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Cabinet approves Additional Incentives under Duty Drawbacks for Garments
Jun 23,2016

The Union Cabinet chaired by Honble Prime Minister Shri Narendra Modi has decided to provide additional incentives for garments under Duty Drawback Scheme. This is one of the various measures that comprise the special package announced by the Government, for job creation & export promotion in the textile and apparel sector.

To implement the decision, in a first-of-its-kind move, a new scheme will be introduced to refund the state levies which were not refunded so far. This move will greatly boost the competitiveness of Indian exports in foreign markets and is expected to cost Rs 5500 crores to the exchequer.

Further, drawback at All Industries Rate will be given for domestic duty paid inputs even when fabrics are imported under Advance Authorization Scheme.

Impact in Three Years

This is expected to yield the following impact in three years:

n++Increase in exports by 9.5 billion US$

n++Increase in employment by 9.5 lakhs

n++Increase in investment by 2.7 billion US$

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Rising tomato price disturbs kitchen budget across metros; tomato puree, ketchup demand rise of up to 40%: survey
Jun 23,2016

Demand for tomato puree and ketchup has shot up by 40 per cent within one month as people have curtailed the use of tomato and prefer dishes which do not require much use of tomatoes, like lady finger or pumpkin etc, according to latest survey done by ASSOCHAM.

A rise in the price of tomatoes has affected the budgets of families in the city. According to the ASSOCHAM recent survey, about 78% of households find difficult to manage their household budget and squeezing families finances to the lowest level due to sudden rise in price of tomatoes, pulses, according to a country-wide survey conducted by the Associated Chambers of Commerce and Industry of India (ASSOCHAM).

As per the government recent estimate, the countrys tomato output is pegged at 18.28 million tonnes in the 2015-16 crop year (July-June) as against 16.38 million tonnes in the previous year. Karnataka, Andhra Pradesh, Telangana, Madhya Pradesh, West Bengal and Odisha are the major tomato growing states.

The survey was conducted in major cities like Delhi-NCR, Mumbai, Kolkata, Chennai, Ahmedabad and Hyderabad. Over 1500 hosewives took part in it. The maximum impact was felt in Delhi-NCR followed Mumbai, Ahmedabad.

According to survey, the local grocers have also increased stock of tomato puree/ketchup . The local grocer said, in the last two weeks there has been a rise in sales of products such as puree, ketchup as one spends less on buying puree/ ketchup than a kilo of fresh tomatoes.

The rise in pulses price has come as a double-shocker for the denizens. Vegetables are increasingly becoming unaffordable as the prices have skyrocketed particularly in metros and major cities, said Mr D.S. Rawat, secretary general of ASSOCHAM while releasing the findings of the ASSOCHAM survey.

Prices have gone up because of tight supply from the major growing states of the south where the rabi crop has been damaged during the flowering stage because of the severe drought, adds the paper.

The price of tomato shooting up to Rs 80-100 per kg, nearly double of what it was selling for just a month back, the average housewife is either giving it a miss or picking up just a quarter of a kilo.

About 56% of the respondents said that they have curtailed the use of tomatoes and prefer dishes which do not require much use of tomatoes, like lady finger or pumpkin and some are substituting it with raw mango to get that sour taste, add the respondents.

In the last one month, the rates have gone through the roof and the key vegetable is being sold at Rs 80-100 per kg by local vegetable vendors depending on the quality and locality, adds the paper.

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Amendment in Rule 114H of Income-tax Rules, 1962
Jun 23,2016

The Rule 114H of the Income-tax Rules, 1962 (the Rules) has been amended vide Notification No.48/2016 [S.O.2151(E)] dated 20th June 2016.

In order to provide sufficient time to the reporting Financial Institutions for completing the due diligence procedure in respect of other reportable account referred to in Rule 114H (3)(d)(ii), which is high value account as on 31st December, 2015, the timeline specified for review of pre-existing individual account has been extended from 30th June, 2016 to 31st December, 2016. The timeline in case of U.S. reportable account which is low value account as on the 30th June, 2014, shall continue to be 30th June, 2016.

