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[india-drug] Nationwide pharmacovigilance for drug officials
- From: Sunitha Srinivas <s.srinivas@ru.ac.za>
- Date: Mon, 22 Dec 2003 03:20:10 -0500 (EST)
(The much needed Pharmacovigilance program is in the news in Pharmabiz.
A discussion from the India drug participants on the advantages of this
envisaged program would lead us forward. Thanks??SS)
Nationwide pharmacovigilance for drug officials to be in place soon:
DCGI
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Saturday, December 20, 2003 08:00 IST
Our Bureau, Chennai
A countrywide pharmacovigilance programme has been finalized and will
be in place soon. Under this, a major training programme for all drug
regulatory and quality assurance personnel and technical staff of the
pharma industry will be organized in coordination with NIPER, according
to Ashwini Kumar, DCGI.
Delivering his presidential address at the 55th Indian Pharmaceutical
Congress (IPC 2003) in Chennai, Ashwini Kumar said that the government
needs support from a wide cross-section of expert faculty to conduct
these training programmes in various facets of pharmaceutical sciences.
Delving into the theme of IPC 2003 titled ?Pharmacy Medicine Management
and National Health Policy?, he also called upon senior fellow
pharmacists to share their expertise to enable the government to
achieve the objective of bringing in a paradigm shift in professional
pharmacy.
He expressed concern over the sporadic reports of spurious and
counterfeit drugs in various parts of the country and the non-
harmonization of drug enforcements in the states.
It is unfortunate that the government had to set-up committees to
recommend measures against spurious drugs, he added. Talking about the
pharmacy profession, he said that pharmacists are bound by a code of
ethics to deliver best pharmaceutical care in healthcare products.
Over 33 per cent of the country?s population, which is below the
poverty line, lacks the adequate means to access the required medicines
and healthcare facilities.
Majority of the population has to spend from their own pockets to meet
their healthcare needs. The public health spending is only 17 per cent
of the 5.2 per cent of GDP expenditure in the health sector.
The DCGI lauded the efforts of Indian pharmacists who have made their
mark in various disciplines at home and abroad.
The vision of the Indian pharmaceutical industry is to become a global
player in generics. The country is also poised to become a preferred
global destination for drug development research including clinical
research. The government initiatives to achieve these objectives are
clearly perceptible, he said.
While the Indian pharma industry has made its mark on the world map,
the need now is to reinforce the ?India brand? as a reliable source for
quality medicines at competitive prices.
There is a serious dichotomy. ?Our per capita consumption of drugs is
the lowest. The chasm between availability and affordability is a major
challenge for healthcare professionals, particularly the pharmacists,?
he said.
The role and involvement of pharmacists in medicine management and
overall healthcare programmes is crucial, as resources with patients
are limited. ?We are bogged down by issues like low education level,
burden of the disease, limited public healthcare coverage and the
increased burden on physicians.?
There is a need to make sure proper storage of a wide range of drugs.
The distribution of drugs and proper use by patients needs to be
ensured.
Unfortunately, the vision of pharmacists must be articulated in the
National Health Policy. Appropriate policy recommendations needs to
streamline pharmacy with healthcare. The quality of pharmaceutical
products along with the overall quality of pharmaceutical service is of
critical importance. It is only the pharmacists who can deliver both
these components in healthcare, he stated.
The first National Health Policy was formulated in 1983. The
government?s initiative in public health sector has helped the
eradication of small pox, guinea worm, near eradication of polio,
leprosy and drop in the level of mortality rates and increased life
expectancy from 36.7 years in 1951 to 64.4 years in 2002. There has
also been an epidemiological shift in common vector borne diseases and
manifold growth in primary, secondary and tertiary healthcare
infrastructure.
Although the National Health Policy of 1983 was formulated with the
objective to provide ?Health for All? by 2002, this basic objective
needs to be reviewed and reexamined.
The pharmaceutical industry has made spectacular progress in the
various disciplines of pharmacy, specially in areas like pharma
industry, education, regulation and research, yet there is not much
achieved in community and hospital pharmacy.
Despite the fact that pharmacists are readily available professionals
in the country, people are deprived of quality pharmaceutical care. We
have continued with aberrations, which crept in during the 30s and 40s
when the healthcare system was shaping. In 2003, we are still in the
same dilemma. There the issue would require consideration in greater
detail, he informed.
The DCGI also expressed that a professionally sound and national level
drug regulatory system would have provided the much-needed environment
for pharmacy professionals.
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