Does not keep this
drug
2000 amp Does not keep this
drug
The retailers on monthly bases reorder these drugs.
22
o The factors kept in mind while the purchase of these drugs.
As mentioned earlier there are many legal formalities involved in selling of this
drugs. Because of this reason there are few retailers who sell these drugs.
From this sample of retailers I tried to find that what are the factors that these
retailers keep in mind while selling of this drugs inspite of the legal hurdles
faced in selling of these drugs.
The options given to them were:-
 Higher margin they get in selling of these drugs.
 Lack of competition (because only few retailers have license to sell this drugs)
 High consumption of these drugs.
The results derived were
23
Factors that prompt retailers to sell this
drugs
0%
20%
40%
60%
80%
100%
120%
Lack of
competition
High margin High
consumption
Factors
Series1
o The hurdles faced in selling of this drugs
As morphine, fentanyl and pethidine are prohibited drugs retailers face some
hurdles in selling of this drugs. The hurdles faced by the retailers are legal
formalities, storage, slow moving product etc. The results were.
Rank 1 Rank 2 Rank 3
Legal formalities 100% 0% 0%
Storage 0% 100% 0%
Slow moving
product
0% 0% 100%
Thus legal formalities involved in selling these drugs are the biggest hurdle.
24
Hurdle faced in using this drugs
0%
20%
40%
60%
80%
100%
120%
Rank 1 Rank 2 Rank 3
Ranks
Legal formalities
Storage
Slow moving
product
• In case of margin fluctuations between two companies preference of the
retailers
The options given to the retailers in this case were as follows.
o Company giving higher margin.
o Drugs of the company that doctor prefer.
o Stockist relationship.
Here the retailers feel that that they would prefer the drugs of the company which
the doctors prefer more.
Company giving higher
margin
Drugs of the company
that doctors prefer more
Stockist relationship
0% 100% 0%
25
Conclusions
Conclusions from the sample to understand the demand pattern
(anesthesiologist) of narcotic analgesic drugs.
 Preference of narcotic analgesic over non narcotic analgesic –About 94%
of the doctors prefer narcotic analgesics during surgeries compared to non
narcotic analgesic.
 About 26% of the doctors prefer narcotic analgesics in 80% to 100% of
surgeries they perform. While about 46% of the doctors prefer this drugs
in 60% to 80% of surgeries they perform.
 Out of the three narcotic analgesic drugs Fentanyl is the most preferred
drug by the doctors. The second preferred drug is pethidine and then
morphine.
 For the new molecule sufentanyl 67% of anesthesiologist responded that
they would use this drug even if the cost is high while 33% responded that
they would not use it.
 Out of the total sample 46% of the doctors prefer these drugs in pre
surgery, 96% of the doctors prefer it in pre surgery and 26% of the doctors
prefer it in post surgery.
 53% of the doctors felt legal formalities are hurdle in using these drugs.
Avaibility is not a hurdle.13% felt that cost is a hurdle.34% felt that they
don’t face any hurdles in using these drugs.
 46% of the doctors felt that sometimes they faced short supply of this
drugs,27% felt that they faced the short supply rarely and 27% felt that
they never faced short supply of this drugs.
26
Conclusions from the sample to understand the supply pattern of narcotic
analgesic drugs (retailers).
 Fentanyl is kept by all the retailers. While only one retailer kept pethidine.
 Retailers reorder this drugs on a monthly bases
 Lack of competition is the factor that retailers keep in mind in selling of
this drugs.
 Legal formalities are the biggest hurdle is selling of these drugs. The
second hurdle is the storage as these drugs have to be kept in a locked
place.
 In case of margin fluctuations between two companies retailers would
prefer the drugs of the company, which doctors prefer.
27
BIBLIOGRAPHY
Books
Kotler, Marketing management, Pearson education, eleventh edition
Cooper, D.R. and Schindler,P.S.,Business research method,eigth
edition
Rao, S.S, Handbook for writers and editors,AMA
28
Annexure
Annexture 1
Anesthesia
Anesthesia has an effect on a part of nervous system which results in depression
or numbing of nerve pathways.Anesthsia is devided into three basic catogeries.
29
G e n e ra l A n e s th e s ia R e g io n a l A n e s th e s ia L o c a l A n e s th e s ia
A n e s th e s ia
General Anesthesia:-General anesthesia affects the brain cells which causes
a person to lose consciousness. General anesthetics produce an
unconscious state. In this state a person is:
• unaware of what is happening
• pain-free
• immobile
• free from any memory of the period of time during which he or she is
anesthetized
General anesthetics affect the spinal cord (resulting in immobility), the brain-
stem reticular activating system (resulting in unconsciousness) and the
cerebral cortex (seen as changes in electrical activity on an
electroencephalogram).
General anesthesia can be administered as an inhaled gas or as an injected
liquid. There are several drugs and gases that can be combined or used
alone to produce general anesthesia. The potency of a given anesthetic is
measured as minimum alveolar concentration (MAC). This term describes
the potency of anesthetic gases. (Alveolar is the area in the lung where
gases enter and exit the blood stream via the capillary system). Using MAC
as a guideline, the amount of anesthetic given to a patient depends on that
particular patient's needs.
30
Regional Anesthesia:- Regional anesthesia is so named because a "region"
of the body is anesthetized without making the person unconscious.Regional
anesthesia techniques can be used to block very specific areas such as one
foot, one leg, one arm, or one side of the neck. One example of this is spinal
anesthesia, which is often used on women during childbirth. A local
anesthetic is injected into the spinal fluid and causes a loss of sensation of
the lower body. Spinal anesthesia can be used for surgery on the legs or
lower abdomen (below the bellybutton).
