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 In a cramped Mumbai pediatric ward, third-year pharmacology student
Nitin Shinde opens the boy's file and notes the vaccine, his age and
the doctor's diagnosis of a skin infection. That information is
later logged into a computer program linked to a national database,
part of India's fledgling efforts to track, analyze and ultimately
warn patients about unknown side effects of drugs on the market.
India's six-year-old pharmacovigilance program, which collects and
submits suspected adverse drug reactions to a World Health
Organization (WHO) database, is key to improving drug safety in a
country where medicine consumption is high, experts say.
But insufficient staff and equipment, and a lack of awareness among
medical professionals mean many potentially dangerous drug reactions
go unrecorded, hospital personnel across India told Reuters.
Gaps in the system mean the government has less data to determine
whether drugs might have harmful side effects. Also, relatively
little information flows from one of the world's largest
pharmaceutical markets to the WHO database of over 12 million
suspected adverse drug reactions.
"In a country of 1 billion people consuming so much medicine,
obviously safety is a concern," said G. Parthasarathi, dean of the
pharmacy school at JSS University in Mysore, adding the
pharmacovigilance program is still gaining traction. "We've made a
good start," he said.
Last year, India contributed 2 percent of the 2.1 million suspected
reactions added to VigiBase, the WHO's global database. China, with
a comparable population, contributed 8 percent.
Tracking adverse drug reactions is urgent "in public health programs
where huge amounts of medicine are being used," said Sten Olsson, a
WHO program expert at the non-profit Uppsala Monitoring Center (UMC)
in Sweden which maintains VigiBase.
The center analyses the WHO database for worrying patterns among
suspected reactions and, where there are safety concerns, publishes
a "signal" that goes out to member countries. It is up to those
countries to act on that information or not. "We're concerned that
with some of our new signals nothing has been done with them," said
Olsson.
Indian health officials say the monitoring program is a "high
priority" and a $14.5 million annual budget is sufficient.
"We are going to develop a better pharmacovigilance system in India
in due course," said G.N. Singh, India's drug controller. "Patient
health will be assured."
DRUG COMPANIES
The program could improve, experts say, if drugs firms contributed
more.
To make a new drug in India, companies need permission from the
national drug controller after submitting safety and efficacy data
including from local clinical trials. For four years after an
approved drug is on the market, firms must submit safety reports,
including those on adverse drug reactions.
After that there is no mandatory requirement for them to report all
adverse reactions, and smaller firms, which make up over a third of
India's market, often don't have robust monitoring resources.
"They feel after four years, every drug is safe," said a person
working in pharmacovigilance at a multinational drugs company in
India. "That's not the case."
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Last year, only about one tenth of the suspected adverse drug
reactions India collected came from drugmakers, compared to 95
percent in the United States.
But making reporting mandatory for all companies and all drugs is
not realistic, industry advocates say.
"You have up to 80,000 drugs on the market. You think the government
is prepared to do pharmacovigilance for all of them?" said T.R.
Gopalakrishnan, deputy secretary-general of the Indian Drug
Manufacturers Association. "Many manufacturers don't even know where
their drugs are being consumed."
"WHAT CAN I DO?"
Some of India's 179 monitoring centers operate smoothly, but other
parts of the system aren't working, program administrators say. In
interviews with staff at more than 20 centers, program coordinators
cited problems ranging from a shortage of personnel, computers and
funds to raise awareness among staff to a lack of cooperation from
doctors who say they are too busy.
"I call doctors to my office, serve them tea... and push them to
report. What else can I do?" said C.B. Choudhary, who coordinates a
monitoring center at Katihar Medical College in Bihar state. "I want
the program to start, but it isn't happening," he said.
Not all centers require extra personnel or equipment, and those that
do are in the process of getting full staff, said V. Kalaiselvan,
principal scientific officer at the Indian Pharmacopoeia Commission
which hosts the pharmacovigilance program's headquarters in
Ghaziabad outside New Delhi.
Regarding doctors' lack of engagement, "the culture of reporting is
improving," he said.
Reporting numbers have risen, and staff at headquarters used patient
data last year to make seven recommendations to the drug regulator
to add new warning labels - the first time Indian, not foreign data,
was used, said Kalaiselvan.
The body recommended, for instance, that the regulator require an
antibiotic combination of piperacillin and tazobactam, sold in India
by several major drugmakers, be sold with a warning that it could
cause breathing difficulty and potassium deficiency.
($1 = 68.0508 Indian rupees)
(Reporting by Zeba Siddiqui and Krista Mahr, with additional
reporting by Sankalp Phartiyal; Editing by Ian Geoghegan)
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