ORDER SHEET

IN THE HIGH COURT OF SINDH AT KARACHI

 

                                        Suit No.62 of 2015              

 

M/s Getz Pharma (Pvt.) Ltd.

Versus

Province of Sindh & others

 

Date

Order with signature of Judge

 

For hearing of CMA 543/15 (under order 39 R 1 & 2 CPC)

 

Date of hearing: 29.01.2015, 10.02.2015, 12.02.2015, 19.02.2015, 25.02.2015, 27.02.2015, 02.03.2015, 04.03.2015 and 06.03.2015.

 

Mr. Faisal Siddiqui along with Mr. Muhammad Vawda for plaintiff.

 

Mr. Qazi Majid AAG and Ziauddin Junejo, AAG for defendants No.1 to 4.

 

Mr. Haider Ali Khan along with Mr. Sarmad Hani for defendant No.5.

 

Mr. A. Sattar Pirzada along with Mr. Mamoon Chaudhary for defendant No.6.

 

Mr. Yawar Farooqui along with Mr. Irfan Memon for defendant No.7.

 

Mr. Khalid Jawed for defendant No.8.

 

-.-.-

 

Mohammad Shafi Siddiqui, J.- Through these proceedings the plaintiff has challenged the transparency of the tender process initiated by defendant No.4 for supply of medicines, vaccines, machinery, equipment etc. for prevention and/or control of Hepatitis B & C in Sindh for the year 2014 and 2015 and through the listed application under order XXXIX Rule 1 and 2 CPC the plaintiff has prayed for restraining orders till final disposal of the suit to the effect that the defendants No.1 to 4 be restrained from implementing the subject tender for procurement of Hepatitis B & C medicines and defendants No.5 and 8 from supplying their medicines/drugs in respect thereof.

Learned counsel for the plaintiff in support of the application has contended that initially the subject tender process was advertised through newspapers of dated 28.11.2014 and 29.11.2014 however through a corrigendum issued in newspapers of 30.11.2014 the defendant No.4 extended the tender opening date to be 18.12.2014. The plaintiff also participated in the tender process through defendant No.6 A.J. Mirza Pharma (Pvt.) Limited.

          Learned counsel for the plaintiff submitted that after obtaining complete set of tender and its related documents, the documents were submitted which pertain to eligibility criteria as well as the evaluation criteria. The counsel contended that in terms of eligibility, the manufacturer must have ISO certificate and either Good Manufacturing Practices (GMP) or Food & Drug Administration (FDA) (USA approved). The evaluation criteria are stated to be based on 22 points. The plaintiff through defendant No.6 submitted the bid in relation to its products Unipeg and Ribazole, along with all the requirements as emphasized and needed for the subject tender. It is claimed by the learned counsel that since the plaintiff has made/fulfilled all the eligibility and evaluation criteria, therefore, both the products of the plaintiff were eligible and entitled to have a highest number of points in evaluation however through letter dated 26.12.2014 the defendant No.4 accepted the technical bid of defendant No.6 on behalf of the plaintiff in relation to its product Ribazole but the same was declined in relation to its product Unipeg on approximately five points which are incorporated in remarks column of the said letter.

It is contended by the learned counsel that none of the grounds, as alleged, to such rejection are applicable to the product in question i.e. Unipeg. In addition, the learned counsel submitted that the malafide on behalf of the defendants is apparent as the rejection letter of 26.12.2014 contains reference to an order passed in CP No.D-6723 of 2014 on 30.12.2014. Thus it is claimed that it is inconceivable that the defendants came to know about the order of 30.12.2014 on 26.12.2014. According to the learned counsel it clearly smells malafide, apart from the fact that indeed it was never refused on 26.12.2014.

Learned counsel further, without prejudice to the above, submitted that perusal of order of 30.12.2014 passed in the aforesaid petition clearly shows that it does not contain any direction for the defendants, particularly defendant No.4, to enforce and/or implement any additional condition to the eligibility criteria i.e. it should be only FDA/EMA approved. Furthermore, as against this product of plaintiff, the defendant No.5’s bid through defendant No.7, for its product was accepted in relation to Unipeg and the bid of defendant No.8 has also been accepted in relation to its product Pegintron through defendant No.7.

It is contended by the learned counsel that previously in the year 2013 and 2014 similar kind of tender was floated by defendants No.2 to 4 in relation to Inj: Pegylated Interferon Alfa2a and Alfa2b with Cap: Ribavirin 400 m.g. wherein arbitrary and discriminatory conditions of FDA/EMA approval was incorporated, which led to the disqualification of the plaintiff and other similarly placed pharmaceutical companies. Prima facie this condition was imposed only to favour a single bidder i.e. defendant No.5 who could qualify such condition in respect of his previous medicine namely Pegasys. It is claimed that although such imposition of condition was challenged by the distributor of the plaintiff when he filed petition No.D-3300 of 2013 however the same was dismissed on the ground that the principal/plaintiff/manufacturer did not itself challenge the impugned condition which order has been challenged by the Distributor before the Hon’ble Supreme Court and the same is pending adjudication wherein leave has been granted. It is urged that it is only on account of realization of imposition of such arbitrary and discriminatory condition that in the impugned tender, which is the subject matter of this suit, such conditions were not incorporated.

While arguing the case insofar as the rejection of plaintiff’s medicine Unipeg is concerned, it is urged that the acceptance of defendant No.5’s bid is also illegal and malafide as the very registration of defendant No.5’s product is under challenge on account of being deceptive marketing practices as it is claimed in the advertisement and promotion that Ropegra i.e. Pegylated Interferon alfa-2a 180 mcg (40KD) is identical to Pegasys. Learned counsel submitted that there is a series of litigation between the plaintiff and defendant No.5 as they are business competitors and in pursuit thereof some malafide proceedings were initiated by defendants through their front man when a Constitution Petition No.2891 of 2010 was instituted in relation to plaintiff’s drug wherein he has filed certain documents which could not have been in his possession unless supported by defendant No.5. It is also contended that in those proceedings the respondents, including the Ministry of Health, Additional Secretary Health, Registration Board and Federal Drug Inspector have filed their comments and have denied the contention as raised in the petition against the present plaintiff by the petitioner in the said petition who is a front man of defendant No.5.

Thus, learned counsel submitted that rejection of the plaintiff’s product in relation to Unipeg on the allegation that it does not have approval by FDA/EMA is illegal and malafide as it is not the eligibility criteria in tender conditions and furthermore all other ancillary and co-related reasons for such rejection also do not borne out such conditions and that the self-claimed conditions, in terms of order of 30.12.2014 passed in CP No.6723 of 2014, are also not established.

It is further contended by the learned counsel that the alleged disqualification of the plaintiff product on the pretext that the molecular weight of Unipeg is 20 Kilo Daltons (KDa) is also malafide as the drug of Schering Plough (defendant No.8) has been accepted in relation to its product Pegintron which is 12 KDa. It is contended that if at all a molecular weight of 20 KDa in relation to the medicine Unipeg is not recommended how the product of Schering-Plough defendant No.8 which carries 12 KDa can be accepted. It is contended by the learned counsel that such rejection on the basis of its molecular weight was otherwise made only to favour the product of defendant No.5 as the malafides are prima facie established.

