Gujarat High Court
Ashok Naik vs Union Of India
ASHOK NAIK....Applicant(s)V/SUNION OF INDIA THRO SECRETARY C/WPPIL/159/2011 CAV ORDER WPPIL1592011Co23.doc IN THE HIGH COURT OF GUJARAT AT AHMEDABAD WRIT PETITION (PIL) NO. 159 of 2011 FOR APPROVAL AND SIGNATURE: HONOURABLE THE CHIEF JUSTICE MR. BHASKAR BHATTACHARYA Sd/- HONOURABLE MR.JUSTICE J.B.PARDIWALA Sd/- =========================================================1
Whether Reporters of Local Papers may be allowed to see the judgment ?
Yes 2 To be referred to the Reporter or not ?` No 3 Whether their Lordships wish to see the fair copy of the judgment ?
No 4 Whether this case involves a substantial question of law as to the interpretation of the constitution of India, 1950 or any order made thereunder ?
No 5 Whether it is to be circulated to the civil judge ?
No ========================================================= ASHOK NAIK Versus UNION OF INDIA THRO SECRETARY & 148 ORS.
========================================================= Appearance:
MR.
MIHIR JOSHI, SR. ADVOCATE with MR. PARTH CONTRACTOR, ADVOCATE for the Applicant.
MR PS CHAMPANERI, ADVOCATE for the Opponent(s) No. 1 MR PK JANI, GOVERNMENT PLEADER with MS. KRINA CALLA, AGP for the Opponent No. 4 MR ABHISHEK MEHTA for M/S TRIVEDI & GUPTA, ADVOCATE for the Opponents No. 6 , 20 , 27 MR MOUSAM R YAGNIK, ADVOCATE for the Opponent(s) No. 140 MR NACHIKET D MEHTA, ADVOCATE for the Opponent(s) No. 54 MR NIRAD D BUCH, ADVOCATE for the Opponent(s) No. 16 , 52 , 114 MR NV GANDHI, ADVOCATE for the Opponent(s) No. 134 MR PA JADEJA, ADVOCATE for the Opponent(s) No. 36 MR RAJESH K KANANI, ADVOCATE for the Opponent(s) No. 30 MR RUTURAJ NANAVATI, ADVOCATE for the Opponent(s) No. 126 MR SATYAJIT SEN, ADVOCATE for the Opponent(s) No. 67 MR SHASHIKANT S GADE, ADVOCATE for the Opponent(s) No. 12 MR SN SOPARKAR, SR. ADVOCATE with MR. ADITYA B MEHTA, ADVOCATE for the Opponent No. 10 MR NIRUPAM NANAVATI, SR. ADVOCATE, with MR. YASH N NANAVATY, ADVOCATE for the Opponent No. 138 MR YOGEN N PANDYA, ADVOCATE for the Opponent(s) No. 37 MR ZUBIN F BHARDA, ADVOCATE for the Opponent(s) No. 145 MR.
BHAVIK P SHAH, ADVOCATE for the Opponent(s) No. 51 MR.YOGENDRA THAKORE, ADVOCATE for the Opponent(s) No. 39 - 41 , 55 , 63 , 89 MR K S NANAVATI, SR. ADVOCATE with MR. N Y CHUDGAR AND MR RAHEEL S PATEL for NANAVATI ASSOCIATES, ADVOCATE for the Opponent No. 7 NOTICE SERVED for the Opponent(s) No. 1 - 5 , 35 , 38 , 50 , 58 - 61 , 77 , 79 - 81 , 95 , 134 , 145 NOTICE SERVED BY DS for the Opponent(s) No. 5 NOTICE UNSERVED for the Opponent(s) No. 85 MR BM MANGUKIYA, ADVOCATE for the Opponent(s) No. 17 MR CHETAN K PANDYA, ADVOCATE for the Opponent(s) No. 21 MR CHINTAN S POPAT, ADVOCATE for the Opponent(s) No. 74 MR DEVANG R BHATT, ADVOCATE for the Opponent(s) No. 44 , 53 , 58 , 68 , 118 , 129 - 131 MR HB CHAMPAVAT, ADVOCATE for the Opponent(s) No. 121 MR JAYSINH R JADEJA, ADVOCATE for the Opponent(s) No. 149 MR JINESH H KAPADIA, ADVOCATE for the Opponent(s) No. 38 ========================================================= CORAM:
HONOURABLE THE CHIEF JUSTICE MR.
BHASKAR BHATTACHARYA and HONOURABLE MR.JUSTICE J.B.PARDIWALA Date :
30/11/2013 CAV ORDER (PER :
HONOURABLE THE CHIEF JUSTICE MR. BHASKAR BHATTACHARYA)
1.
By this Public Interest Litigation, the petitioner has, in substance, prayed for the following three reliefs:
A. That the Hon ble Court be pleased to issue a writ of mandamus or a writ in the nature of mandamus or any other appropriate writ, order or direction, directing respondent number 2,3 and 5 to inquire into the distribution channels of all the blood banks and take steps against such blood banks which are found to be trading in blood or its components or are found to be selling blood or its components for any purpose other than clinical use;
B. That the Hon ble Court be pleased to appoint a committee for investigating and preparing a report on the demand for blood or its components for clinical use at various hospitals in the State, the supply of blood or its components to the various hospitals in the State, the quantum of collection of blood by various blood banks, the end use of blood/its components collected/manufactured by the blood banks, the prices at which blood or its components are made available by the blood banks and for all matters connected with distribution of the blood collected by blood banks;
C. That the Hon ble Court be pleased to direct respondent no.2 and 5 to monitor public blood donation camps and prohibit all blood banks supplying blood or its components to M/s. Celestial Biological Ltd. or M/s. Lambda Therapeutic or any other organization for non-clinical use and prohibit such blood banks from holding public blood donation camps;
2. The grievance of the writ-petitioner may be summed up thus:
[A]. In spite of a clear mandate under the National Blood Policy to take adequate regulatory and legislative steps for monitoring and evaluation of blood transfusion services and to take steps to eliminate profiteering in the blood banks, there is no effective regulation or implementation of the policy in this regard.
[B]. Fresh licenses to stand-alone blood banks in private sector cannot be granted under the policy. The renewal of licenses of such blood banks is required to be subjected to thorough scrutiny and shall not be renewed in case of non-compliance of any of the conditions of the license. The respondent authorities have not undertaken any scrutiny with respect to the working and operations of the blood banks to which licenses have been granted.
[C]. Any blood bank, found involved in trading of blood or its components in violation of the policy and/or for any purpose other than for clinical use of such blood or blood components, cannot be permitted to continue its operations in the guise of a charitable organization. The respondent authorities have failed to take appropriate action and measures against such blood banks.
[D]. Blood donation, when done voluntarily, is not meant for enabling the drug manufacturers to reap benefits from the acts of charity. The donor, at the time of donation, believes that his blood will be used for saving the life of a person in need of blood and that the blood so donated or its components will be utilized clinically only. In the circumstances, it is highly unjust and unethical on the part of the blood banks which have acquired licenses in the pretext of charitable work to acquire free blood and then, to use it for their personal economic/commercial gain.
[E]. In spite of having drawn attention of the respondent authorities to the illegal activities of the blood banks with an intention to deceive the bona fide donors, no serious action has been taken for cancellation or suspension of such licenses.
[F]. Under Part XIIB of the Drugs and Cosmetics Act, 1940, it is mandatory that blood and/or its components shall be distributed on the prescription of a registered medical practitioner. However, in reality, number of blood banks are flouting this requirement. It is, therefore, essential that there is an inquiry into the outflow of blood or blood components from the blood banks.
[G]. The blood banks, registered as charitable Trusts, are enjoying tax benefits as charitable organizations. However, the blood banks, which profiteer, are not charitable organizations and do not deserve to be granted any benefits for the acts done in flagrant violation of the law and the public policy.
