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more or less been half hearted and stagnated, due to commercial reasons
and others.
so currently the term antibiotics,loosely, includes all the natural ,semisynthetic
or synthetic compounds which prohibit or kill the bacterial growth.
3)Life cycle of Antibiotics -vipin
fig: a general life cycle diagram showing various stages of a product (src:
pininterest.com)
{src: http://www.webpal.org/SAFE/aaarecovery/7_medicine/Medicine%20%20antibiotics/Medicine%20Making%20Antibiotics.pdf}
the most significant raw materials are the organisms themselves. , energy
and carbon resource along with other nutrients essential for faster rate of
growth of the organisms is provided by the growth media.Also some fixed
precursors for the particular antibiotic (for example phenyl acetic acid for
penicillin) are required for production.
apart from this large amount of chilled cooling water is required for controlling
the large amount of heat produced during the fermentation process.
MANUFACTURING vipin
the figure on the previous page shows the typical production scheme of
antibiotics.
the process in general is electricity intensive as large amounts of electricity is
used for transferring oxygen in aerobic fermentation and for production of the
cooling water.
one important point to be noted during manufacturing is that antibiotics can
be destroyed or rendered useless by some other microorganisms. So we
need to maintain a sterile environment to avoid contamination.
{lack of info. over the net about the exact figures is the reason behind missing
energy consumption n other tables}
some worthwhile points -girdhari
.environmental pollution is caused due bio excreata to a limited scale but on
large scale environmental pollution is caused due to the emission from drug
manufacturing as a source of much higher environmental discharges that, in
some cases, greatly exceed toxic threshold concentrations
2.There were scattered, early indications of discharges from manufacturing
being a source of active pharmaceutical ingredients (APIs) in the environment
[16],
3.The discovery of oestrogens in sewage effluents as a cause of the
feminization of fish in the late 1990s sparked an exponentially increased
interest in pharmaceuticals in the environment
4.The pharmaceutical industry argued that significant discharge of APIs from
manufacturing is unlikely based on several lines of reasoning, including that
the extremely high value of drugs would prevent their release for purely
economic reasons .but this assumption was later demonstrated to be
antibiotics have long been, across the world, an instrumental part of meat
producing animals feed. In such animals like poultry they are used for mainly
three reasons:
therapeutic ie treatment of infected
prophylactic implies prevention of those at the risk
and growth promotion for enhancing rate of growth and feed efficiency.
Across these three the third accounts for the most antibiotic consumption in
India as well as other countries.
Such unsustainable use of antibiotics for not just animals but also plants(will
be covered subsequently) and crops has led to the trending phenomenonal
problem of ANTINIOTIC RESISTANCE!!
the figure shows the complete life cycle along with the steps during which
antibiotic stewardship can be shown!!
(for ref and credit for this awesome graph : http://www.epa.gov/esd/bios/
daughton/drug-lifecycle.pdf)
1.Drug Controller General of India (DCGI) Dr G N Singh had written to the Union
health minister to notify a new schedule H1 in the Drugs and Cosmetics
Rules.Drugs that Indians are becoming resistant to or can become resistant to are
being put under schedule H1.these drugs cannot be sold without prescription.
2.The drugs to come under H1 includes Moxifloxacin, Meropenem , Imipenem,
Ertapenem, Doripenem, Colistin, Linezolid , Cefpirome, Gentamicin, Amikacin,
Pencillin, Oxacilin, Zolpidem, Cefalexin, Norfloxacin , Cefaclor, Cefdinir,
Tigecycline , Tobramycin, Tramadol and Vancomycin.
3.To check the indiscriminate use of antibiotics, anti-tuberculosis and some other
drugs in the country, the union health ministry has notified amendments to the
Drugs and Cosmetics Act, 1940 under which a new provision Schedule H1 has
been included to curb over the counter (OTC) sale of certain antibiotics and antituberculosis drugs from March 1, 2014.
Forty-six drugs, comprising mainly third and fourth generation antibiotics, have
been placed under this restricted category and the sale of these drugs could only
be done on furnishing an appropriate prescription letter of a doctor. Also, the seller
has to retain a copy of the prescription letter and maintain a separate register that
records the name of the buyer and the doctor who prescribed the medicine along
with other necessary details.
To spread awareness, a mandatory warning has to be printed in a red box on the
label of listed drugs and any violation of the new rule can result in prosecution,
states the notification, which was issued on August 30.
Dr Madhukar Pai, associate professor at McGill University and associate director,
McGill International TB Centre, in an exclusive conversation with India Medical
Times said, This Government of India order and the Chennai Declaration are
important to raise awareness about the rampant abuse of antibiotics, including antiTB drugs, in India, especially over the counter use.
4.Dr A Muruganathan, president, Association of Physicians of India, told IMT,
Personally, I believe it should not be only about certain antibiotics and anti-TB
drugs for which a prescription letter should be mandatory. No drug in India should
be sold without a doctors advice. Also, the seller should ask for fresh prescription
letter if there is a gap between the patient buying over the counter medicine and the
date on which the doctor recommended. Like in other countries, India should take
sincere steps to stop the practice of over the counter sale of antibiotics as it leads
to growing antimicrobial resistance.
5.WHAT THE NEW SCHEDULE H1 NORM MEANS
FOR RETAILERS
* Will require more time and add to work in the form of record keeping
* Will slow down dispensing process
* Will have address of patient so can recall medicines in case of problems in a
particular batch or spurious drug
* Loss of Over The Counter (OTC) sale
FOR DOCTORS
* Will need to be extremely judicious while prescribing these medicines
* It will help minimize resistance in patients
* Patients will come for repeat prescriptions for chronic diseases
FOR PATIENTS
* Will have to buy medicines in lumpsum for at least a month
* Patients cannot buy medicine OTC in case of emergency
* Patients who cannot go to doctors often but are on certain medicines lifelong will
have to shell out more money on doctor visits
7)way ahead
Now the Case study revelations along with the findings of the
antibiotics report by WHO together clubbed with the precautionary
principle can easily be used to bring out some long needed stringent
laws to stop over the counter sale(without prescription) of antibiotics,
also to put a stop to antibiotics in animal feed as growth promoters.