IN THE HIGH COURT OF KERALA AT ERNAKULAM PRESENT : THE HONOURABLE MR. JUSTICE A.K.BASHEER & THE HONOURABLE MR. JUSTICE P.Q.BARKATH ALI MONDAY, THE 27TH JUNE 2011 / 6TH ASHADHA 1933 WP(C).No. 11410 of 2011(A) PETITIONER: K.C.ABRAHAM, SOLE PROPRIETOR OF M/S.KUNNATH PHARMACEUTICALS, VELLOORKUNNAM, MOOVATTUPUZHA, ERNAKULAM DISTRICT-676 308. BY ADV. SRI.E.K.NANDAKUMAR SRI.A.K.JAYASANKAR NAMBIAR SRI.K.JOHN MATHAI SRI.P.BENNY THOMAS SRI.P.GOPINATH SRI.PAULOSE C. ABRAHAM RESPONDENTS: 1. THE STATE OF KERALA, REP. BY THE SPECIAL SECRETARY TO THE GOVERNMENT, HEALTH AND FAMILY WELFARE (F) DEPARTMENT, SECRETARIAT, THIRUVANANTHAPURAM-695001. 2. DRUGS CONTROLLER (AYURVEDA, SIDDHA, UNANI), DRUGS CONTROL ADMINISTRATION, THIRUVANANTHAPURAM-695 035. 3. DRUGS INSPECTOR (AYURVEDA), OFFICE OF THE DRUGS INSPECTOR, CIVIL STATION, ERNAKULAM-682 030. Addl R4. PEOPLES UNION FOR CIVIL LIBERTIES REPRESENTED BY ITS STATE GENERAL SECRETARY P.A.POURAN, S/O ANTONY, ADVOCATE, AGED 61YEARS, RESIDING AT “SILENT VALLEY” MANJERI, MALAPPURAM-676 121. (Impleaded as additional respondent No.4 vide order dated, 27/6/2011 in I.A.6796/2011) Addl R5 AYURVEDA MEDICAL ASSOCIATION OF INDIA (AMAI) AYURVEDA BHAVAN, XVIII/2-A, ANGAMALY ERNAKULAM, REP. BY ITS GENERAL SECRETARY DR.V.G.UDAYAKUMAR (Impleaded as additional respondent No.5 vide order dated, 27/6/2011 in I.A.9159/2011) GOVERNMENT PLEADER SMT.R.BINDU SRI.K.JAYAKUMAR, SR. FOR ADDL. R4 SMT.K.NANDINI FOR ADDL.R4 SRI.B.S.SWATHY KUMAR FOR ADDL.RES.4 SMT.ANITHA RAVINDRAN FOR ADDL.RES.4 SMT.M.G.AISHWARYA FOR ADDL.RES.4 THIS WRIT PETITION (CIVIL) HAVING COME UP FOR ADMISSION ON 27/06/2011, ALONG WITH WPC NO. 37511 OF 2009, THE COURT ON THE SAME DAY DELIVERED THE FOLLOWING: W.P.(C)No. 11410 of 2011 (A) APPENDIX PETITIONER'S EXHIBIT: Ext.P1: True copy of the license bearing No.72/25D/2007 dated 28-6- 2007 issued by the 2nd respondent to the petitioner. Ext.P2: True copy of the validity certificate dated 14-9-2010 issued by the 2nd respondent to the petitioner. Ext.P3: True copy of the notification dated 1-4-2011 issued by the 1st respondent along with the Explanatory Note. Ext.P4: True copy of the stop production memo dated 6-4-2011 issued by the 3rd respondent to the petitioner. RESPONDENT'S EXHIBITS: Ext.R1(a): True copy of complaint No.CC No.325/2010. Ext.R1(b): True copy of communication dated 7-12-2009 received from Food and Drug Administration, Mumbai. Ext.R1(c): True copy of communication dated 29-4-2010 received from Government of India, Ministry of Health & Family Welfare (Ayush Department). Ext.R1(d): True copy of communication dated 30-4-2010 received from Government of Goa. // True copy // P.A. to Judge A.K.BASHEER & P.Q.BARKATH ALI, JJ. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - W.P.(C)Nos.37511 OF 2009 & 11410 OF 2011 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Dated this the 27th day of June 2011 JUDGMENT Basheer, J. Since these two writ petitions (one of which is instituted as a Public Interest Litigation) relates to a common issue, they are being disposed of through this common judgment. 2. Writ Petition No.37511/09 is filed by Peoples Union for Civil Liberties (PUCL), a Non Governmental Organisation, with a primary prayer to issue a writ in the nature of mandamus or such other appropriate writ or direction to the State of Kerala and the Drugs Controller and Licensing Authority (Ayurveda) to ban the drug “Musli Power Xtra” being manufactured and marketed by M/S Kunnath Pharmaceuticals (respondent No.4 in this Writ Petition). There is a further prayer to issue an order of permanent prohibitory injunction restraining the manufacturer, respondent No.4 from publishing any advertisements, brochures, sign boards, hoardings, pamphlets, press releases, etc. claiming to have a cure or treatment for diseases listed in Schedule (J) of the Drugs and Cosmetics Act and in violation of Section 3(b) of the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 and the schedule there under. 3. Writ Petition No.11410/2011 is filed by the sole proprietor of M/S Kunnath Pharmaceuticals, who is the manufacturer of Musli Power W.P.