New Delhi : After intervention of National Human Rights Commission(NHRC), the Ministry of Health and Family Welfare has amended the Drugs and Cosmetic Rules,1945 to prevent misuse of the painkiller banned drug ‘diclofenac’.
The Ministry in its reply to a case tells the Commission that the rules have been amended vide Gazette Notification GSR 503(E) on 14 July 2014. Now ‘it is mandatory that the drug (diclofenac) for human use shall be packed in single unit dose pack only’.
In last may, acting on a complaint of Odisha based human rights campaigner Akhand, NHRC had taken cognizance over the misuse of banned drugs ‘dicolfenac’, a livestock painkiller and a killer of vultures in the country. The Commission has directed Secretary of health & family welfare and Environment & Forest Ministry to submit their reply in the matter with in four weeks.
The Petitioner had alleged that the drug is misused. Though it is banned for animal use, Diclofenac is readily available with the chemists and private drug stores because it can be used to treat humans also. So, now the chemists selling veterinary drugs have started selling those meant for human beings. Mass killing of vultures creates environment imbalance that affect human life. As carcasses once eaten by vultures now rot in village fields, drinking water has become seriously contaminated, endangering human life.
To comply the commission’s direction, Shailendra Kumar,
Director(Drugs) in the Health Ministry has submitted the report. He said in the report “In view of the reports that one of the cause of decline in vulture population was the use of the Diclofenac sodium in the treatment of live stock, the Government has prohibited the manufacture, sale and distribution of the drug and its formulation for animal use .”
In order to further restrict the illegal use of diclofenac injection in animals meant for human use, the matter was considered by Drugs Technical Advisory Board (DTAB), a statutory body of Central Government under Drugs and Cosmetic Acts, 1940. The normal dose of the drug in animals is about 11 ml for three or four days while the human dose is only 3ml per dose. To prevent the illegal use of the drug diclofenac in animals, the Drugs and Cosmetic Rules,1945 have been amended to make it mandatory that drug for human use shall be packed in single dose pack only.
The Environment & Forest Ministry has not submitted its report yet to the commission, said Akhand.
Diclofenac issue_Health dept report0001.pdf