3. This application is opposed by the Respondent no. 7, against whom mostly the allegations have been levelled, by filing affidavit and the defence of the above Respondent may be summed up thus:
3.1 The respondent no.7, Prathama, is a not for profit company and is carrying out charitable activities and is registered under section 25 of the Companies Act, 1956. The respondent no. 7 is also registered under the provisions of the Bombay Trust Act, 1950. Prathma is regularly complying with all the applicable laws including the activities as prescribed under Section 25 of the Companies Act, 1956, the Bombay Public Trust Act, 1950 and the Drugs and Cosmetics Act, 1940 and the Rules made there under.
3.2 Prathma, the blood bank operated by Advanced Transfusion Medicine Research Foundation, is a unique, modern and the most advanced blood banking model of our country.
3.3 Prathma, a unit blood banking model, envisages the 100% blood componentization of the whole blood into Red Blood Cell (RBC), Platelets and Fresh Frozen Plasma [FFP] and thereby, reaches large number of patient-population and satisfies their specific needs for a particular component having regard to the nature of ailment vis-¿-vis the requirement of deficient blood component. This unique method of blood componentization has resulted into optimum usage of the blood which is always a scarce natural resource.
3.4 The Respondent no. 7 is the largest contributor fulfilling the requirement of needy patient-population inasmuch as it is distributing about 1,25,000 blood components without replacement to 35,000 patients irrespective of any discrimination, age, caste, creed, class of society etc. through 2000 doctors in and around Ahmedabad.
3.5 Prathma, through its scientific and systematic donor awareness initiatives, has popularized the concept of blood donation so as to ensure steady stream of regular blood donors in the society. Almost 50% donors at Prathma are repeated donors, which show the commendable patronage of voluntary donors ranging from College-going students to those who are on the verge of being senior citizens, is enjoyed by Prathma.
Prathma s donor deferral rate is about 30% which indicates that Prathma has high ethical and medical standards in the process.
3.6 Prathma has three major functions such as, [1]. to do blood donation camps which is source of the raw material, [2]. to do the blood collection, process the blood into components, test them, store them and make them available for the patients use, and, [3]. distribute the blood components to the patient either directly or indirectly through the transfusion center based in the hospitals. All these activities need to undergo in an environment of very high-quality management and administration systems complying with all applicable regulatory requirements and guidelines. Before Prathma came into existence, there were many private blood banks operating in Ahmedabad with poor infrastructure and offering blood only against replacement which ultimately led to motivate professional donors resulting in exploitation of the society. In the year 2003, Prathma motivated many blood banks to raise the standard of blood banking. As such, the efforts of Prathma eased the struggle of patients and doctors to have safe blood in shortest possible time with affordability and without replacement. Prathma has given a platform to about 2 lac voluntary blood donors who also want to contribute their bit in saving somebody from dying. Prathma fulfills significant blood requirement of the population of Ahmedabad and nearby areas. Prathma has also set up storage centers in many hospitals not only in Ahmedabad and but also in Government PHC centers in rural areas. Prathma was appointed as consultant by the State Blood Transfusion Council, Govt. of Maharashtra to set up a modern blood bank in J.J. Hospital, Mumbai. Besides, a unique technique is developed by Prathma by providing a blood mobile van to give prominence to blood banking in the society and motivate voluntary blood donors, to donate blood at their door steps.
3.7 Prathma is operating its activity of blood banking as recommended by the World Health Organization(WHO). The first and foremost duty of any blood bank is to see that blood is collected from healthy volunteers with no risk behaviour. Today, India collects 8.1 million units of blood for a population of more than 1.15 billion which is a meagre 07% of the total population. When blood is so scarce, the optimum usage through componentization into RBC, Platelets and FFP is the only scientific way to meet the growing need of blood. About 5% i.e. equivalent of total population blood should be donated every year to meet the need of the society. The collected blood is separated into different blood components viz. Red cell, platelets and FFP. FFP is further separated into Cryo Poor Plasma [CPP] and Cryo precipitate. Thereafter, surplus plasma i.e. FFP and CPP are sent to plasma fractionation facility for making additional life saving medicines like ALBUMIN, IMMUNOGLOBIN, FACTOR VIII AND IX, FIBRINOGEN etc. Fractionation facility did not exist in India till very recent past. The Government of India through NACO is also proposing to plan such facility. It clearly recognizes that plasma fractionation is an additional support system required in modern health care and for transfusion medicine. In these circumstances, the allegations attributing motives against Prathama are unfounded, imaginary and there is lack of bona fides.
3.8 Prathma has also corrected the petitioner by submitting a detailed reply to his queries. Despite that, the petitioner has kept carrying his misconception. The allegation levelled against the Prathma that the directors of Celestial Biologicals Ltd. have controlling interest in Prathma is false and baseless. The petitioner seems to be indicating that the land given to the Prathma by Ahmedabad Municipal Corporation (AMC), the respondent no.6, has also been used for the purpose of objective of Celestial. However, the said fact is not correct and the same is made without any basis. It is pertinent to note that the above two organizations have professional working relationship only. Prathma is in the field of blood banking while Celestial is engaged in plasma fractionation.
3.9 1 unit of blood is made into 3 main components viz. red cells, platelets and Fresh Frozen Plasma [FFP]. Requirement of these 3 components directly by the patient is not in the ratio of 1:1:1. There is 100% demand of red blood cells, whereas platelets demand is about 30% of total blood collection and fresh frozen plasma demand is about 15-20% of total blood collection.
3.10 The surplus platelet has no medical use and those are destroyed after de-activation while Fresh Frozen Plasma has a pharmaceutical use. It can be converted into different types of plasma fractionation proteins in a facility called Plasma Fractionation Facility . It is pertinent to note that Drug Controller General of India [DCGI] gave permission to fractional company to collect surplus plasma from the blood banks.
3.11 It appears that in the year 2000 when Prathma came into existence, there was in existence only one fractionation facility centre available viz. National Plasma Fractionation Centre [NPFC] at KEM Hospital, Mumbai. In those days, there was a competition amongst the blood banks to get their plasma picked up by NPFC. At that time, NPFC used to pick up plasma from Prathma. There were few companies in India which ran fractionation activity. There is not an iota of evidence that Prathma used to sell plasma to Celestial at concessional rate. There were occasions when huge quantity of plasma remained unsold and the same was ultimately deactivated or discarded.
3.12 Prathma has already started selling plasma to Reliance Life Science from July 2011. Prathma had made last transaction with Celestial Biologicals Ltd. in March 2011.
3.13 Prathma has all the requisite licences, approvals and authorizations as are required under the applicable regulatory requirements and its accounts are regularly audited in accordance with the applicable statutory Rules and Regulations. Prathma is following guidelines provided by the National Blood Policy. The activities of Prathma are falling within the ambit of Drugs and Cosmetics Act, 1940.
3.14 The Government of India fully supports plasma fractions as life saving drug for the patients of the country. The Supreme Court itself in its historical judgment of 1997 advised the Government of India to set up various large blood banks as well as plasma fractionation centers. Around 60% to 70% plasma in a blood bank is not used, unless it is fractionated. It is only upon proper deliberation that the Drug Controller General of India has allowed the companies in India to undertake the activities of fractionation/contract fractionation.
3.15 So far as the allegation that the land given to Prathma by AMC has been used for the purpose and the objective of M/s. Celestial is concerned, the matter is sub judice before this Court. Prathma has challenged the action of AMC by filing an application being Special Civil Application No. 5392 of 2003 before this Court and this High Court [Hon ble Mr. Justice Jayant Patel] on 25th April, 2003 was kind enough to protect Prathma by passing status quo qua the possession of the land in question. The said order has been confirmed by subsequent order passed by this Hon ble Court [Hon ble Mr. Justice K.A. Puj] on 8th September, 2003. The petitioner has pressed into service unnumbered Civil Application for vacation of interim, relief preferred by AMC in Special Civil Application No. 5392 of 2003. Even otherwise, no order is placed in the petition which is passed below the unnumbered Civil Application. The petitioner should be directed to place on record the order passed below unnumbered Civil Application.