It is urged that the plaintiff’s product Unipeg has undergone all kinds of testing, which is established from various letters issued by the Centre for Applied Molecular Biology, Ministry of Science & Technology, Government of Pakistan, and on various occasions Government of Pakistan issued Lot Release Certificates from 07.07.2010 to 31.12.2014. Learned counsel submitted that this product is being exported to various countries such as Cambodia, Lao and Myanmar. Learned counsel has further added that the safety, reliability and effectiveness of plaintiff’s products have also been approved by independent medical sources which are part of the record.

          Learned counsel for the plaintiff in support of his contention has relied upon the cases as under:-

i)             Transparency in respect of tender process:- 2012 CLC 1780, PLD 2012 Sindh 434, 2013 CLC 476, 2012 SCMR 1651, PLD 2013 Islamabad 1651, PLD 2012 Lahore 503, PLD 2010 Lahore 289, PLD 2012 Baluchistan 208, 2012 YLR 1426 and 2014 SCMR 676;

 

ii)           Change in tender condition:- 2007 YLR 161, 2010 CLC 1370 and PLD 2011 Lahore 16;

 

iii)         Discrimination as against Pakistani products:- PLD 2020 SC 759;

 

iv)          Injunction and damages:- PLD 1982 Lahore 49, 1993 MLD 1308 and 2008 YLR 2040;

 

v)           Latches:- AIR 1994 Delhi 322 and 2013 MLD 433;

 

vi)          Ouster clauses:- PLD 2005 SC 873, 1974 SCMR 356, 2007 SCMR 554, PLD 1994 SC 738, 2000 SCMR 1137, 1999 YLR 166, PTCL 2000 CL 764, 1999 PTD 1310 and PLD 1997 SC 3;

 

vii)        Malafides:- PLD 2014 SC 47 and PLD 1973 SC 49;

 

viii)      alternate remedy:- 2001 CLC 1618;

 

ix)          Undertaking and Court order:- 1997 SCMR 193;

 

x)            Expert opinion:- AIR 1931 Lahore 364, 2001 YLR 749, 1989 MLD 3325, 1996 MLD 762 and 2004 SCMR 1859;

 

xi)          Court’s role in assigning medicine quality:- NLR 1992 AC 563, 1992 MLD 481, 2003 YLR 3056, PLJ 2003 Lahore 886, PLD 2003 Lahore 115 and

 

xii)        Substandard drug and jurisdiction of Drug Court:- 2002 PTD 1800.

 

Mr. Qazi Majid, learned AAG appearing for defendants No.1 to 4, at the very outset contended that although this condition of FDA/EMA approved medicines was not the condition prescribed for the bidders to be qualified however in all previous tenders such evaluation in relation to FDA/EMA was a condition precedent and further the orders passed in CP No.6723 of 2014 also confirms that no such medicines, which are in violation of FDA/EMA, could be approved.

Learned AAG further added that this parameter, insofar as the approval of the FDA/EMA is concerned, is internationally reliable as it confirms the safety and efficacy of the medicine. He further added that in terms of molecular weight of plaintiff’s medicine, the committee has decided that its efficacy is not up to the mark.

          Learned AAG further added that as far as reports of Unipeg is concerned it is not published at as great extent as compared to Ropegra (Pegasys). He argued that drug of defendant No.8, which contains molecular weight of 12 KDa, as it is recommended for children and under-weight patients.

He further submitted that the plaintiff’s bid was rejected on 26.12.2014 which was dispatched in the afternoon of 30.12.2014 through TCS and this suit has been filed after delay of 16 days and as such the balance of inconvenience would not be in favour of the plaintiff.

          Mr. Haider Ali, learned counsel for defendant No.5, contended that the plaintiff is not a bidder in the impugned bidding process for the procurement of Hepatitis B and C medicines and hence the plaintiff has no legal status to maintain the suit. He further submitted that it involves lapse/latches of 16 days and as such the plaintiff is not entitled for any relief on this score alone as during this 16 days the contract of supply was awarded.

It is further contended that the plaintiff is suppliers of spurious Peg-2A and its own manufacturer and exporter has stated it to be not fit for human therapy and that the specification of 20 KDa in respect of plaintiff’s drug has no international testing or study. It is further argued that the plaintiff does not have a license/letter of registration to conduct any form of manufacture of its registered product Unipeg and they are only allowed to import and fill the products in vials. It is argued that whether or not the plaintiff’s drug met the evaluation criteria is a question that can be answered by Government of Sindh.

It is further argued that one of the aggrieved bidder for the year 2014-2015 tender process initiated proceedings by filing CP No.D-6723 of 2014 and one of the preliminary objection therein was that the tender process of the Government of Sindh for 2014-2015 was tainted as the standard to meet the quality of the drug was reduced as compared to the previous evaluation criteria. The said petition was dismissed on 30.12.2014 upon the guarantee and undertaking of defendant No.2 that all drugs procured by the Government of Sindh for 2014-2015 tender for Hepatitis B & C would be of international standards and WHO, FDA and EMA approved and hence the Government of Sindh was bound by the undertaking given to the Court. It is further argued that defendant No.7 has informed defendant No.5 that it received letter of the Government accepting its bid on 02.01.2015 and also that defendant No.6 was present in meetings of 18th, 26th and 31st of December, 2014 and the presence of defendant No.6 was marked in the government record.

Learned counsel further contended that the government expert Dr. Bhika Ram and Dr. Badar Fayyaz Zuberi objected to the Unipeg on the ground as available to the rejection letter. Learned counsel also denied that Unipeg is certified by WHO as Annexure A/2 merely provide the list of WHO pre-qualified quality control laboratories. He argued that on the contrary Ropegra is EMA approved and such approval is a public document and is available on website.

Learned counsel further added that the word “international standard” as incorporated in order referred above means standard without any dispute. He contended that the impugned letter dated 26.12.2014 does not at all smell malafide as it provided a plausible reason for rejecting bid of the plaintiff in respect of Unipeg. He further argued that if any one of the four reasons is correct then it should be held correct and the other incorrect decisions, if at all they are, does not come in the way of one correct decision. He asserted that in the instant case all the reasons assigned are correct. Learned counsel has also taken me to various definitions provided under the Rules called Drug License & Regulatory Rules, 1996 such as bulk product, manufacturer, goods manufacture practices and rules 2(j),(d),(s)(t) etc.

Learned counsel further added that defendant No.5 in fact is the original manufacturer of Pegasys Peginterferon Alpha 2a having molecule weight of 40 kDa and hence they have their patent registered. It is for this reason that the plaintiff neither can nor has any sort of approval from EMA/FDA.

