IN THE HIGH COURT OF JUDICATURE AT MADRAS DATED : 09-09-2011 CORAM: THE HONOURABLE MR.JUSTICE V.DHANAPALAN W.P.No.7458 of 2011 & M.P.Nos.2, 3 and 4 of 2011 CIPLA Ltd., Regional Office, 106/A, Allapakkam Main Road, Allapakkam, Chennai 600 116, rep. by Depot Manager .. Petitioner Vs. 1. Union of India, through Secretary, Ministry of Health and Family Welfare, FDA Bhavan, ITO Kotla Road, New Delhi–110 002. 2. The Drug Controller General of India, FDA Bhavan, ITO Kotla Road, New Delhi–110 002. .. Respondents Writ Petition filed under Article 226 of the Constitution of India praying for issuance of a Writ of Certiorarified Mandamus to call for the entire records in connection with the impugned notification issued by the 1st respondent in GSR No.82 (E) published in Gazette of India Extraordinary Part II–-Section 3-–sub-section (i), dated 10.02.2011 and quash the same in so far as it relates to Item No.3 viz., Phenylpropanolamine and direct the respondents to review the prohibition after giving an opportunity to the petitioner. For Petitioner : Mr.G.Masilamani, Senior Counsel for Mr.C.Mohan, for M/s.King and Patridge **M/S.P.UMA For petitioner in M.P.No.4/2011:Mr.Arya Raj. For Respondents : Mr.S.Haja Mohideen Gisthi, Senior Central Govt.Standing Counsel https://hcservices.ecourts.gov.in/hcservices/ ORDER Heard Mr.G.Masilamani, learned Senior Counsel appearing for Mr.C.Mohan, learned counsel for the petitioner and Mr.S.Haja Mohideen Gisthi, learned Senior Central Government Standing Counsel appearing for the respondents. 2. Challenging the Notification dated 10.02.2011 issued by the 1st respondent in GSR No.82 (E) published in Gazette of India Extraordinary Part--II Section 3-–sub-section (i), seeking to quash the same in so far as it relates to Item No.3 viz., Phenylpropanolamine with a direction to the respondents to review the prohibition after giving an opportunity to him, the petitioner has come up with the present writ petition. 3. Facts, in a nutshell run thus : 3(i). Chemical, Industrial & Pharmaceutical Laboratories of India, popularly known as CIPLA, the petitioner herein, was formed in the year 1935. It is among the largest pharmaceutical Companies in India with a gross annual turnover of more than Rs.5,000 crores per annum. In the year 1952, a research division was set up by the petitioner with the view to attain self-sufficiency in technological development and since then, the petitioner has been progressing steadily in pharmaceutical, medicinal and drug development fields. At present, the petitioner has 31 world-class manufacturing facilities spread across the country with dedicated plants for oncology products, hormones, inhalers, carbapenems and cephlosporins among others. The various manufacturing facilities of the petitioner have been approved by several regulatory authorities, (both national and international) including : (i) Food and Drug Administration (FDA), USA; (ii) Medicines and Healthcare Products Regulatory Agency (MHRA), UK; (iii)Therapeutic Goods Administration (TGA), Australia; (iv) Medicines Control Council (MCC), South Africa; (v) National Institute of Pharmacy (NIP), Hungary; (vi) Pharmaceutical Inspection Convention (PIC),Germany; (vii) World Health Organisation (WHO); (viii) Department of Health, Canada; (ix) State Institute for the Control of Drugs, Solvak Republic and (x) ANVISA, Brazil. 3 (ii). According to the petitioner, their Active Pharmaceutical Ingredients (API) manufacturing plants are amongst the most sophisticated plants in the world, capable of complex multi- storage synthesis producing over 120 API's from high potency actives in grams to those made in several tonnes. The petitioner produces one of the widest range of products and dosage forms in the world https://hcservices.ecourts.gov.in/hcservices/ today including metered-dose inhalers, pre-filled syringes, trans- dermal spray patches, lyophilized injections, nasal sprays, medical devices and thermolabile foams. The petitioner was the first company in the world to offer the Triple drug AIDS cocktail for less than $1 a day to patients in several countries. In fact, one out of every three patients in Africa suffering from HIV AIDS, who are under treatment, are using the drugs/medicines manufactured by the petitioner. 3(iii). The petitioner would submit that Phenylpropanolamine (for short 'PPA') is a synthetic sympathomimetic amine, which is commonly used in cough and cold preparations and is also used as a nasal decongestant and respirator. The petitioner has been selling products with PPA for the last 20 years and the products containing PPA have been duly approved by the relevant authorities under the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the 'Act') without any objection or complaint of after/side adverse effects. PPA is openly sold in USA, UK, Japan and in neighbouring Asian countries and the ban on the sales of products containing PPA with immediate effect is completely illegal, unlawful and contrary to law. The proposal for the ban of the said drug ought not to have been kept as closely guarded secret, but it should have been transparent and all the stake-holders ought to have been consulted and considered, as the drug is openly available in most countries of the world on prescription or over the counter. It is noteworthy that PPA has been in the world market since more than 50 years and in the Indian market since 20 years. 