Similarly, in respect of other reportable account referred to in Rule 114H(5)(e)(i), timeline specified for review of pre-existing entity account has been extended from 30th June, 2016 to 31st December, 2016. The timeline in case of a U.S. reportable account shall continue to be 30th June, 2016.

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Union Minister of Human Resource Development announces new UGC foreign academic collaboration regulations
Jun 23,2016

Indian Universities and Colleges, having the highest grade of accreditation/ threshold accreditation, will now be able to apply online to the University Grants Commission (UGC) for starting twinning and collaborative arrangement with quality Foreign Educational Institutions (FEIs) in undergraduate and postgraduate programmes leading to the award of a degree. The degree will be awarded by the Indian Educational Institutions (IEIs) alone; joint degrees are not permitted. However, the name of the collaborating FEI can be indicated on the degree, the logo and primacy being of the Indian institution. Credits from collaborating FEI when jointly signed by the IEI shall form part of the transcript. FEI may also sign the transcript/credit issued by the IEI.

Announcing this the Minister of Human Resource Development mentioned that this step has been taken by the UGC today in order to promote foreign collaborations with a view to increasing synergy between Indian and foreign academic institutions, to offer students additional choices, improve curriculum and the delivery of knowledge and educational content.

The UGC has superseded its 2012 regulations with its new regulations for promoting and maintaining standards of academic collaboration between Indian and Foreign Higher Educational Institutions. The regulations will be notified shortly by the Ministry. The amendments respond to a felt and aspirational need expressed by students to engage with FEIs of repute, study in part in these institutions and acquire a formal recognition of this in the degree and related transcripts.

For students wishing to study abroad, for the experience, exposure and academic benefits, this represents lower cost to achieve that. This will offer unprecedented academic mobility through acquiring of credits and study at reputed institution abroad.

The dedicated UGC portal to receive applications and convey approvals will be launched shortly by the UGC. Timelines have been stipulated at different stages of the application.

The regulations do not cover technical institutions, for which AICTE will leverage and bring out similar methodology and facilitative regulations. Universities/institutions that are recognized by UGC and FEIs intending to collaborate will be benefitted.

The Regulations stipulate that only IEIs with A grade or threshold accreditation (or IEIs other than governing institutions) should have experience of 6 years or at least 2 batches passed out and similarly A grade or threshold level accreditation if the IEIs in their own country will be eligible for collaboration. A bench mark for quality has therefore been set for the collaborations. To maintain academic credibility and seriousness, a minimum duration of collaboration has been specified under one semester for postgraduate degree and 2 semesters for undergraduate degree.

The UGC will examine complaints relating to academic collaborations being run in violation of these regulations and if prima-facie evidence of fraud is found, it will inform Central and State authorities for appropriate action under the framework of the law, including penal action.

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More than enough sugar in the country to meet domestic requirement
Jun 23,2016

There is more than enough sugar in the country to meet the domestic requirement. Even in coming sugar season 2016-17, there would be no shortage of domestically produced sugar in India.

During the current Sugar Season 2015-16, India had started with a carryover stock of 9 million MT of sugar. The production of sugar has been estimated at about 25.1 million MT in the current sugar season while demand about 25.5 million MT. Exports being low, the stock position at the close of the current sugar season (Sept. 2016) will stand at 7 million MT which will be carried forward for the next sugar season 2016-17

Thus with the closing stock of about 7-7.5 million tonnes, and the estimated production of about 23 - 24 million tonnes, during 2016-17, the total availability of sugar during 2016-17 season will be over 31 million tonnes, against the domestic demand of about 26 million tonnes.