He contended that insofar as drug of defendant No.8 i.e. Alfa2b with 12 KDa is concerned it is a separate drug. He added that the pre-trial discovery proceedings available at page 373 and 405 would come in the way insofar as the efficacy is concerned and the decree obtained in pursuance thereof is a collusive. He further added that the certificate of Goods Manufacturing Practices (Page 277 Part I) does not show that the Pegylated Interferon is manufactured by the plaintiff.

Insofar as the issue of Anti-Dumping Duty is concerned, learned counsel submitted that if the sale price in the country of import is lower than the price of country of origin, the country of import imposes Anti-Dumping Duty. Although they dispute such imposition but without prejudice in view of the orders of the Regulatory Authority as well as Court the defendant No.5 was coerced to reduce such prices. However, in order to overcome such issue, defendant No.5 has now registered the same drug under the name and style of “Ropegra”. Learned counsel has also relied upon Section 15 and 16 of Sales of Goods Act on the ground that the plaintiff’s goods are not sellable as they are not fit for human therapy as their efficacy is questioned, therefore, the plaintiff’s bid also stands disapproved on this score as well.

          Learned counsel for defendant No.5 in support of his contentions has relied upon the cases reported in PLD 1976 Lahore 580, 2012 CLC 1409, 2011 SCMR 1360, PLD 1969 SC 65, 2000 YLR 469, 2001 CLC 781, 2005 SCMR 564, 2009 SCMR 385, 2010 YLR 1161, PLD 1974 SC 151, 2002 SCMR 549, PLD 1964 WP Karachi 608, PLD 1970 Karachi 125, 1992 CLC 1138, PLD 1965 WP Karachi 202, PLD 1973 Karachi 361 2012 CLC 1434, 2010 CLD 1648, PLD 2012 Sindh 434, 2004 SCMR 1092, 1999 CLC 1719, 1982 CLC 2369, PLD 1965 SC 83, 2007 CLD 966, 2009 CLD 716, 2011 CLC 1985, PLD 2008 SC 472, 2013 CLC 476, 2002 CLD 231, PLD 1974 Karachi 29, 1988 CLC 779, 1989 CLC 75, 1995 CLC 952, 1997 SCMR 906, PLD 1955 Sindh 351, 1987 CLC 345, 2010 SCMR 121, PLD 1975 SC 506, PLD 1966 SC 793, 2012 SCMR 455, PLD 1983 SC 151, 1994 SCMR 782, PLD 1992 SC 723, PLD 1971 SC 205, 1991 CLC 1277, PLD 2003 SC 344, 2010 CLC 285, 2011 MLD 925, 2007 MLD 2019, 2002 SCMR 1150, 2000 SCMR 1557, 2014 CLD 1410, 2014 CLD 1133, 2010 SCMR 286, 2010 SCMR 1811, 2010 SCMR 1861, PLD 1972 Karachi 119, PLD 1996 Karachi 365, PLD 2003 Karachi 691, 2003 CLC 1602 and 2013 MLD 1132.

Mr. Abdul Sattar Pirzada, learned counsel appearing for defendant No.6, has also argued in line and in support of the contention of the plaintiff as being the agent of the plaintiff. He submitted that they have submitted the bid for the manufacturer and the bid documents, which provide the evaluation criteria as Point No.6. He submitted that the evaluation criteria is point-based system and the reasoning assigned in the rejection letter are devoid of the application of such evaluation criteria. Learned counsel for defendant No.6 further relied upon letter dated 15.12.2014 available at page 207 Part 1 which confirms that they are reputable manufacturer of Pegylated Interferon alfa-2a 180 whereby they have authorized defendant No.6 to submit a bid, subsequently to  follow up, negotiate and sign the contract on their behalf. Learned counsel submitted that in response to a technical specification of an earlier tender one of the dealers has filed a petition bearing No.D-3300 of 2013 which was disposed of on 06.09.2013 on the ground that the petitioner who has filed the petition was not a manufacturer of the drug offered to respondent No.4 therein, whereas the actual manufacturer was M/s Getz Pharma, plaintiffs herein. It was observed in that case that the actual manufacturer has not come forward to question imposition of the conditions of the tender and that it was prerogative of purchaser to impose restrictions as it deem fit and proper. Ultimately, the petition was disposed of on the ground that the plaintiff who is the actual manufacturer of the drug would have been an appropriate party to deny such position but it chooses not to take any legal action. Hence, it was dismissed. However, it was left open to the manufacturer to establish before the concerned authority regarding efficacy of its product which is equivalent to the drug having been approved by FDA/EMA. Learned counsel submitted that it is this background that perhaps the manufacturer has filed this suit and its agent (defendant No.6) has been arrayed as one of the defendants.

Learned counsel further relied upon the registration of the subject drug under section 7 of Drugs Act, 1976 and rules framed therein on 29.03.2010 and that certificate of Goods Manufacture Practices was also issued by DRAP which is available at page 277 which shows that they are authorized to export in terms of bullet point 1 thereof. Learned counsel further submitted that the laboratory of the plaintiff has been pre-qualified by WHO as Eastern Mediterranean Region. He has further relied upon Bio-Activity Potency test carried out by Centre for Applied Molecule Biology which concerned the subject drugs as of good quality and these drugs through an Award/contract by respective governments are being supplied to Baluchistan, Azad Jammu & Kashmir and such purchase orders are available at pages 1177 etc. and other purchase orders of different renowned hospitals such as MEO Hospital Lahore, Fatima Jinnah Medical College, Services Institute of Medical Sciences, Department of Gastroenterology, Liauqat National Hospital, Agha Khan Hospital, Ayub Teaching Hospital and other private institutes and doctors are available on record which are not denied.

He submitted that in view of aforesaid facts and circumstances the undertaking given in CP No. D-6723 of 2014, as relied upon by other defendants, are ill-founded as such undertakings was not formed part of the order.

He further relied upon attendance sheet available at pages 527 and 529 of the file and argued that such attendance sheet and the endorsement therein only show that the sealed bids were opened in their presence and the procedure adopted for opening such bids was transparent however it has nothing to do with the remarks as endorsed in the refusal note.

Learned counsel further submitted that insofar as the counter-affidavit filed by defendant No.5 is concerned that is misleading as in Para 4 it is stated that the Government of Sindh for the year 2014-2015 tender invited the drugs of international standard and WHO/FDA/EMA approved and hence the government is also bound by the undertaking to re-examine each of the technical bid on such basis. He further contended that in Para 10 of the written synopses filed on behalf of defendants No.1 to 4 they have stated that the bid was rejected on 26.12.2014 and the rejection letter was dispatched on 30.12.2014 which include the observation of the learned Division Bench. He further relied upon the clause 2 of Para 13 of the written synopses wherein the defendants No.1 to 4 have admitted that the expertise of notified purchased committee announced that for Pegylated Interferon (mentioned in tender No.1) there is no criteria meant for technical evaluation and/or to adjudge and evaluate such an important life-saving drug. It is further highlighted that the first parameter that was considered was FDA and EMA approval followed by four phases which are also not tenable under the law. He further contended that the arguments were misconceived that there was no evaluation criteria as it is mentioned in the tender documents. He has argued that registration of Ropegra is also newly registered therefore it should not have been considered as compared to the plaintiff’s product duly registered in the year 2010. It is claimed in Para 12 of the counter-affidavit that the Ropegra has been recently imported in Pakistan in January, 2014 and has been marketed and supplied since March, 2014 by defendant No.5.

