' SHAMS MEHMOOD MIRZA, J. By this writ petition filed under Article 199 of the Constitution of the Islamic Republic of Pakistan, 1973, the petitioners seek to challenge the decision of the Grievance Committee rendered on 24.03.2016 dismissing the representation of petitioner No, 2.
2. Petitioner No, 2 (Getz) is a drug manufacturing company and petitioner No, 1 (Alfalah) is its authorized distributor. Getz imports and markets a drug called Uni peg-V (Unipeg) in Pakistan, which is statedly used primarily for the treatment of Hepatitis C. The Director General, Health Services through advertisement in the newspaper invited bids for procurement of a number of drugs/medicines, which included "Injection Peglated Interferon 180 mcg Alpha2a/120mcg Alpha 2b". (hereinafter referred to as Interferon). The procurement of the Interferon was sought in connection with the prevention and control of Hepatitis Control Program initiated by the Government of Punjab. Getz claims that Unipeg is biosimilar to interferon in dosage form, strength, quality, performance characteristics and intended use. Clause 12 of the bidding documents required Bio equivalence/Bio Similarity study from World Health Organization (WHO) audited laboratory/DRAP authorized laboratory/ICH certified/audited laboratories (hereinafter referred to as the prescribed laboratories). It is an admitted position that Unipeg has not yet been certified by any of the prescribed laboratories and, therefore, does not fulfill the criteria mentioned in the bidding document. Alfalah applied for the bidding documents and feeling dissatisfied by insertion of clause 12 contained therein filed a suit for declaration and permanent injunction before the Civil Court at Lahore. The Trial Court on 15.12.2015 suspended the operation of clause 12 of the bidding document. On 07.01.2016, the Director General, Health Services again advertised for procurement of Interferon but this time it required prequalification of suppliers. In the second round, Getz obtained the biddina documents for prequalification instead of Alfalah. Clauses 10 and 11 of the bidding documents again required Bio equivalence/Bio Similarity study from World Health Organization audited la boratory/DRAP authorized laboratory/ICH certified/audited laboratories. Getz, it is claimed, tendered the prequalification documents on 22.01.2016 under protest. There were four other bidders in addition to Getz. The prequalification applications of Getz and another were, however, rejected on 17.03.2016 on the ground that their drugs did not meet the Criteria mentioned in clauses 10 and 11 of the bidding documents whereupon a grievance application was moved by Getz on 18.03.2016 before the Grievance Committee, prequalification Hepatitis Control Program. On 19.03.2016, Alfalah, although not an applicant in the second procurement process, moved a stay application before the Trial Court in the suit earlier filed by it whereupon the Trial Court directed the respondents to comply with its earlier stay order dated 15.12.2015 and operation of order dated 17.03.2016 was suspended. The petition filed by Getz before the Grievance Committee was dismissed on 24.03.2016 on the ground that it had failed to comply with clauses No, 10 & 11 of the bidding document, hence this writ petition.
3. During the pendency of this writ petition, CM No, 1295 of 2016 was filed by intervener, Roche Pakistan Limited (Roche), which was pre-qualified in the second round of procurement and was later declared the successful bidder. This application was contested by the petitioners by filing their written reply. The said application was allowed on 14.04.2016 by this Court and the petitioners were directed to file the amended memo. Of parties reflecting the name of Roche as respondent No, 5.
4. The respondents have filed their reply and parawise comments to the writ petition in which the stance of the petitioners has been controverted.
5. Learned counsel for the petitioners made the following submissions:--- a. Alfalah being a distributor of the medicines manufactured by Getz can maintain this writ petition even though it did not apply for and participate in the pre-qualification of bidding advertised by the respondents in the second round. b. The advertisement for prequalification of tenders for supply of Interferon was in violation of stay order dated 15.12.2015 passed by the Trial Court in the suit initiated by Alfalah. It was further submitted that this Court can take notice of the disobedience by the respondents of the order of the Civil Court. c. Unipeg is registered with Drug Regulatory Authority of Pakistan (DRAP) since 2010 and is being sold throughout Pakistan. DRAP gave two years time to Getz for carrying out Bio-similarity Studies as per the guidelines of WHO on 20.10.2015 and as such the petitioner still has time available to it for complying with clauses No, 10 & 11 of the biding documents. d. Clauses 10 & 11 of the bidding document violate Article 148 of the Constitution of Islamic Republic of Pakistan, 1973 as the said clauses deviate from the Federal standards, which is not conducive for the inter-provincial trade. e. Clauses 10 & 11 impede free competition as Roche has a monopoly over the medicine to be supplied to the respondents.