Local Anesthesia:- Local anesthesia involves numbing a small area by
injecting a local anesthetic under the skin just where an incision is to be
made. When used alone, this type of anesthesia has the least number of
risks. Local anesthetics are thought to block nerve impulses by decreasing
the permeability of nerve membranes to sodium ions. There are many
different local anesthetics that differ in absorption, toxicity, and duration of
action. There are many different local anesthetics that differ in absorption,
toxicity, and duration of action.
Annexure 2
Analgesics
Analgesics(pain killers) are of two types based on intensity of pain.
• Non-Narcotic Analgesics (NSAIDs).
• Narcotic analgesics (Opioids)
In 1982, a WHO experts panel established a relatively inexpensive, easily
applicable approach for pain treatment, known as the 'Three-step Analgesic
Ladder', this approach has become accepted worldwide and is being
implemented in several countries.
31
• NSAIDs- They are used for slight to moderate pain. They include Salicylic
Acid (Aspirin), acetaminophen (Tylenol), Ibuprofen (Motrin), Aleeve
(Naproxen) and many others. As they have anti-inflammatory effect they are
often referred to as non-steroidal anti-inflammatory drugs (NSAID).
• Opioids- They are used in case of severe pain.They act on the nervous
system, altering pain perception and awareness, they make the person
drowsy, sleepy, and they may be addictive. Narcotics require a prescription to
be dispensed.
 WHO STEP-1
The first step is the use of acetaminophen, aspirin, or other non-steroidal anti-
inflammatory drug (NSAID) for mild to moderate pain.
 WHO STEP-2
When pain increases or persists, a mild opioid such as codeine or hydrocodone should be
added to the NSAID.It should only be used in cancer patients in special situations such as
difficulties in providing morphine or the patient refusing to use opioids
 WHO STEP-3
When higher doses are needed and the maximum therapeutic dose has been reached,
they should be replaced with potent opioids such as morphine, hydromorphone or fetanyl.
( Adjuvant drugs may be used at any time to enhance analgesic efficacy for specific
types of pain )
32
Annexture 3
Major narcotic analgesic drugs
 Morphine:-( C17H19NO3 285.37)
Morphine is naturally occurring substance in the opium poppy, Papaver
Somniferous. It is a potent narcotic analgesic, and its primary clinical use is in the
management of moderately severe and severe pain. After heroin, morphine has
the greatest dependence liability of the narcotic analgesics in common use.
Morphine is administered by several routes (injected, smoked, sniffed, or
swallowed); but when injected particularly intravenously, morpine can produce
intense euphoria and a general state of well-being and relaxation. Regular use
can result in the rapid development of tolerance to these effects.
Medical Uses
* symptomatic relief of moderately severe to severe pain;
* relief of certain types of difficult or labored breathing;
* suppression of severe cough (rarely);
* suppression of severe diarrhea (e.g., that produced by cholera).
Routes Of Administration
Morphine may be taken orally in tablet form, and can also injected
subcutaneously, intramuscularly, or intravenously; the last is the route preferred
by those who are dependent on morphine.
 Fentanyl
Fentanyl belongs to the group of medicines called narcotic analgesics . The
transmucosal form of fentanyl is used to treat breakthrough cancer pain.
Breakthrough episodes of cancer pain are the flares of pain which “breakthrough”
the medication used to control the persistent pain. Transmucosal fentanyl is only
used in patients who are already taking narcotic analgesics.
Fentanyl acts in the central nervous system (CNS) to relieve pain. Some of its
side effects are also caused by actions in the CNS. When a narcotic is used for a
long time, it may become habit-forming (causing mental or physical
dependence). However, people who have continuing pain should not let the fear
of dependence keep them from using narcotics to relieve their pain. Mental
dependence (addiction) is not likely to occur when narcotics are used for this
purpose. Physical dependence may lead to withdrawal side effects if treatment is
33
stopped suddenly. However, severe withdrawal side effects can usually be
prevented by reducing the dose gradually over a period of time before treatment
is stopped completely.This medicine is available only with doctor’s prescription.
Pethidine
Pethidine is an analgesic (a painkiller) but also an anti-spasmodic, which is a
drug that helps you relax. It's a drug rather similar to morphine — in fact, a
synthetic version of morphine . . It is given as an injection and often combined
with another drug — an anti-emetic — to control sickness because pethidine
often causes sickness.It’s been around a long time-sixty years and more.It helps
a person to relax.Sideeffects of this drug are that it makes the person depressed
and sick even if you have an anti-emetic.
34
Annexure 4
Questionnaires
35
Questionnaire for the doctors
(Information of the doctor)
Name: ___________________
Qualification: ___________________
Hospital: ___________________
Sign: ___________________
(Note: I assure you that the information given by you will be used purely
for the academic purpose and will not be passed on to any unauthorized
person.)
1.How many anesthesia do you perform per month?
____________
2.Please write the number of different type of anesthesia you perform.
General
Anesthesia
Regional
Anesthesia
Local
Anesthesia
3.State your preference for narcotic analgesic drugs over non-narcotic
analgesic drugs.
Narcotic
analgesic
drugs
2 3 4 Non-narcotic
analgesic
drugs
4.In how many surgeries do you use narcotic analgesic drugs?
___________
5.Which of the following narcotic analgesic drugs you prefer.(Please rank your
preferences)
Morphine Fentanyl Pethidine
6. How many units following narcotic analgesic drugs do you prescribe per
month.
Morphine- _______
Fentanyl- _______
Pethidine- _______
Yes
36
7.If new drug like Sufentniyl is introduced in the market would you prefer it if the cost
is high.
Yes
No
8.Please tickmark where you use narcotic analgesic drugs.
Pre surgery
Peri surgery
Post surgery
9.Which molecule do you use in the followi ng cases.
