JUDGMENT : N. Kirubakaran, J. 1. The most notorious disease is Cancer, which is a killer disease. Many researches are being undertaken to invent a knight [Medicine] to wage war against the killer monster. In the year 2000, Cancer was responsible for the death of 12% of the nearly 56 million world wide from all sources. As per GENEVA Cancer Report 2003, the global Cancer rate could be increased by 15 to 50 million by 2020. India is not an exception and more than 1300 Indians die due to the dreaded disease everyday, with new Cancer cases and in India the same are estimated to grow by 25% by 2020. According to the Cancer Registry published by Indian Council of Medical Research, Cancer has become one of the major causes for death and women, especially, are being increasingly diagnosed with Cancer. 2. Cancer burden is astonishingly increasing across the world. According to the UN agency low and middle income countries account for 2/3rd of Cancer deaths as many of them lack early screening and basic treatment facilities. In India, 10 lakh new cases of Cancer are diagnosed every year, however, due to late diagnosis, over 7 lakh people die each year due to the said disease. Indian Council of Medical Research projected that India is likely to have 17.3 lakhs new cases of Cancer and over 8.8 lakhs deaths due to the disease by 2020. National Cancer Registry Programme data shows that India recorded about 3.9 million Cancer cases in 2016. Cancer is a leading cause of death world wide accounting to 8.8. million deaths in 2015. Though India has lower Cancer rates than many other countries, it has a very high death rate. In India, almost 50% of all Cancers are diagnosed in late stages, which is the reason for higher death rate than western countries. 3. As per the Cancer Statistics given by National Institute for Cancer Prevention and Research, in India, for every 2 women newly diagnosed with breast Cancer, one woman dies of it. 4. As many as 2500 persons die every year due to Tobacco related diseases in India. Smoking accounts for 1 in 5 deaths among women, 1 in 5 deaths in men. According to the estimate of 9,30,000 deaths in 2010, estimated number of people living with the disease is around 2.5 million. Every year, over 7 lakhs new Cancer Patients are registered. Smoking accounts for 1 in 5 deaths among women, 1 in 5 deaths in men. According to the estimate of 9,30,000 deaths in 2010, estimated number of people living with the disease is around 2.5 million. Every year, over 7 lakhs new Cancer Patients are registered. Cancer related deaths is 5,56,400. The number of deaths are more due to Cancer in India due to the fact of late diagnosis and only 15% of the Diagnosed Cancer Patients opt for treatment, while a notable majority cases remain untreated. As already observed nearly a million new cases of Cancer are diagnosed annually. 5. It is stated that primarily due to increased use of Tobacco, limited access to prevent, screening methods and poor treatment outcome, there is increase in death due to Cancer in India. Hence, there is a need to have Cancer Research in India. Further, Cancer Research in India is stated be a complex one and it is different from many developed countries, as Indian patients go for alternate medicine like Homeopathy, Ayurveda, Siddha, Unani, Naturopathy among others. When the situation warrants more research, invention of new medicine, availability of medicine at a lower rate, early screening and diagnosis and continuous treatment should be provided 6. According to the study done by the Cancer Registry published by the Indian Council of Medical Research [ICMR], the incidences of Cancer are expected to increase by 15,10,396 in the year 2025 that is 35.2% higher than the 2014 figure. 7. The estimated mortality in the year 2014 is 4,91,598, which means that: (1) more than 1300 people died every day in India due to Cancer; (2) 2 new Cancer cases are detected every minute in India. The most common Cancers in men are Mouth, Lung, Prostate and Larynx and in Women are breast, cervical, ovary, corpus, uterus and bladder. Though the country is seeing a sudden rise in Cancer, the health support systems are not that much equipped and there are only 1500 Oncologists for a population of 1.5 billion which means 1 Oncologist for every 8,12,500. India recorded about 3.9 million Cancer cases in 2016 as per National Cancer Registry Programme Data. The World Health Organization Medical definition of Cancer is "An abnormal growth of cells which tend to proliferate in an uncontrolled way and in some cases, to metastasize (spread)". India recorded about 3.9 million Cancer cases in 2016 as per National Cancer Registry Programme Data. The World Health Organization Medical definition of Cancer is "An abnormal growth of cells which tend to proliferate in an uncontrolled way and in some cases, to metastasize (spread)". Cancer is the leading cause of death world wide and responsible for 8.2 million deaths in 2012. The number of Cancer deaths in India is 2.2 million per year, since 70% of the Cancer Patients consult the Doctor at the terminal stage. 