S. B. SINHA, J. ( 1 ) IN this writ petition filed by way of public interest litigation the petitioner has sought for the following relief: to issue a writ, direction or order especially in the nature of mandamus, prohibiting Bharat Biotech International Limited from manufacturing or marketing or administering Hepatitis-B vaccine using Pichia Pastoris as a vector. ( 2 ) WHEN the matter came up for admission, on 4. 10. 2001 a learned single Judge of this Court passed the following interim order: in the circumstances, 1 am of the considered opinion that public interest requires immediate analysis of the samples of vaccine manufactured by Bharat Biotech (3rd respondent in the writ petition) and for the aforesaid purpose, 1 am of the considered opinion that CCMB is the organisation which should be entrusted with this responsibility. In the circumstances, a Director of CCMB is directed to purchase three vials of Hepatitis-B vaccine known as Revac-B manufactured by Bharat Biotech from the open market as its cost and also receive three vials to be made available by the petitioner and three vials to be made available by Bharat Biotech and test and analyse the same and submit a comprehensive report to this Court by Tuesday i. e. 9. 10. 2001. The samples shall be made available by the petitioner as well as the 3rd respondent before 11. 00 a. m. on 6. 10. 2001. The Director of CCMB shall receive the same and acknowledge. ( 3 ) AGGRIEVED by the said order, 3rd respondent has preferred the aforesaid writ appeal. With the consent of the Counsel for both the parties, the writ appeal and the writ petition were taken up together and are being disposed of by this common order. The parties will be referred to by their status in the writ petition. ( 4 ) THE writ petitioner Dr. P. M. Bhargava is a famous scientist and recipient of padma Bhushan award. He is connected with many organisations. He was the founder and Ex-Director of Centre for Cellular and Molecular Biology (CCMB), Hyderabad. Presently, he is the scientific advisor to one Pharmaceutical Company known as Shanta Biotechnics Pvt. Ltd. Hyderabad (for short shanta ) and President of Society for Scientific Values, DST Centre for Visceral Mechanisms, VP Chest Institute, University of Delhi, Delhi. He was the founder and Ex-Director of Centre for Cellular and Molecular Biology (CCMB), Hyderabad. Presently, he is the scientific advisor to one Pharmaceutical Company known as Shanta Biotechnics Pvt. Ltd. Hyderabad (for short shanta ) and President of Society for Scientific Values, DST Centre for Visceral Mechanisms, VP Chest Institute, University of Delhi, Delhi. ( 5 ) IT is not in dispute that Shanta and Respondent No. 3 herein are trade rivals. Both of them manufacture various drugs including vaccine Hepatitis B. In his capacity as Scientific Advisor to Shanta, the petitioner has received a letter on 6. 7. 2001 from the Managing Director of Shanta alleging that the 3rd respondent herein instead of using Saccharomyces cerevisiae for the purpose of manufacture of Hepatitis-B vaccine as a vector had been using Pichia Pastoris for manufacture of recombinant Hepatitis-B although no licence therefor had been granted to it. The 3rd respondent was issued licence only for the use of Saccharomyces cerevisiae as a vector for the manufacture of Hepatitis B vaccine. Allegedly, Shanta arrived at the aforementioned conclusion as a result of its investigation carried on form the vials manufactured by 3rd respondent. According to Shanta, the following evidence establishes that pichia pastoris has been used for the manufacture of the Hepatitis B vaccine (Revanc-B) by Bharat Biotech: 1. The sequence of ribosomal DNA isolated and amplified from the vaccine matches exactly the sequence of pichia pastoris ribosomal DNA, but differs from that of Saccharomyces DNA. 2. A DNA fragment of expected size and having the expected sequence could be isolated and amplified from the vaccine using primers which are specific to pichia pastoris only and would not work with Saccharomyces. 3. The above DNA, applied using pichia specific primers, could not have been derived from our vaccine or from the environment as it has a ECO RI restriction endonuclease site which is absent in our clone. ( 6 ) THE writ petitioner in his capacity as scientific advisor to Shanta and President of Society for Scientific Values immediately took up the cause without making any further investigation. ( 6 ) THE writ petitioner in his capacity as scientific advisor to Shanta and President of Society for Scientific Values immediately took up the cause without making any further investigation. He wrote a letter to the Secretary, Department of Science and Technology on the same day, which reads thus: i am enclosing a note I have just received from Shantha Biotech which, in my professional opinion, clearly establishes that Bharat Biotech which has been licensed to produce Hepatitis B vaccine using only S cevisiae as the vector has been using Pichia Pastoris as the vector for producing the vaccine. This is both illegal and unethical. I am bringing this to the notice of the Drug Controller General of India, the State authorities here and the Governmental intelligence and law and order agencies. Some of the vials of the Bharat Biotech vaccine on which the enclosed tests were done, are still available with Shanta Biotech, thus the tests done by Shanta Biotech can be repeated anywhere else you wish. The analysis mentioned in the enclosure was done by my former colleague, Dr. K. S. N. Prasad, whose ability and integrity has never been in doubt. 