6. Learned counsel for the respondents, on the other hand, submitted that clauses 10 & 11 were not only not inconsistent with the Drug Regulatory Authority of Pakistan Act, 2012 (DRAP Act) rather they complied with the Federal standards provided therein. It was further stated that free competition was not stifled on account of inclusion of clauses 10 & 11 as five bidders participated in the prequalification process out of which two bidders were selected. Learned Assistant Advocate General submitted that drug manufactured by Getz did not comply with the Federal Standards contained in the DRAP Act. It was also alleged that the Government of Punjab included clauses 10 and 11 for pre-qualification of the contractors as it wanted to provide the best medicine for Hepatitis C, which disease was endemic in the Province of Punjab.
7. Learned counsel for the intervener submitted that Roche applied for registration of its drug "Pegasys" which is the trade name of Pegylated Interferon and is approved by FDA, EMA and Swiss medic for treatment of Hepatitis B and C, which application was granted approval by the Ministry of Health. On account of disputes between Roche and Ministry of Health, Roche introduced "Ropegra" in Pakistan at a much more reduced price. Ropegra, it is claimed, is exactly the same substance as Pegasys and is imported from the same manufacturer, the only difference being that Ropegra is sold in vial form at a much lower price. A number of serious objections were raised on Unipeg with regard to its quality, safety and efficacy.
8. Arguments heard and record perused.
9. The primary question requiring determination is whether the terms contained in the bidding documents requiring Bio equivalence/Bio Similarity study of the drugs from the prescribed laboratories violated the federal standards and stifled free competition. In order to resolve the controversy, it is imperative to look at the various provisions of DRAP Act to ascertain whether the enhanced requirement in the bidding document violated its provisions. Section 32 of the DRAP Act clearly states that its provisions shall not be in derogation to the provisions of Drug Act, 1976 rather they will be in addition to them. Section 4 of the Act deals with the composition of DRAP and one of its directors namely "Director Biological Drugs" is incharge of a Division of Biological Evaluation and Research which is responsible, inter alia, for the evaluation, assessment, registration and licensing of Biologicals and shall perform other functions connected therewith including all the functions of National Control Authority for Biologicals as required for the pre-qualification by WHO of locally manufactured human biological drugs. One of the core functions of DRAP is to implement the internationally recognized standards such as good laboratory practices, current good manufacturing practices, bioequivalence studies, clinical trials, biosimilar evaluations, and endorsement and systematic implementation of World Health Organization Guidelines etc [see Section 7 (ix) of the DRAP Act].
10. The definition of "Biologicals" in terms of Section 2(v) read with Schedule 1 of the DRAP Act, insofar as it is relevant, reads as under:--- BIOLOGICALS includes,---
(1) Biological drugs produced by biological systems and which require standardization by biological assays according to the relevant and updated recommendations of the World Health Organization published in Technical Report Series and Biological Standardization report and includes:
(a) Blood products including Plasma, Albumin, Clotting Factors, Factors VIII, IX, Mixed Clothing Factors Tractions, Fibrinogens, lmmunoglobulins: (b)
(c)
(i) human interferons, natural hormones, recombinant antibodies, monocolonal antibodies and derivatives gene therapy products; ' Similarly the definition of biosimilar drugs is contained in clause 6 of the Act, which reads as under:---
(6) Originators Biological Drugs means a biological drug which has been licensed by the national regulatory authority on the basis of a full registration dossier i.e, the approved indication(s) for the use were granted on the basis of full quality, efficacy and safety data:
(a) reference biotherapeutic product (RBP) means an originator biological drug product that was licensed on the basis of a full registration dossier. It does not refer to measurement standards such as international. ' pharmacopoela, or national standards or reference standards:
(b) biosimilar biological drugs mean Similar Biotherapeutic Product (SBP). Which is similar in terms of quality, safety and efficacy .To an already licensed reference- blotherapeutic product;
(c) Similarity means absence of relevant difference in the parameters of interest.
11. The above definition of "Biologicals" makes it clear that these are generally made from human or animal .Materials (or both), as against the most traditional prescription drugs made through chemical processes i.e, generic drugs. Biologicals are 200 to 1,000 times the size of a small molecule (generic) drug, and far more structurally complex. Additionally, biologicals and biosimilars are manufactured in living cells, then extracted and purified, whereas small molecule drugs and generics are manufactured purely via chemical synthesis. A biosimilar product is similar to an existing biological product meaning thereby subject to slight variations there must be clinically no meaningful differences in terms of safety, efficacy, purity, and potency between them.
