AN OVERVIEW OF CLINICAL TRIALS FOR MEDICAL DEVICES

 

-Dr. S. Vijay Kumar, Professor (Associate) & HOD (Retd.)

            

       Medical devices play a critical role in the lives and health of millions of people worldwide. They play an important role in the practice of medicine, with the creativity and diversity of this sector contributing to enhancement in the quality and efficacy of healthcare. MDs cover a wide range of products, from simple bandages to life-supporting devices such as stents, and play a crucial role in the diagnosis, prevention, treatment, and care of diseases. From everyday household items such as oral thermometers to complex implantable such as deep-brain stimulators, patients and the general public rely on regulators to ensure that legally marketed medical devices have been shown to be safe and effective. The Medical Device sector has become increasingly important for the healthcare of citizens, with an immense influence on expenditure. Medical devices play an important role in the diagnosis, prevention, treatment, and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. In many countries, the medical technology industry is dominated by large numbers of SMEs.

Medical Device – WHO Full Definition:

‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:

·        Diagnosis, prevention, monitoring, treatment, or alleviation of disease,

·        Diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

·        Investigation, replacement, modification, or support of the anatomy or of a physiological process,

·        Supporting or sustaining life,

·        Control of conception,

·        Disinfection of medical devices

·        Providing information by means of in vitro examination of specimens derived from the human body.

 

Clinical Research – Clinical  Trials:

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomized clinical trials are impossible to perform. Three major barriers identified for randomized clinical trials on medical devices, namely: (1) Randomization, including timing of assessment, acceptability, blinding, choice of the comparator group and considerations on the learning curve; (2) Difficulties in determining appropriate outcomes; and (3) The lack of scientific advice, regulations, and transparency. Regulators expect data that are provided by device manufacturers to reflect the risk profile of the device and need more crucial clinical evaluation before market approval. Higher-risk and innovative moderate-risk devices (approximately 4%of all medical devices), which generally require the clinical evidence to show that the benefits of technology outweigh its risks are the primary focus. Clinical evidence of medical devices is often critical not only for showing the safety and effectiveness of the device but also for informing clinicians and patients about the preferred use of the device in the marketed clinical setting. Regulators are demanding more clinical evidence because they want to see more of it before granting market approval. Not only regulators but payers are also requiring more of it to substantiate product value claims and approve reimbursement. Even healthcare systems and physicians are asking for more of it when making purchasing decisions. This demand for clinical evidence from various stakeholders is forcing medical device companies to amass more clinical data on their products than ever before. Companies are responding to this pressure by running more clinical trials, focus group studies, and responding in real-time by making changes to the beta version (a version of a piece of software that is made available for testing, typically by a limited number of users outside the company that is developing it, before its general release) of their medical devices. The latest trend is medical device companies increasingly are turning to clinical trials to differentiate their products from competitors and improve their odds of adoption in the marketplace.

Clinical Trials for Medical Devices:

1. Blinding: Blinding is an important element in all clinical trials; it reduces measurement bias related to the observer’s, doctor’s, or patient’s subjectivity. For ethical or practical reasons, blinding is often more difficult to perform in randomized clinical trials on medical devices compared to pharmacological randomized clinical trials. Medical device companies need to remember that when it is not possible to blind healthcare professionals, a blind assessment of the outcome should be planned with experienced and trained staff as outcome assessors. The data managers, the adjudication committee, the independent data monitoring, and safety committee, the statisticians, and the conclusion drawers should also be blinded. In case blinding is not used, medical device companies and their clinical trial correspondent need to give the reasons for not blinding and discuss the limitations when reporting the results. As blinding of patients and trial personnel may be less often achievable in some medical device trials, objective outcomes must be chosen. Recently, regulatory agencies have emphasized for medical device companies to search for creative methods to blind individuals in their trials, if they choose to incorporate a novel technique, they must ensure that the blinding process itself does not introduce bias by impairing the ability to accurately assess the outcome. Any novel blinding technique should have three qualities: (1). Successful concealing of the group allocation, (2). No impairment in the ability to accurately assess outcomes; and (3). Acceptance by the individuals that will be assessing outcomes. Despite careful consideration of methods to blind individuals in medical device clinical trials, situations will invariably arise when some or all groups of individuals simply cannot ethically be blinded. Medical device companies must accept this reality and incorporate other strategies to minimize bias when blinding is not possible.

2. Outsourcing Work to Experts: It is an industry-wide trend that most device makers lack the internal resources and expertise to run a complete clinical trial operation in-house. It might be possible for a large medical device company to have an in-house clinical development team which can help in facilitating the clinical trials, however, for small medical device companies, which have little bandwidth, experience, and margin for error, the success of clinical trial or failure can be very crucial and sometimes clinical trial means life or death for the small company. As a result, we are witnessing a corresponding rise in the outsourcing of clinical services to contract research organizations (CROs). Medical device companies are turning to CROs for assistance with clinical operations management, investigator recruitment, clinical monitoring, data management, biostatistical analysis, health economic and outcomes strategy, quality assurance, regulatory approval, and other needs. The single most important factor to consider when choosing clinical service providers or a CRO is experience in the medical device clinical trials or expertise in the field. A new way of working is outsourcing work to on-demand experts. This is particularly beneficial to small companies who cannot afford the heavy costs and management spends on working with CROs  or traditional consulting firms. Hiring individual medical device consultants can help to save time and costs, while working with experts directly to customize deliverables. Specialists in the medical device industry are offering their services on a freelance basis.

3. Outcome Assessment for Clinical Trials on Medical Devices: Defining relevant outcomes for clinical trials on the medical device is complex. This is partly due to the great variation in complexity and application for the different types of medical devices such as pacemakers, insulin pumps, operating room monitors, defibrillators, and surgical instruments, and partly due to a large variety of potentially relevant outcomes. A barrier specifically related to the medical device industry is that a common understanding of the concept of outcomes is missing. In clinical trials with medical devices, traditional outcomes such as survival, complication rates, or surrogates (biomarkers, imaging techniques, and omics) are used instead of the more appropriate hermeneutic outcome measures such as quality of life, autonomy, discomfort, disability, and life satisfaction. This does not mean to exclude specific outcomes for the functionality of medical devices such as device failure, device breaking, device slipping, migrating of the device or screw loosening, etc. Trials on medical devices funded by industry are prone to report positive outcomes and to conclude in favour of experimental interventions when obtaining non-significant test results. While industry involvement is necessary to improve technology and to drive innovation of medical devices, it must be based on scientific grounds and fully transparent. The outcome measures selected for MDs should reflect the whole procedure, and all different kinds of settings that the MD can be used in. According to the expert panel, the choice for the most appropriate outcome measure depends on the (1). Primary objective (increase of benefit, reduction of harm); (2). State of development of the technology (feasibility, effectiveness, efficiency); (3). Quality criteria (validity, reliability); (4). Acceptance (by patients, physicians, and scientific community); and (5). Acknowledgement of the value of better tolerability or convenience.