3.16 While receiving blood donation from a donor, a 5 ml sample is collected in EDTA [Ethylene Diamin Tetra Acetic]. This blood goes for testing. After testing is over, these samples are usually discarded as biohazard. However, Prathama developed a validated protocol to pool this sample and make them available to Contract Research Organization as pooled and tested EDTA plasma or pooled and tested EDTA Serum. Both the above are not drugs, not for human or animal use but only a reagent which is used for calibration of HPLC machines at various Contract Research Organizations [CROs]. Prathma used to give EDTA plasma to large number of organizations. In light of the above facts and circumstances, reliefs claimed against the respondent no.7 Prathma Blood Center requires to be turned down.
4. The Respondent no. 1 filed separate affidavit thereby making following defence:
4.1 The blood transfusion service in the respective States is implemented by the state-level functionaries. Department of AIDS Control [DAC] and National Blood Transfusion Council are making all efforts by working with the States and providing funds for augmenting voluntary blood donation. This aims at promoting voluntary non- remunerated blood donation and phasing out of replacement donation and thus, bridging the gap between demand and supply of blood and its components in the states. In accordance with the policy, all donors are to be counselled and provided information on the importance of voluntary blood donation under the programme.
4.2 The NBTC in its governing body meeting on 5th February, 2007 has issued guidelines to State Blood Transfusion Councils that no licence will be given to stand-alone blood banks for private commercial purposes.
4.3 The decision with regard to organization, monitoring and supervision of voluntary blood donation camps in a state lies with the concerned State Blood Transfusion Council in association with State AIDS Control Society.
4.4 In accordance with the National Blood Policy, trading of blood i.e. sale and purchase, is prohibited. Further, the voluntary blood donation programme aims at collection of blood through non-remunerated donation to meet the supply of blood and its components for clinical use.
4.5 The National Blood Transfusion Council [NBTC] is a policy- making body and implementation of all decisions taken by NBTC are in the purview of the State Blood Transfusion Council in co-ordination with the State Drug Authority. According to the existing directives issued by NBTC, the blood and blood components are supplied free of cost only to patients of Haemophilla, Thalessemia and Sickle cell anemia, by blood banks in the Government sector and under NACO support and at a subsidized rate to poor people as decided by the SBTC.
5. The respondent nos. 2 & 4 filed joined affidavit disclosing their stance in the following way:
5.1 None of the fundamental or legal right of the petitioner has been violated because of any action or inaction on the part of the respondent 2 & 4 and therefore, the present petition is not maintainable in law and the same deserves to be dismissed in limine.
5.2 The petitioner, in the present petition, has prayed for issue of writ of mandamus or a writ in the nature of mandamus or any other appropriate writ, order or direction directing respondent nos. 2, 3 and 5 to inquire into the distribution channels of all the blood banks and take steps against such blood banks which are found to be trading in blood or its components or are found to be selling blood or its components for any purpose other than clinical use. The petitioner has also prayed for appointment of committee for investigating and preparing a report on the demand for whole human blood or its components to various hospitals in the State the quantum of collection of blood by various blood banks, the end use of blood/its components collected/manufactured by the blood banks, the prices at which blood or its components are made available by the blood banks and for all matters connected with distribution of the blood collected by blood banks. The petitioner has also prayed for direction upon the respondent nos. 2, 3 and 5 to monitor public blood donation camps and prohibit all blood banks supplying blood or its components to M/s. Celestial Biological Ltd. or M/s. Lambda Therapeutic or any other organization for non-clinical use and prohibit such blood banks from holding public blood donation camps and such other similar prayers as mentioned in the petition.
5.3 It would be necessary for this Court to consider several legal provisions as well as the object of Drugs and Cosmetics Act, 1940 under which State Government being one of the licensing authority, has granted licence to respondent no. 7 for the purpose of establishing blood banks and preparing several components from whole human blood. The licence given to the respondent no. 7 has been granted in Form No. 28-C, in which there are certain conditions, which are to be fulfilled by the licensee. It is required to be noted here that the said licence is mainly for the purpose of establishing blood banks as well as for the purpose of preparing certain components from whole human blood. The said blood banks are required to obtain permission from the State Government as well as Central Government to prepare other components from whole human blood.
5.4 The object of the said Act of 1940 is to regulate import, manufacture, distribution and sale of Drugs and Cosmetics. If the object of the said Act of 1940 along with legal provisions and schedule are considered by this Court, it would be very clear that the prayer made by the petitioner in the present petition, seeking direction to inquire into the distribution channel of all blood banks and taking necessary steps, if the concerned blood banks are found trading whole human blood or its components, is beyond the power of the State Government and as such, cannot inquire into the said aspect.
5.5 The objects of the said Act are very clear and specific, giving only regulatory powers of manufacturing, importing, distributing and sale of Drugs and Cosmetics. The Rules framed under the Act do not give powers to the State Government to check upon profiteering done by the blood banks established under the said Act. The said powers are only given to National Blood Transfusion Council. This can be observed from its object which is forming part of this petition being Annexure-B to this petition. The objective of NBTC is that it shall be developed to ensure establishment of non-profit integrated National and State Blood Transfusion Service in the country. There are several such other objects of NBTC, which on perusal make it very clear that the State Government would not be liable or responsible for looking into profiteering on trading of whole human blood. The role of the State Government is very limited in the said issue after taking into consideration certain requirements for the functioning and operation of the blood banks and/or preparing of blood components. The said detailed procedure is incorporated in Schedule-F of Drugs and Cosmetics Rules 1945. The said procedure is to be followed at the time of establishment of blood bank. The State Government as well as the Central Government is bound to fulfill the procedure and requirements mentioned in the Schedule-F. On following the said procedure and after filing of the Form No. 27-C by the concerned applicants, the State Government which is one of the Licensing authorities prepares licence in form No. 28-c and forwards the same to the Central Government i.e. Drugs Controller General [India], a licence approving authority, for its final approval. The Central Government, on receipt of the said form along with joint inspection report of the State Government as well as Central Government i.e. Drugs Controller General [India], independently scrutinizes and verifies the said details submitted by the State Government and approves the licence for establishment of blood bank. It is also required to be noted here that even Central Government may not have powers to inquire into aspects of profiteering which is the issue involved in the present petition. As mentioned above, it is only NBTC, who has the authority and power which is cast upon it by the Hon ble Supreme Court of India by laying down certain guidelines in the case of Common Cause vs. Union of India reported in AIR 1996 SC
929. 5.6 Even if this Court considers that in Rule 122EA enacted under the Drugs and Cosmetics Act being Drug and Cosmetics Rules, 1945, there are several conditions which are mandatory in nature, in the said Rules, there is no such provision which gives powers to the State Government to inquire into profiteering aspect as contended in the present petition. Therefore, under the Drugs and Cosmetics Act, 1940, the role of the State Government is very limited as mentioned above which is only qua the issue of licence and renewal thereof and the conditions mentioned in the Act, Schedule and Rule are also in light of the issue of licence and renewal. The State Government is only one of the licensing authorities, whose proposal for establishing blood banks would be finally dealt with by the Central Government. Even the judgment of the Supreme Court laying down guidelines on this issue does not empower the State Government to look into the said aspects as prayed by the petitioner.
5.7 In view of the facts and circumstances stated herein above, this petition deserves to be dismissed against respondent nos. 2 and 4 in the interest of justice. Moreover, the petitioner is not entitled for any of the relief as prayed for in the petition against respondent nos. 2 &
4.
6. The Respondent no. 5 by its affidavit took the following stance:
6.1 Every blood bank must follow the directives given by the GSCBT to conduct Outdoor Blood Donation Camps in their territorial [District] limits, so that every blood unit collected during the camps can be separated within the 6 hours time-limit for maintaining the quality of blood components in accordance with the Drugs & Cosmetics Act, 1940.
6.2 Every blood bank having permission for Outdoor Blood Donation Camps must have to follow Rules and Regulations of Drugs & Cosmetics Act, 1940 which says that the designated Regional Blood Transfusion Centre, Government blood bank, Indian Red Cross Society and a licensed blood bank run by registered voluntary or charitable organizations recognized by State or Union Territory Blood Transfusion Council shall intimate within a period of seven days, the venue where the blood camp was held and details of groupwise blood units collected in the said camp to the Licensing Authority and Central License Approving Authority.