The government has taken necessary steps to maintain sufficient stocks in the country. It has imposed 20 % duty on export of sugar and has empowered state governments to impose stockholding limits on traders to ensure availability of sugar at reasonable prices.

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Cabinet decides to bring in more Flexibility in Labour Laws to increase Productivity
Jun 23,2016

The Union Cabinet chaired by Honble Prime Minister Shri Narendra Modi has announced a set of measures that would bring in more flexibility in labour laws in the textile and apparel sector. These measures form a part of the special package announced by the Government today, for job creation & export promotion in the sector.

Following are the labour reform measures, announced by the Government:

Increasing overtime caps

Overtime hours for workers will not be allowed to exceed 8 hours per week in line with ILO norms. This shall lead to increased earnings for the workers.

Introduction of fixed term employment

Considering the seasonal nature of the industry, fixed term employment will be introduced for the garment sector. A fixed term workman will be considered at par with permanent workman in terms of working hours, wages, allowanced and other statutory dues.

Employee Provident Fund Scheme Reforms

EPF will be made optional for employees earning less than Rs. 15,000 per month. This will leave more money in the hands of the workers and also promote employment in the formal sector.

Impact in Three Years

This is expected to yield the following impact in three years:

n++Increase in exports by 1.4 billion US$

n++increase in employment by 1.75 lakhs

n++increase in investment by 4.2 billion US$

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Cabinet approves Special Package for Job Creation & Export Promotion in Textile & Apparel Sector
Jun 23,2016

Jobs for 1 crore people, mostly women; US$ 30 bn. in exports; and investment worth Rs. 74,000 crores - all in three years. These are the expected outcomes of a special package for textile and apparel sector, approved today by the Union Cabinet under the Chairmanship of Prime Minister Shri Narendra Modi.

The package is a strategic decision that would strengthen and empower the Indian textile and apparel sector by improving its cost competitiveness in the global market. The measures assume significance due also to its potential for social transformation through women empowerment; since 70% of the workforce in the garment industry are women, majority of the new jobs created are likely to go to women.

Whats in the Package?

The special package includes a slew of labour-friendly measures that would promote employment generation, economies of scale and boost exports.

The salient features of the package are:

A. Employee Provident Fund Scheme Reforms

n++ Govt. of India will bear the entire employers contribution of 12% under the Employers Provident Fund Scheme, for new employees of garment industry earning less than Rs. 15,000 per month, for the first three years.

This marks an increase from the present Government provision of 8.33% towards employers contribution, being provided under Pradhan Mantri Rozgar Protsahan Yojana (PMRPY). With todays decision, Ministry of Textiles will provide the remaining 3.67% share towards employers contribution, amounting to Rs. 1,170 crores over next 3 years.

n++ EPF will be made optional for employees earning less than Rs. 15,000 per month.

This will leave more money in the hands of the workers and also promote employment in the formal sector.

B. Increasing overtime caps

n++ Overtime hours for workers not to exceed 8 hours per week in line with ILO norms.

This shall lead to increased earnings for the workers

C. Introduction of fixed term employment

n++ Considering the seasonal nature of the industry, fixed term employment will be introduced for the garment sector.

A fixed term workman will be considered at par with permanent workman in terms of working hours, wages, allowanced and other statutory dues.

D. Additional incentives under ATUFS

n++ The subsidy provided to garmenting units, under Amended-TUFS, is being increased from 15% to 25%, providing a boost to employment generation.

The package breaks new ground in moving from input-based to outcome-based incentives; a unique feature of the scheme will be to disburse subsidy only after expected jobs have been created.

E. Enhanced duty drawback coverage

n++ In a first-of-its-kind move, a new scheme will be introduced to refund the state levies which were not refunded so far.

This move will greatly boost the competitiveness of Indian exports in foreign markets and is expected to cost Rs 5500 crores to the exchequer.

n++

Drawback at All Industries Rate will be given for domestic duty paid inputs even when fabrics are imported under Advance Authorization Scheme.