1 am writing this letter to you, specially as I believe that the TDB has given a grant of some Rs. 25 crore to Bharat Biotech recently. (In fact, when this was brought to my notice I was a little surprised at the value of grant which seemed out of proportion to the job that was reported to be done by Bharat Biotech under the grant ). In view of what I have mentioned above, you may like to review the grant once again. 1 may also add that the DNA sequencing reported in the enclosed material was done by a commercial organisation in the United Suites. ( 7 ) RESPONDENT No. 1-Drug Controller Genera! of India immediately acted thereupon and asked the 2nd rcspondent-Assistant Drug Controller. Sub-Zonal Officer, Hydrabad to take neccessary action by letter dated 24. 7. 2001. It reads thus: m/s. Bharat Biotech has been granted licence to manufacture and market recombinant Hepatitis B vaccine using only Saceharomycis cervisiac as vector. However, il has reported to this office thai, She firm also manufacturing and marketing rccombinant Hepatitis B vaccine using Pichia pastoris as vector, for which M/s. Bharat Biotech do not have licence. 7. 2001. It reads thus: m/s. Bharat Biotech has been granted licence to manufacture and market recombinant Hepatitis B vaccine using only Saceharomycis cervisiac as vector. However, il has reported to this office thai, She firm also manufacturing and marketing rccombinant Hepatitis B vaccine using Pichia pastoris as vector, for which M/s. Bharat Biotech do not have licence. The proposal to manufacture Hepatitis B vaccine using P. Pastoris is still under experimental stage. The said vaccines manufactured by M/s Bharat Biotech vide batch No. RVB 11, 13, 15 and RVB 046 was tested for DNA contaminant. The report stated that the vaccine must have been produced using rccombinant Pichia pastoris that carries Hbsag gene under AOX promoter. In view of above, you are requested to investigate the above subject-matter, and furnish the factual position to this office, as early as possible, so that suitable action can be taken against the firm manufacturing DNA Hepatitis P vaccine (P. pastoris) without proper licence. ( 8 ) BY letter dated 25. 7. 2001, the 1st respondent inter alia, recommended to the Drugs Controller General, Directorate General of Health Services, New Delhi, that facilities for testing the said vials are available at the Centre for Cellular and Molecular Biology and though it is not a recognised Government Laboratory but for the purpose of obtaining prima facie opinion in respect of the yeast used in the production of Hepatitis B vaccine its views can be obtained if the samples are accepted by them for testing. He however requested the drugs Controller General to take a decision in this regard. ( 9 ) ON or about 7. 8. 2001, the Assistant Drugs Controller however came out with another suggestion that samples drawn by his office may be sent to another authentic recognised laboratory, inter alia, on the grounds: 1. Dr. P. M. Bhargava is retired Director of M/s. CCMB and settled at Hyderabad. 2. Dr. P. M. Bhargava has made the complaint against M/s. Bharat Biotech Ltd. alleging and stating that M/s. Bharat Biotech Ltd. has used the vector pichia pastoris in the manufacture of Hepatitis B vaccine. The name of the vector used in the manufacture of Hepatitis B vaccine is generally not indicated in the licence granted in Form No. 28d. 3. Dr. P. M. Bhargava has made the complaint against M/s. Bharat Biotech Ltd. alleging and stating that M/s. Bharat Biotech Ltd. has used the vector pichia pastoris in the manufacture of Hepatitis B vaccine. The name of the vector used in the manufacture of Hepatitis B vaccine is generally not indicated in the licence granted in Form No. 28d. 3. Dr. P. M. Bhargava is the Technical and Scientific Advisor to M/s. Shanta Bio Technics Pvt Ltd. , Hyderabad president of M/s. Shanta Marine Products, Hyderabad, a sister concern of M/s. Shanta Biotechnics Pvt Ltd. , Hyderabad. 