A) Pre surgery
1 Hr
surgery
2 Hr
Surgery
More than 2 hr
surgery
Morphine
Fentanyl
Pethidine
B) Peri surgery
1 Hr
surgery
2 Hr
Surgery
More than 2 hr
surgery
Morphine
Fentanyl
Pethidine
C) Post surgery
1 Hr
surgery
2 Hr
Surgery
More than 2 hr
surgery
Morphine
Fentanyl
Pethidine
10.Please tickmark the drugs used in following surgeries
Morphine Fentanyl Pethadine
Cardiac surgery
Onco surgery
Nephro surgery
Ortho surgery
Neuro surgery
Gastroentero
surgery
37
11.Rank the hurdles that you face in using narcotic analgesic drugs.
Legal formalities
Avaibility
Cost
12.How frequently do you face short supply of this drugs.
Very frequent Frequent Sometimes Rarely Never
13.According to you what benefits narcotic analgesic drugs have over NSAIDs
1._______
2._______
3._______
4._______
5._______
Date:
Place:
Signature:
38
Questionnaire for the retailers
(Information of the retailer/Pharmacy)
Name: ___________________________
Hospital/Shop: ___________________________
Sign: ___________________________
(Note:I assure you that the information given by you will be used purely
for the academic purpose and will not be passed on to any unauthorized
person)
1.Which of the following narcotic analgesic drugs do you keep?
Morphine
Fentanyl
Pethidine
Others
2.In how many units following narcotic analgesic drugs are
sold/consumed/used?
Morphine- _______
Fentanyl- _______
Pethidine- _______
3.Tick mark the frequency in which you reorder this drugs.
Morphine Fentanyl Pethidine
Monthly
Bimonthly
Quaterly
As per the
need
4.Rank the factors kept in mind while purchase of this drugs.
High margin
Lack of
competition
High consumption
39
Continued
5.Rank the hurdles that you face in selling this drugs.
Legal formalities
Storage
Slow moving
product
6.What is the permitted stock that you can keep of this drugs.
__________
7.What amount of stock do you keep.
__________
8.What are the legal requirement you need from the person purchasing this
drugs .
Yes No Form
Prescription
License
9.What is the procedure you adopt to purchase narcotic analgesic drugs from
the stockiest?
__________________________
10.In case of margin fluctuations between two companies rank your
preferences.
Company giving higher
margin
Drugs of the company
which doctors prefer
more
Stockist relationship
11. If new drugs come in the market what will be the procedure to include the
drug in the license?
_________________________________
Date:
Place:
Signature:

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NARCOTIC ANAGETIC DRUG AHMEDABAD

  • 1. Objective of the study The purpose of this research was:-  To understand demand of narcotic analgesic drugs (morphine, pethidine, fentanyl) in Ahmedabad.  To understand supply of narcotic analgesic drugs (morphine, pethidine, fentanyl) in Ahmedabad. By this research I will also try to find preference level of narcotic analgesics (opioids) over Non-narcotic analgesics (NSAIDs) by the doctors of Ahmedabad. By this research I also tried to find hurdles faced by the doctors in using this prohibited drugs and also the hurdles faced by the retailers in selling this drugs. Even I tried to find out what will be preference of the doctors if new molecule Sufentanyl (this drug is much more potent than other narcotic analgesic drugs) is introduced.
  • 2. ASSUMPTIONS AND LIMITATIONS Assumptions  In this study it is assumed that the entire population of anesthesiologist and retailers selling narcotic analgesic drugs is represented by the selected sample. Limitations  The selected sample may not be representing the entire population. The results from the entire populations may be different.  The responses given by the respondents may be biased. This may distort the results.  The sample is selected only from the city Ahmedabad .So the results may not reflect the view of entire state or nation. 2
  • 3. Pharmaceutical industry The Indian Pharmaceutical Industry stands at an interesting stage today. Having started out in a small way in 1901 India was highly dependent on U.K., France and Germany for its requirements of drugs and medicines. In 1948 the sale of pharmaceuticals products in the country amounted to just Rs.10 crores. By 1954 the figure had risen to Rs.54 crores and by 1960 to Rs.70 crores today the Indian Pharmaceuticals market, with a size of USD 2.7 billion is ranked 20th in value terms. The market is estimated to grow at over 11.6% annually. (Source: ORG- MARG, August 2002.) In 1961 Senator estes Kefauer who headed an official committee to investigate the monopolistic practices of U.S. drug firms reported: Prices of certain drugs and antibiotics in India were among the highest in the world and that, in drugs, India was one of the highest priced nations. Today, the situation has been reversed with the prices of formulation in India among the lowest in the world. The rapid development of the Indian drugs and pharmaceutical industry has made it easier for people to access almost all-new therapies that are launched worldwide. As a result the life expectancy has also increased substantially from 45 to 65 years. The Indian pharmaceutical industry is highly fragmented with over 20,000 pharmaceutical companies. The leading 250 pharmaceutical companies control 70% of the market. While, the domestic companies account for the MNCs. contributes 67% of the total market (source: ORG-MARG, Moving Annual Total, and August 2002) Over the years, the Indian pharmaceutical companies have used reverse engineering capabilities to pioneer new process for products. This combined with a strong distribution network and brand management skills have helped the Indian pharmaceutical companies dominate the market. Over the next five to ten years, however, the competitive dynamics of the Indian pharmaceutical industry is all set to change .The introduction of product patents beyond 2005 and exclusive Marketing Rights (EMRs) will change the rules of the game. Companies will also have to focus on basic research or collaborate with patent holders to launch new products in the market. Globalization will become increasingly important for Indian companies in the post GATT era. To succeed in a new competitive environment, Indian pharmaceutical companies will have to focus on new product introductions and innovations through Research and Development. 3
  • 4. Industry analysts have been optimistic that the Indian Pharmaceutical companies will be able to successfully meet the challenges of the competition. Indian companies have gone ahead and R & D is emerging as a profit center. New drug delivery systems and even drug testing or clinical trials can be a profit center in India. This sector will never run out of fashion. 4