3(iv). The impugned notification of the Government claims that the Government is satisfied that there are risks in the use of PPA and that safer alternatives are available. Whether the alleged alternatives are available and if so whether they are efficacious or risky is an issue which requires consultation and debate. Further, it is not disclosed, what risk was involved and what was the reliable and proven evidence or report which deserve acceptance unquestionably. Such a consultation having not been done, the so called satisfaction of the Government is completely misplaced and unsupported by proven or recorded evidence. For any pharmaceutical company to make available alternate drugs, minimum time gap of six months is required considering the time consumed in preparation of new formulations, packaging preparations, approvals by the authorities under the Act, etc. and also the time consumed in development, analysis, stability studies, etc. Thus, the immediate ban is drastic especially when hundreds of crores of worth formulations are lying distributed in more than about four lakh retail drug shops in the country and it is practically very difficult to withdraw the products besides the huge loss that will be caused to manufacturers. It would also result in denial of access to medicines to patients across the country and to consumers who have been using PPA products regularly. https://hcservices.ecourts.gov.in/hcservices/ 3(v). In the pharmaceutical industry, it is a well known fact that there is a complete cycle which is established from the procurement of raw material till the sale to the patients. The manufacturing and sale involves preparation of various formulations, manufacturing processes under stringent conditions, preparation of packaging like strips, bottles, cartons, blister packs, etc. The products are thereafter distributed through super-stockists, stockists, pharmacists, chemists, hospitals, healthcare centres across the country. Any immediate ban which is resulting in overnight withdrawal of products from all these parties across the supply chain is not only drastic, but also results in huge losses for all the enterprises involved, as also a complete and immediate denial of this medicine to the patients. Moreover, immediate withdrawal of drugs which are manufactured under stringent manufacturing conditions and quality standards of companies like the petitioner, would also result in patients exposed to medicines which are non-standard, spurious, adulterated or mis-branded. Patients may also be forced to take recourse to various other remedies which may not be equally efficacious and also harmful for the health of the public. 3(vi). The ban on PPA without any reported side effects in India is completely un-thought of inasmuch as the drug PPA which is in use for the last 20 years does not have any reported side effects. The petitioner, being a well known pharmaceutical company, if any report of side effects had been known to it, would have immediately notified the Government of the same. The fact that several established manufacturers of pharmaceutical preparations sell formulations with PPA as an ingredient without any reported side effects establishes that there was no requirement to ban PPA in India. The ban is per se illegal, unlawful and is liable to quashed immediately. 3(vii). The impugned notification dated 10.02.2011 came into the public domain only after 14.02.2011 and the respondents prohibited the manufacture, sale and distribution of six drugs including PPA and its formulations for human use, which is violative of the petitioner's Fundamental Rights. 3(viii). Referring to the Act and Rules, the petitioner would submit that a very elaborate and stringent procedure has been prescribed for the purposes of ensuring that the powers conferred on the Central Government under the Act inter-alia under Section 26A is not misused and is not exercised in an arbitrary and irrational manner. The said Act provides for the constitution of a Drugs Technical Advisory Board under Section 5. Further, under Section 7 of the Act, the Central Government is also to be advised by a Drugs Consultative Committee on any matter tending to secure uniformity throughout India in the administration of the Act. The constitution of these expert bodies have been provided to enable the Government to https://hcservices.ecourts.gov.in/hcservices/ receive informed advice so that the satisfaction of the Government warranting the exercise of drastic powers under the Act is based on relevant considerations and on the basis of materials generated from and deliberated upon by the experts in the relevant field. 