Learned counsel has also relied upon Rule 4, 13, 36 and 44 of Sindh Public Procurement Rules 2010 (hereinafter referred to as Rules 2010) and so also Rule 21 and 32 thereof and submitted that perusal of these rules and the amended rules would show that the refusal and decision declining to accept the bid of the plaintiff through defendant No.6 is arbitrary, illegal and contrary to Rules 2010.

In support of case of defendant No.7, Mr. Yawar Farooqui learned counsel, argued that in terms of publication dated 28.11.2014 defendants No.1 to 4 invited bids in single stage two envelops through authorized dealers, manufacturers, distributors, wholesalers, and in terms of the publication the date of opening the technical bid was 15.12.2014 however in view of corrigendum three days’ time was extended except the tender of Peg interferon. It is contended that the attendance sheet available on record in respect of Hepatitis medicine clearly shows that the procedures adopted was transparent and the participants were satisfied. He submitted that all the bids except for tender 1 were opened on 18.12.2014. It is argued that the opening of the bid of Pegylated Interferon was not opened due to some reservations of evaluation criteria by the technical committee and hence it was adjourned to 26.12.2014. He further argued that even on 26.12.2014 it was not opened and the matter was adjourned to 30.12.2014 to be taken up at 2:30 p.m. It is urged that as per tender document there were certain conditions for eligibility including FDA condition. He has relied upon order passed in CP No.D-6723 of 2014 which was filed by some bidder alleging therein that the government intends to purchase substandard medicines and has willfully omitted condition of FDA/EMA and that on an undertaking given by the Secretary Health the petition was disposed of on the assurance that all the supplies in consequence to the tender process would be of international standard.  Hence, in consequence thereof such meeting of the Evaluation/Technical Committee was adjourned to 30.12.2014 and the defendant No.6’s bid for product 3 miv injection was accepted however for Peg Interferon, the defendant No.6’s bid for plaintiff product was rejected.

Learned counsel on preliminary issue in view of the above contended that as per Rule 31 of SPPRA Rules the suit would not lie as an alternate remedy is provided to the aggrieved party who may avail such opportunity of filing of complaint to the Complaint Redressal Committee and hence they have not preferred any complaint before CRC until filing of the suit.

He further added that in all previous occasions when such tenders were invited there was condition of FDA/EMA approval and that previously plaintiffs bid through its distributor Hamza was also rejected by the Evaluation committee which reasons are also available on record at page 625 of the file. He further added that in view of such refusal the Distributor of the plaintiff at the relevant time filed CP No.D-3300 of 2013 however the learned Division Bench of this Court disposed of the same with the observation that it is the prerogative of the purchaser to impose conditions and against this it is argued that the plaintiff’s distributor filed CPLA before the Hon’ble Supreme Court in which leave has been granted vide order dated 06.11.2013.

In view of the above, it is argued by the learned counsel that instead of establishing the efficacy of their product being equal to FDA/EMA as observed in order dated 06.11.2013 in above referred CP the plaintiff has filed this suit directly challenging the well reasoning refusal of the evaluation committee. He argued that the suit has been filed apparently after delay of 16 days and hence when the contract has already been awarded, the balance of inconvenience does not lie in favour of the plaintiff. He argued that since the plaintiff has not participated in the tender proceedings, therefore, he has no locus standi and/or cause of action to file the present suit.

Mr. Khalid Jawed, learned counsel for defendant No.8, contended that the defendant is a leading research-based pharmaceutical company and is also one of the contestants of the subject tender who offered one of its product Peg Interferon (Alfa 2b) which is the only Alfa 2b Pegelated Interferon available in Pakistan in four dosages strengths to suit the individual need of patients based on their body weight and is also based on clinical trial of high repute. Learned counsel further contended that this Pegylated Interferon Alfa 2b (Pegintron) is prescribed by doctors which is different and distinct from Pegylated Interferon Alfa 2a which is a product of plaintiff and defendant No.5. He further added that the product of defendant No.8 is duly approved by FDA and EMA and is also GMP certified. He added that in terms of its peculiar weight of 12 KDa which represents PEG-chain size in its molecule, is unique chain size and is thus responsible for certain clinical advantages like bioactivity and drug penetration in tissues and organs and hence the question as raised by the plaintiff is baseless.

Learned counsel lastly argued that the suit is barred under Rule 31 of SPPRA Rules 2010. He further added that the balance of inconvenience is not in favour of plaintiff since the contract has already been awarded to the respective defendants for supply of medicines which is urgent requirement of the patients.

Learned counsel for defendant No.8 in support of his contentions has relied upon the cases reported in PLD 1993 Karachi 190, 1998 CLC 441 and 1998 CLC 374.

I have heard learned counsel for the parties at length and perused the material available on record.

There is no cavil to the proposition that the paramount consideration for deciding the pending issues is transparency in its process. Though other ancillary issues followed are inter linked which may transform themselves to expose transparency or otherwise.

In order to decide the controversy insofar as the rejection of the plaintiff’s product is concerned, I would limit the scope of lengthy argument to the extent of refusal note available at page 441. For convenience I would reproduce these rejection note/remarks as under:-

i)             M/s Getz Pharma Pakistan are not FDA/EMA approved;

 

ii)           It is 20 KD which is not recommended for human being therapy;

 

iii)         It is not available in its country of origin;

 

iv)          Phase-IV Efficacy and biogenrics

 

v)           Phase I-IV trial for bio similarity are not available.

 

vi)          Orders passed in CP No.D-6723 of 2014 dated 30.12.2014.

 

I would give my observation regarding transparency process once I would determine as to whether the defendants No.1 to 4 were justified in rejecting the plaintiff’s product/bid offered for subject tender through defendant No.6. There is no cavil to this proposition that previously instant products were being procured by defendants No.1 to 4 through tender documents containing requirements of FDA/EMA approval. The primary remark attributed to the refusal is of course that the drugs as offered by the plaintiff are not FDA/EMA approved. The tender documents are available as Annexure D to the plaint. It provides the definition for eligible bidders as 2.1 which is reproduced as under:-

“2.1    This invitation for Bids is open to all original Manufacturers, within  Pakistan and abroad, and their Authorized Agents/importers/Suppliers subject to the conditions that:

a)       ISO Certified manufacturer with the following standard:

(i)      ISO

(ii)     GMP or FDA approved.”

 

Thus, no rocket science is required to determine the eligibility of the bidders as it says that the bidders should be ISO certified manufacturer having standard as (i) ISO (ii) GMP or FDA approved. The procuring agency itself has highlighted the eligibility that it should be either GMP, Goods Manufacturing Practices or Federal Drug Agency USA approved. There is no denial that the plaintiff is GMP certificated dated 19.06.2014. Thus, it appears that insofar as the eligibility is concerned, the plaintiff has succeeded in qualifying the eligibility criteria in pursuance of tender documents.

