Recent Regulatory Initiatives at the Indian Central Drugs Standards Control Organization (CDSCO)

2017 ◽  
Vol 10 (1) ◽  
pp. 3567-3572
Author(s):  
Bobby George
Keyword(s):  
Quality Standards ◽  
Manufacturing Firms ◽  
Who Guidelines ◽  
Checks And Balances ◽  
Doing Business ◽  
Indian Central ◽  
Inclusive Approach ◽  
Regulatory Submissions ◽  
Ease Of Doing Business ◽  
The Government

The Government of India, through the CDSCO office, has been trying to engage with the drug industry and other stakeholders through its inclusive approach for instituting measures, through administrative orders, in helping remove regulatory bottle necks, and thereby improve ease of doing business. Some of the measures which have been instituted include facilitating the conduct of trials; rationalizing and simplifying various formats of applications; doing away with pre-inspection of manufacturing sites for grant of test license; potentially reducing approval timelines for different kinds of regulatory submissions by making the submission process online etc. These measures have helped to remove the constraints which have been plaguing the industry. At the same time CDSCO has been building in enough checks and balances within the system to monitor quality, safety and compliance. Emphasis has been laid on quality standards being followed by manufacturing firms with a view to bringing the GMP standards at par with the WHO guidelines. There are plans which include scrapping the need to renew manufacturing licenses at the end of five years etc for which industry and other stakeholder’s opinion is being sought. 

scholarly journals Ease of Doing Business Index: An Analysis of Investors Practical View

2021 ◽  
Vol 17 (1) ◽  
pp. 101-123
Author(s):  
Shakirat Adepeju Babatunde ◽  
Mohammed Kayode Ajape ◽  
Kabir Dandago Isa ◽  
Owolabi Kuye ◽  
Eddy Olajide Omolehinwa ◽  
...  
Keyword(s):  
Private Sector ◽  
World Bank ◽  
Return On Investment ◽  
Government Procurement ◽  
Cross Sectional ◽  
Procurement Process ◽  
Chamber Of Commerce ◽  
Doing Business ◽  
Ease Of Doing Business ◽  
The Government

Abstract: This study investigates the effect of Ease of Doing Business Index (EDBI) on Return on Investment (ROI). The study employs a cross-sectional survey design covering five years from 2015 to 2019. The sample is 47 registered companies with the Lagos Chamber of Commerce and Industry, which is the most representative of the organised private sector group in Nigeria. The study adopts descriptive and linear regression statistical analysis. Findings show a statistically significant negative effect of Government policy continuity. The government procurement process, Raw materials availability and Quality of workforce show adverse effects. Traffic and transportation management, power supply and Security infrastructure show insignificant effect on ROI. Hence, findings indicate that Government procurement process is inimical to ease of doing business in Nigeria despite the government improvement efforts. Since government efforts are insufficient, the World Bank should incorporate private sector ideals into EDBI to create a synergy a robust EDBI. Keywords: Ease of Doing Business, ease of doing business index, return on investment, investors, World Bank.      Ease of Doing Business Index: Sebuah Analisis terhadap Pandangan Praktis InvestorAbstrak: Penelitian ini menginvestigasi pengaruh Ease of Doing Business Index (EDBI) terhadap Return on Investment (ROI). Penelitian ini menggunakan desain survei cross-sectional dari tahun 2015 sampai dengan tahun 2019. Sampel penelitian ini adalah 47 perusahaan yang terdaftar di Lagos Chamber of Commerce and Industry. Penelitian ini menggunakan analisis deskriptif dan statistik regresi linear. Dari berbagai elemen EDBI, temuan dari penelitian ini menunjukkan adanya pengaruh negatif yang signifikan antara keterlanjutan kebijakan pemerintah terhadap ROI. Proses pengadaan pemerintah, ketersediaan bahan mentah, dan kualitas tenaga kerja menunjukkan pengaruh berkebalikan dengan ROI. Lalu lintas dan manajemen transportasi, supply listrik, dan infrastruktur keamanan menunjukkan pengaruh tidak signifikan terhadap ROI. Usaha pemerintah dalam meningkatkan proses pengaadaan pemerintah masih belum memadai karena masih kecilnya pengaruh terhadap EDBI Nigeria. World Bank sebaiknya memasukkan pengaruh sektor privat dalam indikator EDBI sebagai upaya menciptakan sinergi antara pemerintah dan sektor privat untuk peningkatan EDBI dan dampaknya pada ekonomi. Kata kunci: Ease of Doing Business, indeks kemudahan berbisnis, pengembalian investasi, investor, Bank Dunia

scholarly journals The relationship between government, market and enterprises in Vietnam