4. Early Scientific Advice and Expert Panels: The medical technology industry is dominated by large numbers of Subject Matter Experts (SMEs). They are not trained in running trials or in trial methodology but have a high output of diverse and innovative products. Access to early scientific advice, especially for smaller companies and academia, needs to be as easy and affordable as possible. Early scientific advice about the clinical development strategy and clinical trials for their devices is wished for. Engaging in the relationship in a meaningful way early helps align on SOP (standard operating procedure) and technology.

5. Regulatory Requirements for Medical Device Clinical Trials: The above tips represent only a fraction of the best practices of clinical trials for medical device manufacturers. Apart from these key tips, compliance with regulatory and ethical requirements is also very important. The new Regulations on Medical Devices imposes increased responsibilities and well-defined interactions between all economic stakeholders involved, like medical device manufacturers, authorized representatives, importers, and distributors. Last, but not the least, trust, and transparency in clinical trials of medical devices is vital. Reviewing clinical trial data. Regulatory review and peer-review of clinical trial results have different objectives, but final published results for either process should conform to the approved clinical trial protocol and specify major deviations and amendments. There should be strict “Regulatory Mechanism”  to check the performance  and authenticity of the medical devices manufactured in a country.

Regulatory Strategy: In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945. Under these, 14 medical devices were notified as ‘Drugs’. These ranged from disposable hypodermic syringe and needle, perfusion sets, cardiac and drug eluting stents, catheters, intraocular lens, intravenous cannulae, bone cement, heart valve, scalp vein, orthopedic implant, internal prosthetic replacement, and in vitro diagnostic kits for human immune deficiency virus (HIV), Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV). The Medical Devices Rules, 2017 of the Drugs and Cosmetics Act, 1940 came into force with effect from January 1, 2018. The rules are applicable for (i) substances used for in vitro diagnosis and sterile surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood, and blood component collection bag with or without anticoagulant, (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides; and (iii) devices notified from time to time. A regulatory strategy is often a formal plan that aligns regulatory activities to business strategy, so as to bring a new or modified medical device product to market. Formulating this plan would require, consideration of various regulatory issues in the target markets one wish to place the product. When well planned, a regulatory strategy should be balanced, realistic, achievable, and in support the organization’s mission and vision. It identifies important regulatory requirements to be addressed and provides overall definition and clear direction for the product development team, even outlining the reasons for the path to be taken. Planning regulatory strategy should be done at the earliest possible stage of product development, while putting D&D (Design & Development) work structure in place. There are three points to consider with specific regard to regulatory concerns: (1). Target markets for commercialization. (2). Medical Device Classification and (3). Overall project milestones and timeline.

1) Target Markets for Commercialization: “In which countries product to be sold ?”It is important to know in which markets the products to be sold and prioritize the various market entries. Different markets have varying market size, medical practices, pricing, and reimbursement, as well as distribution activities. Furthermore, regulatory regimes differ between markets. One would need to evaluate all these different factors when considering regulatory strategy. It can be helpful for D&D plans as well. An example of regulatory difference is the risk classification of medical devices, where the same product might be classed slightly differently under different regulatory regimes. With this differentiation, the timing and ease of product release could be affected as well.

2) Medical Device Classification: “Which risk classification does one’s medical device belong to? “As mentioned above, medical device classification is important in establishing the pathway to a specific market. When one has clearly established the options and requirements for “route to market”, one can better plan your product development with a “go-to-market” strategy. Identifying medical device classification  correctly can allow to clearly establish the relevant controls for the product development and risk management. It is also useful for understanding the risk profile of the product, as well as the competitors’. Based on regulatory requirements for the medical device risk classification, one can determine the required scope of verification and validation, and thus estimate the cost and timeline to bring the product to the market.

3) Overall Project Milestones And Timeline: “What milestones one  can look to gauge the progress of his project? “Tying in with the above points, one would be able to craft regulatory strategy when one have a clear idea of his target market’s regulations and requirements that need to be met. For example, one might find that certain markets require more extensive pre-clinical and clinical trials to be done, while others might request for relevant comparisons of his product. Knowing this would also give a good gauge of the time needed for each step of the certification and product registration process. One can then align his product development and business plans accordingly, to maximize his team’s efficiency. With proper consideration of the key information mentioned, one can have a good grasp on timeline for market entry and product development, as well as the cost involved. Accordingly, this means one able to craft his regulatory strategy to bring his device to the market. Crucial to meeting regulatory requirements throughout the world is having a proper QMS (Medical Device Quality Management System). The ISO 13485:2016 standard is often the reference for best practice QMS processes. One can read and learn more about the ISO 13485.

           To conclude, the Study protocol and a summary of the results are to be made publicly available in databases for clinical trials of medical devices. Moreover, access to individual patient data should also be secured. Trust and  transparency of MDs is very important. In many countries, the medical technology industry is dominated by large numbers of SMEs. The global medical devices market size was valued at USD 425.5 Billion in 2018 and is expected to reach USD 612.7 Billion by 2025, grow at a Compound Annual Growth Rate (CAGR) of 5.4% 2018 to 2025. According to a Deloitte report, the growth rate of India’s medical-device industry is around 15 per cent which is more than double of the global industry growth rate of 4-6 per cent, and is expected to become a $ 25-30 billion industry in India by 2025.

References:

1.     European Commission. Growth. Internal Market, Industry, Entrepreneurship and SMEs; Medical Devices. 2016. Accessed 24 May 2020.

2.     Eikermann M, Gluud C, Perleth M, Wild C, Sauerland S, Gutierrez-Ibarluzea I, et al. Commentary: Europe needs a central, transparent, and evidence based regulation process for devices. BMJ. 2013.