I would now deal with the evaluation criteria which is point No.23 in the tender documents. The eligibility criteria is based on point system. It contains a chart of as many as 22 points which the eligible bidder would contest and procure points accordingly. The rejection or refusal note as available at page 441 at the very outset does not describe as to what evaluation method has been applied as these 22 points are totally absent in the determination and some other criteria for its evaluation was imported and applied. This rejection note does not even discuss as to whether evaluation criteria, as mentioned in the tender documents was ever observed and/or that in addition to this criteria they have applied some other evaluation method. The evaluation criteria which each individual/bidder would undergo would fetch him points and the net result of the point scored and obtained could lead to a decision for a successful bidder which is not the case here.

The counsels for the defendants except defendant No.6 have heavily relied upon two orders of the learned Division Bench; one passed in CP No.D-3300 of 2013 and the other in CP No.6723 of 2014. Since wordings of these two orders are very important and relevant, therefore, I would reproduce the same as under:-

“CP No.D-6723/2014

The petitioner has impugned notice inviting tender bearing No.INF/KRY-3611/2014 for procurement of medical products of various categories mentioned therein for Hepatitis Prevention and Control Program as unlawful and violative of Sindh Public Procurement, 2010.

          Counsel for the petitioner contends that the respondents have invited tender for procurement of substandard medical products for Hepatitis Prevention and Control Program. According to the counsel the petitioner was awarded tender for the year 2008-09, 2011-12 and 2013-2014 for the procurement of various medical products for the Prevention and Control of Hepatitis and the technical specification always provided that all the supplies/medical products should be WHO certified FDA/EMA approved and the petitioner has been supplying high quality of such drugs for the last many years but this year the Respondents have deliberately and malafidely omitted such condition for obvious reason. Counsel while referring to the technical specification for 2013-14 contends that the specification clearly provide that all the supplies should be WHO certified/FDA/EMA WHO compliant, per counsel however, the technical specification of this year does not provide such condition leaving it open for the Respondents to procure substandard drugs. It was next contended that the respondents deliberately delayed providing tender documents to petitioner in order to oust him from submitting his tender. According to the counsel petitioner was issued belated tender documents on 11th December 2014, knowing it very well that it will not be possible for him to complete the lengthy process and requirement by 15th December 2014 which was the date for opening the bids. It is, therefore, prayed that the process be declared unlawful and the Respondents be directed to initiate de novo process of tendering.

          On the other hand concerned Secretary Health has effected appearance and stated that the petition is mala fide as petitioner has failed to participate in the process and therefore, he wants de novo process, according to him the tendering process stands concluded and even the bids were opened on 18th December 2014. He has categorically denied that any drugs of inferior quality is being purchased by the Respondents in consequent to the tendering process questioned in this petition would be of the best quality WHO certified FDA/EMA approved/compliant. Secretary Health has further denied the allegations of not issuing timely documents to the petitioner. He has made a very categorical statement that no sooner the petitioner requested tender documents were provided to him through the same process as were provided to all. He further says that the petitioner was quite experienced as he has remained successful tenderer for the last 2-3 years, therefore, he knew the requirements and could have filed a form within three days which were sufficient even for a new comer to submit his offers.

          As to the first contention, since the Secretary Health has made a categorical statement and has assured that all supplies in consequent to the tendering process, subject matter of this petition, would be of international standard therefore, apprehension of the petitioner regarding procurement of substandard drugs appears to be misplaced and therefore, is turned down. As to the allegation regarding belated supply of tender documents, firstly, this appears to be a factual controversy which cannot be entertained while exercising constitutional jurisdiction and secondly, the petitioner admittedly had received the documents on 11th December 2014 which were to be submitted on 15th December  2014, leaving four days to complete the tender documents which was sufficient time for a tenderer of his experience. No case of interference is made out. Petition is dismissed.

CP No.D-3300 of 2013

4.       We have noted that the petitioner is not a manufacturer of the drug offered to respondent No.4. The actual manufacturer is Getz Pharma. The bid documents show that it is not necessary that the participants should be manufacturer only. It could be distributor, supplier and importer but such person should have good reputation and sound financial position so that if the drugs are found to be harmful or substandard appropriate proceedings could be initiated against solvent supplier. In the present case the actual manufacturer has not come forward to question the imposition of the condition. We are of the view that it is the prerogative of the purchaser to impose restriction. Purchasers want that not only the medicine has approval of the FDA or EMA but they also want that some reputable and sound party should come forward. As the Getz Pharma which is actual manufacturer of the drug in question would have been appropriate party to defend its position but it chose not to take any legal action. We are, therefore, not inclined to interfere in such circumstances in our Constitutional Jurisdiction and dismiss this petition. However, Gets Pharma shall be at liberty to establish before the concerned Authority that the efficacy of its drug is equal to the drug having approval of FDA  or EMA so that in future it may compete.”

 

Insofar as orders passed in CP No.D-3300 of 2013 is concerned the petition was dismissed on the ground that it was not filed by the Manufacturer of the drug in question itself and since manufacturer itself was not before the Court to challenge the imposition of the conditions, therefore the petition was dismissed as it was held that it was the prerogative of the purchaser to impose restriction as it deem fit. It is thus observed that it would be the buyer/purchaser who could impose conditions at the time the tender is floated which conditions of course could neither be arbitrary nor illegal since such parameter is also framed by the Procurement Rules of 2010, therefore, in my opinion though it is prerogative to set terms of the tender but in accordance with law and/or Procurement Rules of 2010. Hence, the defendants would gain nothing on the basis of this order as it only provides support to the plaintiff who has filed this suit as being manufacturer of the drug which was offered in response to the tender through its agent i.e. defendant No.6 and aggrieved and affected party in terms of above order. Whether an agent could be termed as aggrieved or affected party, since this issue is subjudice before Hon’ble Supreme Court therefore no comments are required.

Insofar as the imposition of terms is concerned, there is no doubt that on this tender the condition of approval of FDA/EMA was lifted.

Now I would deal with the order of 30.12.2014 passed in CP No.D-6273 of 2014 on the basis of which bid of the plaintiff was declined. Apparently it appears that drugs of the plaintiff were declined on 26.12.2014 however the arguments of the defendants except No.6 tried to establish that in fact it was adjourned to 30.12.2014.

Firstly, the arguments are contrary to the pleadings which state that the decision was already taken on 26.12.2014. Why would it be adjourned to 30.12.2014 when the decision had already been taken. On the contrary if the bid was opened and it was adjourned to 30.12.2014 why it has been said that the evaluation committee of experts/doctors have decided the efficacy on 26.12.2014. The contrary statements of the defendants, particularly of defendants No.1 to 4, who have not only admitted that the bid was rejected on 26.12.2014 which was dispatched on 30.12.2014 but have also admitted in terms of Para 13(ii) of the synopses that there was no criteria at all to evaluate the Peglated Interferon Alfa 2a on 18.12.2014 which is the initial time of opening of the technical bid. This reply of defendants No.1 to 4 is misconceived, malafide and arbitrary. The synopsis filed by defendants is in term of pleadings and also form part of record now. It appears that these arguments were made without looking at the tender documents which provide an evaluation criteria based on point system. Hence, any novel criteria which is alien to the tender terms would be an unjustified and arbitrary imposition and that too after the bids were opened.