4. The samples of the complained batches are picked and tested by M/s. Shanta Biotechnics Pvt. Ltd. , Hyderabad only who is the business competitor in the field of vaccine manufacture for M/s. Bharat Biotech Ltd. , Hyderabad. The complained batches are not analysed by any of the independent Laboratory/ National Authentic Laboratory. The test report issued and screened by M/s. Shanta Biotechnics Pvt. Ltd. , Hyderabad are handed over to Dr. P. M. Bhargava and on the basis of that Dr. P. M. Bhargava has made a complaint to various authorities. No independent findings are given by Dr. P. M. Bhargava on the samples, therefore, these test reports cannot be accepted at this stage. ( 10 ) IT was also stated that if the samples drawn are sent to CCMB, Hyderabad, it would amount to violation of principles of natural justice as the complainant is the retired Director of the CCMB and had influence in different departments of the said CCMB directly. Therefore, the 2nd respondent suggested that the samples may be sent to an authentic laboratory other than CCMB under the supervision of his office and an expert designated from Central Drugs Laboratory, CRI, Kasauli. The samples for the purpose of testing were drawn by the 2nd respondent on 4. 8. 2001. ( 11 ) IT may also be noticed that a news item was published in "the New Indian Express" dated 6. 8. The samples for the purpose of testing were drawn by the 2nd respondent on 4. 8. 2001. ( 11 ) IT may also be noticed that a news item was published in "the New Indian Express" dated 6. 8. 2001 under the Caption a major drug scandal in the making-City firm releases harmful Hepatitis-B vaccine alleging that the 3rd respondent has been using an yeast strain called pichia pastoris to manufacture Hepatitis B vaccine and it has neither the licence to do so nor has it done any clinical or toxicological studies before leasing the vaccine into the market and it cannot use the genetically modified material to manufacture the vaccine. ( 12 ) THE allegation of the petitioner is that such attitudinal change on the part of the 2nd respondent came in view of a letter of the Chief Minister addressed to the Union Minister for Health and Family Welfare dated 7. 8. 2001 wherein it was contended: dear Dr. Thakurji, as you are aware, Andhra Pradesh is known to be centre of knowledge-based industries such as Pharmaceuticals, Information Technology and Biotechnology. In fact, Andhra Pradesh has been acting as a major hub for Pharmaceutical industries in India for more than two decades. Andhra Pradesh always stood for encouragement of industries and the State has attained a prominent place in the international map. With the introduction of biotechnology policy, Andhra Pradesh was able to attract prominent biotechnology players who have achieved excellent growth. Recently, it has come to my notice that certain prominent biotechnology companies in the State of Andhra Pradesh have been making allegations and counter allegations against each other with vested interest and have filed complaints and allegations with some of the central institutions and regulatory authorities such as, Drugs Controller-General of India, Ministry of Health and Family Welfare. I am of the view that such irresponsible petition-mongering will scuttle the growth of industries in the State, if not properly dealt with. Most of these allegations are made due to professional rivalries and intra-trade jealousies. In this connection, you may kindly issue instructions to the Drugs Controller-General of India not to give undue credence to these biased allegations and to judge applications objectively, duly expediting the clearances requested for. Most of these allegations are made due to professional rivalries and intra-trade jealousies. In this connection, you may kindly issue instructions to the Drugs Controller-General of India not to give undue credence to these biased allegations and to judge applications objectively, duly expediting the clearances requested for. I shall be grateful, if you could kindly issue suitable instructions in this matter to the Drugs Controller-General of India, as early disposal of the pending proposals pertaining to leading biotech units in the State, would lead to the growth of the industry in the State. ( 13 ) THE 2nd respondent in his letter dated 6/8-8-2001 addressed to the Drugs Controller General stated that Mr. B. P. Acharya, secretary, Industries Department, Government of A. P. informed him at the Biotech Conference held on 3. 8. 2001 at Hyderabad about the letter written by the Chief Minister to Union Minister, Health and Family Welfare and the need to clear of the pending applications for grant of licences. It was further stated: m/s. Bharat Biotech Limited, Hyderabad is recently inspected by a team consisting of Officers of CDSCO, Joint Director, Central Research Institute, Kasauli and International Experts from WHO on 28th and 29th June and 2nd July, 2001. In their observation the inspecting Team has pointed out only certain deficiencies relating to documentation and maintenance. No adverse remarks were against the quality of the product and the vector used (pichia pastoris) in the production of Hepatitis B vaccine. ( 14 ) THE Drugs Controller General constituted a committee for making a joint inspection of M/s. Bharat Biotech by experts from ICMR and National Institute of Biologicals (NIB) along with the officials of sub-Zonal Office of CDSCO at Hyderabad and accordingly he addressed letters dated 28. 