The Drugs Technical Advisory Board (DTAB) of the Union health ministry has reiterated its earlier stand that the controversial drug oxytocin injection legitimately manufactured in the country is required for medical purposes and as such it cannot be prohibited. The misuse of the drug in a crude form, can only be curbed through constant surveillance by the regulatory authorities, it said.

The issue of restricting or prohibiting the oxytocin injection because of its misuse by dairy owners to extract milk from milch animals was again discussed in the DTAB's 70th meeting held on August 18, 2015. In the 69th meeting held on April 22, 2015, the DTAB, the highest authority under the Union health ministry on technical matters, had reiterated its earlier recommendations that the drug need not be prohibited as it has definite use for therapeutic purposes.  

The members in the meeting felt that the problem of misuse of oxytocin is more related to stricter control over the manufacture and sale of the drug especially through clandestine channels. The dairy owners get the drug manufactured at dubious premises from unscrupulous suppliers. Constant surveillance by the state drug regulatory authorities and other such regulatory agencies can only curb the misuse of the drug.

It was, however, decided that the issue may be further examined with experts from outside especially related to the animal husbandry for recommendations.

Accordingly, Dr B S Prakash, assistant director general (ANP), ministry of agriculture, Krishi Bhawan, New Delhi, Dr Ajay Kumar Dang, principal scientist, dairy cattle physiology division, NDRI, Karnal, Haryana and Dr Mihiar Sarkar, principal scientist, division of physiology & climatology, IVRI, Izatnagar were invited to the meeting. Dr Mihiar Sarkar, however, could not attend the meeting because of his pre-occupation.

O S Sadhwani, joint commissioner, FDA, Maharashtra stated that the drug manufactured in accordance to the Drugs and Cosmetics Rules, 1945 has high costs and is not used by milkmen for extracting milk from the cows. The raw material or the bulk drug is clandestinely smuggled into the country from the border states which is then crudely manufactured clandestinely and sold to dairy owners at very cheap rate. It only needs sustained efforts through constant surveillance to curb the menace.

Dr B S Prakash informed that extensive work has been done on the use of oxytocin in milch animals and a status report of ICMR - ICAR Technical Working Group was compiled by him on the extent of use of oxytocin in milch animals. As per European agency for evaluation of medicinal products, there are no data on mutagenicity, carcinogenicity and teratogenicity. Oxytocin is inactivated by the reduction of disulfide - chain in the kidney, liver and lactating mammary gland. The drug oxytocin is used by medical practitioners world over for medical purposes and has a place in veterinary medicine.

After deliberations the members agreed that the drug legitimately manufactured in the country is required for medical purposes and as such cannot be prohibited.