European Union issued a new Directive/2011/62/EC dated 8th June 2011 amending earlier Directive 2001/83/EC. The stated objective of this Directive is to lay down a community code relating to medicinal products for human use and to ensure that the defective products do not reach consumers.  The Directive lays down a system of control over the entire supply chain for pharmaceuticals. It controls manufacture and import to marketing, wholesale and retail distribution.  The said directive will be operational from 2nd July 2013.

The changes broadly being introduced now vis-a-vis existing regulations, are as below:

Current Regulation:   Exporter of Active Pharmaceutical Ingredients (APIs) to EU countries should either have a Certificate of Suitability (COS) issued by EU Authority of a Drug Master File (DMF) filed with respective Regulatory Authorities of the respective Member State.  Also a Qualified Person (QP) of the company in EU intending to use the API has to certify that the API is manufactured under Good Manufacturing Practice (GMP) prescribed in International Conference for Harmonisation (ICH) guideline Q7A.

New Legislation:- The new legislation coming into force from 02.07.2013 requires a ‘written confirmation’ by a competent authority nominated by the Government of India that the API has been manufactured in accordance with EU-GMP standards and that the Manufacturing Facility where the API was manufactured is subject to control and enforcement of GMP standards and is equivalent to those in the EU countries.

To comply with the above requirements, the Department of Health & Family Welfare officially declared the Central Drugs Standard Control Organization (CDSCO) on 12.11.2012. It was also decided that a protocol for the procedure to be complied by the India API Exporters would be laid down by the CDSCO which has been done.

The Department of Commerce has been seized of this issue right from the beginning since EU is an important market for the pharma industry. Various EU industry members have been expressing their concern about the ability of India to comply with the new procedure by the deadline of 2nd July 2013. However, Government of India is optimistic that its pharma industry would be able to meet regulatory requirements within the given time frame.

Following are the salient features of the guidelines laid down by the CDSCO, which is also hosted on their website:

· Application for issue of “written confirmation” for APIs for medicinal products for human use is to be made by the exporter in prescribed format.

· After satisfying the completeness of documents submitted, inspection shall be conducted and after satisfactory outcome thereof, formal written confirmation shall be issued.

· Non-compliances noticed after inspection shall be communicated to the EU as per their requirement.

· A time frame of 45 days has been prescribed for disposal of satisfactory applications and the written confirmation shall be valid for the three years.

· Detailed forms have been laid down for purposes prescribed under various Articles of the EU Directives by the CDSCO – running into nearly 70 pages.

In due course of time, online application filing and tracking system would be evolved to bring in sufficient expediency and transparency in the system. This landmark achievement underlines the seriousness the Government of India towards pharma exports. Compliance by pharma industry with the EU directive is expected to have a very positive impact on the companies as many of them aspiring to export to the developed countries shall in the process upgrade their plants to WHO GMP standards.

The detailed guidelines laid down by CDSCO and also approvals granted for various exporters are available at  http://www.cdsco.nic.in/.

“It is a great privilege for me to join you today on this auspicious occasion of laying the foundation stone for the Indian National Defence University. This is an idea that has been long in the making and I am very happy that today we are witnessing the first step towards its becoming a reality.

At the outset, I wish to thank my friend, the Hon’ble Chief Minister of Haryana for his generous support for this project and, in particular, for providing land. The proximity of this University to Delhi would facilitate the much needed close interaction between its faculty and students and defence policy makers and practitioners in the national capital. I would also like to thank my senior colleague Raksha Mantri ji, the senior leadership of the Armed Forces and the Ministry of Defence for the hard work they have done in realizing this project of national importance. I have no doubt that, when completed, this unique University will become a world-class institution for higher defence studies, in which we will be able to take justifiable pride.

India’s defence and security are a fundamental obligation of the Government to our people and an essential prerequisite for our national social and economic transformation. Our Government has attached the highest priority to these tasks. We seek to advance peace, stability, friendship and cooperation in our region and beyond, and we do so with the confidence that our Armed Forces can defend our country against any threat. This confidence is based on the many steps that the Government has taken to strengthen our nation’s defence capabilities.