F. Enhancing scope of Section 80JJAA of Income Tax Act

n++ Looking at the seasonal nature of garment industry, the provision of 240 days under Section 80JJAA of Income Tax Act would be relaxed to 150 days for garment industry.

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Rehabilitation of four lane of Mahatma Gandhi Setu on Ganga River at Patna in Bihar
Jun 23,2016

The Cabinet Committee on Economic Affairs, chaired by the Prime Minister Shri Narendra Modi, has approved the project namely rehabilitation of four lane 5.575 km long Mahatma Gandhi Setu at NH-19 on Ganga River at Patna in Bihar. The bridge will be constructed after dismantling the damaged pre-stressed cantilever arms superstructure and subsequent re-decking by steel truss. The project will be in Engineering, Procurement and Construction (EPC) mode. The cost is estimated to be Rs.1742.01 crore.

The project is covered in the region of Patna-Hazipur connecting North and South Bihar. It will help in expediting the improvement of infrastructure in the State besides reducing the time and cost of travel for traffic, particularly heavy traffic, plying between North and South Bihar. The rehabilitation of Mahatma Gandhi Setu will also help in uplifting the socio-economic condition of this region in the State.

Background:

Four-lane Mahatma Gandhi Setu at Patna on Ganga River was constructed during year 1980s by State Government of Bihar. This distressed Bridge is very important link between North Bihar and South Bihar and is a route for several economic as well as socio political activity. Business of Nepal and Bhutan is also flowing through this connection. Ministry of Road Transport and Highways has made efforts to rehabilitate this Bridge since last 15 years but the efforts were not successful. After a lot of studies through national and foreign experts it has now been decided that only remedy left is to dismantle the existing superstructure followed by subsequent re-decking by steel truss. Accordingly, a detailed estimate has been prepared for rehabilitation of superstructure of Mahatma Gandhi Setu in Patna.

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Cabinet approves special package for employment generation and promotion of exports in Textile and Apparel sector
Jun 22,2016

The Union Cabinet under the Chairmanship of Prime Minister Shri Narendra Modi has given approval for a special package for employment generation and promotion of exports in Textile and Apparel sector.

The move comes in the backdrop of the package of reforms announced by the Government for generation of one crore jobs in the textile and apparel industry over next 3 years. The package includes a slew of measures which are labour friendly and would promote employment generation, economies of scale and boost exports. The steps will lead to a cumulative increase of US$ 30 bn. in exports and investment of Rs. 74,000 crores over next 3 years.

The majority of new jobs are likely to go to women since the garment industry employs nearly 70% women workforce. Thus, the package would help in social transformation through women empowerment.

Salient features of the package announced are:

A. Employee Provident Fund Scheme Reforms

n++ Govt. of India shall bear the entire 12% of the employers contribution of the Employers Provident Fund Scheme for new employees of garment industry for first 3 years who are earning less than Rs. 15,000 per month.

n++ At present, 8.33% of employers contribution is already being provided by Government under Pradhan Mantri Rozgar Protsahan Yojana (PMRPY). Ministry of Textiles shall provide additional 3.67% of the employers contribution amounting to Rs. 1,170 crores over next 3 years.

n++ EPF shall be made optional for employees earning less than Rs. 15,000 per month

n++ This shall leave more money in the hands of the workers and also promote employment in the formal sector.

B. Increasing overtime caps

n++ Overtime hours for workers not to exceed 8 hours per week in line with ILO norms.

n++ This shall lead to increased earnings for the workers

C. Introduction of fixed term employment

n++ Looking to the seasonal nature of the industry, fixed term employment shall be introduced for the garment sector

n++ A fixed term workman will be considered at par with permanent workman in terms of working hours, wages, allowanced and other statutory dues.