6.3 Every blood bank having permission for Outdoor Blood Donation Camps should also follow the Operational Guideline-2007, for Voluntary Blood Donation Programme , published by National Aids Control Organization, Ministry of Health and Family Welfare, Government of India, New Delhi.
6.4 Every blood bank should have adequate transportation facility with cold chain maintenance and for that purpose, should have the Standard Operating Procedure [SOP] for Outdoor Blood Donation Camp.
6.5 Every blood bank should have adequate equipments to store blood and blood components according to their collection with adequate manpower for smooth functioning of blood banks.
6.6 All blood banks must display the stock in detail with blood groups daily on their website and also on the website of Drugs Control Authority and the website of the Gujarat State Council for the Blood Transfusion and/or any nodal agency approved by the State Government/GSCBT.
6.7 Blood banks may dispose of excess plasma for plasma fractionation after meeting the patient s requirements [Fresh Frozen Plasma & Cryoprecipitate] and keeping adequate stock in reserve. Whatever amount of money is received by the concerned blood banks should be deposited in the account of State Government or nodal agency approved by State Government/GSCBT. This money should be utilized for the development of blood transfusion services and for blood product processing like plasma fractionation in the State, to ensure equitable availability in all parts of the State and to uniformly strengthen the activity through the State.
6.8 All hemophilic, sickle Cell Anemic and thalassemic patients will be supplied blood and blood components free of charge.
6.9 The responsible officer in charge of blood bank will submit quarterly report in writing to the Drugs Control Authority and GSCBT that no patient has been charged more than what is prescribed by NACO [National AIDS Control Organization] and GSCBT, and that no extra charges have been levied from the patients or his/her relatives in any form. No additional cost can be charged for any additional tests and blood supply during night.
7. The Indian Red Cross Blood Bank, Ahmedabad by its affidavit has disclosed its stance as follows:
7.1 The blood is an important life saving drug and every blood bank in the country is operational under direct licensing from Food and Drugs Administration. All blood banks are covered under the Drugs and Cosmetics Act, 1940. The collection of blood is a philanthropic activity and now-a-days it also involves various latest technical expertise including human resource, latest technology and state of the art equipments. The blood bank licence is issued with very stringent Rules and Regulations. The blood banking system is very effectively regulated in India by both the Director General of Health Services [DGHS] from Central Government and the State Food and Drug Control Administration [FDCA] along with Gujarat State Council for Blood Transfusion [GSCBT]. The licence is valid for a period of 5 years and after the said period, every blood bank has to apply for renewal. On such application for renewal, again the Central and the State FDA team come for inspection of blood bank before giving renewal of licence. The respondent no. 10 is not only doing work of collection of blood, but is also making the blood components in a very scientific way as per today s need, strictly adhering to Standard Operating Procedure [SOP] as per the DGHS and FDA rules and therefore, there cannot be any violation of any of the rules as alleged by the petitioner.
7.2 Indian Red Cross Society [IRCS], Ahmedabad District Branch, has been actively running the Ahmedabad Red Cross Blood Programme for the past around 50 years. It started its component and fractionation facilities in 2003-04, upon getting recognition as a Regional Blood Transfusion Centre from the Gujarat State Blood Transfusion Council.
7.3 IRCS is committed to rendering humanitarian service to the needy and suffering and accordingly, it is devoted to offering its best services at the most affordable rates. In view of the same, the blood units and components offered to patients of IRCS are at rates, which are among the lowest from the blood banks in Ahmedabad.
7.4 Since 1983, IRCS has also been rendering services to the Thalessemia child patients by offering them blood transfusion, iron chelating treatment and paediatric care. Today, the Ahmedabad Red Cross Blood Programme has nearly 700 Thalessemia children in its fold [the largest single programme in the country], who are offered absolutely free blood transfusion and paediatric care at its blood transfusion centre, round the year. IRCS blood transfusion centre is required to spend over Rs. 50 lac per annum for the free services rendered to Thalessemia children. With the Indian Red Cross Society Blood Bank [IRCS], 703 patients suffering from Thalessemia have been registered. They are dependent on IRCS for their requirement of blood transfusion. IRCS, Ahmedabad runs a dedicated Champaben Chudgar Thalassemia Blood Transfusion Centre which transfuses blood to such affected children. In the last three years [April 2010 to March 2013] 15,943 units of blood was transfused free of charge to thalassemiac children. During the same period, 1739 patients of haemophilia and 1,188 poor patients have received blood absolutely free of service charges from the IRCS as detailed below:
Details of Free Blood supplied from April 2010 to March 2013 [3 years] Units supplied to thalassemia patients 15,943 Units supplied to haemophilia patients 1,739 Units supplied to poor patients 1,188 Units supplied to Govt. Hospital patients 3,947 Total 22,817 7.5 Apart from free supply and transfusion of blood units as referred above to the needy patients, IRCS, Ahmedabad also provides paediatric care and free iron chelation therapy [to reduce iron overload which could be cause of death] to thalassemia patients. All these treatments also add cost to Red Cross Ahmedabad.
7.6 While Fresh Frozen Plasma [FFP], a component extracted from fractionation of blood at the IRCS blood bank is offered free of charge to haemophilia patients, a nominal service charge of Rs. 400/- is collected from other patients. However, FFP units, remained unutilized, after supply to all patients, were sent for further fractionation to Celestial Biologicals Ltd. It is pertinent to note that there is no government agency for collection of unutilized plasma and hence, the FFP units were required to be given to Celestial Biologicals Ltd., a private agency, but which is duly approved for the purpose. The average realization in this regard is Rs. 240/- per unit which works out to Rs. 1,200/- per litre. This arrangement was made effective by IRCS from August, 2010, with the following objectives:
[a] To ensure that the FFP units not required for use by patients do not expire and come to be discarded.
[b] To meaningfully generate financial resources for the fast growing thalassemia care, awareness and prevention activities, undertaken by IRCS. As referred to hereinabove, the blood transfusion, iron chelating and paediatric care alone, calls for an annual spending of over Rs. 50 lac.
7.7 In view of the order of this Court dated 1st April, 2013, IRCS wishes to give the following suggestions for effective utilization of blood collected from voluntary donors as under:
[a] Blood banks should strictly comply with the rates of service charges as prescribed by NACO for supply of blood and blood components to the public at large.
[b] Blood and blood components should be made freely available [without seeking any replacement] to all patients suffering from thalassemia, haemophilia and sickle Cell Anaemia, absolutely free and without collection of any service charges for the purpose.
[c] Blood banks should strictly follow Standard Operation Procedures [SOP] as per DGHS & FDA Rules.
[d] Blood banks should plan for optimum utilization of blood collected from voluntary blood donors by focusing on blood component separation.
[e] The funds received from selling of various unutilized blood components such as FFP etc., should be earmarked for use of promotion of the voluntary blood donation movement and spreading awareness amongst public at large on the prevention of blood related diseases such as thalassemia, HIV Aids, and care of patients suffering from thalassemia, haemophilia, etc.
8. Mr. Contractor, the learned advocate appearing on behalf of the petitioner, at the very outset, emphasised on the question of profiteering by the blood banks. Mr. Contractor submits that the law governing Blood Banking have been framed under the umbrella of the National Blood Policy framed pursuant to the directions of the Supreme Court in the case of Common Cause v. UOI reported in 1996 AIR SC 929, thereby specifically pointing out that there may be no profiteering in Blood Banking activities and that the Government should ensure proper availability of Blood and its components to one and all. Mr. Contractor submits that in spite of the fact that National Blood Policy aims at curbing profiteering , there is nothing in the governing law or the rules to describe what constitutes profiteering . Mr. Contractor further submits that the governing law neither prescribes what constitutes an offence qua profiteering , nor does it provide the requisite punitive actions for the same, and taking advantage of the aforesaid lacuna, certain Blood Banks are indulging in activities which are wholly unethical and immoral, tantamount to exploitation of the donor and the donee, and are against the very fundamental right guaranteed under Article 21 of the Constitution of India.