I would now discuss the order dated 30.12.2014 passed by learned Division Bench in CP No.D-6723/2014. It appears that the petitioner has filed the petition challenging present terms of the tender that the respondents have invited tender for procurement of substandard medical products/medicines of Hepatitis Prevention & Control Program. The petitioner therein argued that he was awarded contract for the previous years in respect of drugs/medicines which were WHO certified and FDA/ EMA approved and such drugs are being supplied to them. It was further emphasized by the learned counsel appearing for the petitioner therein that the technical specification of the previous tender provides that it should be WHO certified, FDA/EMA approved however such has not formed part of the present tender documents which proves that the respondents intend to procure substandard drug. Hence, he has filed the petition that the process of such procurement be declared as null and void and to initiate de novo process. On this contention the concerned Secretary Health appeared and denied the contention that since he has failed to participate therefore he wants de novo process. It is further contended that the tendering process stands concluded and even the bids were opened on 18.12.2014 and the concerned Secretary denied that any product of inferior quality was being procured. He however stated that through the subject tendering process the best quality medicines WHO certified, FDA/EMA approved are being procured. Learned Division Bench has disposed of the petition on the assurance of the Secretary that the medicine so procured would be of international standard. There was no such observation of the learned Division Bench insofar as approval of FDA/EMA is concerned, neither it could be as by that time the tender documents were already opened and it is inconceivable that at such stage such an alien condition could have been imposed. Rest of the orders of the learned Division Bench is not relevant as it deals with the personal grievance of the petitioner that he was not supplied the documents.

In my view the above referred order does not stipulate a condition of FDA/EMA approval. Whatever statement or undertaking claimed to have been given to the Court has not formed part of the order nor it could be in view of the above facts. There can be no two views that the plaintiffs drug Unipeg is being exported and that it has support of GMP issued for the purpose of export.

Insofar as provisions of Rules 2010 is concerned, Rule 4 thereof provides that while procuring goods or services, procuring agency shall ensure that the procurements are conducted in fair and transparent manner and the object of procurement is to bring value for money to the agency and the procurement process is efficient and economical. In the instant case it is a matter of fact that the price at which the plaintiff has offered the subject drug/medicine is much less than at that which defendants No.1 to 4 have procured from defendants No.7 who is agent of defendants No.5 and 8. The price could only become irrelevant had there been a transparent method adopted in procurement as then the efficacy of the drug would play a role.

Insofar as Rule 13 of Rules 2010 is concerned it deals with the specification. It allows the widest possible competition and that it shall not favour any single contractor or supplier nor put others at a disadvantage. It also emphasized that such specifications shall be generic and shall not include references to brand names, model numbers, catalogue numbers or similar classifications unless otherwise required.

Rule 21 of the Rules 2010 provides that the bidding documents shall include detailed and unambiguous evaluation criteria in terms of Rule 21(h). If at all it is claimed that there was no evaluation criteria as admitted by defendants No.1 to 4 then the matter should have ended here. Though the evaluation criteria is available in terms of point 23 of tender terms however if at all it is claimed that there was no such evaluation criteria then it is highly unjustified to evaluate such medicine subsequent to the tenders being floated and opened at their own whims and wishes and self-designed reasons were imposed. Sub rule (2) of Rule 21 also provides that any information that becomes necessary for bidding or for bid evaluation after the invitation to bid or issue of the bidding documents to the interested bidders, shall be provided in a timely manner and on equal opportunity basis. Where notification of such change, addition, modification or deletion becomes essential such notification shall be made in a manner similar to the original advertisement.

Rule 26 of the Rules 2010 deals with re-issuance of tenders in view of any infirmity in the bidding document while in terms of Rule 36 thereof the procuring agencies were obligated to allow the interested bidders to participate in procuring procedure without regard to nationality, except in cases in which any procuring agency decides to limit such participation to national bidders only or prohibit participation of bidders of some nationalities. Thus emphasize was made to the national bidders instead of ousting them by applying FDA/EMA approval, if otherwise the drug meets the international standard as required in pursuance of tender terms in the instant case.

Rule 44 of Rules 2010 also provides that no procuring agency shall introduce any condition which discriminates amongst bidders. Certainly FDA/EMA approval means quality of high standard but then it can always be made a benchmark to provide medicines of equal standard if it is matched by other parties but it cannot be made the only condition precedent.

The rules discussed above emphasize that there should be no discrimination insofar as procurement of goods, services and works are concerned and that the quality that is being required could be asked to be matched with the best quality available in the market. It is certainly for the evaluation committee to decide that the drugs of the plaintiff are as good as the products which are required through tender. However this is not the case here as apparently in terms of refusal note 1 the plaintiff has been ousted on account of the fact that they are not FDA/EMA approved. It has not been said that their drug does not match the equivalence or the minimum standard prescribed by FDA/EMA. This debate is also not relevant for the simple reason that this term as to FDA/EMA approval is not at all included in the tender documents.

Hence, any import of terms, which may oust any of the parties contesting the bidding process, would amount to discrimination and in pursuance of the rules of procurement this condition would also deprive local manufacturers of drugs. Had there been a case of procuring agency that no such drug, as required, is being manufactured by the local manufacturers then imposition of such term FDA/EMA approval would be a better cause in defence but such is not the case here. Besides such discrimination it would be violative of Article 18 and 25 of the Constitution.

Insofar as the expert opinion is concerned, the reliance was placed by the defendants on the deposition/statement of one Dr. Rademaker, however the same does not contain any assertion which could under the law disentitle the plaintiff or could affect efficacy of drug. Opinion of the expert insofar as molecular weight is concerned is also not explained satisfactorily since Pegintron of defendant No.8 having a molecular weight of 12 KDa is being considered by the defendants favorably. This fact cannot be ignored that Peglated Interferon Alfa 2a of the plaintiff is being prescribed by a number of doctors and hospitals such as Agha Khan Medical University Hospital, Meo Hospital Lahore, Fatima Jinnah Medical College Lahore, Services Institute of Medical Sciences, Lady Reading Hospital Peshawar, Liaquat National Hospital, Ayub Teaching Hospital Abbottabad, besides a number of leading doctors.

Insofar as the issue relating to the availability of this drug in country of its origin is concerned, this is hardly sustainable as this drug is being manufactured by the plaintiff in their laboratories which laboratories have been considered as one of the few in eastern Mediterranean region.

Insofar as efficacy and biogenrics and Phase I-IV trial for bio similarity is concerned, learned counsel for the plaintiff has relied upon the research that has been filed along with statement on 09.02.2015. In the light of such research available and the recommendation by renowned hospitals and doctors, the alleged deficiencies as referred in the letter impugned dated 26.12.2014 creates enough doubt that they are less efficacious or not efficacious.