8. According to WHO, in 2015, 8.8 million people died of Cancer which means nearly 1 in 6 global deaths. About 70% of all deaths from Cancer occur in low and middle income countries; less than 30% of low-income countries reported treatment services were generally available compared to more than 90% of high income countries. The economic impact of Cancer is significant and is increasing. The total annual economic cost of Cancer in 2010 was estimated at approximately US $1.16 trillion; world wide, only about 14% people who need palliative care currently receive it and only 1 in 5 low and middle income countries have the necessary data to drive Cancer Policy. 9. According to the National Cancer Registry Programme of the Indian Council of Medical Research [ICMR], more than 1300 die every day due to Cancer. Between 2012 and 2014, the mortality rate due to Cancer increased approximately 6%. In 2012, there were 4,78,180 deaths out of 29,34,314 cases reported. In 2013, there were 4,65,169 deaths out of 30,16,628. In 2014,4,91,598 people died out of 28,20,179 cases. 10. It is stated in India, Cancer risk is constantly on the rise with 10,00,000 people diagnosed with it every year and around 7,00,000 of the patients die, making it one of the leading causes of death. India recorded about 3.9 million Cancer cases in 2016 as per ICMR Reports. India runs 145th among 195 countries in terms health care access and quality in 2016, as assessed in a global burden of diseases study published in LANCET. 11. The aforesaid data would definitely shock everybody as the death rate is increasing due to Cancer in India. India recorded about 3.9 million Cancer cases in 2016 as per ICMR Reports. India runs 145th among 195 countries in terms health care access and quality in 2016, as assessed in a global burden of diseases study published in LANCET. 11. The aforesaid data would definitely shock everybody as the death rate is increasing due to Cancer in India. In the above scenario, the Petitioner, who is an Indian Research Chemist, and is stated to have developed extensive know-how in Generic Cancer Drugs, has approached this Court seeking a Writ of Mandamus directing the Respondents to consider the Petitioner's Representation dated 28.4.2017 to give preferential allotment/necessary quota in all Public programmes for medicines with indigenously produced Active Pharmaceutical Ingredients to facilitate and implement the same with enabling criteria and complying concession measures recommended by the Expert Committee constituted for revival of the Indian Bulk Drugs Industries within a reasonable time frame to be fixed by this Court. 12. As already observed with shocking increase in number of Cancer deaths, definitely India should have facilities to have research and invent Medicines for development and manufacture of Generic Cancer Drugs which could be made available to patients at affordable rates. 13. The Petitioner would state that more than 90% of the raw materials for manufacture of Cancer drugs are imported from China and India has to necessarily depend on China for the same. If the Petitioner is given the required assistance, the Petitioner is sure that he could manufacture Cancer drugs at a lower rate, as he developed extensive knowhow in Generic Cancer Drugs and ultimately the dependence on China would be reduced considerably. 14. It is the case of the Petitioner that the Petitioner has been promoted by an Indian Research Chemist and that they have developed extensive know-how in Generic Cancer Drugs. It is their case that they have commenced their journey in 1994 as researchers cum manufacturers of Active Pharmaceutical Ingredients (API) also known as Bulk Drugs and were successful for years. Active Pharmaceutical Ingredients are the nucleus of Medicines that act upon the illness and according to the Petitioners they have developed generic know-how for certain APIs that are widely applied in Cancer care. 15. Active Pharmaceutical Ingredients are the nucleus of Medicines that act upon the illness and according to the Petitioners they have developed generic know-how for certain APIs that are widely applied in Cancer care. 15. While so, according to the Petitioner, India's robust API segment started facing a meltdown on account of developing indiscriminate reliance upon import of cheap APIs from China; Union Government omitted to ensure level playing field and afford requisite protection to domestic players in the field that has led to virtual crippling of the Domestic know-how segment 16. According to the 1st Petitioner, in these circumstances, the Petitioner availed Loan facilities to upgrade their API facility and put up their own Inject able facility to USFDA (United States Food & Drugs Administration) standards so as to tap the overseas markets. They have also completed and inaugurated the facilities State of the Art to USFDA standards after a tough journey. They also manufactured Drugs and APIs worth several crores; However, when they sought to participate in Public Procurement to gain liquidity for their world class medicines, they were met with entry barriers in the procurement systems such as pre-existence and prior turn over criteria running into several crores prescribed by the State procuring agencies. There is also no level playing field for Domestic Good Manufacturing Practitioners. This has also put the Petitioner in a piquant situation in availing requisite fund support from its Bankers (Bank of India & NABARD) to pursue USFDA approval for the established facilities. 