3 (ix). Without prejudice to what has been stated hereinabove, the petitioner would submit that the consultation with the duly constituted Technical Board is a sine-qua-non before the exercise of power under Section 26A. In the absence of such consideration/consultation, the action of the respondent/Union of India would be wholly vitiated, especially when the Union of India has no technical skill and competence within specialized field of science, without jurisdiction and would deserve to be struck down and quashed on this ground alone. It is important to note that in a batch of writ petitions filed by the Drug Action Forum and others, the Supreme Court had noted and recorded the respondent/Union of India's statement that the Drugs Technical Advisory Board (for short 'DTAB') shall meet at least once in six months and the Expert committee shall meet atleast once in two months. In that context, the Supreme Court disposed of a batch of writ petitions with the direction that "If the petitioners or any other body or undertaking has/have any suggestion to make with regard to any of the drug formulations, they will be at liberty to send the suggestions or the representation to the DTAB which shall consider the same as expeditiously as possible and if possible in the next meeting." 3(ix). In the present case, the petitioner believes and has learnt that before the issuance of the impugned notification, there has been no mandatory consultation whatsoever with the DTAB or the Expert Committee under the Act and on that ground alone, the impugned notification deserves to be quashed. The respondent Union of India has also not invited suggestions or representations from the stake- holders for consideration of the Board or the Committees. According to the petitioner, there is no Board in existence since February 2010. Under Section 5 of the Act, the tenure of the Board constituted thereunder is only for a period of 3 years. The Board, under Section 5 of the Act, was last constituted, vide notification dated 02.02.2007 and the tenure of the aforesaid Board would have expired on 02.02.2010 in accordance with Section 5 of the Act. It is the case of the petitioner that the impugned notification is not only ultra- vires the Act, but is clearly and completely vitiated on account of non-application of mind. 3(x). The petitioner has referred to sub-rule (b) of Rule 74 of the Drugs and Cosmetics Rules, 1945, which clearly provides that "the licencee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the Rules, these would come into force, four months after publication in the Official Gazette." and also, for the violation of the provisions of https://hcservices.ecourts.gov.in/hcservices/ Section 26A of the Act is punishable under Section 28B of the Act with imprisonment and fine. Considering such scheme of the Act, it is improbable that the Legislature ever intended that a ban can be imposed with immediate effect especially when the decision making process has not been notified to all the stake-holders. Furthermore, the stocks on hand of the manufacturers can by itself expose the parties to criminal actions. It is a statutory obligation of the Central Government specifically incorporated in the Act itself that while taking a decision in imposing any prohibition/restriction under the Act, the entitlements/obligations respectively which have come into existence thereby also creating vested rights, should always be suitably provided for in any subsequent policy. 3(xi). The sudden ban of the use of the drug in the formulation, shall result in exposing the petitioner to criminal prosecution under Section 18(vi) read with Section 28-B of the Act, for no fault of their own. Further, the ban order cannot be implemented or enforced overnight. The products containing the prohibited drug has gone into the hands of more than 4 lakh retail outlets located across the length and width of this vast country, over whom the petitioner has no direct control. Hence, the enforcement of the ban order is beyond the control and capability of the petitioner. 4. Respondents have filed counter affidavit stating as follows : 4(i). The notification GSR 82(E) dated 10.02.2011 was issued by the Central Government prohibiting certain drugs in public interest on the recommendations of the Expert Committees constituted for that purpose. The notification under Section 26-A is issued by the Central Government on satisfaction that it is necessary and expedient to prohibit the manufacture, sale and distribution of certain drugs in public interest. The drugs for which harmful effects are reported in the published literature or in the media or if therapeutic justification is considered inadequate in the context of current medical evidence, are examined by Expert Committees on a continuous basis. The use of the drug is assessed on the basis of available technical information benefit ratio-risk ratio, local needs and availability of safer alternatives etc. The action to prohibit the drug is taken by the Government on the basis of the recommendations of the Expert Committee set up to examine issues relating to safety and effectiveness of the drug. The drugs which were earlier examined by the Expert Committee could be further reviewed depending upon the fresh scientific facts coming into knowledge, requiring fresh examination. 