IN THE HIGH COURT OF JUDICATURE AT MADRAS DATE : 09.01.2008 CORAM THE HONOURABLE MR. JUSTICE S.J.MUKHOPADHAYA AND THE HONOURABLE MS. JUSTICE K.SUGUNA W.P. NO. 25322 OF 2003 AND W.P.M.P. NO. 31084 OF 2003 Tamil Nadu Health Development Forum rep. by its Secretary No.43, II Main Road Kasthuriba Nagar Adayar, 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 Court dated 27.11.2006 4. 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. .. Respondents Writ Petition filed for the issuance of a writ of mandamus directing the respondents to ban manufacture and sale of the Nimesulide drug in any form. https://hcservices.ecourts.gov.in/hcservices/ For Petitioner : Mr. N.G.R.Prasad for M/s.S.Ayyathurai For 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 5 ORDER S.J.MUKHOPADHAYA, J. This writ petition in public interest was preferred by petitioner for direction on respondents to ban manufacture and sale of "Nimesulide" drug in any form. The petitioner claims to be a charitable trust and forum of social minded physicians, social workers, women organisations, industrialists, lawyers and like-minded individuals. This was formed as a forum for creating awareness among people, particularly women about prevention of diseases, environmental protection, nutrition, sanitation, family welfare, maternal and child care, rehabilitation, health, literacy, etc. The ultimate object is to ensure community participation in all activities and programmes aimed at promoting healthy community development. According to the petitioner, the drug "Nimesulide" being produced and marketed all over the country by several companies lime Alembic, Panacca, Reddy's Laboratories, etc., it has harmful effect 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 and marketed by pharmaceutical companies for treatment of fever, though it is not 'anti-pyeritic'. It has the effect of bringing down the temperature 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 of their long term health for even fever related to body pain. 2. Learned counsel for the petitioner submitted that Nimesulide has serious harmful side effects causing liver and kidney damages out of which the patient may die because of harmful side effects. Nimesulide is not approved for use even for adults in United States of America, Britain, Canada, Australia and other developed countries. The said drug was banned in Finland, Spain, Turkey and Bangladesh, but Government of India have not banned the drug. https://hcservices.ecourts.gov.in/hcservices/ It was informed that Nimesulide drug is the most expensive non-steroid, anti-inflammatory and is not under the price control regime. It has a prifit margin of 1300% and, therefore, it is largely produced and widely marketed. According to counsel for the petitioner, the respondents can ban the drug u/s 26A of Drug and Cosmetics Act, but they have not done it even after notice by High Court of Delhi in a Public Interest Litigation filed by Social Jurists, a group of lawyers in Delhi. The action of the respondents, Union of India in not banning the Nimesulide drug is alleged to be unreasonable, unfair, arbitrary and violative of Article 14 and 21 of the Constitution of India. 3. The respondents, Government of India and Drug Controller of India, while controverting the stand taken taken by the petitioner has taken plea that no drug is totally safe and can cause adverse reaction if not used in proper dosage. Nimesulide is a non- steroidal, anti-inflammatory drug (NSAID), like other NSAID such as Ibuprofen, Diclofenac Paracetamol, etc., also carries mild to moderate adverse events, which are reported in literature and known to medical community. The safety profile of the drug is similar to other drugs of its category, which are commonly used in management of pain and fever. As per standard texts, Nimesulide is indicated for its anti-inflammatory, analgesic, anti-pyretic (anti-fever) effects. According to Goodman and Gilman's "Pharmacological Basis of Therapeutics" – a text book pharmacology - 10th Edition (2001), a most widely referred text book on pharmacology of drugs and published in USA, Europe and Asia, Nimesulide is used as anti- inflammatory, analgesic and anti-pyretic drug. It is also stated that Nimesulide is associated with very low incidence of adverse side effects. Further "Matindale – The complete Drug Reference - 33rd Edition" in its monogram on Nimesulide states that the drug is indicated for inflammatory condition, fever and pains. It is informed that the Delhi Society for Promotion of Rational use of drug, in collaboration with World Health Organisation – India Programme on essential drugs has published "Standard Treatment Guidelines, 2002" for guidance of medical practitioners. In these guidelines, drug Nimesulide has been recommended for treatment of fever in adults as well as children. The publication clearly mentions that drugs in STG are selected on the basis of balanced criteria of efficacy, safety, suitability and cost. 4. Learned counsel appearing on behalf of Union of India submitted that the drug Nimesulide as stated is considered as a safe drug. However, like other drugs of the same category, NSAID, it has usual side effects. The drug is widely used in many countries and is marketed in more than 50 countries of the world in all major continents. Nimesulide was temporarily suspended in Finland, Turkey and Spain in May 2002 pending evaluation of reports of hepatotoxicity with the drug by the European Agency for the Evaluation of Medical Products. The European Agency for the https://hcservices.ecourts.gov.in/hcservices/ Evaluation of Medical Products established by Council Regulation EEC 2309/93 of 22nd July, 1993 to coordinate and support the EC Licencing system, examined the safety aspect of Nimesulide through the Committee for Proprietary Medicinal Products (CPMP). The CPMP, in its plenary meeting held on 22nd to 24th July, 2003, have now declared Nimesulide as safe and effective for use in patients suffering from wide variety of inflammatory