Adverse drug reactions of most new drugs will be fully known only when they are launched in the market and lakhs of patients start using them. Post marketing surveillance and regular monitoring ADRs of drugs is, therefore, critical for the health authorities to decide their total safety. Pharmaceutical companies normally do not carry out PMS or Phase IV studies even though such studies are mandatory in several countries including India. The need to have regular post marketing surveillance is considered important by the authorities in the wake of recall of quite a few drugs from the market in recent years. Some of the high profile drugs like cisapride, rosiglitazone, nimesulide and phenylpropanolamine were withdrawn from the world markets after years of granting marketing approvals. 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 data of the new drugs are not available with the government. 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 had recently 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 in every six months in the first two years and then annually in the subsequent two years. The Committee had asked the health ministry to direct CDSCO to send out a warning to all companies marketing new drugs to comply with mandatory rules on PSURs or face suspension of marketing approval. In fact, post marketing surveillance is considered helpful to pharmaceutical companies also to find data for newer indications and new markets for which the drug product not initially approved by the drug authorities. Yet and despite warnings from the authorities, the pharma companies do not seem to fall in line with rules. Now, the health ministry is thinking of making post-marketing surveillance of drugs mandatory on pharmaceutical companies for six years instead of current four years. The move comes after the recommendations made by the Prof Ranjit Roy Chaudhury expert committee in this regard. The panel had suggested creation of a detailed protocol to monitor and record the side-effects and efficacy of the drugs already in the market. Unless, these new rules and suggestions of experts are strictly enforced with penal provisions by the office of DCGI, drug safety will continue to remain a serious issue in the country.