4(ii). The Central Government has prohibited the drug Phenylpropanoalmine (PPA) in public interest on the recommendations of the Expert Committee, as its continued use is associated with harmful effects. The safety of the drug formulations presently permitted to be marketed in the country are examined by the Expert Committee in the context of the present scientific knowledge about https://hcservices.ecourts.gov.in/hcservices/ the use of the drug and the risk associated with use. In case, it is found that the risks now considered to be associated with the use of the drug, outweighs the benefit accrued from the drug and safer alternatives are available, it is considered in public interest to prohibit the use of the drug under Section 26A. The Central Government has acted in public interest and in powers vested to it under the Act to prohibit the drugs which have been considered as likely to involve risk to human beings and whereas, safer alternatives to the drug are available. Under Section 26A, there is no provision for issuance of any prior notice before banning of a drug. It gives power to the Central Government to ban a drug upon its satisfaction that the drug is likely to cause risk and harm to the public. The contention of the petitioner that the drug which is in use for many years cannot be banned, is untenable in view of the reasons mentioned herein. 4(iii). PPA is a stimulant, decongestant and anorectic agent. It is one of the ingredients in various drug formulations used in the treatment of common cold, body pain and fever and is a non- prescription drug in the country. Various fixed dose combinations containing PPA were being marketed in the country and available to the consumers with or without any prescription depending on other drugs in the combination. 4(iv). It is a fact that PPA was withdrawn in USA in November 2000 due to its association with cardiac congestive failure/haemorrhagic stroke at higher doses. Based on the reports of increased haemorrhagic strokes associated with the use of PPA, other countries including Canada, Singapore, Malaysia, Brazil, Cuba, Oman, etc., have also decided for withdrawal of PPA containing products from the market in the year 2000-01. 4(v). M/s.Bayers Pharmaceutical Pvt. Ltd. has informed that they have re-formulated its PPA containing products with the decongestant phenylephrine. M/s.GlaxoSmithKline Pharmaceuticals Ltd., has also informed that GSK's Pharmaceutical and consumer business currently does not market any product containing phenylpropanolamine globally. A copy of the information in that regard is annexed as Annexure R2 and therefore, it is not correct to say that PPA is in continuous use in several countries. Its use is being restricted in many countries and is being replaced by safer alternatives by the manufacturers. 4(vi). In India, DTAB, in its meeting held on June 21, 2002 had examined the issues related to continued marketing of products containing PPA in India and then recommended that PPA could be used with the maximum dose restricted to 50mg/day for children and 100mg/day for adults as had been recommended by Medicine Safety Committee of UK for Great Britain. The matter was again examined by the Expert Committee on 8th November, 2010. The Expert Committee opined that PPA being a non-prescription drug, is available in https://hcservices.ecourts.gov.in/hcservices/ various combinations as decongestant for cough and cold. The drug could therefore be taken by the consumer at his will in the doses which may be harmful. The drug is not a drug of choice to be used as decongestant in cough and cold preparations because of its association with hypertensive episodes. There are relatively safer alternatives available such as Pseudoephedrine and Phenylepherine. Alternative as nasal drops and spray for use as nasal decongestants are also available. 4(vii). The matter was again examined by the Expert Committee on 8th November 2010. The Expert Committee opined that PPA being a non- prescription drug, is available in various combinations as decongestant for cough & cold. The drug could therefore be taken by the consumer at his will in the doses which may be harmful. The drug is not a drug of choice to be used as decongestant in cough & cold preparations because of its association with hypertensive episodes. There are relatively safer alternatives available such as Pseudoephedrine & Phenylepherine. Alternative as nasal drops and spray for use as nasal decongestants are also available. In view of the above, the Expert Committee, after deliberation, recommended that all PPA formulations should be discontinued for use in the country. 