17. Therefore, the Petitioner has filed Writ Petitions before this Court seeking revival under Corporate Debt Restructuring Scheme (CDR) from its Banks. The directives in earlier rounds of Writ Petitions filed by the Petitioner, the consequent Expert evaluations and recommendations taken by Banks and connected proceedings that led up to issuance of in principle sanction by Banks dated 23.1.2017. However, by their further Communication dated 8.3.2017, the Banks have stated that they cannot ascribe margin value for the Rs. 41.25 crores stocks of medicines held by the Petitioner, since "the Expert Techno Economic Viability Study" has assigned NIL value to the said stocks on account of barriers faced by the Petitioners in gaining liquidity for their stocks and medicines in State procurements and denied them sanction. 18. 41.25 crores stocks of medicines held by the Petitioner, since "the Expert Techno Economic Viability Study" has assigned NIL value to the said stocks on account of barriers faced by the Petitioners in gaining liquidity for their stocks and medicines in State procurements and denied them sanction. 18. In such circumstances, the Petitioner approached this Court in W.P. No. 11777 of 2017 contending, inter alia, that they are a venture having knowhow that is crucial for the Health Security and Health Care Standards for the nation, that they fall under a category identified for special protection and revival by Government of India, that National Security Advisor has cautioned the Government of the dangers of near total dependence on one single neighbour nation for the country's essential drug requirement, that consequent thereupon the Government has constituted the Expert Committee headed by the then Health Secretary-Dr. V.M. Katoch to recommend the measures to revive domestic API segment and that though the Government has come out with several assurances to implement the recommendations, none of the promises have percolated to real relief and in such circumstances if the Petitioner is left to sink, one more unique indigenous API facility critically relevant for the country's health care and health security would be lost to the nation and it would take years and extraordinary efforts to recreate another one. 19. It has also been pointed out that the dreaded disease Cancer has assumed endemic proportions in India and globally. Every 13th Cancer Patient is an Indian. Every 10 minutes, we lose 2 women and every one day we lose 50 children to the dreaded disease. By 2030, the number of Indian Women patients expected to be diagnosed with Cancer would be equal to the population of Denmark. The age bracket of patients afflicted with Cancer is also getting younger. The Petitioners would further contend that they have world class facilities and drugs and that they have earned the distinction of supplying Candidate material to US Pharmacopeia for their reference bench marks and enabling them would also take India forward in World Cancer Care fetching substantial Foreign Exchange, enhancement of livelihood for farmers of most backward drought District of Southern Tamil Nadu and employment and research benefits. 20. 20. With these contentions, the Petitioners have filed the above Writ Petition seeking preferential allotment/quota in Public procurements for their drugs manufactured with domestic API content and facilitate and implement the same with enabling criteria and applying the concessional measures recommended by the Expert Committee constituted for revival of Indian Bulk Drugs Industry. 21. The under Secretary to Government of India Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers have filed their Counter in the matter. While the Government would contend that the Petitioner cannot seek a general direction for preferential allotment/quota, etc., on the recommendations of the Expert Committee for revival of Indian Bulk Drugs Industry and applying the concessional measures recommended by the said Committee to the Petitioner, the following is their stance: 22. The Respondent-Government, in its Counter, has stated about the intent of the Government to implement the recommendations of the Katoch committee to bring down the import dependence for bulk drugs and various measures taken by them in this regard. For setting up Mega Parks for establishing more API facilities, they have outlined the proposed measures contemplated to be implemented in future and the Respondent-Union of India have further stated that any direct financial assistance is dependent on availability of financial resources with the Department. 