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Abstract: Pharmacovigilance is about detecting new adverse drug reactions. Indian regulatory agencies cannot reckon the experience of other markets to assess the incidence and prevalence of adverse reactions. Post 2005, the Indian Pharma companies realized the impact of the new patent regime and initiated investments for discovery and development of new drugs. This necessitated strengthening of internal Pharmacovigilance standards and realization of the importance of a properly designed Pharmacovigilance system for safety and AE reporting in pharmaceutical industry.
Introduction
‘Pharmacovigilance’ is defined by the WHO as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. In the past, new drugs introduced into the Indian Market included products that were earlier approved and marketed in the US, Western Europe or Japan. Also, there was a time lag of approximately 4 years between the first marketing of a new drug in a foreign country and India. Thus, Pharmacovigilance in India was still in infancy. AE reporting from outside India helped our regulatory agencies to assess the rationale of Pharmacovigilance. Regulatory bodies in India used to take action on marketed drugs on the basis of reports on the harmful effects of drugs marketed abroad. But, there are drugs which were banned or withdrawn in foreign markets are still allowed to be kept in market in India on the basis of conscious decision of the regulatory agency that the benefit to risk ratio is favorable. For e.g. chloramphenicol, cisapride and phenformin.
Post 2005, it became official that India can no longer copy patented products and market them without licence from the innovator company. This evolution of a new patent regime in the Indian Pharmaceutical Industry was a consequence of India being a founder member of World Trade Organization (WTO), and her obligations under TRIPS. As the expenditure on R & D rises, Indian Pharma companies will hopefully be finding new drugs based on pre-clinical and clinical data generated mostly in India. Thus, Indian regulatory body cannot rely now on data generated by other countries to assess the incidence and prevalence of ADRs from drug usage. Thus, the importance of developing sound internal Pharmacovigilance standards / Pharmacovigilance system for safety and AE reporting cannot be overlooked For an effective Pharmacovigilance system to be functional and efficient all the stakeholders including, but not limiting to, regulatory bodies, sponsors and health care professionals (Doctors, pharmacist, nurses) need to be alert and attentive through out the lifetime of the drug in the market.