THE HON’BLE SRI JUSTICE N.V. RAMANA W.P. No. 24504 of 2008 Oral order: Invoking the extraordinary jurisdiction of this Court under Article 226 of the Constitution of India, petitioner No.1, namely M/s. Sun Rise International Labs Ltd., represented by petitioner No.2, namely its Managing Director, have filed this writ petition, praying for the following relief: The Hon’ble Court may be pleased to pass an order or direction more particularly one in the nature of Writ of Certiorari and call for the records along with analytical reports of two drugs by name Paracetamol and Calcium of the order impugned dt. 26-08-2008 issued by the 2nd respondent and quash the same as it is violative of Sec. 18A, 23 and 25 of Drugs and Cosemtics Act, 1940 and its Rules 1945 and declare the action of respondents as illegal, arbitrary exercise of power, violative of principles of natural justice and rights guaranteed under Article 14, 19 and 21 of the Constitution of India and consequently direct the respondent to release the balance payment to the tune of Rs.14,52,350/- to the petitioner and direct the respondents to pay the compensation for the loss of reputation of the petitioner company and to pass such other order or orders as this Hon’ble Court deems fit and proper in the circumstances of the case. The petitioners are the highest bidders in pursuance of the Tender Notification dated 11.02.2008 for supply of 21 medicines mentioned therein, including Paracetamol and Calcium tablets. Thereafter, based on the purchase orders placed by the respondents and within the time extended for supply, the petitioners supplied the medicines. The respondents, out of total amount of Rs.52,73,500/- towards the medicines supplied by them, have paid an amount of Rs.38,21,500/-, and were still liable to pay balance amount of Rs.14,52,350/-. The petitioners state that the requested the respondents to pay the balance amount, but the respondents did not pay the same. While so, the petitioners state that the respondents issued another tender notification for supply of medicines, and when they approached the respondents for tender document, the respondents refused to give the same stating that petitioner No.1 has been blacklisted. Thereafter, vide proceedings dated 26.09.2008, the respondents called upon the petitioners to take back the stocks of Paracetamol 650 and Calcium 500 from the office of respondent No.4. Upon receiving the same, the petitioners state that they made representation dated 07.10.2008 requesting the respondents to send the medicines for analysis, but the respondents did not take any action thereon. Hence, the petitioners filed the present writ petition. The learned counsel for the petitioners submitted that the respondents without furnishing the analytical reports of the medicines, namely Paracetamol and Calcium, and without providing any opportunity of hearing, have branded those two medicines of being of sub-standard quality, and called upon the petitioners to take back the medicines and refused to make the payments which they are liable to pay, which is illegal and arbitrary. Hence, he prayed that the writ petition be allowed and the respondents be directed not to return the medicines, take back them and release the balance payment and remove their name from the list of companies which are blacklisted. Upon receipt of notice, the respondents filed their counter on 22.11.2008. The learned Government Pleader for Home, reiterating the stand taken by the respondents in the counter submitted that the medicines, namely Paracetamol and Calcium supplied by the petitioners were sent to Department of Drugs Control Administration, for test, and they having conducted the tests, submitted report stating that they are not in conformity with the standards prescribed, and therefore, the respondents blacklisted the petitioners from participating in future tenders. Hence, he prayed that the writ petition be dismissed. On 24.11.2008, the petitioners filed application in W.P.M.P. No. 33648 of 2008 praying to permit them to add paras 2 to 6 in the affidavit filed along with the writ petition as additional pleading. In the application, the petitioners inter alia pleaded that they made representation under the Right to Information Act, 2005 and obtained the following documents: 1. Letter of First Appellate Authority, Director General, Drugs & Copyright, Drugs Control Administration, Vengal Rao Nagar, Hyderabad, dated 22.10.2008. 2. Letter of Director General Drugs & Copy Right to respondent No.3, dated 15.07.2008. 