23. From the Report submitted to this Court, it is seen that recommendations of the Dr. V.M. Katoch Expert Committee for revival of Bulk Drugs Industries are as under: "(i) It needs to recognize that some of the issues of consent are generic to the entire Pharma Industry and not confined to the essential drugs alone. Therefore, measures will have to be taken for revival of the Pharma Industry as a whole including those involved in the manufacture of API intermediates. The key requirements for API industry include availability of land, basic infrastructure such as water, electricity and Common state-of-art-facilities such as Effluent Treatment Plants (ETPs), steam, testing facilities, etc. For economizing production, establishment of Large Manufacturing Zones (1 MZs)/Mega Parks for APIs with Common facilities maintained by a separate Special Purpose Vehicles (SPV) will need to be explored. To begin with, such facilities will need to be provided at a concessional rate and preferably free of cost. This will help "in competing with the other countries and also generating large employment. To begin with, such facilities will need to be provided at a concessional rate and preferably free of cost. This will help "in competing with the other countries and also generating large employment. Such mega parks need to be provided with Common facilities such common Effluent Treatment Plants (ETPs), Testing facilities, Caplve Power Plants/assured power supply by state systems, common Utilities/Services such as Storage, Testing Laboratories, IPR Management, Designing, Guest House/accommodation, etc. These zones should be attached with Power Plant and Solvent yards. These zones could be set up in National Manufacturing Investment zones/Petroleum, Chemicals and Petrochemical Investment Regions (PCPIRs) in state that have the requisite facilities/systems in place. The State like Gujarat, Andhra Pradesh, Tamil Nadu and Odisha could be consulted and they could allocate the land and provide other facilities. Parks could be set up in the vicinity of Mega Complexes where chemicals meant for further stages in producing APIs could be produced. The bulk Drug Industry including those involved in the production of APIs is one of the major polluting industries. The cost of the pollution control is very high as it requires highly capital intensive technology to treat pollution. It is, therefore, necessary to have proper Rules and Regulations to have check on the pollution level and the quality of the output. But at the same time there is a need to come out with procedures of implementation which are efficient and effective which include aligning the provisions of the Acts and Rules regarding pollution, quality control, custom and excise duty, exports bodies (DGFT), coal allocating bodies, Electricity Authorities to have a cell in the Mega Complexes proposed for the bulk drugs. (ii) Six large API intermediate clusters in five to six States are expected to transform the Nation. Keeping in view the urgency, it would be necessary to start with at least two fully financed clusters (one focused on fermentation and other on APIs) in the immediate future, this process may be driven by an Empowered Committee for taking decisions in a time bound manner. An average cluster will require about 1000 to 2000 hectares of land and will require about 750 - 1000 crore investment for common facilities/services if all requisite schemes are developed and implemented in near future within 3-6 months. An average cluster will require about 1000 to 2000 hectares of land and will require about 750 - 1000 crore investment for common facilities/services if all requisite schemes are developed and implemented in near future within 3-6 months. These parks could be allotted to large bulk, medium and small manufacturers on the basis of a formula to be specified in the Guidelines, which may be prepared by the Department of Pharmaceuticals. Because of similarities in technologies for chemical or fermentation technologies, separate parks for such manufacturers will be desirable. One such functional cluster can bring benefit of around one billion dollar/Rs. 60 billion per year. It is felt that three clusters may succeed in wiping out dependence in the area of APIs. (iii) A scheme for extending financial assistance to states to acquire land and also for setting up common facilities would be necessary. The States may also establish their own manufacturing zones for this purpose. (iv) Revival of Public Sector units for starting the manufacture of selected and very essential critical drugs (e.g. Penicillins, Paracetamol, etc.)/vaccines or lease the plants/assets possessed by these units is suggested as one of the options for consideration. Where feasible, it would be necessary to evolve ways and means of utilizing the resources available in Public Sector units such IDPL for setting up API industry. Infusion of capital (about 500 crores each) is recommended to these units to start manufacturing important APIs in the very near future. (v) In order to ensure Single Window clearance to manufacturers and provide common facilities and other support, the Department of Pharmaceuticals should have an institutional mechanism which could work in synergy with other important Departments such as Ministry of Environment and Forests, Ministry of Coal, Department of Financial Services, Department of Revenue and others have units co-located at this site. Machines/Equipment: The incentives to the manufacturers for setting up large plants and imports of technology that will reduce the cost of production need to be worked out. Allocation of adequate quantity of coal and electricity at