India needs to build indigenous drug safety database: Pharmacovigilance expert
Mumbai, May 2017: There is a need for collaboration between IT industry, DCGI and CDSCO to build robust electronic database for Pharmacovigilance Programme of India (PvPI) according to Moin Don, a leading pharmacovigilance expert and chief executive officer and founder of PVCON Consulting Services. That will reduce the country's dependance on Uppsala Monitoring Centre (UMC)'s drug safety data.
India, aptly called pharmacy of the world, has mostly introduced medicines which have been approved and marketed in other countries. Earlier there was a long gap in the launch of product in regulated market and India. So the drug safety data generated in other countries was available when the product was launched in India. The decrease in duration of availability of approved drugs in regulated market and India has necessitated the creation of effective India specific pharmacovigilance system to generate drug safety data with the country's own experience, said Moin Don.
Besides this, India's compliance with TRIPS, a new patent regime, has prevented Indian pharmaceutical and biotechnology industries from manufacturing patented products and marketing them without license from the innovator company. A number of Indian drug makers, realising the compulsion of new patent regime, has stepped up efforts to discover and develop new drugs. This will hopefully lead to development of new drugs based on pre-clinical and clinical data generated in India in coming years. In such cases, the Indian regulatory agencies cannot count on the experience of other markets to assess the adverse drug reactions (ADRs). They have to put in place indigenous PV system to monitor ADRs of products first launched in India, he said.
Once developed, the electronic database for PvPI will provide risk-benefit ratio of the drug via computer algorithms that measures the reporting frequency for lot of drug-event combinations and help screening large spontaneous reporting system databases and review of health statistics and drug utilization data.
Data quality is important to establish causality which helps investigate suspect adverse drug reaction reports. This helps find the potential relationship of the reaction with the drug. If the reaction is mainly due to the drug, necessary safety measures can be taken while prescribing the same drug. Even the statistical method can be used to introduce organised signal detection of adverse event information, he added.
Though Indian pharmacovigilance data is being collected through PvPI but that data is only shared by vigiflow to WHO. No efficient official system of communication is set up by which data received by PvPI is shared with the concerned pharmaceutical companies and medical professionals in efficient and effective manner so that the companies and healthcare professionals have direct access to ADR data for understanding and managing the risks identified with the use of specific drugs.