Karnataka Drug Licensing Authority(DLA) of the directorate of Ayush has issued stop production orders to The Himalaya Drug Company's Nourishing Baby Oil via order dated April 25, 2008 Letter No. Ayush 80/DLA 2007-08.

The order is based on the notice from the Maharashtra Food and Drug Administration dated July 18, 2005 banning the product because it contained over 96 per cent of light liquid paraffin and banned its sale in the State. The manufacturer had not indicated the content of liquid paraffin in the label. The Department of Ayush, was also intimated on the same.

Since the company is based in Karnataka at Bangalore the Department of Ayush, via letter No K11027/2008 directed the Karnataka DLA to take action. This led the Karnataka Directorate to form a Technical Committee led by Dr BN Prakash, director, State Directorate of Ayush, on September 22, 2006 to look into the issue and asses the disproportionate use of liquid paraffin. According to Rule 161 and 169, Drugs & Cosmetics Act 1940, the addition of excepients like liquid paraffin need not be mentioned on the label and is permitted in Ayurveda drugs according to the reference standard which is specified in the Rule.

Although the manufacturer was cleared in the label issue, the Karnataka DLA instructed Himalaya to correct the error regarding the proportionate use of liquid paraffin and bring it in conformity within the provisions of the Ayurveda Formulations.

The Technical Committee also stated that the Centre should provide guidelines about the permitted proportion of the excepients for Ayurveda Formulation so that disproportionate usage of the same could be identified. Karnataka DLA issued stop production notice for license AUS 83, through an order dated September 25, 2006, until the amendment was made by the Union government.

According to Dr HT Sreenivas, drug licensing authority, Karnataka Directorate of Ayush and principal & professor, Government Ayurveda College, Bangalore, the product was being manufactured and available despite the suspension notice.

Going by the seized samples, it was clear that Himalaya manufactured under different license No L-AUS 117, May 2007 and No. L-62/Ayur, December 2007. But the label carried the manufacturing address as Himalaya Drug Company, Makali, Bangalore. This led the Karnataka DLA to swing into action because Himalaya manufactured in the Karnataka jurisdiction when it was banned.

On April 25, 2008 the suspension notice was issued based on the company defying the Karnataka DLA's orders. On May 6, 2008, Himalaya in its response to DLA notice stated that production continued because it did not receive any guidelines from the Central Government and would follow the stipulated procedures of the State licensing authority.

"We are not satisfied with the response from Himalaya because the company has grossly dishonoured the State orders by carrying the Bangalore production address, even if it was manufactured elsewhere. If the company fails to give us an appropriate reply, serious action will be taken", stated Dr Sreenivas.

According to Dr Rangesh, head, new product initiatives and Regulatory Affairs, The Himalaya Drug Company, the use of liquid paraffin is well within prescribed limits making the product safe and harmless. It has also undergone extensive clinical tests by paediatricians. In fact, its safety was confirmed by Dr Sreenivas. The company has also provided all technical information to the Maharashtra FDA, Union government and the Karnataka DLA.