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 drug as anti-depressant is also referred by indicating that for the period between June 2012 and May 2013 more than 63 lakhs prescriptions were issued.

3. The petitioner in W.P.Nos.32766- 32768/2013 intended to start the Fixed Dose Combination in the year 2005. Since they were not equipped at that stage, it was manufactured by Ravenbhel Healthcare Pvt. Ltd., Jammu and Kashmir who obtained licence from the Government in the year 2005. In the year 2006-2007 Criss Pharma (India) Ltd., obtained permission from the Authorities in Uttarakhand. Subsequently the petitioners themselves are manufacturing in their unit at Himachal Pradesh from the year 2010. The petitioners herein also contend that the action taken by the respondents in issuing the impugned notification is without opportunity. Since it is the common case of both the petitioners herein except the factual variations, for all purposes, the facts relevant to the petitioners in W.P.No.28354/2013 will be noticed in the course of this order for decision making on all aspects as it is contended that they are the innovator and the result of such consideration would in any event will be relevant to both the parties since the recommendation and notification applies to both the petitioners.

4. At an earlier point, in the year 2011 when the petitioners noticed certain news paper reports referring to the proposed ban of manufacture, supply and distribution of 'Deanxit', the petitioner in W.P.No.28354/2013 herein had approached this Court by filing a writ petition in No.7570/2011. The said writ petition was disposed of by the order dated 03.03.2011 directing the respondents to provide an opportunity of hearing to the petitioner with regard to the proposed action. Pursuant thereto, the third respondent convened the meeting of the Expert Committee along with the petitioners' representative. Since the petitioners had certain inconvenience inasmuch as the subject expert based abroad could not arrive to India on the scheduled day, the petitioners had sought for rescheduling of the meeting. Subsequently in the meeting dated 23.05.2011, the petitioner is stated to have placed sufficient material with regard to the safety and efficacy of the drug. Despite the same, the third respondent is stated to have required the petitioners to conduct the Phase-IV clinical trial to prove the safety and efficacy profile in the 'Indian Population'. Though the petitioners were ready to undergo the same and submitted the protocol, the third respondent is stated to have changed the study protocol to the 'Special Population'. The grievance of the petitioners is that such repeated change of protocol had effected the right of the petitioners and despite the petitioner having produced sufficient material to establish the safety of the