8. 2001 simultaneously to Dr. N. K. Ganguli, Director General ICMR, New Delhi and Dr. (Mrs.) Shashi Khare, Director, NIB, Noida to recommend the names of Scientists who are well-conversant with r/dna technology and DNA sequencing etc. , to inspect the premises of M/s. Bharat Biotech International Ltd. , Hyderabad to ascertain the factual position about manufacture of Hepatitis B vaccine against the recommended and approved Saccharomyces Cerevisiae. They were also requested to identify a suitable laboratory who could carry out the analysis of the samples to determine the actual host vector which was used for manufacture of Hepatitis B vaccine on the complaint samples. They were also requested to identify a suitable laboratory who could carry out the analysis of the samples to determine the actual host vector which was used for manufacture of Hepatitis B vaccine on the complaint samples. Therefore, the 2nd respondent sent the seized vials to Dr. (Mrs.) Shashi Khare NIB. It appears that the joint inspection of the premises was made on 7. 9. 2001. The report on the samples is yet to be received. ( 15 ) AT this stage, the present writ petition was filed on 1. 10. 2001. ( 16 ) MR. K. G. Kannabhiran, learned Counsel appearing on behalf of the petitioner would submit that manipulation in the Drugs Controller Office started upon the receipt of the letter from the Chief Minister by the Union Minister of Health and Family Welfare. He would contend that the attitudinal change on the part of Sri D. P. Sharma, Assistant Drugs Controller, hyderabad (2nd respondent) took place only after the letter of the Hon ble Chief Minister addressed to the Union Minister for Health and Family Welfare. Learned Counsel would urge that since the 3rd respondent has no licence to manufacture the vaccine Hepatitis B using pichia pastor is as vector, action should be iaken against it The Court, Mr. Kannubhiran would urge should lake notice about the manifest manipulation having regard to the fact thai drugs cannot be allowed to be adulterated. Learned Counsel would comend that the fact that DNA test was carried on by Shanta is wholly immaterial inasmuch as no interpolation can be made with the samples as the same would be subject to DNA test He would urge that this Court may direct constitution of an appropriate committee and issue guidelines so that standard of such vaccine may be maintained particularly having regard to the fact that even in terms of the Drugs and Cosmetics Act, 1940 (for short the Act ), the standard required to be maintained should be that of international one. ( 17 ) LEARNED Additional Advocate General appearing on behalf of the State would, however, submit that the allegations made against the Chief Minister are totally unfounded. Learned Advocate-Genera! would contend thai the allegations made by Shanta are affecting the industry as a whole which may have an adverse affect in the growth of industries based on biotechnology. So far as setting up of new biotech Industrie -. Learned Advocate-Genera! would contend thai the allegations made by Shanta are affecting the industry as a whole which may have an adverse affect in the growth of industries based on biotechnology. So far as setting up of new biotech Industrie -. in the State is concemal our mention has been drawn to the document issued by the Department of Industries and Commerce, Government of A. P. on Biotechnology Policy 2001 to show that the names of both Shanta and respondent No. 3 find prominent place therein. ( 18 ) MR. Bhattacharya, learned Counsel appearing on behalf of the Central Government would submit that the writ petition is not maintainable inasmuch as the Central Government had already constituted an expert committee to go into the matter. He would, therefore, urge that no further direction need be issued by this Court. According to the learned Counsel, the suggestion made by the 2nd respondent that the samples drawn be not tested at CCMB cannot be said to be motivated particularly having regard to the fact that the petitioner herein has acted at the instance of Shanta, that be was previously associated with the said laboratory and that it was not a recognised one. ( 19 ) MR. E. Manohar, learned Counsel appearing on behalf of the 3rd respondent has taken us through the statements made in paras 3, 4, 5, 14 and 15 of the affidavit filed in support of the writ petition as also the interim prayer sought for in the writ petition and submitted that a bare perusal thereof would clearly show that the entire exercise had been taken to see that licence for manufacture of vaccine for 1 lepalitis B using pichia pastoris is not granted to the 3rd respondent or the same is delayed. Learned Counsel would submit that so far as grant of licence for manufacture of recombinant Hepatitis B vaceine (expressed in the yeast Saceharomyces cercvisiae) is concerned, regulatory events started from 30. 