Although
pharmacovigilance initiative was launched in the country by Indian
Pharmacopoeia Commission in 2010 to build a national data base of
adverse drug reactions of drugs marketed in the country, its progress
has not been rather satisfactory. Currently, there are only 90 medical
colleges, laboratories and hospitals registered under the PvPI programme
monitoring ADRs of the drugs marketed in the country. The largest
number of ADR centres are located in Karnataka followed by Tamil Nadu.
Through this ADR centres, IPC has been able to collect a data base of
54000 ADR reports from different parts of the country. IPC intends to
bring in all the medical colleges across the country under the
pharmacovigilance programme in the next few years. By the end of March
2014, the target is to increase the number to 150 and by 2015, the ADR
centres are expected to be 350 making the pharmacovigilance programme of
India the largest in the world. There is no doubt that a country of
India’s size requires a massive capacity building for this programme and
the number of these centres should have been expanded much faster.
Regular
monitoring of clinical data of patients taking both old and newly
approved drugs is considered necessary to determine their safety and
efficacy as the 3 phase clinical trials usually cover only a few
thousands of subjects. Adverse drug reaction of some of the drugs may be
only known when the drug is launched in the market and lakhs of people
start using them. Therefore, post marketing surveillance and regular
monitoring ADRs of drugs is extremely necessary for the health
authorities to decide their safety. ADRs of a large number of drugs have
been reported in India and other countries in recent years. It has been
observed that the patients from across the country have been showing
cases of side effects long after they have been under the medication of
these drugs. The data from the ADR centres indicate the disturbing fact
that some of the drugs considered to be safe, have been showing signs
of adverse reactions on the patients over the years. This is mainly
because of the fact that post marketing studies are not undertaken by
pharmaceutical companies in India. Pharma companies are required to
submit Periodic Safety Update Reports listing side effects, fatalities
and injuries of every approved drugs to DCGI every six months in the
first two years and then annually in the following two years. This is
not being done by most companies in India although submission of such
surveillance data is mandatory. Considering the present status of ADR
reporting in the country, there is need for involving pharmacists,
patients and general public in this exercise by educating and training
them about drug reaction reporting. A public awareness campaign on ADRs
by the state health departments and pharmacy councils can be a good
initiative
