Veterinary pharmacovigilance in India: A need of hour.

Veterinary pharmacovigilance (PV) is important for the Medicine which are used for treating disease in animals. It becomes more important when these animals are further used for producing food. Adverse drug reactions (ADRs) have a direct impact on animals and indirect impact on human beings, for example, through milk products, other animal producing food products. Currently, PV program of India is playing a vital role in assessing the safety of medicines in Indian Population. The safety of medicine in animals can be assessed by veterinary PV. The research institutes involved in animal research and veterinary hospitals can be considered as ADR monitoring centers to assess the safety of medicines on animals.

Pharmacovigilance (PV) is a science relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, came into existence to monitor the adverse drug reactions (ADRs) throughout the life period of a drug.[2] In India, Ministry of Health and Family Welfare (MoHFW), Government of India (GOI) launched a nationwide PV Programme of India (PvPI) in the year 2010 to monitor the safety of drugs. Indian Pharmacopoeia Commission under the MoHFW functions as National Coordination Centre (NCC) for PvPI. NCC identified 202 ADRs monitoring centers across the country to monitor, identify and report ADRs to NCC.[12345] The mission of PvPI is “to safeguard the health of the Indian Population by ensuring that the benefits of the use of medicine outweigh the risks associated with their use.” The vision of PvPI is “to improve patient safety and welfare of Indian Population by monitoring drug safety and thereby reducing the risk associated with the use of medicines.” The medicines which are used for the treatment of animals shall be observed for their short- and long-term effects on animals and the effect on the environment because they may affect the ecosystem in one or other way. Unfortunately, there is an acute lack of information on veterinary PV in India. Drug regulatory authority of India banned the diclofenac sodium for animal use because of reducing number of vulture population and also regulate the use of injection oxytocin for animal use. Veterinary PV is same like PV, but it is related to use of medicines in animals. As per European Medicine Agency veterinary PV concerns “monitoring, evaluating, and improving the safety of veterinary medicines, with particular reference to adverse events in animals and human beings related to the use of these medicines.” It also involves the collection of information on adverse events due to off-label use and investigations of the validity of the withdrawal period and of potential environmental problems.[8]

Recent studies reveal that ADR in animals is of major concern to the health of animals. ADRs have a direct impact on animals and indirect impact on human beings. The mortality rate of animals in India due to lack of veterinary PV is very high as compared to other developed countries. The concept of veterinary PV is relatively novel in India although many other countries such as USA, Canada, Europe, Japan, and China have well-established guidelines and systems for veterinary PV. Based on the recommendations of such systems few drugs have been banned by the respective regulatory authorities.[67]

The UK veterinary medicine directorate states that the adverse events due to nonsteroidal anti-inflammatory drugs in various species of animals are similar.[9] According to a study in France, eight signals were identified from the reports received or the periodic safety update reports. They resulted in revisions of the product information in sections addressing contraindications, adverse reactions, or withdrawal times.[10]

The adverse events of medicinal products on animals need to be evaluated in line with international standards such as Veterinary International Conference on Harmonization of USA and European Union. There are many other countries who are viewing veterinary PV very seriously and are conducting research to understand the frequency of ADRs among various species of animals.[11]

Veterinary medicines in India are regulated by Central Drugs Standard Control Organization. The Adverse Drug Events definition for animals is- “any side effect, injury, toxicity or sensitivity reaction (or failure to perform as expected) associated with the use of an animal drug, whether or not determined to be attributable to the drug (As per Centre for Veterinary Medicine, USFDA).

In India, there is a felt need to monitor the safety of drugs which are being used in animals. The consumption of dairy products and products obtained from animals are abundant in India. Hence, the medicines which are being consumed by animals may affect the human population and environment in many ways. Therefore, veterinary PV is important for the reporting of adverse drug events including serious adverse events following use of medicines in animals. It also helps in understanding the resistance of certain medicines in animals. The regulatory authority of India is very active to monitor the safety of medicines; the CDSCO issued a circular no- F. No. X-11026/64/2014-BD dated June 6, 2014, to all State/Union Territories Drugs Controllers regarding the use of antibiotics for treatment of food producing animals and in animal feed. A general awareness among the Indian population is lacking in case of veterinary pharmacovigilance, which needs to be augmented, however various measures being taken by Govt. of India to monitor the safety of medicines for animals. In India PvPI a robust system has been established with a capacity to collate, analyse and to identify drug safety signals. These evidence and scientific base information is provided to CDSCO for taking appropriate regulatory measures. It facilitates to establish a system for monitoring the safety of medicine used in veterinary health. The authors suggest that there is strong need for a system for PV of veterinary medicine, just as the one that exists for medicines meant for use in humans. A system/mechanism for veterinary PV is proposed in Figure 1. A lead role for various stakeholders such as animal research Institutes, Indian Veterinary Research Institute, Veterinary Hospitals, agriculture universities is envisaged for establishing veterinary PV for the welfare of animals and humanity.

Figure 1

Proposed flow diagram for veterinary pharmacovigilance programme of India

Financial Support and Sponsorship

Nil.

Conflicts of Interest

There are no conflicts of interest.