5. 1996 which ended in granting licence on 4. 2. 2000 would show that the 3rd respondent has now acquired the capacity to manufacture 100 million doses. ( 20 ) IT was further contended that with a view to malign the 3rd respondent the news item was got published and by reason of the said publication, much harm was caused to its reputation. 2. 2000 would show that the 3rd respondent has now acquired the capacity to manufacture 100 million doses. ( 20 ) IT was further contended that with a view to malign the 3rd respondent the news item was got published and by reason of the said publication, much harm was caused to its reputation. ( 21 ) THE entire exercise, the learned Counsel would contend is to see that grant of licence to the 3rd respondent to manufacture the vaccine for Hepatitis B using pichia pastoris as vector is delayed. Our attention has further been drawn to the fact that Shanta has close connection with CCMB. It was contended that in fact they started their research activities from there. ( 22 ) THE Drugs and Cosmetics Act, 1940 has been enacted to regulate the import, manufacture, grant of licence distribution and sale of drugs etc. The Central Government, in terms of Section 6 of the said Act is required to establish a Central Drugs Laboratory to carry out the functions entrusted to it by the Act and the rules made thereunder. Sub-section (2) of Section 6 provides for the rule making power. Rules have been farmed by the Central Government in exercise of its rule making power known as Drugs and Cosmetics Rules, 1945. ( 23 ) PART II of the Rules relate to the Central Drugs Laboratory. Rules 3 and 3-A of the said rules read thus: the CENTRAL DRUGS LABORATORY functions:it shall be function of the laboratory (i) to analyse or test such samples of drugs as may be sent to it under sub-section (2) of Section 11, or under sub-section (4) of Section 25 of the Act. xxx (iii) to carry out such other duties as may be entrusted to it by the Central Government or, with the permission of the Central Government by a State Government after consultation with the Drugs Technical Advisory Board. 3-A: The functions of Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Central Research Institute, Kasauli and the functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of the said Institute. 1. Sera 2. Solution of serum proteins intended for injection 3. Vaccines 4. Toxins 5. Antigens 6. Anti-toxins 7. Sterilized surgical ligature and sterilized surgical suture. 8. Bacteriophages. 1. Sera 2. Solution of serum proteins intended for injection 3. Vaccines 4. Toxins 5. Antigens 6. Anti-toxins 7. Sterilized surgical ligature and sterilized surgical suture. 8. Bacteriophages. ( 24 ) SO far as manufacture of Hepatitis B by the 3rd respondent using yeast Saccharomyces cerevisiae as a vector is concerned, there is no dispute that it had been granted permission on 15. 10. 1998 to manufacture and market its products. ( 25 ) INSOFAR as recombinant Hepatitis B vaccine (expressed in the yeast-Pichia pastoris) is concerned, the application had been made on 30. 5. 1996. Production of trial batches started in September, 1998. On 2. 8. 2000 the Genetic Engineering Approval Committee granted clearance to conduct Phase-Ill clinical trials. Phase-Ill trials were initiated and completed in January, 2001 at the Department of Gastroenterology, Osmania General Hospital, Hyderabad and the Department of Gastroenterology, King George Hospital, Visakhapatnam. On 19. 2. 2001 application was made to the Drugs Controller General together with clinical trials data seeking permission to manufacture and market the vaccine. Application was also made to the State Drugs Control Authority in Form 27-D seeking permission to manufacture and market the Hepatitis B vaccine in formulated and bulk form. On 30. 4. 2001 Genetic Engineering Approval Committee upon review of all cynical trial data granted clearance for marketing and manufacturing the Hepatitis B vaccine expressed in pichia pastoris. On 4-8-2001 three test batches of the Hepatitis B vaccine expressed in pichia pasloris Svere cleared by the Central Research Institute, Kasauli. The joint inspection team visited the company for assessment on 7. 9. 