12. Roche with its parawise comments has appended the copy of the "Guidelines on Evaluation of Similar Biotherapeutic Products (SBP's)" issued by the WHO, which were adopted by the 60th meeting of the WHO Expert Committee on Biological Standardization, Geneva, 19th-23rd October, 2009. WHO as part of its mission in setting standards for biological products provides guidelines and recommendations for manufacturing and evaluating biologicals. The scientific principles outlined in the WHO Guidelines for evaluation of SBPs serve as a benchmark for global acceptability of these products. In its introduction, the WHO Guidelines refer to the rationale of launching of Biosimilar Products and SBP's in various countries and provide .The difference betweer SBP and generic drugs. The relevant portions read as under:--- Introduction ' Biotherapeutic products (biotherapeutics) have a successful record in treating many life threatening and chronic diseases. However, their cost has often been high, thereby limiting their access to patients, particularly in developing countries. Recently, the expiration of patents and/or data protection for the first major group of originator's biotherapeutics has ushered in an era of products that are designed to be 'similar' to a licensed originator product. These products rely, in part, for their licensing on prior information regarding safety and efficacy obtained with the originator products. The clinical experience and established safety profile of the originator products should contribute to the development of similar biotherapeutic products (SBPs). A variety of terms, such as 'biosimilar products', 'follow-on protein products' and 'subsequent-entry biologics' have been coined by different jurisdictions to describe these products.
' The term 'generic' medicine is used to describe chemical, small molecule medicinal products that are structurally and therapeutically equivalent to an originator product whose patent and/or data protection period has expired. The demonstration of bioequivalence of the generic medicine with a reference product is usually appropriate and sufficient to infer therapeutic equivalence between the generic medicine and the reference product. However, the approach established for generic medicines is not suitable for development, evaluation and licensing of SBPs since biotherapeutics consist of relatively large, and complex proteins that are difficult to characterize. The clinical performance of biotherapeutics can also be much influenced by the manufacturing process and some clinical studies will also be required to support the safety and efficacy of a SBP.
' Similarly, the reference biotherapeutic product is defined in the WHO Guidelines as under:- Reference biotherapeutic product (RBP)
' A reference biotherapeutic product is used as the comparator for head-to-head comparability studies with the similar biotherapeutic product in order to show similarity in terms of quality, safety and efficacy., Only an originator product that was licensed.On the basis of a full registration dossier can serve as a RBF. It does not refer to measurement ,standards; ,such as international, pharmacopoeial, or national standards or reference standards.
' A reading of the WHO Guidelines shows- that the DRAP Act closely follows it insofar as the definitions of , Biologicals, biosimilars and Reference biotherapeutic product: are concerned.
13. It is an undisputed fact that the reaulatory authorities all over the world have outlined robust data requirements to demonstrate bio-similarity of a drug. Biosimilar manufacturers will generally need to generate data from lab testing, non-clinical testing and clinical testing to show that the bio-similar drug they have develored will provide the same therapeutic benefit and risks to patients as the Reference biotherapeutic product.
14. Having gone through the definitions, it becomes essential to look at the documents available on the record relating to the respective drugs of Getz and Roche. Roche has appended a plethora of documents including the Certificate of Medicinal Product issued by the European Medicine Agency and the summary of its product's (Ropegra) characteristics. The registration certificates issued by the DRAP to the drugs of both Getz and Roche are quite instructive and clearly show that the Roche's drug (Ropegra) was registered with DRAP as "biological" and is, therefore, the Reference biotherapeutic product whereas Getz applied for registration of Unipeg as biosimilar to the reference drug. Accordingly, condition (xvii) contained in petitioner's drug registration letter dated 20.10.2015 was inserted, which reads as under:- The claim to declare Unipeq-V as biosimilar is not authoirized by drug Registration Board. As per decision of meeting of 246th, firm shall conduct parallel biosimilarity study as per WHO guidelines immediately after grant of registration and shall submit complete studies within two years in any case. Manufacture will provide progress report to this effect to Director of Biological Division on quarterly basis. Regular monitoring through pharmacovigilance system shall be observed through pharmacovigilance cell unit of the manufacturer and report be furnished be pharmacovigHance centre, Pharmacy Services and Biological Division. In case of any severe adverse event, immediate mandatory reporting procedure shall be followed if any of the condition is not suited or public health risk reported at any stage during registration shall stand cancelled with immediate effect.
' From the reading of: the above, it becomes apparent that Unipeg was not declared biosimilar drug by DRAP and accordingly the petitioner was required to conduct biosimilarity study along the WHO Guidelines and submit the report within two years. Exactly how this condition was incorporated in the petitioner's drug registration letter also requires to be highlighted. Drug Registration Board in its 244th meeting, amongst others, decided the case of Getz with regard to Unipeg. The relevant extracts of the said meeting reads as under: Final Decision of the Drug Registration Board in its 244th Meeting:---
(a) Biosimiliarity is the principal requirement for the registration of biological drugs, as it is part of requirements of DRAP Act, 2012 mainly focusing on patient safety and also to promote biological production and availability of biological products.
(b) All those manufacturing units which have been approved by Central Licensing Board for manufacturing of biological drugs and also had qualified product specific inspection by panel of Registration Board, are allowed' registrations of applied biological drugs for local manufacturing on case to case basis. Item for which product specific inspection is required, then it will be conducted by already constituted panel of Registration Board.