  • 5. About Claris Claris Lifesciences limited is an international pharmaceutical company dedicated to the development, manufacturing and marketing of research-based products and therapies of world-class quality for acute illness and surgical situations. Claris is an R&D based, international pharmaceutical company offering products and delivery systems of world – class quality, to achieve the objective of saving lives worldwide. The architects of Claris are a team comprising of scientists, pharmaceutical experts and management professionals, who bring to the company a combination of Vision, R&D capabilities, technological know how, International exposure and manufacturing expertise. The company’s range of products and delivery systems extends across Critical care, External and parental Nutrition, Renal care including Transplant Therapy and medical Equipment. The company enjoys Market Leadership position in several product categories in India and significant presence globally. Claris has marketing operations in more than 30 countries, through its subsidiaries, offices and distributors, with a customer profile including institutions, major corporate hospitals and international aid agencies. IT ENABLING The company invested in IT infrastructure by getting the latest PCs, having lease lines at its corporate headquarters, and going in for state-of-the-art hosting facility with one of the top 5 hosting service providers in the U.S.A. It is strengthening its IT infrastructure backbone by investing in high technology servers and high- speed networks. Claris has plans to link our new manufacturing campus with the corporate office so as to enable exchange of data, voice and video in a more sophisticated and economic manner. Claris is further investing in a customized ERP package, which will integrate all its business process tightly .It is going in for CRM (Customer Relationship Management), SCM (Supply Chain Management) and KM (Knowledge Management) packages which will extend to customers, doctors, suppliers , and partners like distributors and C&F agents. TECHNOLOGY The company has laid emphasis on Quality and Technology from its early stages of growth. Its modern manufacturing facility uses sophisticated state of the art 5
  • 6. technology, sourced from world leaders. The facility is designed to produce aqueous and oil based products in glass containers and bags. Apart from manufacturing for Claris, this facility also caters to the needs of companies in India and abroad for international markets of toll manufacturing. PROPRIETARY TECHNOLOGY CAPABILITIES The Company has capabilities in bringing laboratory batches to full production scale successfully, through it process-engineering competence. This technological excellence also goes beyond process and it has executed several projects with its technology platforms including: o Non PVC bag manufacturing technology o Dialysis bags and accessories o Fat emulsion based products o Micro emulsion technology o Integrating of clinical needs and medical devices via custom made software for its delivery systems. o Biomedical equipment development and manufacturing for operation rooms and ICUs. EMOTIONAL PHARMACOPOEIA The quality philosophy of Claris is the commitment to achieve a level of perfection that surpasses every pharmacopoeial standard. It’s final test for quality is a very simple question that they ask themselves without fail, “Would we use it to treat our dearest ones?” If the answer is an unhesitant ‘Yes’ the product has passed final quality test. At Claris this is called ‘Emotional Pharmacopoeia”. Manufacturing processes and systems are oriented for consistent batch quality. This focus on quality begins with the housing of the central laboratory facilities within clean rooms from Clestra, France – a world leader in the industry. Claris has an advanced laboratory set up equipped with facilities for chemical and instrumental analysis. The laboratory is capable of undertaking the most comprehensive tests for various pharmacopoeia parameters. Claris believes in building quality through every step of production. This is done by having a separate team for in process quality checks (QA) and finished products’ testing (QC) at the end. Separate managers head both these functions. This total commitment to quality, coupled with international exposure to technology, aids them in their efforts to help save human lives worldwide. 6
  • 7. Business Profile Critical care The Claris product basket in Critical Care includes Anesthesia, Blood and Plasma products, I.V. fluids and advanced Antiinfectives/Antibacterials.The company’s expertise in lipid based technology has made it one of the few companies in the world to manufacture propofol. The entry of this advanced anesthetic revolutionized the way anesthesia was given in the country.Today,proviveTM i is an internationally accepted brand while profolTM is the no.1 brand of propofol in India and one of the best selling success stories. Claris is the first Indian and one amongst the first few companies of the globe to have manufactured profol Intravenous Injection. Claris is the first Indian and one amongst the first few companies of the globe to have manufactured Profol Intravenous Injection. Nutrition The link between malnutrition and increased risk of complications in patients is a proven one. Good nutrition practice makes a vital difference in quality and time of recovery of such patients. Nutrition solutions from Claris include Enternal and Parental Nutritional products and delivery systems. Claris is the market leader in Parental Nutrition, with a product range encompassing amino acid solutions, fat emulsions, trace elements and advanced delivery systems like PNATM and CelemixTM , which come with the convenience of multiple nutrients and the flexibility to add other nutrients for a tailor made preparation .Products individually or as a combination, are designed to meet specific and unique nutritional needs of different patients suffering from malnutrition. Claris is the first Indian company to manufacture parental fat emulsion. The product range of Claris comprises of Total Parental Nutrition , Blood and Plasma , Anesthetic Range and organ preservation solution RENAL CARE Kidney failure is one of the most debilitating diseases to occur to a human being .Its incurable nature makes it critical diseases like cancer or AIDS. 7