2001. ( 26 ) THE principal question which fall for consideration is as to whether in a situation of this nature, writ tf mandamus as has been prayed for can be issued. The answer to the said question must be rendered in the negative. ( 27 ) THE action of the 2nd respondent in suggesting that the samples be sent to an authentic (recognised) laboratory other than CCMB, in our considered view, cannot be found fault with as the petitioner made the complaint at the instance of Shanta which has trade rivalry against the 3rd respondent and not in his individual capacity. ( 27 ) THE action of the 2nd respondent in suggesting that the samples be sent to an authentic (recognised) laboratory other than CCMB, in our considered view, cannot be found fault with as the petitioner made the complaint at the instance of Shanta which has trade rivalry against the 3rd respondent and not in his individual capacity. When allegations of severe nature are made by a company against its trade rival, the State was under an obligation to see that the enquiry is made in fair and ieasonable manner duly observing the principles of natural justice and having regard to the established principle that justice should not only be done but manifestly seem to have been done. The fact that the petitioner is associated with CCMB previously and the said institute was not a recognised one is not disputed. In such circumstances, in all fairness, the 2nd respondent suggested to the 1st respondent that the analysis of the samples drawn by him be sent to an independent laboratory. We do not find any illegality or irrationality in the said suggestion. ( 28 ) IN the counter-affidavit filed by the respondents 1 and 2, it was clearly staled that the Review Committee on Genetic Manipulation (RCGM) Department of Biotechnology accorded clearance to the 3rd respondent for conducting the clinical trial in regard to manufacture of Hepatitis B surface antigen using Pichia pastoris and permission for conducting phase-Ill trial was granted by the 1 st respondent on 19. 5. 2000. It was also stated that the 3rd respondent was directed to send the sample using pichia pastoris to CDL Kasauli for testing vide letter-dated 20. 4. 2001. It was further slated: the batches were sen; to the CDL, Kasauli found to be of standard quality as reported by CDL Kasauli vide report dated 4. 8. 2001. Based on the clinical data submitted by the firm and reported to be safe and imunogenic responsive this directorate has conveyed its NOC to the Ministry of Environment for GEAC clearance. ( 29 ) IT is, therefore, evident that test batches of Hepauis B vac ;ine using pichia pastoris as vector was approved by C1r, Kasauli. The case of the 3rd respondent is that lliey had not ^one into commercial manufacturing and marketing of the vaccine and licence is yet to be obtained for the same. ( 29 ) IT is, therefore, evident that test batches of Hepauis B vac ;ine using pichia pastoris as vector was approved by C1r, Kasauli. The case of the 3rd respondent is that lliey had not ^one into commercial manufacturing and marketing of the vaccine and licence is yet to be obtained for the same. According to the petitioner, however, the 3rd respondent has already marketed the vaccine without obtaining a licence therefor. Whether the 3rd respondent has marketed the vaccine or not is a matter, which requires thorough investigation by the authorities concerned, and this Court, in exercise of its power of judicial review, cannot make an enquiry on such factual aspects and issue writ of mandamus as prayed for. Further, no material has been placed before us whether any complaint had been lodged against the 3rd respondent for violation of any statutory rules. The matter is yet to be investigated into. The examination and analysis of the vials seized by the authorities is still under process by an expert committee constituted by the 1st respondent. ( 30 ) WOULD this Court in such a situation interfere in the administrative process of the authorities under the garb of judicial review of administrative action or inaction and issue directions in the matter? The answer to the same must be an emphatic no . ( 31 ) PROF. Clive Lewis in his book judicial Remedies in Public Law 1992 Edition at p. 294-295, summarised the present status of judicial review in English Law as under: the Courts now recognise that the impact on the administration is relevant in the exercise of their remedial jurisdiction. . . . Earlier cases took a robust line that the law has to be observed and the decision invalidated, whatever the administrative inconvenience caused. The Courts now-a-days recognise that such an approach is not always appropriate and may not be in the wider public interest. The effect on the administrative process is relevant to the Court s remedial discretion may prove decisive. . . They may also be influenced to the extent to which the illegality arise from the conduct of the administrative body itself, and their view of that conduct. ( 32 ) IN Tata Cellular v Union of India, AIR 1996 SC 11 , the Apex Court opined: observance of judicial restraint is currently the mood in England. . . They may also be influenced to