D. Additional incentives under ATUFS

n++ The package breaks new ground in moving from input to outcome based incentives by increasing subsidy under Amended-TUFS from 15% to 25% for the garment sector as a boost to employment generation.

n++ A unique feature of the scheme will be to disburse the subsidy only after the expected jobs are created.

E. Enhanced duty drawback coverage

n++ In a first of its kind move, a new scheme will be introduced to refund the state levies which were not refunded so far.

n++ This move is expected to cost the exchequer Rs 5500 crores but will greatly boost the competitiveness of Indian exports in foreign markets.

n++ Drawback at All Industries Rate to be given for domestic duty paid inputs even when fabrics are imported under Advance Authorization Scheme

F. Enhancing scope of Section 80JJAA of Income Tax Act

n++ Looking at the seasonal nature of garment industry, the provision of 240 days under Section 80JJAA of Income Tax Act would be relaxed to 150 days for garment industry

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Cabinet approves four laning of Hubli-Hospet Section of NH-63 in Karnataka
Jun 22,2016

The Cabinet Committee on Economic Affairs, chaired by the Prime Minister Shri Narendra Modi, has approved the development of four laning of Hubli-Hospet Section of NH-63 in Karnataka.

The cost is estimated to be Rs.2272.20 crore including cost of land acquisition, resettlement and rehabilitation and other pre-construction activities. The total length of the road to be developed is approximately 144 kms.

This work will be done under the National Highways Development Project (NHDP) Phase-IV on Engineering, Procurement and Construction (EPC) basis.

The project will help in expediting the improvement of infrastructure in Karnataka and in reducing the time and cost of travel for traffic, particularly heavy traffic, plying between Hubli and Hospet section. The development of this stretch will also help in uplifting the socio-economic condition of this region in the State.

It would also increase employment potential for local labourers for project activities. It has been estimated that a total number of 4,076 mandays are required for construction of one kilometre of highway. As such, employment potential of 5,86,600 (approx.) mandays will be generated locally during the construction period of this stretch.

Background:

The project was earlier approved on BOT (Toll). Bids were invited for the project three times and one more time with increased Viability Gap Funding (VGF). However, no bids were received. As such, it was decided to implement the project through EPC mode. The project has been appraised by Expenditure Finance Committee (EFC) in its meeting held in March, 2016.

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Establishment of Fund of Funds for funding support to Start-ups
Jun 22,2016

The Union Cabinet, chaired by the Prime Minister Shri Narendra Modi, has approved the establishment of Fund of Funds for Startups (FFS) at Small Industries Development Bank of India (SIDBI) for contribution to various Alternative Investment Funds (AIF), registered with Securities and Exchange Board of India (SEBI) which would extend funding support to Startups. This is in line with the Start up India Action Plan unveiled by Government in January 2016.

The corpus of FFS is Rs.10,000 crore which shall be built up over the 14th and 15th Finance Commission cycles subject to progress of the scheme and availability of funds. An amount of Rs.500 crore has already been provided to the corpus of FFS in 2015-16 and Rs.600 crore earmarked in the 2016-17. The Fund is expected to generate employment for 18 lakh persons on full deployment.

Further provisions will be made as grant assistance through Gross Budgetary Support by Department of Industrial Policy and Promotion (DIPP) which will monitor and review performance in line with the Start up India Action Plan.

The FFS emanates from the Start up India Action Plan, an initiative of Department of Industrial Policy & Promotion (DIPP). The expertise of SIDBI would be utilized to manage the day to day operations of the FFS. The monitoring and review of performance would be linked to the implementation of the Start Up Action Plan to enable execution as per timelines and milestones.

A corpus of Rs. 10,000 crore could potentially be the nucleus for catalyzing Rs. 60,000 crore of equity investment and twice as much debt investment. This would provide a stable and predictable source of funding for Start up enterprises and thereby facilitate large scale job creation.