3.     Jarvinen TL, Sihvonen R, Bhandari M, Sprague S, Malmivaara A, Paavola M, et al. Blinded interpretation of study results can feasibly and effectively diminish interpretation bias. J Clin Epidemiol. 2014.

4.     Karanicolas PJ, Bhandari M, Walter SD, et al. Radiographs of hip fractures were digitally altered to mask surgeons to the type of implant without compromising the reliability of quality ratings or making the rating process more difficult. J Clin Epidemiol. 2009.

5.     Probst P, Knebel P, Grummich K, Tenckhoff S, Ulrich A, Büchler MW, Diener MK. Industry bias in randomized controlled trials in general and abdominal surgery: An empirical study. Ann Surg. 2016.

6.     Djurisic S, Rath A, Ngwabyt S-N, Neugebauer EAM, Laville M, Hivert V, et al. Barriers to the conduct of randomized clinical trials within all disease areas. Trials 2017.

7.     Rath A, Salamon V, Peixoto S, Hivert V, Laville M, Masson Y, et al. A systematic literature review of evidence-based clinical practice for rare diseases: what are the perceived and real barriers for improving the evidence and how can they be overcome? Trials [accepted for publication]. 2017. 

8.     https://www.fortunebusinessinsights.com/industry-reports/medical-devices-market-100085

9.     https://www2.deloitte.com/content/dam/Deloitte/in/Documents/life-sciences-health-care/in-lshc-medical-devices-making-in-india-noexp.pdf

 

 

 

 

KALESHWARAM PROJECT – A REVIEW

                                                                                -Dr. S. Vijay Kumar                                    

        Agriculture is the mother of most of the economies in the world. Much of its influence is on the other sectors - industry and service. India is the second largest in farm output after China. Hence, India’s economic security continues to be predicated upon the agriculture sector, and the situation is not likely to change in the near future. Even today, the share of agriculture in employment is about 49% of the population, as against around 75% at the time of independence and it is the principal source of livelihood for more than 58% of the population. Hence, Agriculture can be ignored at our own peril. The high vulnerability of agriculture is due to factors like rains, floods, dry spells, etc. beyond human control and other man made uncertainties associated with cultivation. The modern welfare state strives towards removal of uncertainties and attempts to minimize the vulnerabilities in cultivation through necessary interventions. The most important uncertainty to be addressed is the issue of water to irrigate fields, directly or indirectly. The main aim of the construction of Kaleshwaram Project by Telangana government is to address the issues related to irrigation and drinking water. 

The Kaleshwaram Lift Irrigation Project (KLIP) is a multi-purpose irrigation project on the Godavari River in Kaleshwaram, Bhupalpally District, Telangana, India. The foundation for KLIP was laid in May, 2016 by KCR. On 21st June 2019, the FIRST PHASE of the project was opened by the then Telangana Governor E. S. L. Narasimhan, Chief minister K. Chandrashekar Rao and Y. S. Jagan Mohan Reddy Chief Minister of Andhra Pradesh.  In these three years, the government constructed three major barrages at Medigadda, Annaram and Sundilla. “Kaleshwaram is not a single project. It is an aggregation of several projects”. It is expected to be completed by June 2022. Currently the world's largest multi-stage lift irrigation project. The Kaleshwaram Lift Irrigation Project is divided into 7 links and 28 packages spanning a distance of approximately 500 km through 13 districts and utilizing a canal network of more than 1800 km. The project aims at increasing total cultivable command area of 18,25,700 acres across all 13 districts in addition to stabilizing the existing Cultivable Command Area.

History: Kaleshwaram Project has been conceived from the erstwhile Dr. B.R. Ambedkar Pranahita - Chevella Sujala Sravanthi project in Andhra Pradesh. In 2014, the project was redesigned, extended, and renamed as the Kaleshwaram Lift Irrigation Project (KLIP) in Telangana.  Originally, Dr. B.R. Ambedkar Pranahita - Chevella Sujala Sravanthi project was proposed to utilize 160 Thousand Million Cubic Feet (TMC) of allocated water of Godavari basin as per GWDT (The Godavari Water Disputes Tribunal) award. A barrage was proposed at Tummidihetti (V) to divert 160 TMC of water to irrigate 16.40 lakh Ac in 7 districts of Telangana State viz., Adilabad, Nizamabad, Karimnagar, Medak, Warangal, Nalgonda & Rangareddy, besides drinking water & industrial water. Further, it was also planned to provide 10 TMC of Drinking Water to the villages enroute, 30 TMC of Drinking Water to twin Cities of Hyderabad & Secunderabad and 16 TMC of water for Industrial use. The entire project works are divided into 7 links & 28 packages. Agreements are concluded for all 28 Packages during 2007-08 & 2008-09. But, due to the following reasons, the changes were made to the Project: 

Inter State Aspect: Dr. B.R.Ambedkar Pranahita-Chevella Sujala Sravanthi (PCSS) project is an Interstate project between Maharashtra and erstwhile Andhra Pradesh. The barrage was proposed with FRL +152.00 meter and capacity +5.099 TMC. As per the Godavari Water Disputes Tribunal (GWDT) report, dated 6th October 1975, the State of Maharashtra and Andhra Pradesh have agreed to take up 3 projects namely, (1) Lendi Project, (2) Lower Penganga and (3) Pranahita-Chevella at appropriate time with agreed water utilization. Accordingly, Dr. B.R.Ambedkar Pranahita-Chevella Sujala Sravanthi project was taken up. Maharashtra Government expressed concerns over fixing of the proposed FRL (Full Reservoir Level) of +152.00 for construction of barrage near Tummidihetti due to submergence of large extent of land in their territory and requested to reduce the FRL and avoid submergence in their territory. An agreement for constitution of Inter State Board for Pranahita - Chevella Sujala Sravanthi project (PCSS) was entered in to by the then Hon’ble C.Ms of Maharashtra and AP on 5-05-2012. But, the Government of Maharashtra have repeatedly requested to lower the FRL from +152.00 m to +148.00 m and minimize the extent of submergence. Detailed Joint surveys by both the States and the actual submergence extent of Maharashtra territory was assessed as 3,786 acres with barrage at FRL +152.00 m and 285 acres with FRL of +148.00 m.