  • 8. In the Renal Care, segment, Claris offers a range across systems, solutions, medicines, disposables and equipment. The company is the first in India and one of the few in the world to manufacture perfusolTM – cold organ preservation system for transplant, and RenografTM – multi organ perfusion system. Today , RenografTM is used in one out of every three transplants in India. PHARMACEUTICAL GENERICS Claris offers injectables and oral dosage forms across various therapeutic groups with focus on antibiotics , antibacterials , antinfectives ,etc.Medical devices and disposables .The company’s range of products in medical devices and disposables includes blood bags, two piece syringes , needles , I.V. infusion sets and disposables for haemodynamics. MEDICAL EQUIPMENT As in all spheres of life, technology is adding convenience to medicine also. Claris has a broad spectrum of medical equipment including the Protiva 2000TM – anesthesia pump, Infulife SPTM – syringe pump, oxylifeTM – oxygen concentrator and Invocare HDTM – state of the art dialysis chairs and beds .All designed to offer convenience, comfort and ease of use. INTERNATIONAL OPERATIONS The company has a presence in more than 30 countries including Latin America, Europe, CIS, Asia Pacific and Africa through its own sales force and local teams in various countries. This presence is slated to go up to 70 countries and plans for the U.S.A., Australia, and U.K., is in place. Subsidiaries and its own offices in various countries are involved in grass root marketing products. Almost 70% of the Company’s revenues come from international operations, and several major brands like proviveTM (Propofol) are widely recognized and accepted globally. The teams in international markets include sales, marketing and support people, ably complemented by a strong network of distribution partners. This level of infrastructure in international markets helps Claris meet the demands of its international customers including aid agencies, large corporate hospitals and institutions. HOSPITAL CARE 8
  • 9. This division of Claris is recently launched to cater the needs of the hospital. Its product range comprises common IV fluids, antibiotics and antiamoebic drugs. PROPOSED ONCO DIVISION Claris is planning to launch a new division that is Onco division to save the lives of the patients suffering from various types of cancers. This division will be launched in the near future. RESEARCH AND DEVELOPMENT The company is actively involved in the area of Research and Development through Claris research Foundation.The Foundation’s is in the area of development of critical products and new drug delivery system. CRF has developed some pioneering technologies in the last few years and has built its expertise in such fields. One example of this is parenteral fat emulsions (Lipid Drug Delivery System). Claris used this platform to manufacture Propofol, which was introduced in 1998 in India.Since then this product is sold in many countries world wide, and is benchmarked against international products in a large number of countries. CRF has now developed expertise in Liposomal drug delivery systems. In both of these DDS, there are several drugs in the pipeline, which have reached a threshold for the next stage in development. The research pipeline of Drug Delivery Systems for the next three years has been chalked out. The foundation has filed for respective patents. Its IPR Cell has the infrastructure to handle the short term and long term plans. CRF has initiated its research program in the field of Biotechnology with a focus on R&D of Monoclonal Antibodies technology platform and to develop drugs for therapeutic application. CRF’s vision to do advanced research in Oncology fits in well with its Biotech vision. Another area, in which CRF is working, is the recombinant Technology platform. Some specific, rare bulk drugs (API) have also been developed, which makes Claris one of the few manufactures of such drugs in the world today. Several more APIs are in the pipeline. Claris has networking with German and Japanese laboratories for technical alliances are an outcome of the same. Claris continues to add up innovative research projects in its pipeline that have the potential to save human lives across the globe. 9
  • 10. PIPELINE In the pipeline are several innovative research projects in the area of critical care and drug delivery systems. Our world class R&D center undertakes pioneering work in the development of recombinant products for critical care e.g. Erythropoietin, Heparen, Interferon, and Interlukins etc. Liposomal systems are being developed with drugs in various therapeutic segments such an anticancer, anti-fungal agents and antibiotics. Biotechnology is an area of key interest, as one of the major platforms available for producing lead compounds with preselected properties. CLARION CLARION is a bimonthly news magazine of Claris, featuring issues and events at CLARIS. 10
  • 11. Research Design Sample design This design will consist of two different sample .One will be to understand demand pattern of narcotic analgesic drugs and the other one to understand the supply pattern. 11 Sample to understand the demand pattern of narcotic analgesic drugs  Population:- All anesthesiologists of Ahmedabad city.  Sample type:-Convenient sample  Sample size:-15 (The anesthesiologist doctors will be selected randomly from private hospitals like Sterling, SAL, Medisurg and the government hospitals like Vadilal Sarabhai , Shardaben , Rajasthan and LG. Sample to understand the supply pattern of narcotic analgesic drugs  Population:-All retailers having the permit to sell narcotic analgesic drugs.  Sample type:- Probability sample  Type of the probability sample:-Random sample  Sample size:-2
  • 12. Scheduling:- The research is completed within the time span of eight weeks starting from 19th May .The schedule is presented here week wise. Weeks Starting date Work done 1st 19th May Preparing research methodology 2nd 26th May Designing the questionnaire 3rd 2nd June Revising the questionnaire 4th 9th June Revising the questionnaire 5th 16th June Survey 6th 23rd June Survey 7th 30th June Analysis of the data 8th 7th July Presenting the results Research instrument:- The instrument for the research will be a self administered questionnare.There will be two different questionnares for the two different samples. One questionnaire will be for the sample of anesthesiologist (to understand the demand of narcotic analgesic drugs) and the other questionnaire will for the sample of retailers( to understand the supply pattern of narcotic analgesic drugs). The two different questionnaires for two samples were:- o Questionnaire for the sample of anesthesiologist o Questionnaire for the sample of retailers 12