8.1 Mr. Contractor further submits that in spite of the fact that Ahmedabad is the second highest voluntary Blood collecting cities in the world, the Government and Municipal hospitals are always in a perpetual deficit in the supply of blood and its components whereas the private hospitals, which procure Blood from private Blood Banks, never face shortage of blood and its components. This, according to him, has resulted in an unequal and uneven distribution of Blood and its components, which often leads to surgeries being deferred for the want of Blood at such Government and/or Municipal Hospitals. Mr. Contractor further contends that most of the Blood Banks blatantly sell Blood and the components at rates which are much higher than the rates prescribed by the Ministry of Health and Family Welfare. Mr. Contractor complains that a Blood Bank, which constitutes more than 51% of the Blood Banking activities in the city of Ahmedabad (and almost 25% of the Blood Banking activities in Gujarat), in addition to selling Blood at the higher rates, does not even consider it necessary to fulfill the mandatory requirement of giving Blood and its components free of cost to all patients suffering from Heamophilia and Thalassemia.
8.2 Mr. Contractor, therefore, submits that this Court, in this Public Interest Litigation, should pass directions or guidelines which may form the directive principles for the respective Central and State authorities to ensure the enforcement of the National Blood Policy.
8.3 In this connection, Mr. Contractor has proposed two categories of suggestions; first, the suggestions which can be immediately implemented under the existing provisions of law, and secondly, the suggestions which may require framing of specific guidelines.
8.4 As regards the suggestions relating to the category-I referred to above, Mr. Contractor s suggestions are as follows:-
1. Scrutinize the Top 7 Blood Banks which constitute 61% of the Blood Banking in Gujarat.
[a]. As is evident from the data collected from various Blood Banks (and summarized in the affidavit filed on 1st April, 2013), out of the 142 Blood Banks operating in Gujarat, only 7 Blood Banks constitute almost 61% of the total Blood Banking activities in Gujarat. Never has any independent agency carried out any scrutiny or audit of the activities of the aforesaid Blood Banks.
[b]. In order to ensure that the Blood Banking activities are devoid of any malpractices of profiteering activities, it is imperative that a thorough investigation be carried out of the functioning of the aforesaid Blood Banks, including an assessment of the requirement vis-a-vis the actual collection.
[c]. Blood Banking activities are regulated under the Drugs and Cosmetics Act, 1940 ( Act ) and the Drugs and Cosmetics Rules, 1945 ( Rules ). The statutory provisions in relation to the manufacturing, sale and distribution of drugs (which includes within its ambit, Blood and Blood components), are provided in Chapter IV of the Act. The aforesaid statutory provisions, in terms of Section 33 of the Act, grant the power to the Central Government to frame rules in relation to the manufacturing, sale and distribution of drugs. Consequently, Part X-B of the Rules and Part XII-B of Schedule-F have been framed to regulate Blood Banking activities. The aforesaid statutory provisions of Chapter IV, vide Section 21 and 22 of the Act, provide widespread powers to the Central as well as the respective State Government to appoint inspectors with prescribed powers to carry out investigations. The relevant extract of the provisions of Section 21 and 33 of the Act are reproduced hereunder for reference:-
21.
Inspectors (1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central Government or the State Government, as the case may be.
(2) The powers which may be exercised by an Inspector and the duties which may be performed by him, the drugs or classes of drugs or cosmetics or classes of cosmetics in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed shall be such as may be prescribed...
33 Powers of Central Government to make Rules (1) The Central Government may after consultation with, or on the recommendation of, the Board and after previous publication by the notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter:
Provided that consultation with the Board may be dispensed with if the Central Government is of the opiniont that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case the Board shall be consulted with six months of the making the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.
[d]. In view of the aforesaid, this Court should enforce the objective of the National Blood Policy and to protect the fundamental rights of the donor and the donee, should direct the respective authorities to form a team, which may be headed by a Retired Judge of this Court, to investigate into the affairs of the Top-7 Blood Banks which constitute almost 61% of the total Blood Banking in the State of Gujarat. A report of the investigation be then placed before this Court, for its consideration and further directions.
2. Strict adherence to the prescribed rates.
[a]. As stated in the foregoing paragraphs, most Blood Banks blatantly sell Blood (and Blood components) at rates which are much higher than the rates prescribed by the Ministry of Health and Family Welfare, vide the Notification dated 23rd January 2008. Further, a Blood Bank, which constitutes more than 51% of the Blood Banking activities in the city of Ahmedabad (and almost 25% of the Blood Banking activities in Gujarat), in addition to selling Blood at the higher rates, does not even consider it necessary to fulfill the mandatory requirement of giving Blood and its components, free of cost, to all patients suffering from Haemophilia and Thalassemia.
[b]. The aforesaid act tantamounts to a blatant disregard and a naked violation of the directions of the respective authorities. In spite of the aforesaid, there is nothing that is being done against such erring Blood Banks. Rule 122-O of the Rules, at the least, provides for the cancellation / suspension of licenses of erring Blood Banks, by the Licensing Authority. The aforesaid Rule clearly gives the power to the Food and Drugs Controlling Authority (which is the Licensing Authority) to cancel / suspend the licenses of the erring Blood Banks, after taking into consideration the report / suggestions from the respective State Council for Blood Transfusion. The relevant extract of the aforesaid rule 122-O is reproduced hereunder:-
122-O Cancellation and suspension of licenses (1) The Licensing Authority or Central License Approving Authority may for such licenses granted or renewed by him, after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons thereof, cancel a license issued under this part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it related or direct the licensee to stop collection, storage, processing, manufacture and distribution of the said substances and thereupon order the destruction of substances and stocks thereof in the presence of an Inspector, if in his opinion, the licensee has failed to comply with any of the conditions of the license or with any provisions of the Act or Rules thereunder...
[c]. In view of the aforesaid Rules, and in the absence of an inclination on the part of the authorities to take actions against the erring Blood Banks, this Court, should enforce the objective of the National Blood Policy and protect the fundamental rights of the donor and the donee should (i). direct all Blood Banks to adhere to the prescribed rates, and (ii). direct the Food and Drugs Controlling Authority in consultation with the Gujarat State Blood Transfusion Council to cancel/suspend the licenses of the erring Blood Banks.
3. Direct Respondent No. 7 to adhere to the conditions set-out by the Ahmedabad Municipal Corporation [a]. Respondent No. 7 has been given land at a rate of Rs.101/- p.a. for 99 years, by the Ahmedabad Municipal Corporation (Respondent No. 6). One of the conditions set out as a part of the aforesaid deal was that the Respondent No. 7 shall give 10% of all Blood collected, free of cost, to the hospitals run by the Ahmedabad Municipal Corporation, and the balance requirement of the hospitals run by the Ahmedabad Municipal Corporation shall be fulfilled by giving Blood at 30% discount from the prescribed rates.
[b]. The situation, as is prevalent today, is that despite the shortages and deficit, the hospitals run by the Ahmedabad Municipal Corporation do not seek its quota of Blood from Respondent No. 7, and neither does the Respondent No. 7 fulfill the aforesaid obligation. This effectively leaves the patients at such Municipality-run-hospitals to suffer, despite there being a secured allocation of Blood and its components.
[c]. It may be pertinent to note that, in a similar case, the Division Bench of the Delhi High Court in the case of Social Jurist, A Lawyers Group v. Government of NCT of Delhi And Ors. reported in 140 (2007) DLT 698, while directing the hospitals (which received land at concessional rates) to adhere to the conditions of the allotment letter, which effectively resulted in directing the hospitals to render free treatment to a certain specified percentage of patients. One striking observation of the Delhi Court is extracted hereunder:-
In case the hospitals have succeeded in breaching the condition, it means cornering of huge amounts of monies, which were not due to them. In case these hospitals have made unwarranted profits by breach of the terms of allotment of lands to them, the amounts should be recovered and a pool should be set up for the health care of the people.