concessional rates may also be considered. A scheme on the pattern of the modified special incentive package for IT hardware, etc. may be considered. Machines/Equipment: The incentives to the manufacturers for setting up large plants and imports of technology that will reduce the cost of production need to be worked out. Allocation of adequate quantity of coal and electricity at concessional rates may also be considered. A scheme on the pattern of the modified special incentive package for IT hardware, etc. may be considered. Fiscal and Financial Incentives The Following measures are recommended: (a) Immediate financial investment will be required from the Government for development of clusters which may be in the form of a professionally managed dedicated equity fund for the promotion of manufacture of APIs-All Central and State duties, levies, etc. in creating the entire community cluster infrastructure and individual unit infrastructure should be zero. If a unit promises more than 50% capacity utilized for NLEM products then at least these benefits should be given. (b) Soft loans to the Industry through interest subvention upto 7.5%, at least at par with interbank lending rates. (c) Capex loan to the manufacturers of APIs for high priority identified drugs, with a moratorium of 10 years for repayment. Alternatively debt instruments should be long term i.e., 3 + 5 years for APIs/intermediates and 3+7 yrs duration for fermentation. (d) Margin money for strategic projects should be cut down. Preferably to 15% equity and 85% debt. (e) Tax free status to cluster developers and cluster participants for 15 years. (f) Measures to encourage foreign investment including faster clearances, funding for green filed/brown field areas to be appropriately analyzed and support to be encouraged for the brown filed technologies. (g) Income Tax rebates on up gradation of the existing R&D facilities should be doubled to 400% from existing 200%) so as to encourage new development. (h) Income-tax benefits for manufacturing companies for an initial period of 10 years for each product from the date of launch of the product. (i) Tax Benefits in the form of proper Indirect Taxes. (j) A long term strategy keeping a goal of strengthening API sector by involving Ministry of Commerce as well as other Regulatory Authorities is required: (i) Judicious and liberal use of measures like anti-dumping, safeguards/duties, reciprocation and application of Rules of Origin is suggested. (ii) Based on risk analysis, a minimum of one or two inspections per month must be carried out for manufacturing facilities (by Indian regulators) located outside India. (ii) Based on risk analysis, a minimum of one or two inspections per month must be carried out for manufacturing facilities (by Indian regulators) located outside India. (iii) Creation of advance Testing Lab infrastructure at all Indian Ports/Air Ports in a time bound manner to subject imports to risk- based testing. (k) Incentives such as reduction on service tax on the clinical trials for drugs developed in India. (l) Assured percentage of procurement from Domestic bulk drug manufacturers from mega parks in conformity with WTO norms. RESEARCH AND DEVELOPMENT Committee recognizes that investment in R&D is essential to ensure competitive edge. Measures recommended are: (i) Stronger industry-academia interaction by facilitating the to-fro movement of scientists between industry and academic institutions. (ii) Institutional mechanism for Ministry of Human Resources, and various Science Departments/Agencies like DST, DBT, CSIR, ICMR, etc. to work together in synergy on R&D relevant for best procedures of production. (iii) Innovation should be measurable and awards to the Scientists/Industry, who contribute to the development of improved processes relevant to Bulk Drug Industry. Technology development financing to be repaid. (iv) Import Duty Exemption on import of Capital goods In respect of Research and Development (R&D) and Manufacturing of Vaccines/APIs. (v) Other tax benefits/financial incentives/support from Govt. for R&D for development of improved strains; alternate raw materials, and improved/competitive technologies." 24. In this backdrop, this Court has passed Directives from time to time and also suo motu impleaded parties/Respondents so that a know-how facility already in existence said to be critical for nation's health security could be conserved. As per the Directives of this Court, the Central Drug Testing Laboratory have tested samples of the Medicines manufactured by the Petitioner and certified them to be of prescribed standards vide their Reports dated 24th August 2017. In compliance with Directions of this Court, the Drug Controller (I), CDSCO (SZ), Government of India and Director of Drugs Control, Government of Tamil Nadu along with higher officials of NABARD and Bank of India have also visited the Factories of the 1st Petitioner at Tiruvallore, Tamil Nadu & TADA Mandal, AP with their team of Assistant Director of Drugs Control and Drugs Inspectors on 2.3.2018 and submitted their Report which states the following: "As per the records reviewed, it is observed that the manufacturing facilities have been licensed under Drugs