1. The petitioners are before this Court assailing the notification dated 18.06.2013 bearing No. G.S.R. 377 (E) issued by the Ministry of Health and Family Welfare and to quash the recommendations of New Drugs Advisory Committee (Neurology & Psychiatry) (NDAC for short) at Sl.No.7(10) pursuant to the meeting held on 11.05.2013.

2. The petitioners are engaged in manufacturing and marketing of pharmaceutical products. Among others, they are also engaged in manufacture of 'Deanxit' which is a Fixed Dose Combination of 'Melitracen' and 'Flupenthixol'. The permission for manufacture and marketing was granted under Rule 122-B of the Drugs and Cosmetics Rules, 1945 ('1945 Rules' for short) with effect from 28.10.1998 in respect of the petitioner in W.P.No.28354/2013. The petitioners contend that the studies made on the drug has proved its safety, efficacy and benefits. It is stated to be marketed in 23 countries across the world. In India, it was introduced as a new drug by Cosme Farma Laboratories Pharmaceuticals Ltd who are the predecessors of the petitioner. The tests carried out prior to introduction of the drug is referred to in detail in the petition. The popularity of the