A meeting was held on 17th February 2015 between Hon’ble Chief Minister of Telangana and Hon’ble Chief Minister of Maharashtra along with Hon’ble Ministers and officers of Telangana and Maharashtra. In the meeting, the Hon’ble Chief Minister of Maharashtra expressed that considering the unrest, it is necessary to lower down the barrage level and minimize the submergence area. A coordinating committee meeting was held on 29-12-2015 to finalize the FRL of the barrage at +148.00m with a capacity of about 1.85 TMC which was agreed by Government of Maharashtra. The Government of Telangana exercised all efforts and after conducting as many as 12 meetings were held (Technical, Co-ordination committee, Hon’ble Minister’s level & Hon’ble Chief Minster’s level). An Inter -State Board was constituted to resolve the issues between both the states on 8th March, 2016 and finally the Government of Maharashtra has agreed for construction of barrage at Tummidihetti across river Pranahita with FRL +148.00 m during Interstate Board meeting held in Mumbai on 23-08-2016.

Water availability: The detailed water availability studies were carried out and assessed by the Central Water Commission, New Delhi. Accordingly, the net water availability at the barrage location (Tummidihetti) was assessed as about 165.38 TMC at 75% dependability which includes perceived surpluses of 63 TMC from the share of upstream states. Further, the CWC stated that availability of surpluses of 63 TMC from upstream states as estimated at the barrage site may not be reliably available in future. As per the Hydrology studies with FRL +152.00 m, the divertible water would be about 110 to 120 TMC against 160 TMC required and proposed. As per the studies done with FRL of +148.00 m, involving minimum submergence in Maharashtra, the divertible flows is 44 TMC only as against the allocation and utilization of 160 TMC. Thus, the water available is not sufficient to meet the planned utilization of this project.

Storage capacities: Further, the Central Water Commission, suggested to re-look into the integrated Storage Planning aspects of the project to match the demand and supply as the proposed capacities of storage reservoirs is insufficient for success of the project and stated that  there is requirement of artificial reservoirs within and around the project area either by increasing the capacity of existing reservoirs or creating additional new reservoirs. Hence, the CWC suggestion necessitated to have a re-look on the scope of the Project.

Revised Scope of the Project: In order to make the project functional and achieve the contemplated benefits to effectively utilize the Telangana State’s share of Godavari Basin, an alternate location of barrage across river Godavari had to be investigated by M/s WAPCOS Ltd., (A Government of India Undertaking in the field of Water, Power, and Infrastructure Sectors) by using the latest technology i.e., LiDAR (Light Detection and Ranging, a remote sensing laser measuring method) technique and the location was proposed at Medigadda (V) near Kaleshwaram, Mahadevpur (M), Karimnagar District. The location of the barrage is most suitable at Medigadda (V) near Kaleshwaram, Jayashankar Bhupalapally District where the net availability of water has been assessed as 284.3 TMC (as against the proposed diversion of 195 TMC) considering utilization through the projects in Penganga, Wardha, Pranahita, Middle Godavari and Manair sub basins. In view of the above, the original project has been divided into two components viz., Dr. B.R.Ambedkar Pranahita Project (Adilabad) and Kaleshwaram Project as follows:

(1). Dr. B.R.Ambedkar Pranahita project: To divert 20 TMC of water by constructing a barrage across river Pranahita near the confluence of Wainganga and Wardha rivers at Tummidihetti (V), Koutala (M), Adilabad District for irrigating an ayacut of 2,00,000 acres in East Adilabad district against the original proposed 56,500 acres in the district. 

(2). Kaleshwaram Project: Construction of one barrage across river Godavari at Medigadda near Kaleshwaram, and two more barrages between Medigadda and Sripada Yellampally Project at Annaram & Sundilla and to convey water from Sripada Yellampally Project to the command area spread over in 7 districts of Telangana (now 13 districts after re-organization of districts in the state) through components such as canals, tunnels, lift systems, reservoirs, and distributary network for irrigating an ayacut of 18,25,700 acres against the original proposed ayacut of 16,40,000 acres. Further, it is proposed to stabilize the existing ayacut in other major projects viz., SRSP Stage-I, SRSP Stage-II, Flood Flow Canal, Singur and Nizamsagar projects to an extent of 18,82,970 acres. Besides irrigation, drinking water (30 TMC for twin cities and 10 TMC for enroute villages) & water for industrial use (16 TMC) is also proposed. Further, after careful planning, the proposed capacity of reservoirs is increased from 11.43 TMC to 147.71 TMC by enhancing the capacities of existing reservoirs and proposing new reservoirs to match the demand and supply. Thus, it is re-iterated that the Kaleshwaram and Pranahita projects are the off-shoots of Dr. B.R.Ambedkar Pranahita-Chevella Sujala Sravanthi project, necessitated because of comments of CWC and inter-state issues with Maharashtra.

KALESHWARAM PROJECT AT A GLANCE: The Kaleshwaram project has provision for the storage of about 148 tmc ft with plans of utilizing 180 tmc ft by lifting at least 2 tmc ft water every day for 90 flood days. The project is aimed to irrigate around 37 lakh acres in the 15 districts of Telangana. It got the longest tunnel to carry water in Asia, running up to 81 KM between Yellampally barrage and the Mallanna sagar reservoir. On  30th May 2020, Kondapochamma irrigation project has been inaugurated in the presence of Telangana state CM, K. Chandrashekar Rao. This is one of the components of the massive KLIP on Godavari river.

·        Highest pump and motor capacity in package 8 and each is 139 MW

·        Total 7 pumps and Biggest underground pump house in Pkg 8

·        Per day 3 TMC lifting

·        Highest power consumption Scheme in Asia

·        Longest tunnel in Asia 203 in single scheme ( But not single tunnel)

·        Biggest underground surge pool in Package 10

·        New Barrages and Pump Houses each 3

·        Total length : 1832 km

·        Total Gravity Canal : 1531 km

·        Total Tunnel length : 203 (Not Single Tunnel)
Pressure pipe line : 98 km

·        Total Lifts : 20 Nos

·        Total Pump houses : 19 NOs

·        Total Pumps : 82 Nos

·        Power Requirement : 4627.24 MW

·        Power Consumption : 13558 MU

·        New Reservoirs : 20 Nos

·        Old and Existing Reservoirs: 5 Nos

·        Live Storage : 147.71 TMC

·        The Cost of Kaleshwaram Project  is Rs 80,000 crores. Proposed another Rs. 25,000 Crore on Dec, 2019.

