Challenges in the Changing Pharmaceutical

1. Making medicines safer - Express Pharma
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Making medicines safer
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Pharma Ally J Ramnivas, Chief Executive Officer, Sai Pharma Solutions, lists
the many reasons how life saving medicines can turn out to be
Specials
just the opposite
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Every day we read the news of tragic deaths after
Services receiving vaccines. These incidents are putting
question mark on the safety of medicines. Rational
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usage of medicines is the need of the hour. If the
Open Forum corrective and preventive measures are not taken in
Subscribe/Renew time, the people will refuse to vaccinate their
Archives children and which in turn can lead to breakouts of diseases that
Search would have been easily preventable. Instead of shifting blame,
Media Kit there is need for introspection otherwise there is a great risk
lurking right from manufacturing to prescription and ultimately
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usage by patients.
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The official reason for the deaths as per government records is
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adverse events following immunisation. But it is difficult to
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believe how they have arrived at these conclusions. Deaths after
Express Hospitality vaccination could be a reaction to the components of vaccine.
Express TravelWorld Either it could be due to preservatives or the content. The other
Express Healthcare reason may be standard procedures laid down for the usage of
Group Sites these vaccines are violated. If vaccine vials are not used within
stipulated time hours of opening, they can get contaminated and
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vaccination of such contaminated medicines can lead to serious Pharma
Indian Express tragic incidents. Formulation
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METTLER
Before launching the medicine in the market it has to pass
TOLEDO
through preclinical studies followed by clinical studies. The
formulation
manufacturer has to file IND prior to initiation of clinical trials
software
and toxicological studies of the medicine are undertaken. On mt.com/pharmaceutic…
being found safe with least toxicological concerns, clinical studies
can begin only when preclinical studies have been successfully
completed and an approval has been received from the drug Jobs in
regulating authority for the conduct of clinical trials. During Pharma
clinical trial studies where safety and efficacy of medicines is Vacancies in top
determined. The clinical trials for the medicine is started in companies.
different phases which cover treatment trials, prevention trials, Submit Your
diagnostic trials, screening trials and quality of life trials Resume Free.
(supportive care trials).The purpose of conducting clinical trials in Now!
different phases is to monitor and evaluate the safety, efficacy, MonsterIndia.com
purity and quality of medicines to mitigate the risks. During
clinical trials if anything goes wrong and is not investigated, the Clinical
medicine which is supposed to be life saving can turn out to be Research
the medicine of death. Courses
Clinical Research
Lack of adequate post marketing surveillance is one of the root Courses from Top
http://www.expresspharmaonline.com/20110715/management02.shtml[7/8/2011 4:32:26 PM]

2. Making medicines safer - Express Pharma
causes of such eventualities. This is a matter of great concern. Universities. Apply
Once the medicine gets the nod of drug regulatory authorities Now & Get Info!
for marketing approval. This is very important phase because it StudyPlaces.com/Clini…
often garners additional data about the safety and efficacy of
medicines where it has been marketed for patient use. At this Drug
stage, if there is no co-ordination between medical practitioners Interaction
and drug regulatory authorities, there will be no reporting of Center
adverse drug reactions and no corrective and preventive action Learn about
will be taken. At this stage, the involved agencies and drug commonly
regulation enforcing authorities should understand their misunderstood
respective responsibilities. Efforts should be made to make the food-drug
system more effective and foolproof. But unfortunately post interactions.
marketing surveillance is lacking in our country and outcome www.druginteractionc…
thereof is observed when we come across the news of tragic
eventualities in the news papers, TV etc.
There are several reasons for the contamination of medicines
leading to deaths. If these following factors are ignored, life
saving medicine can become medicine of death:
1. Lack of adequate quality systems during manufacturing
of medicines: During the manufacturing, testing, packing
labeling and storage of medicines if there no adequate quality
systems in place and GMP regulations are violated, there are
possibilities for the medicine to get contaminated and can pose
health hazards.
2. Lack of adequate transportation: Shipping of medicines
plays very important role. If during transportation, the required
storage conditions are not maintained, this can lead to the
degradation of the medicines and impurity formation. The toxic
nature of impurities can also trigger health hazards to the
patients and can result in any eventuality.
3. Lack of proper storage conditions: The situation of
pharmacy stores is very pathetic. Hardly there is any pharmacy
store meeting pharmacopoeial storage conditions. Yet they have
approval from the drug regulating agencies. This is matter of
great concern. Within the pharmacy store medicines become
poison if their required storage conditions are not met. In
addition to the storage issues, there is lack of control for the
expired date medicines. The ignorance of drug regulating
authorities and lack of awareness in patients is causing a
threatening situation which needs to be addressed on priority
basis.
4. Lack of adequate prescription: In India, quacks prescribe
medicines which need to be prescribed by qualified medical
professionals. The reason is the redily available treatment at
cheaper cost from quacks. These quacks do not know the right
usage of medicines and ultimately prescription by such quacks
can become a bone of contention for health issues and instead of
remedy, this practice jeopardises the health of patients. In some
cases pharmacists play the role of doctors and deliver schedule
H medicines as the over the counter (OTC) medicines.
Irrational use of medicines is a global problem and particularly
more common in developing countries like India because of
under surveillance from the regulatory agencies and less
awareness among medical professionals and public in general. It
is widely assumed that use of drug by a qualified doctor is
http://www.expresspharmaonline.com/20110715/management02.shtml[7/8/2011 4:32:26 PM]

3. Making medicines safer - Express Pharma
rational but in reality irrationality abounds in many aspects of
medicines, i.e. selection, procurement, storage, prescribing,
dispensing, monitoring and feedback which may lead to
inappropriate, ineffective and economically inefficient use of
medicines. Irrational prescribing and poor dispensing adversely
impact morbidity and mortality in general population and also
leads to wastage of resources, unwanted side effects and
adverse psychological suffering. Interventions to improve
prescribing and dispensing practices can be educational (by
conducting CME, seminars etc) and regulatory. The need of the
hour is the rational usage of medicines and all agencies involved
have to accept this challenge and prove to the world that our
medicinal system is world class!
(The author can be contacted at info@ saipharmasolutions.com)
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