Tamil Nadu Health Development Forum v. The Government of India

IN THE HIGH COURT OF JUDICATURE AT MADRAS DATE : 09.01.2008CORAMTHE HONOURABLE MR. JUSTICE S.J.MUKHOPADHAYAANDTHE HONOURABLE MS. JUSTICE K.SUGUNAW.P. NO. 25322 OF 2003ANDW.P.M.P. NO. 31084 OF 2003Tamil Nadu Health Development Forumrep. by its SecretaryNo.43, II Main RoadKasthuriba NagarAdayar, Chennai 600 020... Petitioner- Vs -1. The Government of India rep. by Secretary to Government Ministry of Health New Delhi.2. The Drugs Controller General of India New Delhi.3. Panacea Biotech B-1 Extn., A-27 Mohan Co-op. Industrial Estate Mathura Road, New Delhi 110 044.Impleaded as per the order of this Courtdated 27.11.20064. Dr. Reddy's Laboratories F-87, 2nd Floor, Green Park New Delhi 110 010.5. Ranbaxy India Ltd. E-221, Block No.B-1 Mohan Co-op. Industrial Estate New Delhi 110 044... RespondentsWrit Petition filed for the issuance of a writ of mandamusdirecting the respondents to ban manufacture and sale of theNimesulide drug in any form. https://hcservices.ecourts.gov.in/hcservices/ For Petitioner: Mr. N.G.R.Prasad for M/s.S.AyyathuraiFor Respondents:Mr.P.Wilson,Asst. Solicitor General of India for RR1 & 2 Mr. Arvind P.Datar, SC for M/s.Muizz Ali Ms. Nalini Chidambaram, SC Mr.Anil Kher, SC, Mr.Kanwal Nain & Mr. Jebi Mather Hisan for RR-3 to 5ORDERS.J.MUKHOPADHAYA, J.This writ petition in public interest was preferred bypetitioner for direction on respondents to ban manufacture and saleof "Nimesulide" drug in any form. The petitioner claims to be a charitable trust and forum ofsocial minded physicians, social workers, women organisations,industrialists, lawyers and like-minded individuals. This wasformed as a forum for creating awareness among people, particularlywomen about prevention of diseases, environmental protection,nutrition, sanitation, family welfare, maternal and child care,rehabilitation, health, literacy, etc. The ultimate object is toensure community participation in all activities and programmesaimed at promoting healthy community development.According to the petitioner, the drug "Nimesulide" beingproduced and marketed all over the country by several companieslime Alembic, Panacca, Reddy's Laboratories, etc., it has harmfuleffect of causing liver and kidney failures.It is a non-steroidal, anti-inflammatory drug, but not an'anti pyreitic'. This anti-inflammatory drug is being produced andmarketed by pharmaceutical companies for treatment of fever, thoughit is not 'anti-pyeritic'. It has the effect of bringing down thetemperature faster than Paracetamol, such as Crocin, Metacin, etc.,and, therefore, it is being prescribed by medical practitioners,who practice medicine going by patient psychology unmindful oftheir long term health for even fever related to body pain.2. Learned counsel for the petitioner submitted thatNimesulide has serious harmful side effects causing liver andkidney damages out of which the patient may die because of harmfulside effects. Nimesulide is not approved for use even for adultsin United States of America, Britain, Canada, Australia and otherdeveloped countries. The said drug was banned in Finland, Spain,Turkey and Bangladesh, but Government of India have not banned thedrug. https://hcservices.ecourts.gov.in/hcservices/ It was informed that Nimesulide drug is the most expensivenon-steroid, anti-inflammatory and is not under the price controlregime. It has a prifit margin of 1300% and, therefore, it islargely produced and widely marketed. According to counsel for thepetitioner, the respondents can ban the drug u/s 26A of Drug andCosmetics Act, but they have not done it even after notice by HighCourt of Delhi in a Public Interest Litigation filed by SocialJurists, a group of lawyers in Delhi. The action of therespondents, Union of India in not banning the Nimesulide drug isalleged to be unreasonable, unfair, arbitrary and violative ofArticle 14 and 21 of the Constitution of India.3. The respondents, Government of India and Drug Controller ofIndia, while controverting the stand taken taken by the petitionerhas taken plea that no drug is totally safe and can cause adversereaction if not used in proper dosage. Nimesulide is a non-steroidal, anti-inflammatory drug (NSAID), like other NSAID such asIbuprofen, Diclofenac Paracetamol, etc., also carries mild tomoderate adverse