(c) Local manufacturer will provide legalized documents from concerned regulatory body confirming the status of licensed manufacturer of concentrate/bulk source in its country of origin.
Moreover manufacturer will provide legalized documents for confirmation that finished product is also available in market from the same biological material. Case will be processed for issuance of registration letter after fulfilment of above-mentioned requirements, with following conditions:---
(i) Registration is exclusively for trial manufacturing of the drug and manufacturer shall not be allowed in any way to sale/utilize these trial manufactured drugs. Manufacturer will perform biosimilarity studies as per WHO guidelines confirming the biosimilarity of applied product to original innovator product.
(ii) Manufacturer will submit actual result of conducted biosimilarity studies to the Biological Division for its scientific evaluation through Expert Committee on Biological Drugs (ECBD). Moreover manufacturer will also provide sufficient quantity of these trial manufactured drugs to Biological Division for testing by National Control Laboratory for Biological (NCLLB) as per WHO guidelines.
(iii) Recommendation of ECBD and report of NCLB will be submitted to Registration Board for permission of commercial manufacturing of the product or otherwise.
(d) This decision supersedes all the already taken decisions so far in the earlier meetings of Registration Board on the subject cases. (Emphasis supplied)
' It is clear from the decisions taken by Drug Registration Board in its 244th meeting that the manufacturer of the biosimilar drug was not allowed its sale rather the registration was meant for manufacturing and for performing biosimilarity studies as per WHO guidelines. It appears that one of the drug companies (M/s. Macter International) approached the Ombudsman concerning its drugs whereafter certain recommendations were made by the Ombudsman. In terms of the recommendations of the Ombudsman, the matter was again taken up by the Drug Registration Board. As is apparent from the minutes of the 246th Meeting of the Registration Board, the drug firms which included Getz made the following demands:- ' The firms unanimously presented/argued that Registration Board previously did not ' implement/ demand CoPP/Free sale certificate from local manufacturer of biological drugs. But now only GMP certificate of the foreign manufacturer can be provided which should be accepted by the Drug Registration Board. Moreover, the condition of providing bio-similarity data should not be imposed as per previous practice of Registration Board for already registered locally manufactured drugs as this condition will result in further delay which can be very damaging to new biopharmaceutical units, Condition of clinical studies should not be imposed. The manufacturer shall ensure the quality, safety and efficacy of locally manufactured biological drugs by them.
' The following decision of the Chug Registration Board in its 246th meeting shows, that the Board agreed to issue the registration certificate subject to certain conditions. It is, however, Important to, note that the waiver of biosimilarity studies as demanded by the firms was not accorded approval by the Drug Registration Board.
1. As the Registration Board in 244th meeting has already approved registration of biological drugs for four manufacturers (M/s. Macter International Karachi, M/s. Getz Pharma Karachi, M/s. a. The firms shall provide legalized GMP certificate of biological drug manufacturer abroad (who will provide concentrate/ready to fill bulk of biological drug to PakistanNextar Pharma, Karachi and M/s. Hilton Pharma, Karachi) for local manufacturing. In order to issue registration letter, the Board advised these manufacturers to provide following document as discussed and agreed during the deliberations with manufacturers:i manufacturers for further processing) as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin. b. The firm shall provide studies conducted by manufacturer_ abroad (dully verified with statement for correctness/genuineness of data) regarding structural similarity of subject biological drug product (concentrate/ready to fill bulk for further processing) with reference biological product (innovator). c. The local manufacturer shall be authorized to manufacture the finished biological product and then perform biocomparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product. Data provided by the local manufacturer shall be evaluated by the Expert Committee on Biological; Drugs. Recommendation of the committee 'shall be considered by the Registration Board for issuance of registration letter. d. The firms shall conduct parallel bio- similarity studies as per WHO guidelines immediately after grant of registration and shall submit complete studies with in two (2) years in any case. Manufacturer will provide progress report to this effect to Directorate of Biological Drugs on quarterly basis. e. Regular monitoring through pharmacovigilance reporting system shall be observed through proper pharmacovigilance cell of the manufacturer and report will be forwarded to the National Pharmacovigilance Centre, Division of Pharmacy Services and Biological Division of DRAP. In case of any severe adverse event, immediate mandatory reporting procedure shall be followed. f. If any of the conditions is not fulfilled or public health risk reported at any stage, the drug registration shall stand cancelled with immediate effect. g. All the provisions as contained in the Drugs Act, 1976 and rules made there under including provisions of Lot Release certification from National Control Laboratory for Biologicals shall be strictly adhered to.
(Emphasis supplied)
' The terms and conditions mentioned in the decision taken by the Drug Registration Board were then incorporated in registration letter dated 20.10.2015 issued to the petitioner.