[d]. Given the aforesaid, this Court should enforce the objective of the National Blood Policy and to protect the fundamental rights of the donor and the donee, and should put Respondent No.7 (and all other Blood Banks which may have been put to such terms) to appropriate terms in order to ensure strict compliance of the conditions set-out in the allotment letter.
4. Direct Municipal and Government hospitals, having license to hold Blood camps, to actually hold Blood camps to satisfy the requirement of Blood.
[a]. Most Municipal and Government hospitals possess licence to to hold Blood camps. In spite of the Blood shortage that these hospitals encounter, these hospitals do not take enough initiatives of conducting regular Blood camps to satisfy the requirement of Blood, and often depend on replacement donors. In cases where the patient is unable to arrange for a replacement, treatments are deferred, delayed or even refused.
[b]. In view of the aforesaid, this Court should direct such Government and Municipal hospital to conduct Blood camps, regularly, based on the assessment of requirement. The Gujarat State Blood Transfusion Council may be entrusted with the responsibility of ensuring that these hospitals first conduct own Blood camps, and only in case of shortage seek replacement.
8.5 As regards the suggestions relating to Category-II regarding framing of appropriate guidelines, Mr. Contractor s suggestions are as follows:
1. Profiteering [a]. In spite of the fact that National Blood Policy aims to curb profiteering , there is nothing in the governing law or the rules to describe what constitutes profiteering . Further, the governing law neither prescribes what constitutes an offence qua profiteering , nor does it provide the requisite punitive actions for the same. Taking advantage of the aforesaid lacuna, as has been highlighted vide the present petition, certain Blood Banks have sought to indulge in activities which are wholly unethical and immoral, tantamount to exploitation of the donor and the donee.
[b]. In this regard, the term profiteering ought to be construed keeping in mind the broader principles of the National Blood Policy. It may be pertinent to refer to certain terms which may broadly define what constitutes profiteering :-
Black's Law Dictionary (5th Edition) defines profiteering as taking advantage of unusual or exceptional circumstances to make excessive profits.
The aforesaid definition has also been relied upon by the Supreme Court in the case of Islamic Academy of Education v. State of Karnataka reported in 2003 6 SCC 697.
In State of Gujarat v. Raipur Mfg. Co. Ltd. reported in AIR 1967 SC 1066, the Supreme Court in relation to profit motive has stated as follows:-
By the use of the expression 'profit motive', it is not intended that profit must in fact be earned. Nor does the expression cover a mere desire to make some monetary gain out of a transaction or even a series of transactions. It predicates a motive which pervades the whole series of transactions effected by the person in the course of his activity. In actual practice, the profit motive may be easily discernible in some transactions; in others it would have to be inferred from a review of the circumstances attended upon the transaction.
[c]. Given the aforesaid, and taking into consideration the interpretation adopted by the Supreme Court in a plethora of case relating to 'right to education', the term profiteer goes much beyond the ambit of simply numbers, and the issues raised in the present petition, fall within the ambit of the term profiteering , something which is clearly impermissible under the National Blood Policy.
[d]. In view of the above, this Court should enforce the objective of the National Blood Policy and protect the fundamental rights of the donor and the donee, should issue directions to the Central Government to frame appropriate Rules (in terms of the powers vested vide Section 33 of the Act), under the Act, to help define the contours of the term profiteering , prescribe the offences in this regard, and provide for punishment and prosecution to all indulging in such ghastly activities as the cost of the donor and the donee.
2. Unaccounted sale of plasma to pharmaceutical companies [a]. It has been time and again brought to the notice of this Court, the fact that certain Blood Banks engage in a disproportionate collection of Blood, simply to provide raw material to pharmaceutical companies manufacturing plasma related medicines. Plethora of evidence has been placed on record, including details which raise concerns over the functioning of a Blood Bank (whose sister concern only manufactures plasma related medicines), to buttress the aforesaid.
[b]. Plasma is the most important raw material for making various life saving medicines, and pharmaceutical companies cannot be deprived of this source, as the same will directly impact the production of these medicines. While the source of making life saving medicines cannot be stopped, certain important measures ought to be taken to ensure that the unethical practices come to an end:-
* All medicines and medicinal preparations for which the primary raw material is Blood plasma, ought to be classified as an 'essential drug', and no profit making must be permitted.
* All Blood Banks and pharmaceuticals companies (which procure plasma from the Blood Banks) must be subjected to some form of a periodic scrutiny to ensure ethical practices;
* The fact that a specified percentage (qua the total Blood collected) of Blood plasma is sold to pharmaceutical companies at a particular price, for making certain specified type of medicines (along with the price range in which such medicines are sold) must be prominently displayed at all Blood collection centres and camps, to ensure that the voluntary Blood donors are aware of this fact.
* Blood Banks must only be permitted to collect Blood from within a 100 km radius, in order to ensure storage in an appropriate manner, so as to keep the plasma worthy of being transfused into patients.
[c]. In order to ensure there are no malpractices in this regard, it is pertinent that appropriate regulations are framed, which regulate the assessment of plasma requirement, the collection of plasma and the sale of plasma to pharmaceutical companies.
[d]. This Court may also consider the formation of a nodal entity, which shall solely be responsible for collecting the plasma from Blood Banks, at predetermined rates, and then giving the same to the relevant pharmaceutical companies for manufacture of plasma related medicines. The revenues that accrue out of the aforesaid activities of the nodal entity, must be used, in turn, to procure equipment and machines that can fractionate plasma, with an intention to equip the state to develop the plasma fractionation facilities.
3. Sufficient supplies to all patients in need [a]. The primary objective of the National Blood Policy is to ensure appropriate availability of Blood and its components to one and all. Sadly, the aforesaid objective is far from being achieved, and the people who suffer the most due to the skewed allocations are the poor and economically down trodden, who cannot afford the higher rates collected by the Blood Banks or who cannot ensure replacement of the Blood.
[b]. To achieve the aforesaid objective of the National Blood Policy, this Court may direct the framing of such guidelines in terms of which,
(i). every Blood Bank is mandatorily:-
* required to get affiliated with a Government / Municipal hospital which Respondent No. 5 (Gujarat State Council for Blood Transfusion) directs, after an appropriate assessment of the requirement of Blood in a particular hospital/area;
* directed to earmark a specified percentage of total Blood collection to be supplied free of cost to the respective Government / Municipal hospital;
* directed to earmark a specified percentage of total Blood collection to be supplied at concessional rate to the respective Government / Municipal hospital.
(ii). every Blood Bank, Storage Centre, and Hospital must display (very prominently at its reception area) the maximum amount prescribed by Respondent No. 1, for whole Blood and the respective components, which can be recovered by Blood Banks from patients;
(iii). Giving of incentives (in cash or in kind) to Blood camp organizers, by Blood Banks, must be strictly prohibited, and all incentives given to donor must be standardized.
[c]. The aforesaid guidelines / directions will fully serve to protect the fundamental right granted under Article 21 of the Constitution of India, and ensure that the National Blood Policy is adhered to.
4. Formation of a Committee.
[a]. In addition to the aforesaid, there are various issues and technicalities which have been raised by various Blood Banks.
[b]. To appreciate and consider all the issues relevant to regulating Blood Banking activities, this Court may consider the formation of a Committee headed by a Retired Judge of this Court, which can delve into the issues that all concerned parties may place before it, and submit a final report to this Court for its consideration and further action.