the extent to which the illegality arise from the conduct of the administrative body itself, and their view of that conduct. ( 32 ) IN Tata Cellular v Union of India, AIR 1996 SC 11 , the Apex Court opined: observance of judicial restraint is currently the mood in England. The judicial power of review is exercise to rein in any unbridled executive functioning. The restraint has two contemporary manifestations. One is the ambit of judicial intervention; the other covers the scope of the Court s ability to quash an administrative decision on its merits. These restraints bear the hallmarks of judicial control over administrative action" ( 33 ) IT is well settled principle of law that a statutory authority must be allowed to perform its statutory functions at the first instance. Whether a licence should be granted in favour of the 3rd respondent for manufacture of Hepatitis B vaccine using pichia pastoris as the vector or not is a matter, which exclusively falls within the purview of the authorities under the Act. The Court cannot substitute itself for the authorities under the said Act and issue a mandamus to the authorities to exercise its discretion in a particular fashion. This Court in exercise of its discretionary jurisdiction cannot issue any direction whether a licence is to be granted or not to be granted in favour of any individual or company and/or whether the procedure required to be followed prior to the issuance of a licence has been followed or not. In State of West Bengal v, Nuruddin Mallick, (1998) 8 SCC 143 , the Apex Court held: the Courts can either direct the statutory authorities, where it is not exercising its discretion, by mandamus to exercise its discretion, or when exercised, to see whether it has been validly exercised. It would be inappropriate for the Court to substitute itself for the statutory authorities to decide the matter. ( 34 ) IT is trite that Court cannot even in PIL cases issue any direction, which would be in conflict with legal provisions. Such directions can be issued only when the law is silent and inaction on the part of the authorities in regulating the same has resulted in violation of fundamental rights or other legal provisions. ( 34 ) IT is trite that Court cannot even in PIL cases issue any direction, which would be in conflict with legal provisions. Such directions can be issued only when the law is silent and inaction on the part of the authorities in regulating the same has resulted in violation of fundamental rights or other legal provisions. In Narmada Bacho Andolan v. Union of India, (2000) 10 SCC 664 , the Apex Court observed: it is now well settled that the Courts, in the exercise of their jurisdiction, will not transgress into the field of policy decision. Whether to have an infrastructural project or not and what is the type of project to be undertaken and how it has to be executed, are part of policy making process and the Courts are ill-equipped to adjudicate on a policy decision so undertaken. The Court, no doubt, has a duty to see that in the undertaking of a decision, no law is violated and people s fundamental rights are not transgressed upon except to the extent permissible under the Constitution. Even then any challenge to such a policy decision must be before the execution of the project is undertaken. Any delay in the execution of the project means overrun in costs and the decision to undertake a project, if challenged after its execution has commenced, should be thrown out at the very threshold on the ground of laches if the petitioner had the knowledge of such a decision and could have approached the Court at that time. Just because a petition is termed, as a PIL does net mean that ordinary principles applicable to litigation will not apply. Laches is one of them. ( 35 ) THE interim prayer of the petitioner if allowed would amount to this Court issuing a writ of mandamus directing the respondents to get the samples tested in a particular laboratory. Even under ordinary law, the same is not permissible. ( 36 ) CORRECTIVE measures can be directed to be taken where the statutory authorities have acted in contravention of statute. Directions can be issued when such authorities are guilty of inaction. ( 37 ) WHETHER or not licence should be granted to a manufacturer of drugs is wholly within the domain of the statutory authorities and Courts should restrain itself interfering in such statutory functions. Directions can be issued when such authorities are guilty of inaction. ( 37 ) WHETHER or not licence should be granted to a manufacturer of drugs is wholly within the domain of the statutory authorities and Courts should restrain itself interfering in such statutory functions. The fact that the complaint of the petitioner herein has received immediate attention by the authorities concerned and action in relation thereto had also been taken itself is a pointer