15. A reading of various provisions of DRAP Act shows that it has adopted the standards/protocols prescribed by WHO in its Guidelines for licensing of a bio-similar drugs. After the promulgation of DRAP Act, all applications for seeking authorization for manufacturing and marketing of biosimilar drugs in Pakistan are required to be evaluated on the basis of the standards set out in the WHO Guidelines regarding licensing of biosimilar drugs. These Guidelines, therefore, by reference have a statutory force. The scientific principles outlined in the WHO Guidelines for evaluation of SBPs serve as a benchmark for global acceptability of these' products. These WHO Guidelines stipulate as mandatory requirement that adequate tests are conducted prior to the approval of biosimilars.
The WHO Guidelines also provide for a robust mechanism and key principles for licensing of a bio- similar drug. For ready reference, the following clauses of the Guidelines are relevant:---
5. Scientific considerations and concept for licensing SBP's ' For the licensing of generic medicines, the regulatory framework is well-established in most countries. Demonstration of structural sameness and bioequivalence of the generic medicine with the reference product is usually appropriate to infer (conclude) therapeutic equivalence between the generic and the reference product. However, the generic approach is not suitable for the licensing of SBPs since biotherapeutic products usually consist of relatively large and complex entities that are difficult to characterize. In addition, SBPs are manufactured and controlled according to their own development since the manufacturer of a SBP normally does not have access to all the necessary manufacturing information on the originator product. However, even minor differences in the manufacturing process may affect the pharmacokinetics, pharmacodynamics, efficacy and/or safety of biotherapeutic products. As a result, it has been agreed that the, normal method for licensing generic medicines through bioequivalence studies , alone is not scientifically appropriate for SBPs, A SBP is intended 'to be similar to a 'licensed biotherapeutic product for which there is a substantial evidence of safety and efficacy. The ability for the SBP to be authorized based on reduced non- clinical and clinical data depends on proof of its, similarity to appropriate RBP through the comparability exercise. Manufacturers should demonstrate a full understanding of their product, consistent and robust manufacture of their product, and submit a full quality dossier that includes a complete characterization of the product. The comparability exercise between the SBP and the RBP the quality part ,represents an additional element to the traditional' full quality dossier. The reduction in data requirements is therefore on possible for the non-clinical and/or clinical parts of the development rogram. The dosage form and route of administration of the SBP should be the same as for the RBP.
Studies must be Comparative in nature employing analytical straties (method) that are sensitive to detect potential differences between the SBP and the RBP. The main clinical studies should use the final formulation derived from the final process material of the SBP. Otherwise, additional evidence of comparability will be required to demonstrate that the SBP to be marketed is comparable to that used in the main clinical studies. If similarity between the SBP and the RBP has been convincingly demonstrated, the SBP may be proved for use in other clinical indications of the RBP that have not directly been tested in clinical trials if appropriate scientific justification for such extrapolation is provided by the manufacturer (see Section 10.7). Significant differences between the SBP and the chosen RBP detected during the comparability exercise would be an indication that the products are not similar and more extensive non-clinical and clinical data may be required to support the application for licensing.
6. Key principles for the licensing of SBPs a. The development of a SBP involves stepwise comparability exercise(s) starting with comparison of the quality characteristics of the SBP and RBP. Demonstration of similarity of a SBP to a RBP in terms of quality is a prerequisite for the reduction of the non-clinical and clinical data set required for licensure. After each step of the comparability exercise, the decision to proceed further with the development of the SBP should be evaluated. b. The basis for licensing a product as a SBP depends on its demonstrated similarity to a suitable RBP in quality, non-clinical, and clinical parameters. The decision to license a product as a SBP should be based on evaluation of the whole data package for each of these parameters. c. If relevant differences are found in the quality, non-clinical, or clinical studies, the product will not likely qualify as a SBP and a more extensive non-clinical and clinical data set will likely be required to support its application for licensure. Such a products should not qualify as a SBP as defined in this guideline. d. If comparability exercises and/or studies with the RBP are not performed throughout the development process as outlined in this guidance document, the final product should not be referred to as a SBP. e. SBPs are not "generic medicines" and many characteristics associated with the authorization process generally do not-apply. f. SBPs, like other biotherapeutic products, require effective regulatory oversight for the management of their potential risks and in order to maximize their benefits. (Emphasis supplied)
' The WHO Guidelines emphasize and highlight the importance of regulating SBP's according to the requirements for biologicals. The approach established for generic medicines, according to the WHO Guidelines, is not appropriate for the evaluation and licensing of biotherapeutics as these consist of large and highly complex protein entities that are difficult to characterize. Accordingly, it is clearly stipulated in the WHO Guidelines that biotherapeutic products should be evaluated as biologicals, not as chemical medicinal products. One of the key principles in establishing an SBP is the demonstration of its similarity to a licensed biotherapeutic product for which there is substantial evidence of safety and efficacy. As per the WHO Guidelines, full comparability exercises should be undertaken starting with the comprehensive assessment of the quality characteristics of the SBP and RBP. This is a prerequisite for the reduction of non-clinical and clinical data required for license. A stepwise approach is recommended. Evaluation of the data after each step of the comparability exercise should serve as a basis for decision regarding the further development of a product. In case of major differences in the quality, clinical and non-clinincal studies, the product cannot be termed as . "similar" and, therefore, cannot be referred to as an SBP. In this regard, the.Definition of Reference biotherapeutic product (RBP) provided in the WHO Guidelines is quite relevant and is reproduced hereunder:--- Reference biotherapeutic product (RBP)
' A reference biotherapeutic product is used as the comparator for head-to-head comparability studies with the similar biotherapeutic product in order to show similarity in terms of quality, safety and efficacy. Only an originator product that was licensed on the basis of a full registration dossier can serve, as a RBP. It does not refer to measurement standards such as international, pharmacopoeial, or national standards or reference standards.