Background:

Accelerating innovation driven entrepreneurship and business creation through Start-ups is crucial for large-scale employment generation. An expert committee on Venture Capital (VC) has opined that India has the potential to build about 2500 highly scalable businesses in the next 10 years, and given the probability of entrepreneurial success that means 10000 Start ups will need to be spawned to get 2500 large scale businesses.

Start-ups face several challenges - limited availability of domestic risk capital, constraints of conventional bank finance, information asymmetry and lack of hand holding support from credible agencies. A large majority of the successful Start-ups have been funded by foreign venture funds and many of them are locating outside the country to receive such funding.

A dedicated fund for carrying out Fund of Funds operations would address these issues and enable flow of assistance to innovative Start ups through their journey to becoming full fledged business entities. This would encompass support at seed stage, early stage and growth stage. Government contribution to the target corpus of the individual Fund as an investor would encourage greater participation of private capital and thus help leverage mobilization of larger resources.

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Cabinet approves extension of timeline for taking over 50% of Outstanding Debt of DISCOMs
Jun 22,2016

The Union Cabinet under the Chairmanship of Prime Minister Shri Narendra Modi has accorded its approval for an extension of timeline for taking over 50% of the Outstanding Debt of DISCOMs, as existing on 30 September 2015, by States and borrowings by State of Jammu & Kashmir under UDAY (Ujjwal DISCOM Assurance Yojana) - a scheme for operational and financial turnaround of DISCOMs. The time limits have now been extended by one year from the earlier stipulated date of 31st March, 2016. This decision would allow States, which could not participate in the scheme UDAY earlier to join the Scheme.

Under UDAY, so far 19 States have already given their consent to join the scheme, out of which 10 States, viz. Rajasthan, Uttar Pradesh, Chattisgarh, Jharkhand, Punjab, Bihar, Haryana, Gujarat, Uttarakhand and Jammu & Kashmir have already signed MOUs with the Central Government. In the year 2015-16, Bonds worth Rs 99,541 crores were floated by the participating States to clear 50% of the outstanding debt of States and outstanding CPSU dues in Jharkhand and Jammu & Kashmir. Further, DISCOM Bonds worth Rs 11,524 crores were floated. In the year 2016-17, Bonds worth Rs 14,801 crores have been floated by the State of Uttar Pradesh.

UDAY provides for the financial turnaround and revival of Power Distribution companies (DISCOMs), and importantly also ensures a sustainable permanent solution to this long standing problem.

  UDAY envisages a permanent resolution of past as well as potential future issues of the sector. It empowers DISCOMs with the opportunity to break even in the next 2-3 years. This is through four initiatives (i) Improving operational efficiencies of DISCOMs; (ii) Reduction of cost of power; (iii) Reduction in interest cost of DISCOMs through States taking over 75% of the DISCOM debts, as on 30th Sep, 2015 over two years, and the rest being re-priced through bonds and loans at lower interest rates; (iv) Enforcing financial discipline on DISCOMs through alignment with State finances.

Operational efficiency improvements like compulsory smart metering, upgradation of transformers, meters etc., energy efficiency measures like efficient LED bulbs, agricultural pumps, fans & air-conditioners etc. will reduce the average AT&C loss from around 22% to 15% and eliminate the gap between Average Revenue Realized (ARR) & Average Cost of Supply (ACS) by 2018-19. Reduction in cost of power would be achieved through measures such as increased supply of cheaper domestic coal, coal linkage rationalization, liberal coal swaps from inefficient to efficient plants, coal price rationalization based on GCV (Gross Calorific Value), supply of washed and crushed coal, and faster completion of transmission lines.

With this approval for extension of timeline, the States shall take over 75% of DISCOM debt as on 30 September 2015 by 31st March, 2017 by issuing Bonds, an intervention to lower the interest burden of debts. With the approval, States which could not join so far would get an opportunity to join UDAY and put the DISCOM reforms on accelerated path.

