Regular monitoring of clinical data of both old and newly approved drugs is considered necessary to ensure their safety and efficacy as three phase clinical trials cover only a few thousands of subjects. Adverse drug reactions of some of the new drugs will be only known when they are launched in the market and lakhs of people start using them. Post marketing surveillance and regular monitoring ADRs of drugs is, therefore, critical for the health authorities to decide their safety. Known also as phase IV study, the post marketing surveillance is considered helpful for the pharmaceutical companies to improve the potential of the marketed product. This phase helps the pharma companies in finding data for newer indications and new markets for which the drug product had not been initially approved by the drug authorities. The need to have regular post marketing surveillance was found extremely important in the wake of recall of quite a few drugs from the market in recent years. Some of the high profile drugs like rosiglitazone, nimesulide, cisapride and phenylpropanolamine were withdrawn from the world markets after years of granting marketing approvals. That would mean that millions of patients had taken those unsafe drugs for years without knowing the harm these drugs might have been caused to them.
In India the decision to recall unsafe drugs from the market is taken usually after the US or European regulatory authorities take such a step. This is mainly because of the fact that post marketing studies are not undertaken by most of the pharmaceutical companies in India. Although submission of post marketing surveillance data is mandatory on the pharmaceutical companies , most of the companies do not care to submit such reports to the DCGI. The Parliamentary standing committee on health & family welfare has taken serious note of this deficiency in enforcement of this rule by the office of the DCGI. In its investigation, the committee found that in the case of most of the approved drugs, the pharmaceutical companies were not submitting Periodic Safety Update Reports (PSURs) listing side effects, fatalities, injuries etc. These reports are expected to be submitted once every six months in the first two years and then annually in the following two years. The Committee asked the health ministry to direct CDSCO to send out a warning to all manufacturers of new drugs to comply with mandatory rules on PSURs or face suspension of marketing approval. Pharmacovigilance or ADR monitoring of the drugs by CDSCO has also been rather weak for several years and it has come into existence only from 2010. Even after launching of the pharmacovigilance programme two years ago, it has not made much progress as yet . In the first phase of the programme, the target was to set up 40 ADR centres, but just 22 were set up. Although 60 more centres were planned last year at an investment of Rs.60 crore, only 40 more added subsequently. In an atmosphere of poor compliance in submission of PSURs by pharmaceutical companies, strengthening of the network of pharmacovigilance centres is the only option left to the government to track the drug safety in the country.