to show that the respondents 1 and 2 are not guilty of any inaction. A committee has been constituted with two independent scientists to analysis the samples collected and inspection report of the committee has also been submitted. The test report of samples is awaited. Prompt action thus having been taken by respondent No. 1, who, on the basis of the reports having been acting fairly and in public interest, this Court is of the opinion that no interference in the matter is legally permissible. ( 38 ) A question has arisen as to whether the samples collected can be tampered with. In the reply affidavit, the petitioner stated that there is no proof that the samples that were given to the inspecting team were the samples that were given by the petitioner to respondent No. 2 and the 3rd respondent might have tampered with the same. Whether tampering can be done by Shanta or 3rd respondent is immaterial. The fact remains that tampering of samples even for the purpose of DNA test is possible. In the circumstances, we find no substance in the submission of the learned Counsel for the petitioner. ( 39 ) WE do not also find any substance on the allegation that samples have been suggested to be sent to recognised laboratory other than CCMB on account of the letter written by the Hon ble the Chief Minister to the Union Minister for Health and Family Welfare. The Hon ble the Chief Minister has not been impleaded in the writ petition. It is not, therefore, proper to make insinuations without giving him an opportunity of being heard. The letter of the Chief Minister is general in nature and no particular reference has been made to the complaint of the petitioner made against the 3rd respondent or anybody else. It is not, therefore, proper to make insinuations without giving him an opportunity of being heard. The letter of the Chief Minister is general in nature and no particular reference has been made to the complaint of the petitioner made against the 3rd respondent or anybody else. What the Chief Minister requested the Union Minister for Health and Family Welfare is that the applications may be judged objectively without giving undue credence to the biased allegations and to expedite the pending proposals pertaining to the leading biotech units in the State. By reason of the same, it cannot be said that there was an attitudinal change on the part of the 2nd respondent. The letter, in our view, must be understood in the context, that it has been addressed in the general interest of growth of biotech industries in the State particularly having regard to the Biotechnology Policy 2001 of the State and the encouragement that the State would like to extend for the said industry. Further, no material has been placed before us to show that the 2nd respondent has been influenced by the letter of the Chief Minister or any instructions thereto had been issued by the higher authorities. ( 40 ) EVEN otherwise also in view of the admitted fact that the petitioner is associated with the CCMB and he is the person who has complained against the 3rd respondent, we are of the view that no illegality is said to have been committed by the 2nd respondent in suggesting that the samples drawn be examined and analysed by a recognised laboratory. Such suggested action conforms to the principle of fair play in action. In our view, in all facts and circumstances, the 2nd respondent has acted fairly and reasonably. We should not also lose sight of the fact that the samples were sent to a recognised laboratory and the entire matter was entrusted to two independent scientists of different laboratories. ( 41 ) WE also do not find any material to arrive at a finding that the first and 2nd respondents had taken recourse to any manipulation whatsoever. Unless any mala fides are alleged against them and proved, no writ can issue against them. ( 41 ) WE also do not find any material to arrive at a finding that the first and 2nd respondents had taken recourse to any manipulation whatsoever. Unless any mala fides are alleged against them and proved, no writ can issue against them. In any event, having regard to the fact that the 1st respondent itself has constituted a committee to enquire into the matter, a direction for constitution of another committee to enquire into the same particularly when no allegation has been made as regards the credence of the members of the said committee does not arise. ( 42 ) FOR the reasons aforesaid, we are of the opinion that no case has been made out for issuance of any writ or order in the nature of mandamus as has been prayed for. The writ petition is accordingly dismissed. ( 43 ) IN view of our above conclusions on the writ petition, interim order dated 4. 10. 2001 passed by the learned single Judge out of which Writ Appeal No. 1560 of 2001 arose stands vacated. WA No. 1560 of 2001 is accordingly disposed of. No order as to costs.