Last May, Indian Pharmacopoeia Commission issued an order mandating all the pharmaceutical companies to submit adverse drugs reaction (ADR) reports of their pharmaceutical products regularly to Pharmacovigilance Programme of India. The order, issued by Dr G N Singh, secretary-cum-scientific-director of PvPI, is expected to have come into force from June 1. The direction is a major step towards achieving total drug safety in the country having several new drugs and thousands of irrational combinations floating in the market. With this step, IPC wants pharma companies to submit the reports of drugs in XML-E2B format to PvPI. IPC office hopes that this format will enable the regulatory authorities to hasten the process of uploading Individual Case Safety Reports of drugs to VigiFlow, a web-based database of the WHO–UMC (World Health Organisation – Uppsala Monitoring Centre). This measure is expected to enhance the process of assessment and signal detection. Although some large pharmaceutical companies in India collect ADR reports of their suspected drugs from medical practitioners through their marketing teams, only a few of them have pharmacovigilance departments and drug safety software databases to generate ADR reports in XML-E2B format.
Pressure on regulatory authorities to make pharmaceutical companies to mandatorily collect ADR reports of their marketed drugs has been building up for some time in India especially after recent withdrawal of quite a few high profile drugs from the US and European markets on account of their serious side effects. These actions of the US and European authorities indicate that all approved medicines are not always totally safe as the three phase clinical trials are usually limited to a few thousands of patients. It is possible that either all adverse reactions of drugs cannot be assessed correctly from a limited group of subjects during trials or the process of trials could be faulty in some cases. It is in consideration of these realities the practice of submission of post marketing surveillance of all approved drugs with the regulatory authorities by the pharmaceutical companies is followed in developed countries. In India, CDSCO issued an order in August 2012 mandating submission of Periodic Safety Update Reports (PSUR) of all new drugs to DCGI every six months for the first two years of launch and annually for the next two years. But most of the companies do not care to submit such reports to the DCGI. Now with IPC also issuing an order in this regard, the heat is on pharma companies to comply with this statutory requirement. The office of DCGI needs to monitor compliance of this order by pharma companies and also take punitive action against the defying companies.