PUBLIC & ADR REPORTING

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.

by

Dr.Akshaya Srikanth B

Pharm.D India