and painful condition. The CPMP considered that the benefit-risk profile of Nimesulide containing products for systematic and topical use is favourable and that Market Authorisations should be maintained/granted. With the findings of the CPMP, the suspicion caused about the safety of Nimesulide because of temporary suspension of drug in the said countries has now been put to rest. 5. According to the respondents, Union of India and Drug Controller General of India, New Delhi, the Department of Health on behalf of the Health Ministry of Great Britain published British Pharmacopoeia, 2002, effective from 1st Dec., 2002 and has included a monograph on Nimesulide. Inclusion of Nimesulide in the said Pharmacopoeia is a clear affirmation of the fact that the health authorities of U.K. have considered the drug to be safe for use in Great Britain as well as in countries in which British Pharmacopoeia is followed. The drug is also included in European Pharmacopoeia. The British Medical Journal, a peer reviewed and most respected journal in the medical world have recently, in its Vol. 327 dated 5th July, 2003, has published an article under the caption "Cohort study of hepatotoxicity associated with Nimesulide and other non-steroidal, anti-inflammatory drug". The study has concluded that the risk of liver injury in patients taking Nimesulide and other non-steroidal, anti-inflammatory drug is small. While dwelling further on the topic, it has been mentioned that the liver injury is a rare class effect of non-steroidal, anti-inflammatory drugs and an increasing risk of hepatotoxicity with Nimesulide was suggested by a few spontaneous reports. However, with the study it has been revealed that the risk of hepatopathy amongst patients taking non-steroidal anti-inflammatory drug, including Nimesulide is small. Further stand of the respondents is that the Indian Medical Association carried out an evaluation on the safety aspect of Nimesulide. The conclusion contained in a report "Nimesulide Controversy Put to Rest" published by Indian Medical Association are broadly as follows :- "i) Nimesulide is safe drug for use in India. ii) Nimesulide is safe even in the pediatric age group. Iii) Nimesulide is safe as or even better than other NSAIDs. iv) A post marketing survey of all drugs in India should be conducted regularly. v) A casual relationship between drug and its https://hcservices.ecourts.gov.in/hcservices/ side effects must be definitely established before any steps for restricted use or banning of a drug are even thought of. vi) It is noticed that all drugs have some or the other side effects and medically it is established that the risk-benefit ratio has to be weighed before a drug is prescribed. vii) IMA strongly recommends that stray cases being reported by lay media without any scientific date and establishment of casual relationship should be given importance by drug regulatory authorities. viii) It has been noticed by the majority of doctors that most of the side effects seen with Nimesulide are common with other NSAIDs, both in pediatrics and adult age groups, and that the benefits far outweigh the side effects." 6. It is informed that many drugs are not introduced in one or other country. The introduction of a drug in a particular country depends on a specific application being made for its marketing in that country. There are number of drugs used in Europe, which are not in use in USA, viz., Analgin. So far as the notice issued by the Delhi High Court is concerned, it is informed that similar matter has already been dismissed. Learned counsel for the respondents referred to the report update report on Nimesulide as published in Drugs 46 (Supplementary-1) 1993. It was brought to the notice of the Court that the report has suggested the use of the same on adults and children and proper dose have been prescribed depending on body weight, etc. 7. In the present case, it is not possible to determine the question whether Nimesulide is toxic, harmful and its general use on patients will affect the kidney or liver of a person. That is a question, which can be determined by expert bodies having knowledge of Pharmacology and medicine, but the Court cannot deliberate on the issue under Article 226 of the Constitution of India. Apart from the fact that the respondents have brought on record different reports submitted in favour of use of Nimesulide, including comparison of Nimesulide and Mefenamic Acid in the treatment of acute upper respiratory drug indication in children, its use on patient having inflammation, fever, etc., and its therapeutic efficiency. It appears that a Division Bench of the Delhi High Court in W.P. (C) No.8335/2002, having noticed similar submission as made by petitioner, asked the Technical Advisory Board to go into the entire 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 court in Drug Action forum & Others, WP (C) No.693/1993, decided on 23rd Feb., 2001, Drug Technical Advisory Board was asked to meet atleast once in six months, which meets generally 5 to 6 times in a year. The said Board, after due deliberation through its experts from various branches, including Pharmacology, submitted a report. Having noticed the report submitted by the Board, the Division Bench of Delhi High Court, by its judgment dated 10th March, 2004, refused to interfere and disposed of the writ petition with certain observations. 8. We have also perused the Division Bench Judgement of Delhi High Court in W.P. (C) No.8335/2002, including the report of the Board, as quoted therein and in view of the stand taken by the Union of India and The Drug Controller of India, we find no ground to issue a writ of mandamus on respondents as sought for in the writ 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. GLN To 1. 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. 1716 1 cc to M/s. Gladys Daniel, Advocate, sr. 1615 1 cc to Mr. Muizz Ali, Advocate, sr. 1781 W.P. NO. 25322 OF 2003 RSV (CO) kk 21/1 https://hcservices.ecourts.gov.in/hcservices/