·        Kaleshwaram Lift irrigation project is being constructed to irrigate 18 lakh acres of land in 13 districts of Telangana State, stabilizing another 17 lakh acres in another 7 districts.

·        Kaleshwaram irrigation project will also be providing drinking water to several Small and Medium towns and cities of the state, especially to Hyderabad and Secunderabad Cities.

·        The project had been conceived to convey water to the command area through components such as canals, tunnels, lift systems, reservoirs, and distributor network The entire project is divided into 7 links and 28 packages.

·        provide 10TMC of drinking water for enroute villages and 30TMC of drinking water for twin cities of Hyderabad and Secunderabad; and 16TMC of water to industries in addition to agriculture. The total power requirement for this project is estimated to be is 4628 MW.

·        The project is programmed to be completed by June 2022.The proposed project reduces the submergence in the state of Maharashtra and eventually becoming mutually agreeable.

·        The total forest area needed for the project is 2866 ha 18. (approximately) and other area needed is 31871.8 ha (Rounded to 32000 ha).

·        Supports Mission Kakatiya, which is a flagship programme launched by the Government of Telangana, aims at rejuvenation of water tanks and other water storage structures to help the small and marginal farmers of the state.

·        Supports Mission Bhagiratha, which is a project for safe drinking water for every village and city household in Telangana State.

Details of Links Regarding Irrigated Command Area/Ayacut (Acres):

Link-I: From Medigadda Barrage on Godavari River to Sripada Yellampally Project (30,000 acres)

Link-II: From Sripada Yellampally Project to Mid Manair Dam

Link-III: From Mid Manair Dam to Upper Manair Reservoir (86,150 acres)

Link-IV: From Upper Manair Dam to Konda Pochamma Reservoir (595,754 acres)

Link-V: From Anicut to Chityala (243,500 acres)

Link-VI: From Sri Komaravelli Mallanna Sagar to Singur Dam (280,296 acres)

Link-VII: From SRSP Foreshore to Nizam Sagar Canals and to Dilawarpur and Hangarga village for Nirmal and Mudhole Constituency (590,000 acres)

Total: 1,825,700 acres (New ayacut) Apart from: 1,875,000 + acres (Stabilization of existing ayacut)

Details of Links Regarding Supply of Water:

Link-I: From Medigadda Barrage on Godavari River to Sripada Yellampally Project

Water will be reverse pumped from the confluence point of Godavari and Pranitha Rivers to Sripada Yellampally Project with the help of 3 barrages (Medigadda, Annaram and Sundilla) and 3 lifts.

As of June 2019, lifts are being commissioned with provision to lift 2 TMC (56,63,36,93,184 liters) of water per day from Medigadda. The water is lifted to backwaters of Annaram barrage. Again, from Annaram barrage to Sundilla barrage. Finally, from Sundilla to Sripada Yellampally Project. Civil works are being executed to lift 3 TMC per day but pumps are being installed to lift only 2 TMC. If need be, only pumps would need to be installed to increase capacity by one more TMC.

Link-II: From Sripada Yellampally Project to Mid Manair Dam

A new balancing reservoir is also being proposed in the outskirts of Hyderabad of 20–30 TMC to store water. The water will be supplied to this balancing reservoir in the same link.

Link-V: From Anicut to Chityala

From Anicut, a series of gravity canals and a small tunnel of 1.2 km are planned to transfer water to Gandamalla Reservoir and Baswapuram Reservoir. Thereafter, gravity canals are planned towards Chityal Mandal and its villages.

Link-VI: From Sri Komaravelli Mallanna Sagar to Singur Dam

From Sri Komaravelli Mallanna Sagar, another sequence of gravity canals, tunnels and lifts are used to transfer water to Singur Dam. Apart from that, if need be, water can be transferred to Nizam Sagar Project and from there, to SRSP.

Link-VII: From SRSP Foreshore to Nizam Sagar Canals and to Dilwapur and Hangarga village for Nirmal and Mudhole Constituency

From the foreshore waters of SRSP, water will be transferred to reservoirs at Hangarga and Dilwapur villages. Apart from this, existing reservoirs like Masani Tank and Kondem Cheruvu will also be linked. Canals under Nizam Sagar will also be irrigated.

Details of Packages:

Sl. No.                                    Description of work                                                No of Packages                                                                         

 

    1        Diverting water to Sripada Yellampally Project by constructing barrages at               6

              Medigadda, Annaram & Sundilla across river Godavari

    2        Sripada Yellampally Barrage to Mid Manair Reservoir                                                3

    3        Manair Reservoir to Upper Manair Reservoir                                                               1

    4        Manair Reservoir to Sri Komaravelli Mallanna Sagar                                                  3

    5       Sri Komaravelli Mallanna Sagar to feed Package-14 & 15 by Gravity canal, to feed   1

             Package-17 through Parallel Canal and serve ayacut of 40000 acres

     6      Package-13 OT-point to Sri Konda Pochamma Reservoir                                             1

     7      End of Package-13 Gravity canal towards Chityala                                                       2

     8      End of Parallel canal of Package-13 to Singur Reservoir                                               3

     9      Foreshore of Sri Ram Sagar Project to Kondem Cheruvu                                              2

    10     From Kondem Cheruvu to irrigate an ayacut of Kamareddy & Yellareddy                   1

             Constituencies

    11     Foreshore of Sri Ram Sagar Project to Dilwapur and Hangarga                                    2

 

Actual Estimated Cost of the project: The actual cost of the project worked out to Rs. 80,190.46 Crores which is approved by the CWC and TAC (Technical Advisory Committee). As on Dec, 2019, TS government proposed another Rs. 25,000 Crore for KLIP, in addition to the above 80190.46 Crore.

 

 SL. No.                   Name of the Item                            Amount (Rs. In Crores)

--------------------------------------------------------------------------------------------------

1	Works	63352.00
2	Sub-Stations	2885.84
3	Land	6953.65
4	Resettlement & Rehabilitation	1464.34
5	Forest Land	741.52
6	Operation & Maintenance	661.08
7	Establishment charges @ 2%	1365.43
8	Tools & Plants and Recoveries	769.27
9	Miscellaneous	868.51
	Total Direct Charges (1+2+3+4+5+6+7+8+9)	79061.64
10	Indirect charges (Capital value of land abatement)	359.55
11	(Audit & Account charges)	769.27
	Total Indirect Charges (10+11)	1128.82

FACTS:

 

·        In Telangana, Godavari water is at lower level, water needs for irrigation is at much higher level, so water need to be lifted through pumps and lift irrigation is capital intensive.