9. After entertaining this Public Interest Litigation and after going through the affidavits filed by the parties, this Court found that every licensee dealing with whole blood is required to collect the whole blood and thereafter, supply the same in the same form i.e. whole blood and if the license holder is having license for preparing the components, in that case, he is required to undergo the procedure for collection, separation and storage of the blood within six hours of the collection of blood which is reflected in the Schedule F , Part XII-B, Chapter-III, Part-E[4], Fresh frozen plasma, in the Drugs and Cosmetics Rules, 1945. It further appears that according to the provisions referred to above, the plasma has to be stored at minus 30 degree centigrade and the same could be preserved for a period of not more than a year. Thereafter, it should be discarded or sent for any other purpose by the blood bank. But at the same time, it is incumbent upon the blood banks to store it for one year for the benefit of the patients. It further appears that once the blood is collected, the plasma from the blood has to be separated and stored at minus 30 degree centigrade. But when the voluntary blood donation camps are held at a distant and far away places, the blood so collected may not reach the blood bank for separation and storage within the period of six hours which might make the plasma contained therein unfit for the purpose of storage and usage to the patients. It may also give rise to a situation wherein the blood banks are likely to take advantage by contending that as the plasma is unfit for consumption by the patients, the same has to be sent for fractionation.
10. We further noticed that according to Schedule F , Part XII-B, Clause-L under the Drug and Cosmetics Rules, 1945, it is mandatory for all the blood banks to keep all the records for checking and functioning of the blood banks.
11. In such circumstances, this Bench, on 20th December, 2012 issued notice to all 145 blood banks, which are functioning within the State of Gujarat, to disclose to this Court whether the formalities required under the aforesaid provisions were complied with by those blood banks. We further directed those blood banks to disclose whether they were complying with the requirement of collection, separation and storage of the blood within six hours of its collection as reflected in the Schedule F Part XII-B Part-E[4] fresh frozen plasma, in the Drug and Cosmetic Rules, 1945. We also directed those blood banks to disclose whether they complied with the formality of storing plasma at minus 30 degree centigrade within six hours of its collection. We further directed those blood banks to furnish necessary information as to the quantity of plasma separated every month, quantity of plasma supplied to the patients every month and the quantity of plasma sent for further fractionation every month.
12. Pursuant to such directions, affidavits have been filed by several blood banks. Subsequently, we also directed all the parties who were added as respondents, to give suggestions for the purpose of resolving the issue raised in this Public Interest Litigation.
13. After hearing the learned counsel for the parties and after going through the materials on record, we find that once the blood is collected, it is separated into different blood components, i.e., red blood cells, platelets, fresh frozen plasma [FFP]. FFP is further separated into cryo-precipitate and cryo-poor-plasma [CPP]. Thereafter, the surplus plasma, i.e. FFP and CPP is sent to the Organization having plasma fractionation facility for making additional life saving medicines such as Albumin, Immunoglobulin, Factor VIII, Factor IX and Fibrinogen. The process of fractionation is a complex and capital intensive process. Until very recent past, there did not exist any fractionation facility in India. There is only one such factory in India, run by Reliance Life Science, in comparison to more than 20 in China. The surplus plasma which can be fractionated into the above referred life saving medicines, if not fractionated within one year of its storage [storage at minus 35 degree centigrade in ultra-modern storage facility], would go waste and would have to be destroyed, as per the rules framed under the Drugs and Cosmetics Act, 1940. On account of the advancement in biotechnology, the fractionation of surplus plasma has been invented so as to manufacture life saving medicines as stated above. Moreover, manufacturing of the above stated medicines from the artificial chemicals is not only highly expensive but is also proved to be not acceptable for being infused in the blood and as such, the surplus plasma lying with the blood banks separated from the whole blood is not only permitted but is encouraged by the government to be used for further fractionation rather than allowing it to go waste to be destroyed.
14. It, therefore, appears that the red cells are the chief component and highly in demand in our country, where Anemia [low hemoglobin] is so much prevalent. All other components, i.e. platelets, plasma and cryo-precipitates are the by-products, but they have their own indications and highly desirable in certain specific conditions. It further appears that by and large, all the blood banks utilize their stock of red cells and in fact, they fall short of the same. But platelets and plasma are utilized up to 20-30% of the stock. It further appears that due to short shelf life of 5 days only, the surplus platelets are discarded by the blood banks. The plasma has a shelf life of one year at minus 30 degree centigrade and the surplus plasma is the only source for other life saving drugs like Albumin and Factor VIII.
15. It appears from the materials on record that there are following six types of blood banks:
[A].
Hospital-based blood banks in the government hospitals.
[B].
Hospital-based blood banks run by the corporate hospitals.
[C]. Stand-alone blood banks run by the Indian Red Cross Society.
[D]. Stand-alone blood banks run by the NGOs.
[E[. Stand-alone private blood banks.
[F]. Regional blood banks.
16. The blood banks can also be categorized in the following different categories:
[a]. Blood bank providing only whole blood.
[b]. Blood bank providing whole blood and/or blood components.
[c]. Blood bank providing whole blood and/or blood components as well as Aphaeresis services.
[A].
HOSPITAL-BASED BLOOD BANKS IN THE GOVERNMENT HOSPITALS:
These blood banks get everything from the government including infrastructure, manpower, equipments, reagents and other consumables. Generally they give blood/BC free of cost to the patients of the government hospitals with service charge from the patients from outside hospitals.
[B].
HOSPITAL-BASED BLOOD BANKS RUN BY THE CORPORATE HOSPITALS:
These types of blood banks generally aim at maintaining the highest standards of quality even if higher amount of cost is involved. Many of the corporate hospital run blood banks maintain quality equal to developed countries.
[C]. STAND-ALONE BLOOD BANKS RUN BY THE INDIAN RED CROSS SOCIETY:
Such blood banks generally get funding from the government as well as from the management of the Indian Red Cross Society. They take service charge from the patients that differs from blood bank to blood bank.
[D]. STAND-ALONE BLOOD BANK RUN BY THE NGOS.:
These blood banks also generally get funding from the government as well as from the Trust management. They take service charge from the patients that differs from blood bank to blood bank.
[E]. STAND-ALONE PRIVATE BLOOD BANKS:
These kinds of blood banks are not getting any funding from the government or other agencies. They take service charges from the patients which differ from blood bank to blood bank.
[F]. REGIONAL BLOOD BANKS:
Big blood banks of any category passing certain criteria can take the designation of Regional Blood Bank from the Gujarat State Council of Blood Transfusion [GSCBT]. These blood banks have certain privileges and get help from the government also. They take service charge from the patients that differs from blood bank to blood bank.
16.1 THE ESSENTIAL REQUIREMENTS OF RUNNING OF THE BLOOD BANKS:
[i]. To run a blood bank, a license is required from the Food and Drugs Control Administration [FDCA] Department, Department of Health and Family Welfare, Government of India.
[ii]. License is valid only for 5 years, i.e. every 5 years, a blood bank has to apply for license and after inspection from the FDCA, it gets the license if it is found eligible.
[iii]. There are definite rules and regulations provided by the FDCA in the form of Drugs and Cosmetic Rules which are mandatorily followed by every blood bank.
[iv]. Blood bank has to take approval of all newly recruited technical staff from the FDCA.
[v]. Blood bank has to inform the FDCA for leaving of any technical staff.
[vi]. Blood bank has to inform the FDCA of any change in the floor plan.
[vii]. Blood bank has to inform the FDCA for any change in the Constitution.
[viii]. Gujarat State AIDS Control Society [GSACS] which is a State branch of the National AIDS Control Organization [NACO], inspects the blood banks from time to time and keeps control on the blood banks by providing different guidelines. Blood banks also send monthly report to NACO through the GSACS.
[ix]. Gujarat State Council for Blood Transfusion [GSCBT] which is a State branch of the National Blood Transfusion Council [NBTC], inspects the blood banks from time to time and keeps control over the blood banks by providing different guidelines. In addition to that, daily stock of blood/blood components of all the blood banks is updated on the GSCBT website.
[x]. Total 12 blood banks of Gujarat [5 from the Government, 5 from the NGOs. one from private and one from corporate hospitals] are accredited from NABH [National Accreditation Board for Hospitals and Healthcare Providers] which is the highest accreditation body of the Government of India. These blood banks are supervised and inspected by the NABH to retain the accreditation.