' A biosimilar product, therefore, must satisfy the rigorous requirements provided for in the WHO Guidelines in order to get approval for registration and license. It is furthermore dear that the key words used in DRAP Act and WHO Guidelines are quality, safety and efficacy of a biosimilar drug to an already licensed reference biotherapeutic product for the proof of which a stringent regulatory framework has been provided by DRAP Act by adopting the WHO Guidelines, the object being to ensure the health and safety of the public. It may be of some importance to note that a similar provision also exists in Rule 29 of the Drugs (Licensing, Registering & Advertising) Rules, 1976, which' reads as under.-
(6) The Registration Flood shall, before registering a new drug [or molecule] for which the research work has been conducted in other countries and its efficacy, safety and quality has been established therein, required the investigation on such pharmaceutical, pharmacological and other aspects, to be conducted and clinical trials to be made as are necessary to establish its quality and, where applicable, the biological availability, and its safety and efficacy to be established under the local conditions: ' Provided that under special circumstances to be corded in writing the Registration Board may register a drug and require such investigations and clinical trials to be conducted after its registration.
(7) A new-drug, [or molecule with a slight change in chemical formula/salt with the same therapeutic indications as of the already registered molecules] where new method of manufacture is contemplated or a change is proposed in sources, standard of specification of the active ingredient or the finished product, may not require full investigations and clinical trials except insofar as they are necessary for the purposes of establishing bio-equivalence absorption, acceptability or other such features.
16. Consistent with the afore-mentioned provisions, DRAP, while conditionally registering petitioner's drug, gave Getz a period of two years to get Unipeg clinically tested as per the WHO standards to ensure that the said drug meets the quality, safety and efficacy of the licensed Reference biotherapeutic product in terms of Clause 6(b) of Schedule 1 to the Act. The petitioners did not append any documents with the petition to demonstrate that the Getz's drug (Unipeg) is under clinical, trials and the conditions attached to its registration are being met with. There did not arise any cause for complaint, therefore, to the petitioner when the Government of Punjab for procuring the drug Interferon imposed the condition on the bidders- for supplying biosimilarity/bioequivalence certificate from the prescribed laboratories, which condition DRAP itself-imposed on the petitioner's drug while granting it conditional registration. The Federal standards for biosimilar drugs provided for in the DRAP Act are the same as mentioned in the .WHO Guidelines. It is an admitted position that the petitioner has not yet obtained the requisite certificate from the prescribed laboratories. It is an equally admitted position that initially the petitioner applied for registration of Unipeg Solution for injection 180 mcg (peg Interferon Alfa 2a), which was being in ported from In Pro Pharma, Netherlands, which registration w: allowed vide DRAP's letter dated 29.03.2010 in terms of Section of the Drugs Act, 1976. However, subsequently, Getz changed the importer to M/s Beijing Kawin Technology Share-holding Company Ltd., China for the import of Unipeg. Be teat as t may. Getz has applied for registration of Unipeg which is presumably undergoing clinical and non-clinical trials as per the WHO Guidelines for it to be registered as a biosimilar drug. The procurement by the Government of Punjab cannot wait till such time Getz fulfills the conditions laid down in the Drug Registration Board's 246th meeting which in turn were reflected in the conditional registration letter dated 20.10.2015. It is furthermore clear the Government of Punjab is well within its rights to demand and lay down the conditions in the tender for biosimilarity studies from the prescribed laboratories, which conditions were consistent with, and conformed to, the standards approved by the DRAP Act. The larger public interest outweighs the narrow commercial interests of Getz in procurement of drugs which comply with the WHO standards as provided for in the DRAP Act and the conditions laid down in the .246th meeting of the Drug Registration Board. The WHO Guidelines provide the, standard for the quality, safety and efficacy of the biosimilar drugs and the same standard has been adopted by the DRAP Act in Section 2(v) read with Schedule 1. The obligations created under the said Act, and performance sought to be enforced has to be given effect to. Getz, it must be noted, was not granted the right to sell Unipeg by the Drug Registration Board as is apparent from the minutes of its 244th meeting.