Insofar as the efficacy of Pegylated Interferon Alfa 2a being 20 KDa is concerned the research is also available as Annexure G/XX with all its beneficial effects. It is claimed that the country such as Egypt has highest HC prevalence in the world mostly genotype 4 and it has been tested and the evaluation report is available as Annexure G/XX and H/XX (Page 1453 and 1459) respectively. In view of such facts and circumstances by a stroke of decision it cannot be said that it is not recommended for human therapy when it is being recommended by renowned hospitals and doctors.

The other requirement that such Pegylated Interferon Alfa 2a should have 40 KDa was never specified in the tender documents and hence on this score alone it cannot be refused as on the contrary Pegintron Alfa 2b of molecular weight of 12 KDa is being accepted on the assertion that it is for children and under-weight patients.

It is also very significant to point out that defendants No.3 and 4 in their tender documents have shown the drug Pegintron as 40 KDa (Page 539 under heading ‘Schering Plough’ at Sr. No. 6 Part II) which is also admitted by defendant No.8. It appears that the only document relied upon by defendants No.3 and 4 to substantiate the claim as to molecular weight of plaintiff product being not fit for human therapy is Email dated 29.10.2014. The solitary document, as mentioned, is neither addressed to this Evaluation Committee nor it relates to them as the aforesaid letter firstly is of a date much before the tenders were floated and secondly this email does not concern and/or is in reference to the subject tender. The conduct of these defendants also become highly doubtful as Dr. Hassan Mehmood addressed to Sammi HPCP of Baluchistan as to recommendation of 40 and 12 KDA Peg Interferon but Dr. Sammi of Hepatitis Program of Baluchistan had issued letters of appreciation and praised plaintiff’s medicine Unipeg (page 501, 505 and 509-509 Part II) and they have been awarded contract of this medicine for the last two years for Baluchistan.

There is also research available to show that the Pegylated Interferon could carry molecule weight of 5 KDa to 40 KDa; relevant research is available at page 1479 Part II.

Insofar as efficacy and bio-generics and Phase I to IV, trials for bio-similarity is concerned all that has been said in the letter rejecting the bid was that such trials are not available although the bid documents submitted by the plaintiff show the status containing these trials which otherwise is admitted by defendants No.3 and 4. Such reports are also stated to have been published however it claimed that they are not published as much as Ropegra (Pegasys) was. In support of these trials on animals and humans the plaintiff has filed a number of documents which learned counsel for the plaintiff has referred during course of his arguments and are available on record.

          Though it is secondary issue insofar as cost of these lifesaving drugs is concerned but when these medicines/drugs are at least at par to each other then this would play a pivotal role as no justified reason would then be made available to procure the drug at a price of Rs.5000/- or more as against Rs.2100/- which is being provided by the plaintiff.

          Insofar as the preliminary issue relating to Rule 31, 32 and 32-A of SPP Rules 2010 is concerned, Article 199 of the Constitution expressly contains bar that if efficacious remedy is available then petition would not lie however in case of civil suits, which are being filed in terms of section 9 CPC, the presence of remedy in terms of Rule 31, 32, 32-A SPP Rules does not bar civil suit. There is no ouster clause relating to the jurisdiction and section 23 which relates to indemnity bars suits against authority i.e. Sindh Public Procurement Regulatory Authority which is defined in section 2(a) of SPRA Act 2009 whereas the suit revolves around procurement agency which is separately defined in terms of section 2(cc) of SPP Rules 2010. Even otherwise the malafides attributed against these procuring agencies would be sufficient for entertaining suit as only those facts which are performed under the Act could be hit by the ouster clauses. The question as to whether Rule 31 of the ibid law provides an efficacious remedy is also a question which requires determination since the officials/procuring agency, against whom the complaint is made, are the officials forming part of the Committee for complaint redressal hence independent forum to undo their own wrong is not available.

          The paramount consideration while entertaining such question is of course transparency as to the acts performed by public functionaries i.e. defendants No.1 to 4 while awarding the contract.

          In the case of M.N. Construction Co. v. Federation of Pakistan (PLD 2013 Islamabad 85) while relying upon the judgment of the apex Court the learned Judge has observed that it is imperative to scrutinize the arbitrary functions and colourable exercise of power of the functionaries which prima facie involves looting/plundering of public exchequer by the executive functionaries in a manner which is not only discriminatory but also smells malafide.

          In the case of Asaf Fasihuddin v. Government of Pakistan (2014 SCMR 676) the Hon’ble Supreme Court has held that it is a duty of the Court to ensure that the relevant laws are adhered to strictly to exhibit transparency. It is universally recommended principle that the transaction involving public money must be made in the transparent manner for the satisfaction of the people who are the virtual owners of the national exchequer which is being invested in these projects.

The government is the trustee of all the amounts of the State and that these trustees should act in a manner which should be transparent and the paramount consideration should be to protect the financial interests of the State.

Insofar as the question of latches is concerned, it may be observed that in such cases where the action apparently and prima facie appears to be malafide or colorable exercise of power and not transparent and/or not in the manner as required in terms of Procurement Rules 2010, the latches would not be an appropriate defencne in such cases. If any reference is needed one may look at the case of Mirpurkhas Sugar Mills v. Federation of Pakistan (2013 MLD 433).

Insofar as ouster clauses are concerned, it is needless to repeat that in case the exercise of power if found to be violative of law or tainted with malafides the Civil Court has the ultimate jurisdiction to take cognizance of such matter. Reliance is placed on the case of Province of the Punjab v. Haji Yaqoob Khan (2007 SCMR 554) and the case of Hamid Hussain v. Government of West Pakistan (1974 SCMR 356).

The Hon’ble Supreme Court in the case of Abbasia Cooperative Bank v. Hafiz Muhammad Ghaus (PLD 1997 SC 03) has held as under:-

“5. The next question which arises for consideration in the cases is, whether the Civil Court was competent to examine the validity of the auction conducted by the authorities? The Civil Court 'under section 9 of the Code of Civil Procedure are competent to try all- suits of civil nature except those or which their jurisdiction is barred either expressly or by necessary implication. It is a well-settled principle of interpretation that the provision contained in a statute ousting the jurisdiction of Courts of general jurisdiction is to be construed very strictly and unless the case falls within the letter and spirit of the barring provision, it should not be given effect to. It is also well-settled law that where the jurisdiction of the Civil Court to examine the validity of an action or an order of executive authority or a special tribunal is challenged on the ground of ouster of jurisdiction of the Civil Court, it must be shown (a) that the authority or the tribunal was validly constituted under the Act; (b) that the order passed or the action taken by the authority or tribunal was not mala fide; (c) that the order passed or action taken was such which could be passed or taken under the law which conferred exclusive jurisdiction on the authority or tribunal; and (d) that in passing the order or taking the action, the principles of natural justice were not violated. Unless all the conditions mentioned above are satisfied, the order or action of the authority or the tribunal would not be immune from being challenged before a Civil Court. As a necessary corollary, it follows that where the authority or the tribunal acts in violation of the provisions of the statutes which conferred jurisdiction on it or the action or order is in excess or lack of jurisdiction or mala fide or passed in violation of the principles of natural justice, such an order could be challenged before the Civil Court in spite of a provision in the statute barring the jurisdiction of Civil Court. In the case before us, the action of the Cooperative Authorities in auctioning the suit property for recovery of the loan against respondent No.1 was challenged in the suit as contrary to the provisions of the Ordinance and M.L.O. 241.”