In the last few years, we have added significantly to the land forces to protect our borders and inducted new equipment to increase the Army’s firepower. Our ability to service our frontiers with improved infrastructure and enhanced air mobility is considerably greater today than in the past. We have enhanced the full spectrum of capabilities of our Air Force and are equipping it to remain at the cutting edge of technology for the decades that lie ahead. Not only are our borders stronger, our seas are also more secure. The capabilities of our sea-borne forces to guard our coastline and offshore assets has seen enormous expansion in the last five years. We have placed special emphasis on strengthening the capabilities of our Navy, which is fully equipped to operate at great distances from our shores, protect our maritime interests, respond to natural disasters and provide humanitarian assistance to the need.

Over the last nine years, our deterrence capabilities have also matured and have been given concrete shape. At the same time, we are better equipped today to deal with non-conventional threats, especially in the cyber and space domains. We are implementing a national architecture for cyber security and have taken steps to create an office of a national cyber security coordinator.

Our government is conscious of the fact that adequate defence preparedness is critically dependent on sound defence acquisition policies. We have paid close attention to this and have continually reformed those policies to ensure that our Armed Forces have the best equipment. We have also been guided by the objective of making our defence acquisition transparent, smooth, efficient and less vulnerable to unethical practices. We will continue to seek the highest standards of probity in defence acquisition.

Another issue to which we have paid close attention is indigenisation of defence procurement. Our government is committed to taking further steps to stimulate the development of our domestic defence industry, including the Indian private sector. This is important not only to enhance our security, but also to spur industrial development and economic growth of our country. We must fully utilize the sophisticated management and technological capacities that are already present in our private sector, including in the defence field, not just for production but also for defence research and development.

India faces the entire spectrum of security challenges. This is inevitable as we live in a difficult neighbourhood, which holds the full range of conventional, strategic and non-traditional challenges. We are also situated at the strategic crossroads of Asia and astride one of the busiest sea lanes of the world. We inhabit a networked and digital world. Our dependence on imported energy is significant and is likely to grow. We are also living at a moment of history when the world is witnessing change on a scale and at a speed rarely seen before.

Nowhere is this change more pronounced than in Asia, where we are witnessing multiple security challenges on account of the intersection of fragile states, internal conflicts, proliferation of arms and terrorist groups. Explosive development of technology is also transforming defence capabilities. As our dependence on the cyber and outer space domains grows, new sets of challenges will emerge, which can also assume military dimensions. The nature of conflict and competition is changing at the same time when national boundaries are being blurred by deepening global integration. Therefore, while defending and securing our homeland, we also have to be prepared to preserve India’s expanding international assets.

These multiple challenges notwithstanding, we must also be conscious of our strategic opportunities. India’s security has never been stronger than it is today and our international relationships have never been more conducive to our national development efforts. Our engagement in our immediate neighbourhood has increased. We have deepened political, economic and strategic relations in the Asia-Pacific, Indian Ocean and West Asian regions. Our relations with all major powers have become stronger and more productive. We are also particularly participating in key global and regional foras, ranging from the Group of 20 to the East Asia Summit and the ASEAN groupings.

Our defence cooperation has grown and today we have unprecedented access to high technology, capital and partnerships. We have also sought to assume our responsibility for stability in the Indian Ocean Region. We are well positioned, therefore, to become a net provider of security in our immediate region and beyond.

Taken together, these challenges and opportunities should prompt a reorientation of our strategic thinking and a reappraisal of our higher defence organisation. It is imperative that our defence professionals remain abreast of the complex environment we face and the avenues that are available as a result of the enormous transition taking place in India. On this occasion, I am reminded of a late 19th century observation by General Sir William Francis Butler. In a biography of the British General, Charles George Gordon, Butler wrote: “The nation that will insist on drawing a broad line of demarcation between the fighting man and the thinking man is liable to find its fighting done by fools, and its thinking done by cowards.”

That is where this great university comes in.