·        The State government started constructing Kaleshwaram with its own funds and raised loans from nationalized banks.

 

·        KLIP is a complex project, since it involves 12 stages of pumping, that means same water has to be pumped at each stage to reach the final destination. Though, several inaugurations took place, but the project is nowhere near completion and promised water for irrigation has not yet delivered, except a fraction of it.

 

·        Initially, Kaleshwaram Lift Irrigation Project was estimated to be Rs.40,000 crores then became Rs.80,000 crores and now it is being reported Rs.100,000 crores. Probably, it may cross another 50,000 to 60,000 crore.

·        The project was originally, as per the Detailed Project Report (DPR) supposed to irrigate 18 lakh acres, but now it seems it has been revised to 36 lakh acres.

·        With revised cost of Rs.100,000 crores, this works out Rs.5,50,000 per acre. These are called capital costs. To maintain this project, as and when it is completed, every year, Government need to spend more money on electricity, for repairs, and other things, these are called variable costs. This works out at least minimum Rs. 50,000 to 100,000 per acre to provide irrigation. But certainly, the operational and maintenance costs  will not be below Rs.50,000 per acre per season.

·        The Kondapochamma component: As mentioned, KLIP has several components, each linked to other and water need to be sequentially has to come stage wise.

·        For example, the Kondapochamma was inaugurated, but unless the earlier stages such as Mallanna sagar and other pumping stations are completed from Medigadda, such inaugurations raise expectations, but will not deliver any water.

·        They synchronization of these stages is extremely important. It is not each stage is completed, but it has to be done sequentially. Kondapochamma is water tank, built over 4,400 acre, evacuating three villages.  

·        A circular bund with 15.8 km with nearly 40 m height has been built at the cost of Rs. 3,500 crores. All this infrastructure is only useful provided the capacity to pump water before this stage has been established. Water will have to come nearly 300 km away after passing through 11 pumps to reach 620 meters reduced level.

·        In order to irrigate 2,85,000 acres, as stated, at least 45 TMC of water is required. This means the tank has to be filled three times at least. In order to pump 1 TMC of water from Medigadda at least Rs.50 crores of electricity is required at Rs.5 unit cost. This means in order to get the required water, 45 TMC to irrigate 2,85,000 acres, the electricity cost would be close to Rs. 2,200 crores.

·        That means, every acre of irrigated with this water, Government is going to spend Rs. 80,000 on electricity alone. If we include all other costs, without capital costs, it will exceed Rs.1,00,000 per acre per season. Though, the project has been inaugurated, its utility is nowhere near.

In view of the above facts, a critical analysis has been initiated.

Critical Analysis: No doubt, KLIP is a engineering wonder and good tourist attractive picnic spot. But, this is not enough, when thousands crores of public money is spent, one has to critically evaluate what are the benefits and costs of this Project in terms of  agriculture i.e. to farmers, industries and drinking water facilities to the public.

·        The Detailed Project Report (DPR) states that it would provide water for irrigation for 18.25 lakh acres and stabilize water for another 6 lakh acres of existing irrigated area. The estimated project cost is Rs. 80,450 crore and the annual maintenance costs including interest payments will be around Rs. 13,923 crore. The projected net annual benefits are estimated at around Rs. 21,521 crore.

 ·        Independent analysis of the DPR by civil society organizations involved in water management and resettlement of evictees have questioned the proposed benefits accruing to farmers. They argue that: (1) The 180 TMC water is not enough for 26 lakh acres for any meaningful irrigation; (2) The crop yields have been grossly inflated almost 10 times as compared to the current levels for projecting highly favorable benefits/outcomes; and (3) the complete omission of social and ecological costs in the report.

 ·        Another disturbing conclusion, which is also acknowledged in the DPR, is that the operation and maintenance costs will be around Rs. 53,000 per acre, while farmers at best may get a benefit of Rs 15,000 per acre.  Under any cropping pattern, with any production increase, farmers will not get even one-third of the O&M costs as net benefit after removing the cultivation costs.

 ·        The report, prepared by civil society organizations in November 2016, has called for an impartial and unbiased Independent Review of the project to assess the claims made by the Telangana government. 

·        The DPR, for example, states that out of Rs. 21,521 crore of annual benefits, the agriculture sector will contribute Rs. 12,730 crore. Even these figures are not properly accounted in the DPR. The benefits from the agriculture sector in the report are based on three assumptions. They include: (1) The project will provide irrigation to 24 lakh acres; (2) Increases in the yield of 12 crops will be of 500-900 per cent more than current reported yields; and (3) All the produce will be getting higher prices. 

·        A farmer who is cultivating chilies, for example, is currently getting net income of Rs. 12,000 per acre as net benefit. But, with KLIP water, the same farmer is expected to get Rs. 1,56,000 per acre, which is 13 times more than the current return, which is far away from truth. Normally, when production (Supply) of any crop increases, the prices will fall with no buyers (less demand) in the market. For example, in case of Chilies in Telangana in 2017, when supply of Chilies increased, there no buyers, farmers in their frustration burnt the produce. Significantly, this is also the case with other crops. The DPR provides the projected benefits of each crop per acre. The net benefits from each crop after removing the cost of cultivation has been mentioned, and the current benefit of that crop has been given brackets. 

·        For reference sake, the details of DPR regarding other crops are: Paddy: Rs 28,000 per acre net projected benefit (Rs 3,200 current benefit); Maize: Rs 24,000 (Rs 3,500); Jowar: Rs 12,000 (Rs 2,400); Green gram: Rs 30,000 (Rs 2,700); Black gram: Rs 34,000 (Rs 2,000); Pigeon Peal Rs 34,000 (Rs 16,000); Ground nut: Rs 46,000 (Rs 10,000); Cotton: Rs 42,000 (Rs 9,000); Vegetables: Rs 44,000 (`3,000); Turmeric: Rs 55,000 (Rs 2,300); Soya bean Rs 40,000 per acre net projected benefit (Rs 19,000 current benefit). 