and Cosmetics Act, 1940 for the manufacture of various Anti-Cancer Drugs. The formulation facility was licensed in 2012 under License No. 29/NL/AP/2012/F/G and valid till 13.8.2017. API Manufacturing Facility was licensed in 2008 under License No. 914/17 is valid till 17.12.2018 As per the records reviewed, both the manufacturing facilities have been inspected at periodic intervals by the Drugs Inspectors of Central and State Government and their compliance with Good Manufacturing practices (Schedule M of Drugs and Cosmetics Act, 1940) were found satisfactory. As per the records reviewed, both the manufacturing facilities have been inspected and on satisfactory compliance with the requirements of Good Manufacturing Practices of world Health Organization were granted WHO GMP Certificate in 2014 & 2017. At the time of inspection, it was found that both the manufacturing facilities have been provided with the necessary equipment for the manufacture of Bulk drugs and formulations of Anti-Cancer Drugs Licensed and the List of Equipment is given below: At the time of inspection, it was found that the facility is in lay-off state and therefore, no technical staffs were available and there was no manufacturing activity. However, the equipments were found in good working condition and there was adequate maintenance." 25. While so, by Orders dated 11.4.2018, this Court has ordered impleadment of Department of Scientific & Industrial Research (DSIR), Ministry of Science and Technology as a party Respondent and have issued further Directives for the Petitioner to submit their revival proposal for due consideration by Ministry of Science and Technology. While so, it has been reported to this Court that on 12.4.2018, the Petitioner has received the following invite from DSIR, Ministry of Science & Technology: "No. DSIR/PACE/ADVT/2017-18 Dated 12.4.2018 To, The Head of the Organisation/Head of R&D Unit Sub: Invitation of PACE Proposals Dear Sir(s)/Madam, 1. Department of Scientific and Industrial Research (DSIR), Govt. of India, appreciate successful execution of Technology Development Projects by your organization with its support in the past. 2. The Department is continuing to operate the 12th Five "Year Plan scheme on "Patent Acquisition and Collaborative Research and Technology Development (PACE)" during 2017-2020. The DSIR through the PACE Scheme provides catalytic support to industries and institutions for development and demonstration of innovative product and process technologies, traversing the journey from proof of concept or laboratory stage to pilot stage, so that they can be launched for commercialization. The DSIR through the PACE Scheme provides catalytic support to industries and institutions for development and demonstration of innovative product and process technologies, traversing the journey from proof of concept or laboratory stage to pilot stage, so that they can be launched for commercialization. The Scheme supports ingenious work and assists in development of new technologies or creative/innovative application of the existing technologies to solve unmet needs of industry. The scheme also strengthens the interface between industry, R&D establishments and academic institutions by supporting collaborative proposals. The Guidelines (with application format) of the Scheme is available on DSIR website www.dsir.gov.in (http://www.dsir.gov.in/#files/12plan/pace/pace.html) 3. DSIR is inviting Technology Development and Demonstration project proposals from industries either on their own or in collaboration with R&D/Academic Institutions/Universities for development and demonstration of innovative Process/Product technologies. The last date for submitting the PACE Applications for 7th batch is extended till 30th April 2018. The Application is required to be submitted in softcopy as well as hardcopy. In case of any queries in this regard, you may send e-mail on: vinaykumar@nic.m. Regards, Vinay Kumar Scientist 'E' Department of Scientific and Industrial Research Ministry of Science and Technology, Govt. of India Technology Bhawan, New Mehrauli Road New Delhi-110016 Tel.: 011- 26529742/26590496, 9868287814 Telefax: 011-26529742 Fax: 011-26960629 E-mail: vinaykumar@nic.in Consequent thereto, on 23.4.2018, this Court has passed the following Order: "In view of the invitation that has been made in Paragraph No. 3 of E-mail dated 20.4.2018, extracted above, the Petitioner is directed to submit Technology Development Board Application Form (Form-A) to the Department of Scientific and Industrial Research, Ministry of Science and Technology, Government of India, Technology Bhawan, New Mehrauli Road, New Delhi-110 016. On receipt of the same, the Department is directed to consider the said Application, in the light of Dr. Katoch Committee's recommendations with regard to API. The outcome of the Application has to be informed to this Court by Mr. G. Karthikeyan, learned Assistant Solicitor General. Post on 4.6.2018...." 