It is meant to ensure that our country, our government and our armed forces benefit from the best military advice that is available. It is meant to provide an avenue for our soldiers to think beyond the physical arts of war and for our thinkers and policymakers to understand the complexities of war and conflict. It is also meant to provide our defence professionals with a deep understanding of the interplay between all attributes of national power. Those who pass through the portals of this university will need to track regional and global trends, new and emerging technologies and developments in defence capabilities and strategies. They will also need to map the contours of future conflicts and understand the relationship between defence and finance, between external and internal security and between defence and diplomacy. Only then would they be able to fulfil the vision of the late Dr. K. Subrahmanyam who, in proposing the establishment of the National Defence University, had highlighted the need to educate and adequately prepare national security leaders to enable them to look at security challenges holistically and frame policies based on informed research.

Our expectations from this institution, therefore, are high. I am equally confident, that they will be met fully. I look forward to the Indian National Defence University emerging as an excellent platform to promote scholarship of a high order and train and equip future generations of leaders to meet India’s defence needs and fulfil our international responsibilities. The University, I hope, will set the highest standards of professionalism, creativity and debate. I am sure that it will also foster a climate of closer interaction between defence and civilian leaders.

Once again, it gives me great pride to be here on this auspicious occasion and I look forward to this campus coming up and becoming a great centre of defence studies in the quickest possible time.”

As per the extant policy, Foreign Direct Investment (FDI) up to 100% is permitted in power sector, under the automatic route for generation, transmission, distribution and trading (excluding atomic energy) which includes hydro power generation also.

Forty five (45) hydro projects having installed capacity of 10897 MW (25 MW & above) have been targeted for hydro power capacity addition during the 12thPlan, out of which 534 MW has already been commissioned till date.

The fund requirement for setting up of these projects is about Rs.87,176 crores which is to be met by the hydro developers themselves. However, a few hydro projects of national importance under Central Sector are provided partial gross budgetary support (GBS) by the Government for which a provision of Rs.2979.29 crores has been allocated in the 12th Five Year Plan. These funds are released through Central Public Sector Enterprises (CPSEs) on a year to year basis depending upon the progress and requirement of the projects. During the first year of the 12th Plan i.e. 2012-13, GBS of Rs.469.50 crores has been released whereas a provision of Rs.1576.55 crores has been kept for 2013-14.

The Government has taken the following steps to ensure achievement of the 12th  Plan target including for hydro development in the country:-

• Each project is monitored by the Central Electricity Authority (CEA) continuously through frequent site visits, interaction with the developers, critical study of monthly progress reports, etc. Chairperson, CEA holds review meetings with the developers and other stakeholders to sort out the critical issues/bottlenecks.

• A Power Project Monitoring Panel (PPMP) has been set up by the Ministry of Power to independently follow up and monitor the progress of the hydro projects.

• Review meetings are taken by Ministry of Power regularly with the concerned officers of CEA, equipment manufacturers, State Utilities/ Central Public Sector Undertakings / Project developers, etc. to sort out the critical issues.

• Proper Project planning is ensured to take care of difficult weather and work conditions including transportation of critical manpower and material in the available working season.

• A Task Force on Hydro Power Development was constituted on 03.09.2007 under the Chairmanship of Minister of Power to examine & resolve all issues relating to Hydro Project Development. So far five meetings have been held.  The 5thmeeting was held on 27.02.2013.

• An Advisory Group under the Chairmanship of Minister of Power has been set up in January, 2013 to discuss and deliberate periodically issues pertaining to the Power Sector and suggest reforms in different areas related to the sector.

Congratulating Dr Li Bin for taking over as Health Minister of China, Shri Azad stated that in view of her keen interest in the matters relating to health & population, bilateral cooperation will receive substantive fillip.

Speaking on the occasion, Shri Azad said the two countries can learn a lot from each other considering the fact that both countries have huge populations to look after and attained independence at the same time. In this context, he drew attention of his Chinese counterpart towards the bilateral agreement of 1994 relating to health sector and emphasized the need to hasten the work in the areas identified for bilateral cooperation.

Responding to Shri Azad, the Chinese Health Minister Dr Li Bin stressed to have a more broad-based cooperation in healthcare sector and suggested to formulate a comprehensive framework after mutual consultations to give further impetus to bilateral ties.