·        Thus, it is clear that the figures indicated in the DPR fail to reflect the current realities of cultivation. In short, this project is unlikely to generate benefits of more than Rs. 4,000 crore while the State would spend Rs. 13,000 crore every year. The Telangana government is going to spend four times more on the operation and maintenance costs than all the benefits that would accrue to farmers.

·        The projected agricultural benefits of KLIR are based on the assumption “that farmers will grow high-value crops at high yields” which is uncertain, a study points out.

 ·        The detailed project report assumes six crops – chili, turmeric, cotton, groundnut, soybean, and vegetables – will together cover 6.46 lakh hectares or 85% of the proposed irrigated area under the Kaleshwaram scheme,  which is again not certain, because sown area and crop yields depends on several natural and manual factors. 

·        There is a lot of debate on the Kaleshwaram Lift Irrigation (KLI) project, mainly on its costs and benefits, apart from its complex technical aspects. Many economists think that it can perhaps irrigate about 20 lakh acres, not the scheduled 38 lakh acres. Spending Rs 80,000 crore on it, needing to run it with over 4,000 MW power and other operation and maintenance (O&M) costs can be more than the increased agricultural production. They opine that the merely increased yield and its value will not be sufficient to make the project economically viable. 

·        It is almost as if the state will prescribe to the farmer which crop to produce, and in how much quantity. The projections do not properly taken into account multiple factors, including demand and price, that impact farming decisions.

·        Growing acreage and rising yields, on the back of confirmed water supply and better methods of irrigation and use of better seeds and inputs will lead to 2847% increase on total net return, the detailed project report claims.

 ·        “No farmer in Telangana will ever believe that such high incomes are possible,” said a Study. “It is certain that credibility and reliability of the cost benefit figures presented in DPR are completely fabricated at the best” says Biksham Gujja, former senior advisor of water policy at the World Wild Fund for Nature.

Debt Burden:

·        KLIP being the costliest Project in the country, Telangana State public debt is set to touch Rs. 2.29-lakh crore in 2020-21, up from an estimated Rs. 1.99-lakh crore in 2019-20. The State debt is poised to go up by nearly Rs. 31,000 crore in FY2021, up 21 per cent over the current financial year and will be 20.5 per cent of Gross State Domestic Product. The per capita debt for the State with a population of about 3.7 crore works out to over Rs. 61,000 by the end of fiscal 2021.

 

Jayaprakash Narayan Objections to KLIP: 

·        Jayaprakash Narayan, A former Indian Public Administrator, Politician (President  & Fonder of Lok Satta Party, Ex-MLA), Political Reformer, Columnist to Times of India, The Economic Times, Financial Express, The Hindu and Eenadu said over twitter that “I was the only one who consistently raised voice against it in the Assembly and outside. All major parties are guilty. Kaleshwaram will cost nearly Rs 100,000 Cr and will cost about Rs 20,000 Cr every year for maintenance. The poor people and tax payers will bear the burden”.

Environmental Law Violations:

·        In October 2020, the National Green Tribunal, India's court for environmental issues, directed the Telangana government to halt work on the KLIP except the drinking water supply component. A petition had been filed by a farmer from Siddipet district, whose land was affected by the KLIP. The National Green Tribunal found, on hearing his petition, that the environmental clearances for the KLIP had not been obtained before the project, as is required by law, but had been granted by the Union Government of India after work on the project had already begun by the Telangana government. The National Green Tribunal has directed the Indian government's Ministry of Environment, Forests and Climate Change to constitute a committee to investigate the illegally granted clearances, and to file a report with them within six months.

Concerns About Quality of the KLIP:

·        Breach in Kondapochamma Sagar Reservoir: Kondapochamma Sagar Reservoir a part of the Kaleshwaram Lift Irrigation Scheme, which was inaugurated by the CM on May 29th, with in a short time  i.e. on June 12, the left and right canals suffered breaches. Due to this, Shivar Venkatapur village in Markook Mandal of Siddipet district got flooded with Godavari water and submerged fields adjoining the village, where paddy, vegetable and other crops had been planted.

·        An under-construction tunnel of Kaleshwaram Collapsed: In Sept, 2020, under-construction tunnel of Kaleshwaram irrigation project in Sircilla district collapsed on Wednesday, killing seven workers, and seriously injuring one.

·        Under Construction tunnel Collapses in Palamuru – Rangareddy Lift Irrigation Project: Two labourers died and 14 others were injured after the wall of an under construction tunnel being built for an irrigation project caved in on them in Nagarkurnool district, which comes under KLIP.

High Costs:

·        What explains the government’s dubious claims about the benefits to farmers? Experts suspect this has been done to justify the high costs of the project. 

·        Apart from the construction cost of Rs 80,500 crore, the annual cost of running the project is projected at Rs 13,923 crore. The estimated energy cost of pumping water alone is Rs 4,067 crore. The state will also have to pay a 10% interest on the project capital, which works out to Rs 8,050 crore. 

·        Despite the high costs, the detailed project report has estimated a benefit-cost ratio of 1.55. This is higher than the benchmark ratio recommended by the Comptroller and Auditor General of India, which says a project is viable if it achieves a benefit-cost ratio of 1 in drought-prone areas. The ratio is calculated by dividing the total estimated benefit by the total estimated cost. 

·        The report claims a part of the project’s cost will be recovered from annual drinking water charges of Rs 1,699 crore and charges for water diverted to industrial units – about Rs 4,077 crore. 

·        But the major portion of the costs can only be justified by projecting large agricultural benefits. Agricultural production, which depends on a variety of factors including the weather, falls short, there could be a fall in the projected benefits and the overall benefit-cost ratio. 

Cost of lifting water:

·        It is estimated that power bills would be to the tune of 7000 to 8000 crores. It will be incurred by the Government. Finances of DISCOMS have been already hit hard by the 24/7 free agricultural power supply, around 1000 crore is the estimated impact on State budget. This adds to existing 3000 crore burden from electricity subsidies. State would need to make budgetary cuts somewhere to accommodate this.

