The Union health ministry is considering to make it mandatory for the pharmceutical companies to have a Pharmacovigilance system within their organisation for the post marketing surveillance of new drugs launched in the market. The Drug Testing Advisory Board (DTAB) is working on a draft rule for the same so as to put in place a system of collecting, processing and forwarding the Adverse Drug Reactions report to the licensing authority by the companies. Pharmacy Council of India and Indian Council of Medical Research had suggested setting up of a pharmacovigilance department within each pharma company some time back as most of them do not have such a system. The objective of the ministry is to make pharmacovigilance reporting mandatory on pharma companies in a bid to have detailed ADR data from the industry. In fact, the health ministry directed all the pharmaceutical companies last year to follow the practice of submission of Periodic Safety Update Reports (PSURs) of drugs on a regular basis but there has been no response from the industry so far.
In the absence of any cooperation from industry to generate detailed and reliable post marketing data of new drugs marketed in the country, the government itself took the initiative and established Pharmaco-vigilance Programme of India in 2010. The mission of PvPI is to safeguard the health of Indian population by ensuring that the benefit of use of medicine outweighs the risks associated with its use. ADRs are reported from different centres of the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute to the global ADRs data base. Drugs and pharmaceuticals are produced by pharmaceutical industry and approval for marketing the same is granted by the national regulatory authorities after duly verifying their efficacy and safety profile. But even after three phase clinical trials, all approved medicines are not always found to be totally safe as trials are usually limited to a few thousands of patients. The need to have periodic safety assessment of any drug cannot be underestimated considering the fact that many drugs are getting withdrawn from the market even after their successful launches and remaining in the market for years. Apart from the safety of individual drugs, ADRs of thousands of combination drugs marketed especially in India are not all ascertained. This is a serious health issue neglected for so many years in India. It will be very difficult for the government's pharmacovigilance machinery to collect such huge data of ADRs of all individual drugs and combinations from the market. Therefore, fixing that responsibility of collecting ADR data of drugs on the companies themselves is possibly the best option.
In the absence of any cooperation from industry to generate detailed and reliable post marketing data of new drugs marketed in the country, the government itself took the initiative and established Pharmaco-vigilance Programme of India in 2010. The mission of PvPI is to safeguard the health of Indian population by ensuring that the benefit of use of medicine outweighs the risks associated with its use. ADRs are reported from different centres of the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute to the global ADRs data base. Drugs and pharmaceuticals are produced by pharmaceutical industry and approval for marketing the same is granted by the national regulatory authorities after duly verifying their efficacy and safety profile. But even after three phase clinical trials, all approved medicines are not always found to be totally safe as trials are usually limited to a few thousands of patients. The need to have periodic safety assessment of any drug cannot be underestimated considering the fact that many drugs are getting withdrawn from the market even after their successful launches and remaining in the market for years. Apart from the safety of individual drugs, ADRs of thousands of combination drugs marketed especially in India are not all ascertained. This is a serious health issue neglected for so many years in India. It will be very difficult for the government's pharmacovigilance machinery to collect such huge data of ADRs of all individual drugs and combinations from the market. Therefore, fixing that responsibility of collecting ADR data of drugs on the companies themselves is possibly the best option.
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