Both the sides were of the opinion to have a closer cooperation in specific areas like maternal and child health, infectious diseases, geriatrics, emerging health challenges, besides collaboration in specific projects. It was also realized that Working Groups should meet more frequently to do the groundwork for more intense and meaningful cooperation.

The Chinese Health Minister was especially enthusiastic to forge collaboration for dealing with the threat posed by leukemia. She also offered to have joint research projects in this area. In this regard, Shri Azad drew her attention towards the cost-effective medicines that China can access from India for the treatment of leukemia.

Pointing towards the strength of both the countries in traditional medicines, Shri Azad noted that the two countries being great proponents of traditional medicines can fruitfully collaborate in this area for mutual benefit. Given the fact that India is one of the largest suppliers of quality generic medicines, he said China can reduce healthcare costs and out-of pocket expenses by sourcing medicines from India. He especially drew attention of Chinese Health Minister towards the dilatory and cumbersome registration process of medicines in China and urged her to take steps for making it smooth.

The Chinese Health Minister informed that a separate Ministry of Food & Drugs has been constituted recently and she would convey the views expressed by him to her colleague in China.

Dr. K. P. Krishnan, Principal Secretary, Government of Karnataka, in his Key Note Address on the overview of Indian Financial Code briefed about the series of financial sector reforms since 1992. He said that there is an internally consistent and complete approach to financial sector legislative reforms since mid 2000 and said that laws needed to be changed contemporariously and as a whole. He said the Indian Financial Code would remove the vague objectives and vague powers; and establish accountability mechanism.

Ms. Chitra Ramakrishna, Managing Director and CEO, National Stock Exchange, in her Special Address said that the spirit of the Financial Code can be achieved only if sub-ordinate and sectoral regulations stay in course with the Code. She also emphasized on the need for training and capacity building, to create a cadre to deal with the new paradigm.

Shri S. N. Ananthasubramanian, President, Council of the ICS,I in his Welcome Address said that market governance fosters corporate governace in even manner and provides building blocks to facilitate dialogue and new ideas to emerge.

In addition, 10 farmers received award and cash prize of Rs. 1 lakh each for their commendable work in plant genome protection. Fifteen other farmers also received citation for their efforts in this field as a mark of recognition.

Highlighting the importance of conserving genetic resources of economic plants, the Minister said that the process of development of new varieties through plant breading is a long and expensive process, farmers and others engaged in this process duly rewarded so that they continue their efforts in this endeavour.

The Minister stressed upon the need to develop new and improved varieties suitable for different agro climatic regions and are tolerant to biotic and abiotic stresses. The role of farmers, farming communities, research institutions and seed industry becomes important. He appreciated the Authority (PPV&FR) for its role as a bridge between plant breeding institutions and seed industry to make available quality seed of new varieties to farmers.

The awards are being given since 2009 to farming communities and farmers, particularly the tribal and rural ones, engaged in conservation, improvement and preservation of genetic resources of economic plants and their wild relatives particularly in the areas identified as agro-biodiversity hotspots.

Four farming communities who received the Plant Genome Saviour Community Awards are: Seed Saver Farmers Group, Pune (Maharashtra), Sanjeevini Rural Development Society, Vishakapatnam (Andhra Pradesh), Deepaoli Women’s Self Help Group, Thiruvannamalai (Tamil Nadu) and Akampadam Chimpachala Punchakkadu Padasekhara Samithi representing rice farming communities in Palakkad (Kerala).

The 10 farmers who received Plant Genome Saviour Farmer Rewards are: Shri P. Devakanta, Imphal (Manipur), Shri Maha Veer Singh Arya, Churu (Rajasthan), Shri N. Vasavan, Kannur (Kerala), Shri Purnanand Venkatesh Bhat, Uttar Kannada (Karnataka), Shri Jai Prakash Singh, Jhakini, Varanasi (Uttar Pradesh), Sri Pravat Ranjan Dey, Panpara, Nadia (West Bengal), Ushagram Trust, Bimagar, Nadia (West Bengal), Shri Chandra Shekhar Singh, Varanasi (Uttar Pradesh), Shri Ciby George Kallingal, Pattikkad, Thrissur (Kerala) and Shri Narendra Singh Sipani, Mandsour (Madhya Pradesh).