  • 13. Data Analysis First of all I will present the analysis of the sample of anesthesiologist.  Preference of narcotic analgesics (opioids) over non narcotic analgesics (NSAIDs) In the sample of anesthesiologist that was selected 94% of the doctors prefer narcotic analgesics (opioids) while only 6% of the doctors prefer non-narcotic analgesic drugs. PREFERENCE OF NARCOTIC ANALGESICS OVER NON NARCOTIC ANALGESICS 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Narcotic analgesics Non narcotic analgesics PERCENTAGE 13
  • 14. • The number of surgeries in which doctors use narcotic analgesic drug Percentage of surgeries No.of doctors using narcotic analgesics 0% to 20% 6.6% 21% to 40% 0% 41% to 60% 13.3% 61% to 80% 46.7% 81% to 100% 26.6% 14 Percentage of surgeries in which doctors use narcotic analgesic drugs 0.00% 5.00% 10.00% 15.00% 20.00% 25.00% 30.00% 35.00% 40.00% 45.00% 50.00% 0% to 20%21% to 40%41% to 60%61% to 80% 81% to 100% Percentage of surgeries Percentageofdoctors usingnarcoticanalgesic drugs No.of doctors using narcotic analgesics
  • 15.  Preference of following narcotic analgesic drugs . o Morphine o Fentanyl o Pethidine In preference level for morphine, fentanyl and pethidine o Rank 1 100% doctors gave rank1 to fentanyl in preference. o Rank 2 87% of doctors gave rank2 to pethidine in preference. 13% of doctors gave rank2 to morphine in preference. o Rank 3 87% of doctors gave rank3 to morphine in preference. 13% of doctors gave rank3 to pethidine in preference. Morphine Fentanyl Pethidine Rank 1 0% 100% 0% Rank 2 13% 0% 87% Rank 3 87% 0% 13% 15
  • 16. • Preference of Sufentanyl (In the selected sample 67% of the anesthesiologists replied that they would prefer Sufentanyl even if the cost is high while 33% of the doctors gave negative answer) 16 Preference level of Sufetanyl Would prefer sufentanyl Would not prefer sufentanyl
  • 17. • How many doctors use narcotic analgesics in pre-surgery, peri- surgery, post-surgery. Do prefer narcotic analgesics Do not prefer narcotic analgesics Pre surgery 46% 54% 100% Peri surgery 94% 6% 100% Post surgery 26% 74% 100% When the drug is used 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Pre surgery Peri surgery Post surgery Do prefer narcotic analgesics Do not prefer narcotic analgesics 17
  • 18. • Hurdles faced in using narcotic analgesic drugs o 53% felt legal formalities is a hurdle. o Avaibility is not a hurdle. o 13% felt that cost is a hurdle. o 34% felt that they don’t face any hurdles in using these drugs. 18 HURDLES FACED IN USING NARCOTIC ANALGESIC DRUGS 0% 10% 20% 30% 40% 50% 60% Legalform alities Avaibility Cost No hurdle HURDLES PERCENTAGE Series1
  • 19. • Short supply of this drugs The sample was asked that how frequently they face short supply of these drugs and the options given to them were very frequently, frequently, sometimes, rarely, never. The results are as under. Very frequent Frequent Sometimes Rarely Never 0% 0% 46% 27% 27% 19 Short supply of Narcotic analgesic drugs Very frequently Frequently Sometimes Rarely Never
  • 20. • Comparison between narcotic analgesics and non narcotic analgesic According to the doctors the benefits of narcotic analgesics over non-narcotic analgesic were as follows:- o They are potent analgesic. o They decrease the volume of the anesthetic agent required. o Drugs like fentanyl have shorter duration of action .So they can be used for short duration surgeries. o They prevent much variation in haemodynamic changes. o These drugs can easily be used on the patient having bleeding tendencies. o Provides better pain control o Cardiovascular stability Thus overall Narcotic analgesic (opioids) are potent analgesic,have short duration of action.,provide haemodynamic stability and cardiovascular stability, decrease the requirement of anesthetic agents compared to non narcotic analgesic drugs(NSAIDs). 20
  • 21. • Data analysis of sample retailers (to understand the supply of narcotic analgesic drugs). As morphine, fentanyl and pethidine are the prohibited drugs the retailers need to get permit from narcotic department to sell this drugs. Also they need permit to transport this drugs .The retailers having the permit to sell this drugs are needed to maintain a record of prescriptions, record of person to whom they have sold this drugs. Due to all this legal formalities involved in selling this drugs there are few retailer who have license to sell the drugs in Ahmedabad.I could meet two retailers who keep this drugs. Here is the analysis of the data, which I could get from the two retailers through the questionnaire. o Which narcotic analgesic drugs do they keep? The three main narcotic analgesic drugs are morphine, fentanyl, pethidine and as can be seen from the analysis of the sample of anesthesiologist fetanyl is widely used and most preferred narcotic analgesic drug. Out of two retailers I met:-  One of the retailers kept two drugs fentanyl and pethidine.  The other retailer kept only fentanyl. 21
  • 22. o Amount of morphine , fentanyl and pethidine kept by the retailers in units Out of the two retailers one retailer kept only fetanyl while the other kept fetanyl and pethidine. The amount in which they kept these drugs is as follows. Morphine Fentanyl Pethidine Retailer 1 Does not keep this drug. 2ml x 5000 amp and 10ml x 100 amp 1ml x 500 amp Retailer 2 Does not keep this drug 2000 amp Does not keep this drug The retailers on monthly bases reorder these drugs. 22
  • 23. o The factors kept in mind while the purchase of these drugs. As mentioned earlier there are many legal formalities involved in selling of this drugs. Because of this reason there are few retailers who sell these drugs. From this sample of retailers I tried to find that what are the factors that these retailers keep in mind while selling of this drugs inspite of the legal hurdles faced in selling of these drugs. The options given to them were:-  Higher margin they get in selling of these drugs.  Lack of competition (because only few retailers have license to sell this drugs)  High consumption of these drugs. The results derived were 23 Factors that prompt retailers to sell this drugs 0% 20% 40% 60% 80% 100% 120% Lack of competition High margin High consumption Factors Series1