However, subsequently-the Drug Registration Board allowed its sale on the basis of representations made by various drug companies on which decision this Court does not wish to comment. Suffice it to state the quality, safety and efficacy of Unipeg is yet to be determined as per the WHO Guidelines and as such this Court cannot issue a direction to the Government of Punjab to allow Getz to participate in the prequalification process. It is furthermore clear that clauses 10 and 11 in the bidding documents were in compliance with the DRAP Act and as such did not violate Article 148 of the Constitution. The arguments advanced by the petitioners' counsel in this regard have no merit.
17. Some arguments were addressed by The learned counsels for the petitioner and Roche regarding the safety of petitioner's drug, Unipeg. This Court is, however, not concerned with the fact whether the petitioner's drug is safe for human consumption or not. DRAP has granted two years time for Unipeg's clinical trials and thereafter a determination shall be made by it on the basis of studies conducted on the said drug along WHO Guidelines whether it is bio-similar to the licensed biotherapeutic reference product. Needless to state that it is a highly technical issue one with which this Court is not suitably equipped to pass a judgment on. The only question posed in this judgment is whether the inclusion of clauses No, 10 and 11 in the prequalification documents offended the provisions of DRAP Act. This Court has no hesitation to answer the said question in negative. Clauses No, 10 and 11 in the prequalification documents requiring Biosimilarity studies from the prescribed laboratories were in compliance with the provisions of DRAP Act, the provisions whereof manifest their intention by adopting the WHO Guidelines insofar as the Similar Biotherapeutic Products are concerned. For this very purpose, Getz was granted a conditional license, the terms whereof have not yet been met with. Conditions No, 10 and 11, therefore, do not offend in any manner whatsoever the standards set out in DRAP Act with regard to the biosimilar drugs.
18. It is also apparent from the record that the Government of Punjab issued a public awareness notice showing its intent to include the Bio-equivalence/Bio-similarity study report as a compulsory parameter in the Bid Evaluation Criteria for procurement of drugs/medicines etc from the Financial Year 2014-2015 and also listed out the DRAP/WHO audited laboratories for obtaining the Bioequivalence/ Biosimilar studies. The prospective bidders/ manufacturers/suppliers were accordingly advised to arrange Bioequivalence/Biosimilar studies for the edicines/drugs before 01.07.2014. However, 'vide letter dated 21.10.2015, the Health Department waived, the requirement of Bio-equivalence/Bio-similarity study report for procurement of medicines/drugs till further orders except for Anti-Tuberculosis drugs and Peg-Interferon. Subsequently, a meeting of the -Provincial Steering Committee was held, on 30.12.2015 participated by a large number of experts/professors of various medical colleges in which it was, inter alia, decided that the condition for making available the Biosimilarity study for Interferon shall continue to remain implemented but the condition of three years market experience was reduced to one year. The Government of Punjab, ,as per its reply, has put in place a policy for prevention and control of Hepatitis B & C with a total approved cost of Rs, 2407.2 Million. It was asserted that the Government of Punjab has the right to impose conditions No, 10 and 11 in the bidding documents for providing the best possible medicine to the patients suffering from Hepatitis C. The decision to impose the . Condition for supplying bio- similarity study by the manufacturers intending to take part in the tender for supply of Interferon was taken by a committee consisting Of experts which after due consideration and application of mind took the decision on which this Court does not think appropriate to interfere. This Court in the exercise of its Constitutional jurisdiction is only concerned with the process of the decision of which judicial review is sought and not the merits of the decision. Ordinarily, the Courts are reluctant to interfere in decisions of the nature involved in this case as the Government is the best judge of its policy initiatives. It is neither the duty of the Court nor is it desirable for it to pass a decision on the fairness of a particular policy or the decisions taken in fulfilment of that policy. This is not to say that where the decision is based on irrelevant considerations or is arbitrary, Whimsical and illegal, the Courts will not interfere. In the present case, however, it appears that the Government of Punjab through the relevant ministry took a well informed decision to provide the best possible medicine/drug to the patients suffering from Hepatitis C. The position- of the Government of Punjab was made known to the manufacturers and suppliers through advertisement regarding obtaining Bio-equivalence/ Bio-similarity study for procurement of medicines and drugs w.e.f, 01.07.2014. Getz, while participating in the prequalification process, was in the knowledge of this requirement which was compliant of the standards adopted by DRAP Act for biosimilar medicines.
It cannot, therefore, turn back and impugn the decision of the Grievance Committee, which rightly rejected The representation of Getz as Unipeg did not qualify conditions No, 10 and 11 of the bidding documents. It may further be added that the procurement in question was regulated by the Punjab Procurement Regulatory Authority Rules 2014. However, the learned counsel for the petitioners did not bring to the notice of this Court any Rule which was violated by the prequalification process initiated by the respondents.