 

          Insofar as undertaking is concerned learned counsel for the plaintiff has relied upon Naveed Nawazish Malik v. Ghulam Rasool Bhatti (1997 SCMR 193) on the pretext that though there is no such undertaking given yet such undertaking is required to form part of the order and in absence thereof it does not amount to be an undertaking to the Court.

On minutely observing order of learned Division Bench whereby in CP No.D-6723 of 2014 was disposed of it cannot be squeezed out from the order that insofar as applicability of FDA/EMA approval is concerned that forms part of order. Rather it has been rightly observed by the learned Division Bench that it is the prerogative of the authorities concerned to impose conditions and restrictions as they deem fit and proper and since no such condition was prescribed in the tender as to FDA/EMA therefore it cannot be ascertained that such condition was imposed in pursuance of order referred above. All that was ordered was that the medicine/drug so procured should not be substandard and in fact should be of international standard.

In the case of Abdur Rehman v. the State (2001 YLR 749) learned Division Bench observed that insofar as expert opinion is concerned that must be based on reasons for giving such opinion as export and any opinion not backed by sound reasons is to be discarded and thrown out of consideration. Same observation was made in the case of Muhammad Aslam v. Allah Ditta (1989 MLD 3325). In the instant case also prima facie it appears that the expert opinion relied upon by defendants No.1 to 4 is without any reasoning.

In the case of Provincial Quality Control Board v. Irza Pharma (1992 MLD 481), learned Division Bench of Lahore High Court has observed as under:-

“6.     …….There is nothing on the record to show, as to what is the nature of the particles found in the samples, and what are its consequences. If we allow these reports to hold the field, we would thereby give a long handle to the functionaries under the Statute to victimize anyone they choose. We cannot allow the way of arbitrariness and the capricious course of action to be adopted by the functionaries so as to render the lives of the citizens miserable. It is well settled that when the law requires a particular thing to be done, it should be done in that way, or not at all. The learned single Judge rightly held that the term substandard drug with particles is not known to the Drugs Act; and that is true. We have reproduced earlier the definition of the adulterated, spurious and substandard drugs. To hold the samples as spurious or adulterated drugs, it was incumbent upon the Government Analyst to state so, or to declare the same as filthy, putrid or decomposed or to contain vermin, worm, rodent or insect or the same had been prepared under the unsanitary conditions so as to be contaminated with dirt, filth or any foreign matter, whereby it could have been rendered injurious to the health. A careful perusal of the definition of the adulterated drug clearly lays down the test and a report which does not conform to the test provided by law cannot be considered to be valid and legal report. Similarly, we have also considered the reports of the Government Analyst within the meanings of the definition of the spurious drugs, but the same also fall outside the category of the said definition.”

 

Similarly in the case of Kakasian Pharmaceuticals (Pvt.) Limited v. Government of Punjab (2003 YLR 3056) it was observed as under:-

“7‑A. The perusal of the reports and the definitions of the adulterated drug and the substandard drug would show that the report issued by the Central Drug Laboratory at Karachi does not indicate any filthy, putrid or decomposed substance or which, contains any foreign matter, vermin, worm, rodent or insect or the drug has been manufactured, packed or held under unsanitary conditions whereby it may have been contaminated with dirt, filth or any other foreign matter or whereby it may have been rendered injurious to health and simply remarking that the sample contained suspended particles which are visible to the naked eye would not be sufficient to declare the drug as substandard and adulterated and so far the second report issued by the Drugs Control and Traditional Medicines Division, National Institute of Health, Islamabad, is concerned it has been mentioned in the column of remarks that manufacturer was repeatedly directed to supply complete specification/method of testing but he failed to respond within stipulated time and on basis of the test the sample was found of substandard quality and whereas the order dated 5‑7‑2002 is concerned, it indicates that Muhammad Iqbal Khan Executive of the Firm was provided an, opportunity of personal hearing who was not a Technical Expert. Therefore, it looks that the entire exercise was completed with delay in collection of samples and preparation of the reports against the relevant provisions or the Drugs Act and that of giving of opportunity of hearing to the representatives of the firm who was not an expert, therefore, the circumstances require the re‑start of the same exercise but in accordance with law and to be positively concluded by both the parties within two months from the date of drawing samples.

8. In, view of above, reports dated 6‑11‑2000 and 17‑4‑2001 and also the order dated 5‑7‑2002 are set aside with the direction to decide the matter afresh in the light of the observations as made above by collecting the fresh samples in accordance with rules.”

 

The drug reports, as available on record in relation to the medicine of the plaintiff, not only provide the analyses but also prescribes the standard as to the contents of the drug and the method applied to test a drug. These reports are issued by DRAP and in the presence of these reports it would be difficult to swallow the observation given by the technical committee and that too without reasoning.

Insofar as the question as raised by the learned counsel for defendant No.5 in relation to severability, it appears that all the points on the basis of which the bid in respect of drug of the plaintiff was declined are seriously interlinked and netted with each other. No doubt every possible explanation for validity of the decision of the public authorities should be explored however when some of the conditions imposed for the rejection which are interlinked with rest of the conditions are so colorable that none other but a non-transparent procedure is revealed and since they are interlinked the entire structure would tend to fall.

In the case of State Bank of Pakistan v. Franklin Credit & Investment Co. (2010 SCMR 121) it has been observed as under:-

“Now, we need to examine whether an order based on several reasons should or should not be struck down if one or some of them are found to be bad in law. In our view, if the bad reasons are severable from the good ones and are not intertwined or inter-linked, an order passed by an administrative authority may not be quashed if otherwise sustainable on remaining valid grounds.”

 

          Therefore the principle of severability, as relied upon by learned counsel for defendant No.5 could not be applied in the instant case. No doubt if any one independent ground and reasoning, could stand alone to oust the plaintiff in the instant case then it can form a solitary ground to decline the plaintiff’s stand however as observed all such points assigned in the rejection note are so closely inter linked that if any one falls it would take rest of the grounds and points with itself.

          The case law relied upon by the learned counsel appearing for the defendants, except defendant No.6, are not applicable.

          In view of above facts and circumstances the application is allowed as prayed however since these medicines are required for the hepatitis patients on priority basis therefore defendants No.1 to 4 may opt to float the tenders afresh for procurement in accordance with relevant laws and the observations as made above as by this order only interlocutory steps are taken and by any means it is not a final judgment.

Dated: 26.03.2015                                                             Judge