  • 24. o The hurdles faced in selling of this drugs As morphine, fentanyl and pethidine are prohibited drugs retailers face some hurdles in selling of this drugs. The hurdles faced by the retailers are legal formalities, storage, slow moving product etc. The results were. Rank 1 Rank 2 Rank 3 Legal formalities 100% 0% 0% Storage 0% 100% 0% Slow moving product 0% 0% 100% Thus legal formalities involved in selling these drugs are the biggest hurdle. 24 Hurdle faced in using this drugs 0% 20% 40% 60% 80% 100% 120% Rank 1 Rank 2 Rank 3 Ranks Legal formalities Storage Slow moving product
  • 25. • In case of margin fluctuations between two companies preference of the retailers The options given to the retailers in this case were as follows. o Company giving higher margin. o Drugs of the company that doctor prefer. o Stockist relationship. Here the retailers feel that that they would prefer the drugs of the company which the doctors prefer more. Company giving higher margin Drugs of the company that doctors prefer more Stockist relationship 0% 100% 0% 25
  • 26. Conclusions Conclusions from the sample to understand the demand pattern (anesthesiologist) of narcotic analgesic drugs.  Preference of narcotic analgesic over non narcotic analgesic –About 94% of the doctors prefer narcotic analgesics during surgeries compared to non narcotic analgesic.  About 26% of the doctors prefer narcotic analgesics in 80% to 100% of surgeries they perform. While about 46% of the doctors prefer this drugs in 60% to 80% of surgeries they perform.  Out of the three narcotic analgesic drugs Fentanyl is the most preferred drug by the doctors. The second preferred drug is pethidine and then morphine.  For the new molecule sufentanyl 67% of anesthesiologist responded that they would use this drug even if the cost is high while 33% responded that they would not use it.  Out of the total sample 46% of the doctors prefer these drugs in pre surgery, 96% of the doctors prefer it in pre surgery and 26% of the doctors prefer it in post surgery.  53% of the doctors felt legal formalities are hurdle in using these drugs. Avaibility is not a hurdle.13% felt that cost is a hurdle.34% felt that they don’t face any hurdles in using these drugs.  46% of the doctors felt that sometimes they faced short supply of this drugs,27% felt that they faced the short supply rarely and 27% felt that they never faced short supply of this drugs. 26
  • 27. Conclusions from the sample to understand the supply pattern of narcotic analgesic drugs (retailers).  Fentanyl is kept by all the retailers. While only one retailer kept pethidine.  Retailers reorder this drugs on a monthly bases  Lack of competition is the factor that retailers keep in mind in selling of this drugs.  Legal formalities are the biggest hurdle is selling of these drugs. The second hurdle is the storage as these drugs have to be kept in a locked place.  In case of margin fluctuations between two companies retailers would prefer the drugs of the company, which doctors prefer. 27
  • 28. BIBLIOGRAPHY Books Kotler, Marketing management, Pearson education, eleventh edition Cooper, D.R. and Schindler,P.S.,Business research method,eigth edition Rao, S.S, Handbook for writers and editors,AMA 28
  • 29. Annexure Annexture 1 Anesthesia Anesthesia has an effect on a part of nervous system which results in depression or numbing of nerve pathways.Anesthsia is devided into three basic catogeries. 29 G e n e ra l A n e s th e s ia R e g io n a l A n e s th e s ia L o c a l A n e s th e s ia A n e s th e s ia General Anesthesia:-General anesthesia affects the brain cells which causes a person to lose consciousness. General anesthetics produce an unconscious state. In this state a person is: • unaware of what is happening • pain-free • immobile • free from any memory of the period of time during which he or she is anesthetized General anesthetics affect the spinal cord (resulting in immobility), the brain- stem reticular activating system (resulting in unconsciousness) and the cerebral cortex (seen as changes in electrical activity on an electroencephalogram). General anesthesia can be administered as an inhaled gas or as an injected liquid. There are several drugs and gases that can be combined or used alone to produce general anesthesia. The potency of a given anesthetic is measured as minimum alveolar concentration (MAC). This term describes the potency of anesthetic gases. (Alveolar is the area in the lung where gases enter and exit the blood stream via the capillary system). Using MAC as a guideline, the amount of anesthetic given to a patient depends on that particular patient's needs.
  • 30. 30 Regional Anesthesia:- Regional anesthesia is so named because a "region" of the body is anesthetized without making the person unconscious.Regional anesthesia techniques can be used to block very specific areas such as one foot, one leg, one arm, or one side of the neck. One example of this is spinal anesthesia, which is often used on women during childbirth. A local anesthetic is injected into the spinal fluid and causes a loss of sensation of the lower body. Spinal anesthesia can be used for surgery on the legs or lower abdomen (below the bellybutton). Local Anesthesia:- Local anesthesia involves numbing a small area by injecting a local anesthetic under the skin just where an incision is to be made. When used alone, this type of anesthesia has the least number of risks. Local anesthetics are thought to block nerve impulses by decreasing the permeability of nerve membranes to sodium ions. There are many different local anesthetics that differ in absorption, toxicity, and duration of action. There are many different local anesthetics that differ in absorption, toxicity, and duration of action.
  • 31. Annexure 2 Analgesics Analgesics(pain killers) are of two types based on intensity of pain. • Non-Narcotic Analgesics (NSAIDs). • Narcotic analgesics (Opioids) In 1982, a WHO experts panel established a relatively inexpensive, easily applicable approach for pain treatment, known as the 'Three-step Analgesic Ladder', this approach has become accepted worldwide and is being implemented in several countries. 31 • NSAIDs- They are used for slight to moderate pain. They include Salicylic Acid (Aspirin), acetaminophen (Tylenol), Ibuprofen (Motrin), Aleeve (Naproxen) and many others. As they have anti-inflammatory effect they are often referred to as non-steroidal anti-inflammatory drugs (NSAID). • Opioids- They are used in case of severe pain.They act on the nervous system, altering pain perception and awareness, they make the person drowsy, sleepy, and they may be addictive. Narcotics require a prescription to be dispensed.