19. The argument that Alfalah could join the present proceedings has no merit in it. Both Getz and Alfalah acted in somewhat unusual manner in approaching the courts for redressal of their grievances. In the first round of tender, Alfalah procured the bidding documents and feeling aggrieved by clause 12 in the tender document approached the civil Court and obtained a stay order. The said bidding process was suspended and the respondents decided to pre-qualify the bidders instead. In the second round, only Getz applied for the bidding documents whereas Alfalah chose to sit it out and then inexplicably filed for stay of the bidding process, which stay order for equally inexplicable reasons was granted by the civil Court on 19.03.2016 although the bid documents submitted by Getz had already been rejected on 17.03.2016. Be that as it may, stay order granted on 19.03.2016 is of no help to Getz as it was not a party to the civil suit. The present writ petition is filed by Getz challenging conditions No, 10 and 11 of the bidding documents in the second round of tender in which Alfalah did not participate. A fortiori, Alfalah .Is not a necessary or indeed a proper party in the present proceedings. Its name is accordingly ordered to be struck off from the array of the parties. This Court shall now advert to, the judgments cited by the learned counsel for Getz to support the filing of present petition filed by Alfalah. Mian Fazal Din v. Lahore Improvement Trust, Lahore and another PLD 1969 SC 223 was a judgment concerning a case where the appellant purchased a plot in Gulberg-III scheme knowing that the plot opposite thereto was earmarked for construction of a market in which he desired to open a branch of his business. Upon alteration of the scheme by Lahore Improvement Trust whereby a mosque was allowed to be built on the plot in question, the appellant filed writ petition, which was dismissed as the Court came to the conclusion that the scheme was still at the execution stage and, therefore, Lahore Improvement Trust retained the authority to alter the same. In appeal, responding to the objection that the appellant had no enforceable right to agitate, the Hon'ble Supreme Court held that seeking performance of a legal duty which if not performed would result in lois of some personal benefit or advantage can be sufficient for maintaining the writ petition. The ratio of the judgment is of no avail to the petitioners as Alfalah did not participate in the second tender and stayed out of the prequalification process. Even if it be assumed that the process of the second tender allowed Getz to participate which it could not for the reasons explained above, this Court is at a loss to understand as to how'Alfalah could benefit by a contract going in favour of Getz given that despite the similarity of the tenders, it participated in the first but let go of the second tender. This brings us to Messrs S.M. Ilyas & Sons Ltd. v. Monopoly Control Authority, Islamabad and others PLD 1976 Lahore 834, the next judgment cited by the learned counsel. At issue was the General Order issued by the Monopoly Control Authority under Section 7 of the Monopolies and Restrictive Trade Practices (Control and Prevention) Ordinance, 1970 which, inter alia, provided for appointment of.Two additional distributors in large cities by the manufacturers registered with the 'Authority. A challenge was thrown to the Ordinance by the sole distributors of various manufacturers by filing writ petitions in which the question arose as to the locus stand! Of the distributors. This Court dismissed the said objection. The reason why the objection to locus standi did not find favour with this Court was that the business of the existing distributors was likely to be proportionately decreased with the induction of additional distributors and thus the existing distributors stood to gain in case the General Order was struck down. The substantial interest in the matter tilted the balance in favour of the distributors and according to the learned Judge deciding the case brought the distributors in the category of "aggrieved person" within the contemplation of Article 199 of the Constitution. In the said case, the statutory dispensation itself curtailed the business prospects of the distributors with a direction to the manufacturers' for appointing' additional distributors and as such the ratio of this judgment does not apply to the facts of the present case.
Alfalah of its own free will did not participate in the second procurement process and perhaps through a mutual arrangement Getz was put forward to participate therein. Needless to point out that the only reason Alfalah was made a party in the present writ petition was that Getz wanted to avail itself of the stay orders passed in the civil suit filed by Alfalah. This, however, is not a good ground to allow Alfalah to become a party in .a petition,which challenges procurement process in which Alfalah did not participate. There cannot be laid down a broad, general principle\ that every distributor would ipso facto become a necessary party in an action brought by the manufacturer for protecting its potential profits and business. The petitioners' counsel also relied upon some other judgments mostly from Indian jurisdiction to support the proposition that respondents committed contempt of the stay orders granted by the Civil Court of which a notice ought to be taken by this Court. Suffice it to state that the said judgments do not advance the case of Getz in any meaningful way as it is open to Althlah to approach the Civil Court by filing the contempt petition against the respondents, which petition, if filed, shall be decided on its own merits. In any event, Getz was not a party in the civil suit and as such stay order granted on 19.03.2016 by the Civil Court cannot benefited.
20. In the result, this writ petition being devoid of any merit is dismissed.