3. Copy of annexure containing Identification and content of Drug. 4. Copy of Drug Letter No.10580/DCLAB/2008, dt. 11.09.2008 to the respondent No.3 by the Director General of Drugs & Copy Right Drug Control Administration, Vengal Rao Nagar, Hyderabad. Pointing to the letter dated 11.09.2008 addressed by the Director General, Drug and Copy Rights, Drug Control Administration, to the respondents, the petitioners submitted that in the said letter, the Director General, Drug and Copy Rights, observed that all the samples are of “standard quality”, but the tablets are interchanged Sl. No. 18 in place of 37 and vice versa and Sl. No. 26 in place of 24 and vice versa at the time of coding the above samples. He thus contended that for the lapses committed by the respondents, the petitioners cannot be held responsible. As the Government Pleader for Home did not get any instructions on this aspect of the matter, this Court made the following interim order: Hence, taking into consideration the material placed on record, the 3rd respondent is directed to reconsider the whole issue in the light of the additional material placed by the petitioner, particularly, the letter dated 11.09.2008 issued by the Director General of Drugs and Copyrights, within a period of two weeks and submit a report to this Court. List the matter after two weeks “for orders”. Thereafter, the respondents submitted a report stating that there is no error in coding the samples. However, since the report did not indicate as to whether the respondents have considered the whole issue in the light of the letter dated 11.09.2008 of the Director General, Drugs and Copyrights, as directed above, this Court by order dated 06.04.2009, directed the appearance of the respondents along with the record. On 08.04.2009, the respondents as directed appeared before the Court, and contended that the medicines supplied by the petitioner are of substandard quality. This Court upon hearing the learned counsel for the petitioner and the learned Government Pleader for Home and considering the stand taken by the respondents that the drugs supplied by the petitioner are of substandard quality and that the suo motu letter addressed by the Director General, Drugs and Copyrights to be of no relevance, felt that the drugs in question should be sent for analysis. Accordingly with the consent of the parties, this Court made the following order: The 3rd respondent is directed to send the samples of the two drugs to the Directorate, Central Drug Laboratories, 3 KYD Stret, Kolkata by a special messenger with a request to analyse the samples and to send a report in a sealed cover to this Court, which shall be opened before this Court on the next date of hearing. Thereafter, the matter was adjourned on five occasions as the report of the Central Drug Laboratory was not received. On one of the occasions, 08.06.2009, the respondents produced the reports received from the Director, Central Drugs Laboratory, Kolkota, by him in a sealed cover. The same having been opened in the Court, a copy of the reports was furnished to the counsel for the petitioners. Heard the learned counsel for the petitioners and the learned Government Pleader for Home for the respondents. I have perused the analysis reports dated 01.05.2009 of the two drugs received from the Director, Central Drugs Laboratory, Kolkata, produced before the Court by the respondents. The report relating to Calcium, which is issued in report No. 21-5/2009-P&P/M-1/127, dated 01.05.2009, declares that the sample is not of standard quality, and the remarks against such declaration, is that the sample does not conform to the claim with respect to content of “Vitamin D3”. Insofar as Paracetamol is concerned, the analysis report in report No. 21-5/2009- P&PM-2/129, dated 01.05.2009, though in the remarks column states that the sample conforms to I.P. with respect to the two tests mentioned therein, but records the following foot notes: 1. The tests “4-Aminophenol and Related substances” could not be carried out due to technical difficulties (for want of reference standard). 2. The date of expiry written on forwarding memo (i.e. April, 2009) does not tally with that printed on sample strip (i.e. April, 2011). The contents of the above reports, as noted above, clearly indicate that Calcium tablet does not conform to the claim with respect to content of “Vitamin D”, and even though Paracetamol conforms to I.P. with respect to the tests carried out therein, the fact remains, the tests “4-Aminophenol and Related substances” test was not carried out due to technical difficulties (for want of reference standard) and that the expiry date is not tallying. Since complete tests of Paracetamol were not carried, it cannot conclusively be said that it conforms to the prescribed standards. The report in respect of Paracetamol does not clearly state whether the sample conforms to the prescribed standard or not. Since the two drugs supplied by the petitioners did not satisfy the standards prescribed by the respondents, it is not proper for this Court in exercise of its jurisdiction under Article 226 of the Constitution of India, to grant any relief to the petitioners, much less direct the respondents to take back the samples and pay them the money for the said quantity, for if any such direction as prayed for by the petitioners is given, it would amount to forcing upon the respondents to take back sub-standard quality of drugs, which if used would have a telling effect on the health of the police force for whose use the drugs were sought to be procured/purchased by the respondents. There is no merit in the writ petition, and the same is accordingly dismissed. No costs. _________________ N.V. RAMANA, J. Date: 18th June, 2009 KSR