Union Health Ministry has decided to put a warning on the label of diclofenac preparations to prevent the use of the drug on animals. The decision was taken by the Drug Consultative Committee (DCC) in a meeting early June against the backdrop of complaints about its ongoing use of non-steroidal anti-inflammatory drug despite the ban on its veterinary use.
The ministry had decided to phase out its use in animals almost a year ago. However, diclofenac is reported to be still being used by veterinarians for treating animals in rural areas of the country. Union Ministry of Environment and Forest has thus sought action from the Ministry of Health to prevent the veterinary use of the drug. It is in response to this complaint, the DCC decided to add a caution on the label to avoid further misuse. The DCC will pass its recommendation to the Drug Technical Advisory Board (DTAB) for its approval.
According to the decision, the label of diclofenac products should carry the caution, 'for human use only, not to be used by the veterinarian' as mandatory. When asked about such a decision after one year of banning the drug from veterinary use, a member of DCC told Pharmabiz, "The DCC met to discuss the suggestion from the ministry of environment on the misuse of the drug in animals from various parts of the country. Though we have disallowed the use of the drug for veterinary use earlier, it is a question that how do we demonstrate that such a decision was taken by the authority."
The source also said that the caution on label would alert the pharmacist against sales of the drug for veterinary usage. The drug is mostly misused in the rural area and the label will alert the pharmacy stores against selling the drug for veterinary use. However, the authority may not go for more a total ban of the drug, as it is a widely prescribed drug for various human diseases, it is learnt.
The veterinary Diclofenac widely used in cattle as an anti-inflammatory drug has reportedly caused the death of three main species of vultures in India when they ingest the drug after feeding on the carcass. The vulture species, Slender-billed Gyps Tenuirostris, Indian G indicus and White-rumped Vultures G Bengalensis die from kidney failure after eating the flesh of cattle and water buffalo treated with diclofenac, according to reports.
The Drug Controller General of India had directed pharma companies as per an order in May 2006 to replace the drug with an alternative Meloxicam in three months time. Nature loving groups including the Bombay Natural History Society (BNHS) were demanding for the ban of the drug since the issue came up. Veterinary Diclofenac had a sales of Rs 20 crore market in India.