(C)Nos.37511 OF 2009 & 11410 OF 2011 :: 2 :: Xtra. He prays for issue of a writ in the nature of certiorari or such other appropriate writ or direction to quash Ext.P3 notification issued by the Government prohibiting the manufacture of Musli Power Xtra for the purposes of sale or for distribution. There is a further prayer to quash Ext.P4, memo issued by the Drugs Inspector (Ayurveda), Ernakulam Bureau pursuant to the above notification directing the petitioner to stop production and distribution of the drug forthwith. 4. It is on record that a learned Single Judge of this court, before whom the latter writ petition came up for consideration, has issued an interim order directing to the authorities not to initiate any “coercive steps”. We are informed that the licensee/proprietor M/S Kunnath Pharmaceuticals is even now manufacturing and marketing the above drug on the strength of the above interim order. Similarly, the advertisements, both on the print and electronic media, Internet, etc. are also being published on the strength of the above order. 5. The primary contention raised by the Non Governmental Organisation in its writ petition is that the large scale advertisements, publication of brochures, erection of hoardings etc. in addition to the exhortation for self medication being made through print and electronic media as well as on inter net depicting the above drug as a magical solution for all disorders of sex related problems, is in total violation of Schedule (J) of the Drugs and Cosmetics Act and Section 3(b) of the W.P.(C)Nos.37511 OF 2009 & 11410 OF 2011 :: 3 :: Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954. 6. The grievance of the manufacturer of the above drug in his writ petition viz.W.P.(C)No.11410/2011, is that Ext.P3 notification is ex facie invalid and illegal. It is contended by the petitioner that the said notification has been issued without any sanction or authority of law in as much as the State Government does not have any power to issue such a notification under Section 33 EEC of the Drugs and Cosmetics Act 1940, particularly to prohibit the manufacture and sale of the drug for which he has been granted a license as provided under the Act and the Rules. It is further contended that going by the provisions contained in Section 33EED of the Act, it is only the Central Government which is vested with the power to prohibit the manufacture, sale or distribution of a particular Ayurvedic, Siddha or Unani drug and that too only when it is necessary or expedient to do so in public interest. 7. We do not deem it necessary to refer to or deal with the various contentions raised either by the NGO or by the manufacturer at this juncture. But it has to be noticed that the Ayurveda Medical Association of India, which has been impleaded as additional respondent No.4 in Writ Petition No.11410/11 has given a further dimension to the issue. According to this Association, the production and sale of this particular drug, projecting it as an absolute cure for all kinds of sexual disabilities and malfunctions and also proclaiming it to be a rejuvenating W.P.(C)Nos.37511 OF 2009 & 11410 OF 2011 :: 4 :: drug to enhance sexual pleasure is absolutely illegal and misleading. The Association has tried to trace the history of this product as it first emerged in the market, which later on assumed this self proclaimed potency for cure of all sex related diseases. Yet again, we refrain from making any comment on this aspect at this stage. 8. Having heard Sri.K.Jayakumar, learned senior counsel who appears for the NGO, and Sri.Jayasankar, for the manufacturer and Sri.SwathiKumar, who appears for the Association of Ayurveda Practitioners in the State, as well as learned senior Government Pleader Smt.R.Bindu, we are of the view that the entire issue has to be dealt with and considered by the Government and other competent authorities, having necessary expertise and wherewithal, and decide the question whether there is any merit in the contentions raised by the NGO as well as the Ayurveda Medical Association. 9. As regards the challenge raised by the manufacturer regarding the legality of Ext.P3 notification and also the competence of the Government to issue such a notification, it has to be noticed that the manufacturer was not given any opportunity at all to be heard before the said notification was issued. A perusal of the notification, especially, the explanatory note therein, will show that the Government appears to have been concerned about publication of advertisements in mass Media by the manufacturer “inducing citizens to self medication of the drug at W.P.(C)Nos.37511 OF 2009 & 11410 OF 2011 :: 5 :: the risk of public health”. It is further mentioned in the explanatory note that the manufacturer is violating the provisions contained in the Drugs & Magic Remedies (Objectionable Advertisement) Act, 1954 even after initiation of prosecution against him in the Jurisdictional Criminal Court. We have referred to this aspect only to highlight the contention of learned counsel for the petitioner that the Government in Ext.P3 does not have a case that the product as such is in any way harmful. Yet again, we do not propose to make any comment on this aspect. However, we cannot ignore the contentions raised by the NGO and the Association for Ayurveda Medical Practitioners questioning the credibility and effectiveness of the drug. In our view, the entire issue has to be considered by the appropriate authorities at the appropriate level. Therefore, Exts.P3 and P4 in W.P.No.11410/2010 are quashed. 10. On a query made by us in the course of hearing of these case, we are informed by the learned counsel for the parties that Pharmacopoeial Laboratory for Indian Medicine at Ghaziabad has been designated as the Central Drugs Laboratory (CDL) for the purpose of testing or analysis of Ayurveda, Sidda and Unani drugs as provided under Rule 163(A) of the Drugs and Cosmetics Rules 1945. In view of the serious complaints or allegations against this particular drug as regards its harmful effects on the human body and widespread skepticism about its potency and efficacy to cure many sexual disorders, W.P.(C)Nos.37511 OF 2009 & 11410 OF 2011 :: 6 :: we are of the view that the Government has to be directed to take appropriate steps through its designated agency to send the above drug for analysis/test to the Central Drugs Laboratory, Ghaziabad. We do so. 11. The steps in this regard shall be initiated by the Government within one month from the date of receipt of a copy of this judgment. It shall be ensured by the Government that the authority concerned which is authorized to take samples complies with the statutory procedural mandates as regards sampling, sealing, etc. as provided in the relevant Act and Rules. The manufacturer (petitioner) shall whole heartedly co- operate with the process of sampling and such other formalities to be carried out by the statutory authorities in this regard. The Laboratory shall ensure that the test report is furnished to the Government as expeditiously as possible, at any rate, within two months from the date of receipt of samples and the Government in turn shall take a decision in the matter within two months from the date of receipt of the test report. 12. In the meanwhile, the manufacturer viz. petitioner in Writ Petition No.11410/11 shall not publish any advertisements about the drug in the print or electronic media or through any of its websites till appropriate orders are issued by the Government after obtaining the test report. 13. The manufacturer shall also ensure that all hoardings put up W.P.(C)Nos.37511 OF 2009 & 11410 OF 2011 :: 7 :: by him directly or through his athorised dealers, stockists/agents, etc. are removed from all public places forthwith, at any rate, within two weeks from today. 14. It will be open to the manufacturer to submit a detailed representation highlighting his objections to the alleged violations of the provisions contained in the Drugs & Magic Remedies (Objectionable Advertisement) Act, 1954 as reflected in Ext.P3 notification, in which event the Government shall afford him sufficient opportunity to be heard. The Government shall also hear authorised representatives of PCUL as well as the Association for Ayurveda Practitioners (additional respondent No.4) in Writ Petition No.11410/11. 15. As regards prayer No.4 in Writ Petition No.37511/2009 is concerned, we make it clear that we have not considered the above issue in this judgment. In other words, it will be open to the NGO to pursue the matter in other appropriate proceedings, if so advised. Above writ petitions are disposed of in the above terms. A.K.BASHEER, JUDGE P.Q.BARKATH ALI, JUDGE jes