26. In this backdrop, this Court is of the considered view that the National importance and benefits of the Petitioner as contended by the Petitioner should be gone into by appointing an Amicus Curiae to assist the Court to pass necessary further Orders in the matter. The Counsel representing the Bankers to the Petitioner would submit that their reservation for the Court to appoint Amicus Curiae may be recorded and the same is recorded. The Counsel representing the Bankers to the Petitioner would submit that their reservation for the Court to appoint Amicus Curiae may be recorded and the same is recorded. However, with regard to the variances in their facility visit Report with that of the Regulators, it has been fairly submitted by them that their Statements in their Report on the know-how of the Petitioner have not been aided by opinion from domain Experts. Moreover, the Amicus Report would only help this Court to pass appropriate Order. By appointment of Amicus, no prejudice is caused to the bankers. 27. In these circumstances, this Court deems it fit to appoint and appoints Senior Advocate Mr. N.L. Rajah to act as Amicus Curiae to study and Report on the following to this Court: (1) The rising incidence and spread of the disease Cancer. (2) Relevance of the APIs & Cancer Medicines manufactured by the Petitioner for National Health Security and Health Care Standards. (3) Applicability of the V.M. Katoch Committee's recommendations vis-à-vis the Petitioner. (4) The investment and timeline that would be required to establish know-how and put up facilities equivalent to that of the Petitioner. (5) Extent of benefits that would accrue to the farming community by nurturing this Industry of the Petitioner. (6) Extent of Foreign Exchange & other benefits that could accrue to the Nation from Cancer Medicines manufactured by the Petitioner. The amicus would visit the facilities of the 1st Petitioner with requisite teams of Experts. The Amicus is at liberty to enlist necessary support of co-professionals and would also engage requisite domain Experts and Report on the above mandates. He could also seek such information and data as may be deemed fit from the State and Central Government which they shall provide expeditiously and Counsel representing the State and Center are requested to facilitate the same to be furnished expeditiously. The 1st & 2nd Petitioners in the Writ Petition are also directed to furnish any requirements stipulated by the Amicus. The Amicus would report the progress of their evaluations to this Court in the hearing to be held on 11.6.2018 and submit his Report to this Court by 27th June 2018. 11.6.2018 28.[1] When the matter is called today, Mr. T. Mohan, learned Counsel appearing for the Petitioner filed an additional typed set of papers containing two documents viz., 1. The Amicus would report the progress of their evaluations to this Court in the hearing to be held on 11.6.2018 and submit his Report to this Court by 27th June 2018. 11.6.2018 28.[1] When the matter is called today, Mr. T. Mohan, learned Counsel appearing for the Petitioner filed an additional typed set of papers containing two documents viz., 1. Purchase Order from US Pharmacopeial for 30 grams of Vinorelbine related compound A for USD 66000 and 2. License Retention Certificate for formulation facility at TADA Mandal AP. 29.[2] It is evident from the Purchase Order dated 15.02.2018 placed by US Pharmacopeial that the materials available with the Petitioner are standard ones. USP is a scientific non-profit organization that sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements manufactured, distributed and consumed world wide. USP's drug standards are enforceable in the United States by the Food and Drug administration, and these standards are used in more than 140 countries. 30.[3] The very fact that the said US Pharmacopeial Convention (USP) has placed orders for 30 grams is a proof for the quality of the Medicine manufactured by the Petitioner and the standard adopted by the Petitioner and the capacity/capability of the Petitioner. 31.[4] The second document is the License Retention Certificate dated 06.06.2018 for formulation facility at the Petitioner's Company at TADA Mandal AP issued by the Director and Licensing Authority, Drugs Control Administration, Government of Andhra Pradesh. The License issued to the Petitioner is valid up to 13.08.2022. It has to be noted that the License already expired on 14.08.2012 and the same has been renewed for five years until 13.08.2022. Therefore, the aforesaid document is also in favour of the Petitioner, which would show that the Company has got facilities to get the mandatory services from the Authorities. 32.[5] Mr. S. Sathyanarayanan, learned Counsel appearing for the NABARD and Bank of India would submit that for non-filing of Annual Reports of the Petitioner-Company, the Directors of the Petitioner's Company have been disqualified. In this regard, an assurance has been given by the Petitioner that steps would be taken to rectify the above mistakes. 33.[6] Mr. T. Mohan, learned Counsel appearing for the Petitioner would submit that already AGM has been convened and Annual Report has been passed in the AGM and they have been filed before the ROC. 34.[7] Mr. In this regard, an assurance has been given by the Petitioner that steps would be taken to rectify the above mistakes. 33.