events, which are reported in literature and knownto medical community. The safety profile of the drug is similar toother drugs of its category, which are commonly used in managementof pain and fever. As per standard texts, Nimesulide is indicatedfor its anti-inflammatory, analgesic, anti-pyretic (anti-fever)effects. According to Goodman and Gilman's "Pharmacological Basisof Therapeutics" – a text book pharmacology - 10th Edition (2001), amost widely referred text book on pharmacology of drugs andpublished in USA, Europe and Asia, Nimesulide is used as anti-inflammatory, analgesic and anti-pyretic drug. It is also statedthat Nimesulide is associated with very low incidence of adverseside effects. Further "Matindale – The complete Drug Reference -33rd Edition" in its monogram on Nimesulide states that the drug isindicated for inflammatory condition, fever and pains. It isinformed that the Delhi Society for Promotion of Rational use ofdrug, in collaboration with World Health Organisation – IndiaProgramme on essential drugs has published "Standard TreatmentGuidelines, 2002" for guidance of medical practitioners. In theseguidelines, drug Nimesulide has been recommended for treatment offever in adults as well as children. The publication clearlymentions that drugs in STG are selected on the basis of balancedcriteria of efficacy, safety, suitability and cost.4. Learned counsel appearing on behalf of Union of Indiasubmitted that the drug Nimesulide as stated is considered as asafe drug. However, like other drugs of the same category, NSAID,it has usual side effects. The drug is widely used in manycountries and is marketed in more than 50 countries of the world inall major continents. Nimesulide was temporarily suspended inFinland, Turkey and Spain in May 2002 pending evaluation of reportsof hepatotoxicity with the drug by the European Agency for theEvaluation of Medical Products. The European Agency for the https://hcservices.ecourts.gov.in/hcservices/ Evaluation of Medical Products established by Council RegulationEEC 2309/93 of 22nd July, 1993 to coordinate and support the ECLicencing system, examined the safety aspect of Nimesulide throughthe Committee for Proprietary Medicinal Products (CPMP). The CPMP,in its plenary meeting held on 22nd to 24th July, 2003, have nowdeclared Nimesulide as safe and effective for use in patientssuffering from wide variety of inflammatory and painful condition.The CPMP considered that the benefit-risk profile of Nimesulidecontaining products for systematic and topical use is favourableand that Market Authorisations should be maintained/granted. Withthe findings of the CPMP, the suspicion caused about the safety ofNimesulide because of temporary suspension of drug in the saidcountries has now been put to rest.5. According to the respondents, Union of India and DrugController General of India, New Delhi, the Department of Health onbehalf of the Health Ministry of Great Britain published BritishPharmacopoeia, 2002, effective from 1st Dec., 2002 and has includeda monograph on Nimesulide. Inclusion of Nimesulide in the saidPharmacopoeia is a clear affirmation of the fact that the healthauthorities of U.K. have considered the drug to be safe for use inGreat Britain as well as in countries in which BritishPharmacopoeia is followed. The drug is also included in EuropeanPharmacopoeia. The British Medical Journal, a peer reviewed andmost respected journal in the medical world have recently, in itsVol. 327 dated 5th July, 2003, has published an article under thecaption "Cohort study of hepatotoxicity associated with Nimesulideand other non-steroidal, anti-inflammatory drug". The study hasconcluded that the risk of liver injury in patients takingNimesulide and other non-steroidal, anti-inflammatory drug issmall. While dwelling further on the topic, it has been mentionedthat the liver injury is a rare class effect of non-steroidal,anti-inflammatory drugs and an increasing risk of hepatotoxicitywith Nimesulide was suggested by a few spontaneous reports.However, with the study it has been revealed that the risk ofhepatopathy amongst patients taking non-steroidal anti-inflammatorydrug, including Nimesulide is small.Further stand of the respondents is that the Indian MedicalAssociation carried out an evaluation on the safety aspect ofNimesulide. The