The United Nations has proclaimed May 22 as the International Day for Biological Diversity to commemorate the adoption of the Convention on Biological Diversity. Celebrating International Day for Biological Diversity every year affirms our resolve and responsibility to safeguard the precious heritage of bio-resources for the future generations.

Having hosted the Eleventh Conference of Parties (CoP-11) to the CBD in Hyderabad in October 2012, India is presently the President of CoP.

As part of the celebrations, Dr V. Rajagopalan , Secretary , Ministry of Environment & Forests inaugurated a function organised by the Ministry of Environment & Forests in collaboration with Wetlands International – South Asia and WWF-India here today . On the occasion , the Ministry released a “Water is Life” poster, designed by Centre for Environment Education, Ahmadabad, a Centre of Excellence of the Ministry of Environment and Forests, depicting how all life forms including human beings are interconnected by, and through, water. The poster can be utilized for a wide range of activities by students and teachers, for education and awareness purposes. The poster is presented in 16 major official languages of the country and will be distributed countrywide. A soft copy of the poster will also be available on a weblink soon, for download and local printing. CEE is working out a scheme where the best entries/activities done by children around this poster can be evaluated and awarded.

During the event the following book, newsletter and DVDs were also released:

• A book entitled ‘Mangroves of India – Their Biology and Uses’ – This book is published by Zoological Survey of India containing 56 papers representing the state of the art science and management information on mangroves of the India.

• A DVD by the Botanical Survey of India, digitizing all its publications under the Bulletin of the Botanical Survey of India, to date. All results of exploratory and scientific activities of BSI and information relating to floristic and utilitarian aspects of Indian botany are now readily accessible in this digital archive.

• Digital Edition of Checklist on Blue Green Algae of the India: The BSI has been engaged on research on Cyanoprokaryotes, commonly known as blue-green algae which are primitive but important group of micro-organisms. The BSI has prepared a checklist of 1,232 taxa including 939 species, 207 varieties and 86 forms. This is being released in the form of CD.

• A DVD: Digital Archives: Zoological Survey of India containing Zoological Survey of India’s past research spanning 98 years, including 111 volumes of records, 31 memoirs and 335 occasional papers into a searchable digital database, accessible on a CD. This is also being placed on the website of the Zoological Survey of India and Ministry of Environment and Forests.

• Sarovar Newsletter: Wetlands International-South Asia has devoted its second issue of Newsletter “Sarovar” on the theme water and wetland management, presenting important perspectives on the way managers of water and wetland resources can benefit by cooperative action.

During the day long event , an Expert Consultation Meeting on Water and Biodiversity, between policy-makers, decision-makers, research institutions, NGOs etc. related to water and biodiversity conservation and management sectors will also be organised. The Consultation aims to encourage a participatory approach, by involving not only various governmental agencies but also the users and other stakeholders, in an effective and decisive manner, in various aspects of planning, design, development and management of the water resources schemes. One of the components of the Consultation will be to discuss the necessary legal and institutional changes that are required to be made at various levels supporting mainstreaming of biodiversity conservation within water resources planning and decision making.

As CoP Presidency India had launched the Science Express Biodiversity Special (SEBS) train, which received over 2.3 million visitors on its journey covering over 50 stations across India, and played a key role in creating awareness about biodiversity in the country. After the resounding success of SEBS in 2012, the iconic train has been flagged off for its 2013 run on 9th April 2013. It is scheduled to cover 62 locations during its journey till 28th October 2013. The International Day for Biological Diversity was also celebrated aboard the SEBS train which is presently stationed at Bhagalpur in the eastern part of the country. The state-of-the-art exhibition aboard SEBS is making significant contributions towards achieving Aichi target 1 during the UN Decade on Biodiversity by creating widespread awareness on biodiversity.

