At last the Central Drugs Standards Control Organization will be setting in motion a structured system for monitoring of adverse drug reactions in India for the first time. That should hopefully replace the existing disorganized and weak ADR reporting practice in this country. The current system of ADR monitoring had miserably failed to guide the regulatory authorities to achieve some reasonable level of safety of drugs marketed in the country. CDSCO has planned to set up a network of 40 pharmacovigilance centres across the country in a few weeks from now. All the new drugs approved for marketing by the DCGI during the last four years will be monitored by these centres. These pharmacovigilance centres are expected to operate from the government and private medical institutions. The activities of these centers will be monitored and coordinated by six regional centers ,two zonal centers and a supreme control point at CDSCO.The centers will be given specific targets to be met at a given time. The whole operation of monitoring ADR in the country will now be headed by a senior official to be appointed by the government specifically for this purpose. Perhaps that is the best part of this exercise. It is extremely important that this critical function of the country's drug administration should be headed by a senior official to have any meaningful outcome.
ADR monitoring is considered to be an integral part of drug administration in any civilized nation. And that exists in all the countries wherever there is a well-developed pharmaceutical industry. Post marketing surveillance or phase IV trials are conducted by the international pharmaceutical companies in all the developed countries. But, in India the same international pharmaceutical companies have never cared to do post marketing surveillance. ADR monitoring is one of the most important ways of monitoring safety of a drug throughout its marketed life. Spontaneous ADR reporting by the health professionals forms the cornerstone of post marketing drug safety surveillance. The relevance of this vigilance is particularly important for India with the entry of increasing number of new drugs into the domestic market in recent years and floating of thousands of irrational and harmful combinations. Many of these new drugs and combinations are not allowed to be marketed in developed countries. More than the new drugs, irrational combinations are causing more damage to the patients as most pharma companies manufacture these combinations without actually assessing dangerous chemical reactions caused by the drugs while combining. The CDSCO has not been able to effectively curb the growth of the irrational combinations just because of the absence of a system to generate adequate data of ADR. Now with effective pharmacovigilance machinery in place, it should not be difficult for the regulatory authorities to withdraw harmful drugs and combinations from the market.