conclusion contained in a report "NimesulideControversy Put to Rest" published by Indian Medical Associationare broadly as follows :-"i) Nimesulide is safe drug for use in India.ii) Nimesulide is safe even in the pediatric agegroup.Iii) Nimesulide is safe as or even better thanother NSAIDs.iv) A post marketing survey of all drugs in Indiashould be conducted regularly.v) A casual relationship between drug and its https://hcservices.ecourts.gov.in/hcservices/ side effects must be definitely established beforeany steps for restricted use or banning of a drugare even thought of.vi) It is noticed that all drugs have some or theother side effects and medically it is establishedthat the risk-benefit ratio has to be weighedbefore a drug is prescribed.vii) IMA strongly recommends that stray casesbeing reported by lay media without any scientificdate and establishment of casual relationshipshould be given importance by drug regulatoryauthorities.viii) It has been noticed by the majority ofdoctors that most of the side effects seen withNimesulide are common with other NSAIDs, both inpediatrics and adult age groups, and that thebenefits far outweigh the side effects."6. It is informed that many drugs are not introduced in one orother country. The introduction of a drug in a particular countrydepends on a specific application being made for its marketing inthat country. There are number of drugs used in Europe, which arenot in use in USA, viz., Analgin.So far as the notice issued by the Delhi High Court isconcerned, it is informed that similar matter has already beendismissed.Learned counsel for the respondents referred to the reportupdate report on Nimesulide as published in Drugs 46(Supplementary-1) 1993. It was brought to the notice of the Courtthat the report has suggested the use of the same on adults andchildren and proper dose have been prescribed depending on bodyweight, etc.7. In the present case, it is not possible to determine thequestion whether Nimesulide is toxic, harmful and its general useon patients will affect the kidney or liver of a person. That is aquestion, which can be determined by expert bodies having knowledgeof Pharmacology and medicine, but the Court cannot deliberate onthe issue under Article 226 of the Constitution of India.Apart from the fact that the respondents have brought onrecord different reports submitted in favour of use of Nimesulide,including comparison of Nimesulide and Mefenamic Acid in thetreatment of acute upper respiratory drug indication in children,its use on patient having inflammation, fever, etc., and itstherapeutic efficiency.It appears that a Division Bench of the Delhi High Court inW.P. (C) No.8335/2002, having noticed similar submission as made bypetitioner, asked the Technical Advisory Board to go into theentire aspect and submit a report. Before the Delhi High Court it https://hcservices.ecourts.gov.in/hcservices/ was informed that as per the mechanism evolved by the Supreme courtin Drug Action forum & Others, WP (C) No.693/1993, decided on 23rdFeb., 2001, Drug Technical Advisory Board was asked to meet atleastonce in six months, which meets generally 5 to 6 times in a year.The said Board, after due deliberation through its experts fromvarious branches, including Pharmacology, submitted a report.Having noticed the report submitted by the Board, the DivisionBench of Delhi High Court, by its judgment dated 10th March, 2004,refused to interfere and disposed of the writ petition with certainobservations.8. We have also perused the Division Bench Judgement of DelhiHigh Court in W.P. (C) No.8335/2002, including the report of theBoard, as quoted therein and in view of the stand taken by theUnion of India and The Drug Controller of India, we find no groundto issue a writ of mandamus on respondents as sought for in thewrit petition. The writ petition is accordingly dismissed.Consequently, connected miscellaneous petition is also dismissed.But there shall be no order as to costs.Sd/-Asst. Registrar./true copy/Sub Asst. Registrar.GLNTo1. The Government of India rep. by Secretary to Government Ministry of Health New Delhi.2. The Drugs Controller General of India New Delhi.1 cc to Mr.S. Ayyathurai, Advocate, sr. 17161 cc to M/s. Gladys Daniel, Advocate, sr. 16151 cc to Mr. Muizz Ali, Advocate, sr. 1781 W.P. NO. 25322 OF 2003RSV (CO)kk 21/1