Shri Verma was not satisfied with the performance of SAIL on the whole and advised the company to take corrective measures immediately. He expressed his concern on the progress of modernisation and expansion and directed the PSU to bring synergy in various activities of expansion so that integrated commissioning of facilities is achieved quickly. The Minister said that profitability of the company can improve only if the expansion projects are completed and stabilized within a short period of time. He expressed concern over the performance of Durgapur and Bokaro Steel Plant and advised the plants to prepare an action plan for improving the same.

The company produced 14.27 MT of Hot Metal in 2012-13 which has grown by 1% over Corresponding Period Last Year (CPLY). Total sales registered a growth of 2.8% in Q4 at 3.24 MT as compared to CPLY. SAIL showed improvement in Blast Furnace productivity, energy consumption and coke rate of 5%, 3% and 1% respectively. Bhilai and Rourkela developed new grades of ASTM 537 plates which find application in pressure vessels for the petrochemicals industry. Bokaro Steel Plant came out with ultra high strength HR and CR steel especially for automobile industry. For the first time, Durgapur Steel Plant rolled out 31 CrV3 grade billets, a product highly sought after among makers of spanners and hand-tools.

Modernization projects at Rourkela Steel Plant (RSP) including the new Sinter Plant and new Coke Oven Battery no. 6 have commenced production. While at IISCO Steel Plants (ISP), a new Coke Oven Battery no. 11 and Sinter Plant have been operationalised and hot trials for the new Wire Rod Mill have also commenced.

SAIL employees won the maximum number of Vishwakarma and Shram Awards declared in the country, the highest for any organization both among private and public sector.

The crude oil price in rupee terms also increased at Rs 5641.60 per bbl on 20.05.2013 as compared to Rs 5596.58 /bbl on 17.05.2013. This was due to price increase in dollar terms and also because of rupee depreciation.  Rupee dollar exchange rate on 20.05.2013 at Rs 55.04/US$ against Rs 54.89/US$ on previous trading day of 17.05.2013.

The table below gives details in this regard:

Particulars	Unit	Price on May 20, 2013 (previous trading day i.e. 17.05.2013)	Last Fortnight May 1-15, 2013(previous fortnight  i.e. April 16-30, 2013)
Crude Oil (Indian Basket)	($/bbl)	102.50    (101.96)	101.21    (99.38)
	(Rs/bbl	5641.60  (5596.58)	5497.73 (5385.40)
Exchange Rate	(Rs/$)	55.04      (54.89)	54.32     (54.19)

NCJ/RKS–Daily Crude oil price- 21.05.2013

Speaking on the occasion, Shri Azad said that friendship between India and Switzerland goes as back as Independence of India, strongly rooted as it is in shared values of multi-culturalism, democracy and rule of law. Recalling the historic ties between the two countries, Shri Azad said that a treaty of friendship between India and Switzerland was signed at New Delhi as early as 1948, soon after India’s independence.

Emphasizing the special nature of relationship between the two countries, Shri Azad said that many high level visits have been exchanged in the recent past and that many bilateral institutional arrangements like Indo-Swiss Joint Commission, Swiss- India Chamber of Commerce, Indo-Swiss Joint Committee on Science & technology, etc. exist to further cement our strong relations. Shri Azad noted that in the continuum of strong Indo-Swiss bilateral cooperation, an MOU between the two countries will be inked soon to further broaden the scope of bilateral ties.

“Considerable progress has been made in this regard and an MOU in the field of health is being signed to promote bilateral cooperation between the two countries”, Shri Azad said.

The major areas of cooperation will be as under:

i) Non-Communicable Diseases including controlling the associated risk factors of tobacco use, harmful alcohol use, unhealthy diet, etc.
ii) Communicable Diseases and Anti- Microbial resistance
iii) Universal Health Coverage
iv) Maternal & Child health
v) Sexual & Reproductive Health
vi) Health & Medical Research
vii) Therapeutic Products
viii) Electronic Medical Records
ix) Global Health Governance

Shri Azad noted that these areas are of immense significance for India, considering the enormous public health challenges that we are faced with. Highlighting the role of Indian generic Drug industry to make available affordable medicines across the world, Shri Azad exuded confidence that Switzerland will extend full support to India on global platforms in order to carry forward our pursuits of providing high quality generic medicines at affordable prices.