4(viii). Once the Central Government arrives at a conclusion and is satisfied that the drugs are harmful to the public, it cannot be allowed to be manufactured, sold and distributed as it would mean compromising with the health and safety of the general public. Banning of the drug with immediate effect or not also depends upon the recommendations of the Expert Committees. In cases where the Committee had reasons to believe that a time limit may be provided for withdrawing the drugs from the market, a suitable time period is provided through the notification. In cases, where no such consideration has been made, the drugs are prohibited with immediate effect in public interest. 4(ix). Once a Gazette Notification is published, it comes under the public domain. The petitioner is trying to mislead this Court by stating that the Notification came into existence only after 14.02.2011. According to the respondents, on 11.02.2011 itself, the Minister of Health and Family Welfare, Shri Ghulam Nabi Azad, in reply to a question in the Lok Sabha, gave the information about the drugs prohibited by the Government of India on 10.02.2011 in the Parliament. The news about the banning of the said drugs was reported in the major Dailies on 12.02.2011. It is further denied that the notification is violative of the Constitution. The banning of a drug has been dealt with under Section 26A of the Act, wherein there is no provision of issuance of any prior notice before banning of a drug. The Section gives power to the Central Government to ban a drug upon its satisfaction that the drug is likely to cause risk and harm to the public. https://hcservices.ecourts.gov.in/hcservices/ 4(x). As the impugned notification has been issued in public interest keeping in mind the health and safety of the general public, the respondents pray for dismissal of the writ petition. 5(a). Learned Senior Counsel appearing for the petitioner has raised the following contentions : (i) Whether there is urgency to prohibit the drugs containing PPA, as it has been in the world market for more than 50 years and in the Indian market for 20 years? (ii) Whether DTAB is validly constituted under Section 26A of the Act to discharge its obligations under the Act? (iii) Whether the Expert Committee, in its meeting dated 08.11.2010 had recommended the immediate ban on the drug PPA? and (iv) Whether the ban on the usage of drugs containing PPA is in the interest of larger public? 5(b). In support of his case, learned Senior Counsel for the petitioner, has relied on the following decisions : (i) Supreme Court : AIR 1975 SC 2299 in the case of Smt.Indira Nehru Gandhi Vs. Shri Raj Narain : "327. A sovereign in any system of civilized jurisprudence is not like an oriental despot who can do anything he likes. "On Sunday morning, November 10, 1607, there was a remarkable interview in Whitehall between Sir Edward Coke, Chief Justice of the Common Pleas and James I. We have only Coke's account of the interview and not the King's, but there is no reason to doubt its essential authenticity. The question between them was whether the King in his own person might take what causes he pleased from the determination of the judges and determine them himself. This is what Coke says happened: "Then the King said that he though the law was founded upon reason and that he and others had reason as well as the Judges: to which it was answered by me. that true it was that God had endowed His Majesty with excellent science and great endowments of nature, but His Majesty was not learned in the laws of his realm of England, and causes which concern the life, or inheritance, or goods, or fortunes of his subjects, are not to be decided by natural reason but by the artificial reason and judgment of law, which law is an act which requires long study and experience before that a man can attain to the cognisance of it; and that the law was the golden metwand and measure to try the causes of the subjects; and which protected His Majesty in safety and peace: with which the King was greatly offended and said, that then he should be under the law which was treason to affirm, as he said: to which I said that Bracton saith https://hcservices.ecourts.gov.in/hcservices/ quod Rex non debet esse sub-homine sed sub Deo etlege." It would be hard to find a single paragraph in which more of the essence of English constitutional law and history could be found. The King ought not to be under a man, non debet esse sub homine but under God and the law sed sub Deo et lege. ..." (ii) Supreme Court : 1994 Supp (1) SCC 160 in the case of Systopic Laboratories (Pvt.) Ltd. Vs. Dr.Prem Gupta and others : "4. Reference, at this stage, may be made to the relevant provisions of the Act. As stated in the