DCGI directs DCs to cancel mfg licenses of diclofenac for veterinary use, phase out in 3 months
The Drug Controller General of India (DCGI) has directed the State Drug Controllers to cancel the manufacturing licenses issued for diclofenac formulations for veterinary use and to ensure the marketing of such formulations are phased out within a period of three months.
"Serious concern has been expressed at different fora over the decline in vultures population in the Indian subcontinent. Extensive studies have indicated that the use of diclofenac in various livestock's is the major cause for vultures decline. Vultures are exposed diclofenac when they consume carcasses of livestocks treated with diclofenac before death. This results the poisoning of vultures leading to their death because of renal failure. It has therefore been felt that the veterinary use of diclofenac should be phased out and alternate and safer drug like meloxicam should be permitted to be used for the treatment of animals in veterinary healthcare. This would help in saving the vulture population and ecological balance in animal world" noted the DCGI in his communication to the drug controllers.
The DCGI also noted that the Department of Animal Husbandry and Dairying, Ministry of Agriculture, has also issued directions to state veterinary departments not to purchase diclofenac for veterinary use.
It may be noted Pharmabiz was the first to report on an impending ban on the usage of diclofenac for veterinary use in India and on the Prime Minister Dr Manmohan Singh's move to call for a meeting of all ministries concerned to discuss the ban. About 110 pharmaceutical companies in the country use diclofenac, which has a market size of about Rs.200 million in India. Of this about 25 companies are exclusively catering to the veterinary sector.
The need to ban the drug was raised by many NGOs and the Environment Ministry. The National Board of Wildlife had recently called for a phase out of the drug within six months due to its indirect threat to the vulture population.