  • 32.  WHO STEP-1 The first step is the use of acetaminophen, aspirin, or other non-steroidal anti- inflammatory drug (NSAID) for mild to moderate pain.  WHO STEP-2 When pain increases or persists, a mild opioid such as codeine or hydrocodone should be added to the NSAID.It should only be used in cancer patients in special situations such as difficulties in providing morphine or the patient refusing to use opioids  WHO STEP-3 When higher doses are needed and the maximum therapeutic dose has been reached, they should be replaced with potent opioids such as morphine, hydromorphone or fetanyl. ( Adjuvant drugs may be used at any time to enhance analgesic efficacy for specific types of pain ) 32
  • 33. Annexture 3 Major narcotic analgesic drugs  Morphine:-( C17H19NO3 285.37) Morphine is naturally occurring substance in the opium poppy, Papaver Somniferous. It is a potent narcotic analgesic, and its primary clinical use is in the management of moderately severe and severe pain. After heroin, morphine has the greatest dependence liability of the narcotic analgesics in common use. Morphine is administered by several routes (injected, smoked, sniffed, or swallowed); but when injected particularly intravenously, morpine can produce intense euphoria and a general state of well-being and relaxation. Regular use can result in the rapid development of tolerance to these effects. Medical Uses * symptomatic relief of moderately severe to severe pain; * relief of certain types of difficult or labored breathing; * suppression of severe cough (rarely); * suppression of severe diarrhea (e.g., that produced by cholera). Routes Of Administration Morphine may be taken orally in tablet form, and can also injected subcutaneously, intramuscularly, or intravenously; the last is the route preferred by those who are dependent on morphine.  Fentanyl Fentanyl belongs to the group of medicines called narcotic analgesics . The transmucosal form of fentanyl is used to treat breakthrough cancer pain. Breakthrough episodes of cancer pain are the flares of pain which “breakthrough” the medication used to control the persistent pain. Transmucosal fentanyl is only used in patients who are already taking narcotic analgesics. Fentanyl acts in the central nervous system (CNS) to relieve pain. Some of its side effects are also caused by actions in the CNS. When a narcotic is used for a long time, it may become habit-forming (causing mental or physical dependence). However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is 33
  • 34. stopped suddenly. However, severe withdrawal side effects can usually be prevented by reducing the dose gradually over a period of time before treatment is stopped completely.This medicine is available only with doctor’s prescription. Pethidine Pethidine is an analgesic (a painkiller) but also an anti-spasmodic, which is a drug that helps you relax. It's a drug rather similar to morphine — in fact, a synthetic version of morphine . . It is given as an injection and often combined with another drug — an anti-emetic — to control sickness because pethidine often causes sickness.It’s been around a long time-sixty years and more.It helps a person to relax.Sideeffects of this drug are that it makes the person depressed and sick even if you have an anti-emetic. 34
  • 35. Annexure 4 Questionnaires 35 Questionnaire for the doctors (Information of the doctor) Name: ___________________ Qualification: ___________________ Hospital: ___________________ Sign: ___________________ (Note: I assure you that the information given by you will be used purely for the academic purpose and will not be passed on to any unauthorized person.) 1.How many anesthesia do you perform per month? ____________ 2.Please write the number of different type of anesthesia you perform. General Anesthesia Regional Anesthesia Local Anesthesia 3.State your preference for narcotic analgesic drugs over non-narcotic analgesic drugs. Narcotic analgesic drugs 2 3 4 Non-narcotic analgesic drugs 4.In how many surgeries do you use narcotic analgesic drugs? ___________ 5.Which of the following narcotic analgesic drugs you prefer.(Please rank your preferences) Morphine Fentanyl Pethidine 6. How many units following narcotic analgesic drugs do you prescribe per month. Morphine- _______ Fentanyl- _______ Pethidine- _______ Yes
  • 36. 36 7.If new drug like Sufentniyl is introduced in the market would you prefer it if the cost is high. Yes No 8.Please tickmark where you use narcotic analgesic drugs. Pre surgery Peri surgery Post surgery 9.Which molecule do you use in the followi ng cases. A) Pre surgery 1 Hr surgery 2 Hr Surgery More than 2 hr surgery Morphine Fentanyl Pethidine B) Peri surgery 1 Hr surgery 2 Hr Surgery More than 2 hr surgery Morphine Fentanyl Pethidine C) Post surgery 1 Hr surgery 2 Hr Surgery More than 2 hr surgery Morphine Fentanyl Pethidine 10.Please tickmark the drugs used in following surgeries Morphine Fentanyl Pethadine Cardiac surgery Onco surgery Nephro surgery Ortho surgery Neuro surgery Gastroentero surgery
  • 37. 37 11.Rank the hurdles that you face in using narcotic analgesic drugs. Legal formalities Avaibility Cost 12.How frequently do you face short supply of this drugs. Very frequent Frequent Sometimes Rarely Never 13.According to you what benefits narcotic analgesic drugs have over NSAIDs 1._______ 2._______ 3._______ 4._______ 5._______ Date: Place: Signature:
  • 38. 38 Questionnaire for the retailers (Information of the retailer/Pharmacy) Name: ___________________________ Hospital/Shop: ___________________________ Sign: ___________________________ (Note:I assure you that the information given by you will be used purely for the academic purpose and will not be passed on to any unauthorized person) 1.Which of the following narcotic analgesic drugs do you keep? Morphine Fentanyl Pethidine Others 2.In how many units following narcotic analgesic drugs are sold/consumed/used? Morphine- _______ Fentanyl- _______ Pethidine- _______ 3.Tick mark the frequency in which you reorder this drugs. Morphine Fentanyl Pethidine Monthly Bimonthly Quaterly As per the need 4.Rank the factors kept in mind while purchase of this drugs. High margin Lack of competition High consumption
  • 39. 39 Continued 5.Rank the hurdles that you face in selling this drugs. Legal formalities Storage Slow moving product 6.What is the permitted stock that you can keep of this drugs. __________ 7.What amount of stock do you keep. __________ 8.What are the legal requirement you need from the person purchasing this drugs . Yes No Form Prescription License 9.What is the procedure you adopt to purchase narcotic analgesic drugs from the stockiest? __________________________ 10.In case of margin fluctuations between two companies rank your preferences. Company giving higher margin Drugs of the company which doctors prefer more Stockist relationship 11. If new drugs come in the market what will be the procedure to include the drug in the license? _________________________________ Date: Place: Signature: