E-DRUG: Defamamtion cases filed by Lundbeck against MIMS in India
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Lundbeck India Private Limited, wholly owned by Lundbeck, Denmark has filed criminal and civil cases against Editor of MIMS (Monthly Index of Medical Specialities) under defamation laws seeking imprisonment for the Editor that can last for as long as two years and civil damages for as much as Indian Rs. 20 millions (US$ 300,000). Unlike most western countries defamation or libel is subject to both criminal and civil proceedings in India.
Lundbeck has claimed that MIMS carried the following article in an issue in 2010: Deanxit: Dubious,Unlawful Approval
'The fixed-dose combination of flupenthixol and melitracen, sold under the brand name of Deanxit by Lundbeck, is not permitted for use in Denmark, its country of origin but is exported to many developing countries.'
'Deanxit is not approved by drug control authorities of advanced countries such as United Kingdom, Canada, Australia, Japan etc. Interestingly, both flupenthixol and melitracen are not allowed for use by the U.S.Food and Drug Administration (USFDA) even as individual medicines.'
'Melitracen does not appear in any standard, authoritative text book of pharmacology such as Goodman and Gilman or Avaido. It is not listed in any Pharmacopoeia.
'Even though melitracen, one of the two ingredients is not approved, the Drugs Controller, India (DCI), cleared the combination without mandatory clinical trials on patients in India. • It isbeing aggressively promoted for a wide range of known and unknown disorders such as psychogenic depression, depressive neuroses, masked depression,psychosomatic affections, menopausal depression, dysphoria in alcoholics anddrug addicts etc. without mandatory clearance from DCI.'
In response to Court notices, he Editor of MIMS claimed that all statements were factual and irrefutable evidence was available with the Journal. Besides the article was published for public good, specifically permissible under Indian laws.
So far 15 hearings have taken place in the city of Bangalore, over 2,000 kilometers from New Delhi. The Editor of MIMS is located in New Delhi while Lundbeck has its offices in Bangalore.
In compliance with Indian legal practices, the Editor of MIMS has personally attended all the hearings. The Complainant, the Chief Executive Officer of Lundbeck in India, who lives within two kilometers of the Court premises has failed to appear in a dozen hearings in violation of Indian laws which require the personal attendance of both the Complainant and the Accused at each hearing.
In the last hearing which took place on July 1, 2016 the lawyer representing the Editor of MIMS told the Magistrate that Lundbeck was deliberately remaining absent in the proceedings because its case was "false and frivolous."
In its Report tabled in May 2013 on the state of affairs of drug regulation in India, the multi-party 31-member Parliamentary Committee on Health picked up several cases of wrongful approval including Deanxit by Lundbeck. The Report held Drugs Controller General of India responsible for the lapse. The Report virtually validated the article in MIMS both in content and spirit.
Since then Deanxit and its generic versions have been banned in 2014 for being injurious to patients.
So while the "defamed" drug is banned, the multinational manufacturer Lundbeck with deep pockets is continuing its legal tirade against MIMS merely to harass the Editor.
Dr. Pankaj Talwar, MD.
Consultant Physician.