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Cabinet approves Protocol amending the Agreement for avoidance of double taxation and prevention of fiscal evasion with Belgium
Jun 22,2016

The Union Cabinet chaired by the Prime Minister Shri Narendra Modi has approved today the signing of a Protocol amending the Agreement between India and Belgium for avoidance of double taxation and prevention of fiscal evasion with respect to taxes on income.

The amendment in the Protocol will broaden the scope of the existing framework of exchange of tax related information between the two countries, which will help curb tax evasion and tax avoidance. The Protocol will also revise the existing treaty provisions on mutual assistance in collection of taxes.

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Cabinet approves MoU between India and Germany
Jun 22,2016

The Union Cabinet chaired by the Prime Minister Shri Narendra Modi has been apprised of signing of a Memorandum of Understanding (MoU) with Steinbeis GmbH Co. KG for Technologietransfer, Germany on technology resourcing in manufacturing, including sub-sectors of Capital Goods. The MoU was signed on 25th April, 2016 during the Industrial Exhibition Hannover Messe 2016 in Hannover, Germany.

Steinbeis GmbH is leading organization for applied industrial research in Europe. It will act as a Technology Resource Partner for implementing identified projects in manufacturing. The field of cooperation envisaged in the MoU are:

a) profiling of specific technologies;

b) technology road mapping for specified Capital Goods sub-sectors,

c) assessment of technology status of Capital Goods Cluster;

d) cooperation in events on technology; and

e) upgrading existing technology institutes / setting up Greenfield institutes in India and other technology related co-operation and collaboration.

The MoU is a framework instrument to facilitate industrial technology projects by Indian Capital Goods Sector. The MoU will provide a platform to various public sector undertakings and Capital Goods Sector units to have easy access to capabilities and expertise of Steinbeis GmbH for identifying and plugging technology gaps.

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The Union Cabinet decides Withdrawal of the Drugs and Cosmetics (Amendment) Bill, 2013
Jun 22,2016

The Union Cabinet, chaired by the Prime Minister Shri Narendra Modi, has decided to withdraw the Drugs and Cosmetics (Amendment) Bill, 2013, which had been introduced in the Rajya Sabha on 29 August 2013. The Bill had been examined by the Standing Committee of Parliament which had made a number of recommendations for changing the provisions of the Bill.

India is one of the largest manufacturers of pharmaceutical products in the world. The annual production of such products is in excess of Rs. 2 lakh crore. Out of this, over 55% is exported to over 200 countries/economies of the world including the developed countries. As such, the pharmaceutical sector in India plays a vital role in managing the public health in large number countries at a substantially lower cost.

The regulatory framework for ensuring the quality, safety and efficacy of medical products including the medicines, medical devices, in-vitro medical devices, stem cells, regenerative medicines, clinical trial/investigation, etc. is provided for in the Drugs and Cosmetics Act, 1940.

The Cabinet has, keeping in view the role of the sector in managing public health, decided that it will not be appropriate to carry out further amendments in the present Act especially as newer areas of biological, stem cells and regenerative medicines, medical devices and clinical trial/investigation, etc. cannot be effectively regulated under the existing law.

In order to leverage the comparative cost advantage, the demographic dividend and the advantage in information technology, the Indian medical products sector is poised for exponential growth in the near future and it would besides meeting the domestic demand, has the potential to become an international hub for manufacturing these products and attracting investment in the sector.

Keeping in view the objective of make in India, it has been decided to comprehensively review the existing law with two fold objectives viz. to facilitate the ease of doing business and substantially enhancing the quality and efficacy of our products. The Ministry of Health and Family Welfare has, accordingly, undertaken an exercise at two levels namely (i) to frame separate rules under the existing Act for regulating medical devices; and (ii) to bring out separate legislations for regulating medical devices and Drugs and Cosmetics. While, after extensive discussions with all stakeholders, the draft rules for regulating medical devices have been prepared and will be draft notified shortly, work on drafting the new legislation has also commenced.

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