Kaleshwaram project has low benefit-cost ratio, says irrigation expert:

·        Addressing at a Seminar on ‘Alternative Proposals and New Technology’ in the context of redesigning of the Pranahita-Chevella project, T. Hanumantha Rao (Retd. Chief Engineer) admitted that the benefit-cost ratio of the KLIP at the present cost is very low, which makes it highly unviable. However, within the limited scope of technicalities, he complimented the government for choosing Medigadda for barrage, as more water is available at the location. Nevertheless, pumping cost from Medigadda could be reduced with redesigning of the head sluice at Tummidihetti, to draw as much water as possible there itself through widening and deepening of canals. As per his analysis, the disputes over project height are not needed, as only 120 tmcft water is divertible at Tummidihetti, and additional water availability at 152 meters is very negligible.

Other Questions:

·         What would farmers actually get from growing crops with such expensive water?

·         How will the government recover cost by selling water to industry and domestic users to the tune of Rs 6,000 crore annually?

·         Now that project has started and a lot of money is being spent, what can be done?

This is typical of irrigation projects. A lot can still be done to avoid huge costs, by referring to independent experts for  incorporating changes. That will save money and avoid huge O&M costs.

Other side of  the Coin:

Cost-benefit Analysis:

·     The International Water Management Institute’s (IWMI) works reveal that appraisal of irrigation projects are based on only a few direct benefits. In the cost-benefit analysis, many indirect social and environmental benefits are largely ignored. There are capital costs comprise annual depreciation and annual interest charges. O&M costs include administration costs. There is also rehabilitation costs. They may be classified as financial costs. Proper estimation of financial costs is important for determining the economic costs of the project. And the other indirect effects (costs) are estimated and valued in monetary terms. Water is a scarce resource. Economic efficiency is the central concept in the use of scarce resources. For this, we do a cost-benefit analysis, which deals mainly with economic efficiency. It does not account for distributional impact of a project. For it, we need to do Economic Impact Assessment, which accounts for sectoral linkages, including the impacts in secondary and tertiary markets. All the outcomes and impacts that change the net benefits to society should be included in the assessment. Then only, it provides a holistic approach. 

·        Once the benefits and costs are identified, quantified, and valued, the next step is to develop a common measure of index, which allows direct comparison of costs and benefits. The most commonly used measures include net present value, economic rate of return and benefit-cost ratio. They are used to compare costs and benefits of irrigation and to determine returns on irrigation investments. 

·        But it is not right to compare costs with immediate direct benefits, ignoring the economic value of other multiple distributary socio-economic impacts. For such irrigation projects meant to impact the economy of the State, the government should be in a position to meet its annual capital commitments and O&M costs from its revenue expenditure and not just from the utility charges paid by farmers and other users. Confining the cost-benefit of KLI Project to agriculture alone is unwise.

·        The most important uncertainty to be addressed is the issue of water to irrigate fields, directly or indirectly. Mission Kakatiya, though envisaged to increase the storage capacity of the tanks, fares poorly when there is no adequate rainfall. Village tanks are central to farmers as they recharge groundwater substantially. Thus, maintaining sufficient water in the tanks round the year becomes critical. The Kaleshwaram project, apart from directly irrigating 18.25 lakh acres , aims to recharge groundwater by filling tanks, and other water bodies.  The benefits of such an effort are long term and difficult to evaluate through cost-benefit analysis in mere economic terms. For example, how can cost-benefit be calculated if farmers’ choices of crops to cultivate widen as a result of increasing access to irrigation water through 24-hour power supply and heightened groundwater table resulting in greater discharge from bore-wells. Every season thousands of bore-wells are dug in every Mandal across the State by desperate farmers to source more groundwater. Considering that each bore-well costs not less than Rs.1 lakh, stabilizing the groundwater through the Kaleshwaram project will ensure that farmers need not go for new bore-wells — a substantial increase in water table will be a boon for cultivation. 

·        Cost-benefit analyses are vital for planned state initiatives, but such analyses can also sometimes reveal half-truths. The modern welfare State can seldom afford to go with economists’ preference for cost-benefit analysis when millions of farmers are under agrarian distress. The Kaleshwaram project has to be seen in that perspective. The arguments against the Kaleshwaram project also ignore the new seed varieties developed by crop breeders which are of short duration, thus reducing the irrigation days. When there are no rains, if the village tanks are filled, the farmer need not to be worried about weather tantrums. The critics ignored the larger socio-economic benefits of the project, which include development of fisheries, inland waterways, tourism, and biodiversity.

Conclusion: Pragmatically speaking, most of the irrigation projects in India, whether gravity based, or lift based rarely meet the highly optimistic figures told by the government. It is true that this project is going to have heavy burden on exchequer of Telangana government and is not so profitable if we take into account two “wet crops”. But at the same time, it is wrong to say that the project is useless. It is definitely useful, when larger socio-economic benefits of the project, like fisheries, inland waterways, tourism, and biodiversity are taken inn consideration and carefully managed.

References:

 

1. Kaleshwaram Project Summary, Telangana State.

2. Kaleshwaram lift irrigation project: Time for an expert review - DECCAN CHRONICLE - DR. BIKSHAM GUJJA, Published on Jul 4, 2020.

3. Kaleshwaram Lift Irrigation Project: Facts on world's largest multi-purpose lift irrigation project  - India Today – Web Desk, New Delhi, Published on June 21, 2019.

4. Explained: Why the NGT wants a relook at Kaleshwaram project – The Indian Express – Dated: Oct. 2^nd, 2020.

5. Mega Kaleshwaram project becomes operational – The Hindu – Dated: 22/06/2019.

6. Telangana: Kaleshwaram project sets new record, cost to cross Rs 1 lakh – Times of India – Dated: 8/12/2019.

7. A White Elephant in the making – Biksham Gujja – Published in Business Line – Dated: 02/08/2018.

8. Kaleshwaram Project: Will it sink Telangana’s economy? - DECCAN CHRONICLE. | DR BIKSHAM GUJJA – Published on Jul 10, 2018.

9. Kaleshwaram project has low benefit-cost ratio, says irrigation expert -  The Hindu, Dated: 9/04/2016.

10. Irrigation project on Godavari river set to raise Telangana’s debt -  Hindustan Times – Dated: 26/01/2019.

11. Kaleshwaram – The making of an engineering Marvel – Business Line – Dated: 21/06/20019.

12. http://www.irrigation.telangana.gov.in/img/projectspdf/kaleshwaram.pdf

13. https://www.kaleshwaramproject.com/

14. Other Relevant Websites related to Kaleshwaram Project.