[6] Mr. T. Mohan, learned Counsel appearing for the Petitioner would submit that already AGM has been convened and Annual Report has been passed in the AGM and they have been filed before the ROC. 34.[7] Mr. S. Sathyanarayanan, learned Counsel appearing for the NABARD and Bank of India would submit that he needs the Report and also the Statement of Accounts of the Petitioner. 35.[8] Mr. Mohan, learned Counsel appearing for the Petitioner assured to give the same in the next hearing. 36.[9] Mr. N.L. Rajah, learned Senior Counsel, who has been appointed by this Court to act as Amicus Curiae would submit that he has already started working and there should be a meeting of all the stakeholders, so that the matter could be taken and a logical conclusion could be arrived. Unless the stakeholders participate in the meeting to be convened by him, it is impossible to have a consensus. 37.[10] Call the matter on 27.6.2018. 27.6.2018 38. [1]. Mr. N.L. Rajah, learned Senior Counsel appointed as Amicus Curiae would submit that he had visited the Petitioner's Factory and he is very much satisfied with the facilities available in the said Factory. Further, he seeks time till 06.07.2018 to submit his report. 39.[2]. Mr. Om Prakash, learned Senior Counsel appearing for the Petitioner as well as Mr. T. Mohan, learned Counsel filed an Office Memorandum dated 18.04.2018 issued by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers constituting a Task Force on Active Pharmaceutical Ingredients. The said task force consisting of 12 Members headed by Hon'ble Minister of State, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers has been constituted to formulate a road map for the enhanced production of Active Pharmaceutical Ingredients (APIs) in the country. The Terms of Reference of the said Task Force would be as follows: "The Taskforce will formulate a Road map for the sector with implementable recommendations. The interventions recommended will include that concerning the Central Government, State Governments and Regulatory Bodies where applicable. The role of industry may also be clearly delineated. The Terms of Reference of the said Task Force would be as follows: "The Taskforce will formulate a Road map for the sector with implementable recommendations. The interventions recommended will include that concerning the Central Government, State Governments and Regulatory Bodies where applicable. The role of industry may also be clearly delineated. The specific areas of focus may include, but may not be limited to the following: Research & Development Acquisition & Commercialization Application and adoption in specific sectors Development of the Industry Regulatory framework Potential impact on industry, job creation, investments, contribution to the economy, technology infusion, exports, integration with value chains, etc. The Taskforce may study global practices and interact with relevant stakeholders as required." 40.[3]. By the said Official Memorandum, Mr. Om Prakash would submit that the Memorandum is in consonance with the purpose for which the learned Amicus Curiae was appointed by this Court. In the hearing on 11.06.2018, Mr. N.L. Rajah, learned Amicus Curiae submitted that he has already started working and there should be a meeting of all the stakeholders, so that the matter could be taken and a logical conclusion could be arrived. Unless the stakeholders participate in the meeting to be convened by him, it is impossible to have a consensus. In this regard, this Court is of the firm view that the Members of the task force has to visit the facilities of the 1st Petitioner as a pilot case study to take stock of the significance of the API Know-How and Technology of the Petitioner for the Nation. In view of the same, Mr. G. Karthikeyan, learned Assistant Solicitor General of India is directed to get instructions from the Government of India as to when the meeting of the Task force could be convened and when the Members of the Task force could visit the facilities of the 1st Petitioner. 41.[4] Mr. T. Mohan, learned Counsel for the Petitioner would submit that as per the earlier Order dated 11.06.2018, the documents which are required to be filed have already been served upon Mr. Sathyanarayanan, learned Counsel appearing on behalf of the Bank of India and NABARD. Mr. Sathyanarayanan, learned Counsel also accepts that the documents have been served upon him, however, he seeks a Memo to be filed on behalf of the Petitioner in this regard and Mr. Sathyanarayanan, learned Counsel appearing on behalf of the Bank of India and NABARD. Mr. Sathyanarayanan, learned Counsel also accepts that the documents have been served upon him, however, he seeks a Memo to be filed on behalf of the Petitioner in this regard and Mr. T. Mohan, learned Counsel appearing on behalf of the Petitioner undertakes to file a Memo for having served the document. [5] Even though Mr. Sathyanarayanan, learned Counsel appearing on behalf of the Bank of India and NABARD objected for the extension of the Interim Order pertaining to deferment of proceedings before the DRT, this Court is of the view that the earlier Order passed by this Court itself is sufficient as the same is not limited and it is deemed to continue until further Orders. Call the matter on 6.7.2018.