17. As regards the problem of profiteering from plasma, it may be mentioned that establishing and maintaining a blood bank with component facilities, is a very expensive affair. Extra cost of space, expensive equipments, manpower, electricity, costly consumables make component separation expensive. It goes loss making if all the components made from whole blood are not utilized in sufficient quantity. Red cell component is the prime and most desirable component of blood and the other components are by-products. Red cell is used to the fullest extent, but the plasma and platelets are partially used. It has been seen that in most of the centres, plasma and platelets used for patients are less than 20%. For extra plasma, blood bank has choice either to throw it away or to give it to the fractionation agency to make life saving drugs from the said plasma. No blood bank wants to give any plasma for fractionation if it is required by patients as the service charge for patients is generally more than the one given by the fractionation agencies.
18. Therefore, the first and foremost question that falls for determination in this Public Interest Litigation is whether any of the Blood Bank, for the red blood cell component, is indulging in charging more than the rate prescribed by the Ministry of Health and Family Welfare indicated in pages 209 and 212 of this application. It appears that according to the guidelines, the supply of blood should be free of cost to the Haemophilia and Thalassemia patients. It, however, appears that there is no clear law as to what constitutes profiteering, what is the offence qua profiteering and what should be its penal consequence; as a result, the blood banks are given free hand to interpret the law in the manner to suit their convenience and in spite of apparent violations, the regulatory authorities have failed to initiate any action against an errant blood bank. It further appears that no audit or investigation has been undertaken to ensure that the blood banks function to further the objective of the National Blood Policy. We are of the opinion that strictest possible action should be taken against the blood banks which have been violating the guidelines, directions, conditions or regulations and in addition to cancellation of license of such errant blood banks, the differential of amount of money earned by them violating the guidelines, directions and conditions must be deposited with the GSCFBT and be utilized in the furtherance of blood banking activities. It appears from the rate card furnished by the respondent No.7 [at page 72] that the same is, on the face of it, in violation of the rates prescribed by the Ministry of Health & Family Welfare.
19. We also find substance in the contention of Mr. Contractor, the learned advocate appearing on behalf of the petitioner that blood banking activities being regulated under the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945, the aforesaid statutory provisions, as for instance, Section 33 of the Act, confers powers on the Central Government to frame Rules in relation to manufacture, sale and distribution of drugs. Similarly, Part X-B of the Rules and Part XII-B of Schedule-F have been framed to regulate blood banking activities. The aforesaid statutory provisions of Chapter IV vide Sections 21 and 22 of the Act provide for widespread power to the Central Government as well as to the respective State Governments to appoint Inspectors with powers prescribed to carry out any investigation with regard to the violation of the provisions of the Act and the Rules. Thus, it is the duty of the State Government to appoint sufficient number of Inspectors to see that the formalities required under the law for running of blood banks are strictly complied with.
20. It further appears that the respondent No.7 has been given land by the Ahmedabad Municipal Corporation, the respondent No. 6 before us, at the rate of Rs. 101/- per annum for 99 years. One of the conditions set out as part of the aforesaid transaction was that the respondent No. 7 should give 10% of all blood collections free-of-cost to the hospitals run by the Ahmedabad Municipal Corporation and the balance requirement of the hospitals run by the Ahmedabad Municipal Corporation shall be fulfilled by giving blood at 30% discount from the prescribed rate. In such circumstances, we direct the Ahmedabad Municipal Corporation to strictly implement the above conditions and to give a report as to whether the aforesaid conditions imposed at the time of giving land is being complied with by the respondent No.7. If it appears that the respondent No.7 has committed breach of the condition, the same amounts to illegal enrichment of money which were not otherwise due to them by making unwarranted profit by committing breach of the terms of allotment of land to them and, therefore, in such circumstances, the Ahmedabad Municipal Corporation should recover the amount of illegal enrichment.
21. We also find substance in the contention of the petitioner that most of the municipal and government hospitals possess license to hold blood camps and in spite of blood shortage that these hospitals face, they do not take enough initiative for conducting regular blood camps to satisfy the requirement of blood and often depend on the replacement of donors and in cases where patient is unable to arrange for replacement, treatments are either deferred, delayed or even refused. For the purpose of avoiding the aforesaid situation, we direct all the government and municipal hospitals to conduct blood camps regularly based on assessment of the requirement and the Gujarat State Blood Transfusion Council should be entrusted with the responsibility of ensuring that these hospitals should first conduct their own blood camps and only in case of shortage, should seek replacement.
22. We are, however, not impressed by the submission of the petitioner that the blood banks are more interested in fractionation for the purpose of selling blood plasma and platelets. We have already indicated that maximum demand is for red blood cells and the amount received from the sale of blood plasma or platelets is much less than the one received by supplying red blood cells. Therefore, after supply of red blood cells, if the balance amount of blood components is given for manufacture of plasma or platelets, the same cannot be objected to for any reason. However, the amount of components of blood sold to different pharmaceutical companies indicating the price should be taken note of by the State agencies to see that the actual expenditure of the blood banks is taken care of for the purpose of deciding whether the same is really profiteering in running blood bank.
23. In our opinion, to achieve the objective of the National Blood Policy, the State Government should ensure that every blood bank is affiliated with a government or municipal hospital and is also directed to earmark specified percentage of total blood collection to be supplied free of cost to the respective government and municipal hospitals and the balance at a concessional rate to those hospitals.
24. All the blood bank storage centres and the hospitals must display the maximum amount prescribed by the respondent no.1 for the whole blood and the respective components which can be recovered by the blood banks from the patients.
25. We, therefore, direct the State Government to constitute a Committee of the following persons:-
1. Additional Chief Secretary, Health & Family Welfare, Government of Gujarat.
2. Health Secretary (Expenditure), Finance Department, Government of Gujarat.
3. Commissioner, Food & Drug Control Administration.
4. Additional Director, State AIDS Cell.
5. Medical Superintendent, Civil Hospital, Ahmedabad.
6. Professor & Head, Department of Pathology, B.J. Medical College, Ahmedabad.
7. Executive Officer, Indian Red Cross Society, Gujarat State Branch, Ahmedabad.
8. Representative, State Committee of Indian Association of Blood Banks, Ahmedabad.
9. An expert in Blood Transfusion Medicine representing major Medical & Health Institutions of the State.
25.1 The Committee shall ensure the following:-
[i] Every Blood Bank in the State is affiliated with a Government or Municipal Hospital and should earmark a specified percentage of total blood collection to be supplied free of cost to such affiliated government or municipal hospital and the balance at a concessional rate to those hospitals.
[ii]. To ensure that sufficient number of Inspectors are appointed to see that the formalities required under the law for running of Blood Banks are strictly complied with.
[iii]. To ensure that no Blood Bank in the State of Gujarat indulges in profiteering directly or indirectly and to further ensure that such Blood Banks do not indulge in charging more than the rate prescribed by the Ministry of Health and Family Welfare indicated in pages No. 209 and 212 of this application for blood red cell component.
[iv]. To evolve a policy to make it clear as to what constitutes profiteering, what is the offence of profiteering and what should be its penal consequences.
[v]. To ensure that audit or investigation of the Blood Banks is undertaken on a regular basis so that objective of the National Blood Policy is subserved.
[vi]. To ensure that strictest possible action is taken against the Blood Banks who are found to be violating the guidelines, directions and conditions or regulations, and in addition to cancellation of licence of such errant Blood Banks, the differential of the amount of money earned by them violating the guidelines, directions and conditions or regulations is deposited with GSCFBT and is utilized in the furtherance of Blood Banking activities.
[vii]. To ensure that all the Government and Municipal Hospitals conduct blood donation camps regularly based on assessment of the requirement.
[viii]. To look into all other relevant aspects relating to Blood Banking and make recommendations as to how well the National Blood Policy could be implemented in its letter and spirit.
25.2 The Committee shall place its first report before this Court within a period of two months from today so that the matter could be considered further in the light of the recommendations which the Committee may make in its report.
Let a copy of this order be given to the respondents by 2nd December, 2013.
26. Let the matter appear in the 1st week of February 2014 for further consideration.
(BHASKAR BHATTACHARYA, CJ.) (J.B.PARDIWALA, J.) mathew* Page 58 of 58