2014 ◽  
Vol 17 (1) ◽  
pp. 16-28
Author(s):  
Dao Thi Thieu Ha
Keyword(s):  
Economic Freedom ◽  
Government Effectiveness ◽  
Clear Cut ◽  
Governance Indicators ◽  
Doing Business ◽  
The World ◽  
Economic Freedom Index ◽  
Ease Of Doing Business ◽  
The Government ◽  
The Relationship

This article analyses the reality relationship among government, market and enterprises in Vietnam in the period of 1996-2012. We find out that: (i) the effectiveness of government indicators such as ease of doing business index, the economic freedom index, the government effectiveness indicators (belong to the governance indicators) improved considerably overtime but have not reached the average level of the world; (ii) the relationship between government and enterprises has not been clear-cut. As a result, though many reforms have been conducted, state owned enterprises still take up a high percentage in many industries and enjoy multiple preferential polices while operate inefficiently. This articles also points out the reasons of the situation and gives some recommendations for solving those problems.

scholarly journals Executive Law Review in an Effort to Accelerate Program Ease of Doing Business

2020 ◽  
Vol 3 (1) ◽  
pp. 8-13
Author(s):  
Johannes Ibrahim Kosasih
Keyword(s):  
Local Governments ◽  
Central Government ◽  
Contributing Factors ◽  
Five Dimensions ◽  
Doing Business ◽  
Business Program ◽  
Ease Of Doing Business ◽  
The Government ◽  
Business Entities ◽  
Credit Contracts

Indonesia is currently still ranked below in attracting domestic and foreign investment because the existing regulations are not conducive. Many contributing factors, including central government regulations that are inconsistent in their implementation in the regions and the linkages of various regulations that support investment (for example: employment, land, credit, contracts, taxation, cross-country trade, business entities, bankruptcy and etc.), updates adapted to the era of free trade and fair business competition. One of the Government's efforts to improve the investment climate is to implement the Ease of Doing Business program that has been carried out by other countries in various parts of the world. This study aims to carry out the executive law review in an effort to accelerate program ease of doing. This study uses normative juridical research methods by examining various regulations and policies of the Central Government and local governments with a statute approach. The results of this study shows that there are three policies from the Government in the form of revoked, amended or maintained by the regulations referred to in 5 (five) dimensions in the evaluation of regulations, namely the accuracy of the type of legislation, the potential for disharmony in regulations, clarity of the formulation of regulations, assessment of conformity of norms, and effectiveness implementing statutory arrangements. These five dimensions in the Ease of Doing Business program are expected to provide synergy from existing regulations so that foreign investors can look at Indonesia as a country that is comfortable in investing and can provide benefits for businesses that are invested in Indonesia.  

scholarly journals Pembatalan Qanun Aceh Melalui Executive Review Dan Judicial Review

2020 ◽  
Vol 21 (2) ◽  
pp. 129
Author(s):  
Asmaul Husna ◽  
Eddy Purnama ◽  
Mahdi Syahbandar
Keyword(s):  
Economic Growth ◽  
Judicial Review ◽  
Regional Economic Growth ◽  
Regional Economic ◽  
Doing Business ◽  
Aceh Province ◽  
Ease Of Doing Business ◽  
The Law ◽  
The Republic ◽  
The Government

Abstrak: Qanun merupakan pengganti dari istilah peraturan daerah yang dikhususkan untuk Provinsi Aceh sebagai salah satu bentuk otonomi khusus. Di dalam hierarki peraturan perundang-undangan, Qanun merupakan  salah satu peraturan perundang-undangan yang tata urutannya di bawah Undang-Undang. Oleh karena qanun merupakan peraturan perundang-undangan sejenis perda, maka pemerintah memiliki kewenangan untuk membatalkannya jika qanun tersebut bertentangan dengan ketentuan peraturan perundang-undangan yang lebih tinggi. Pada pertengahan tahun 2016, Kementerian Dalam Negeri (Kemendagri) Republik Indonesia telah membatalkan 3.143 Perda karena dianggap menghambat pertumbuhan ekonomi daerah dan memperpanjang jalur birokrasi. Selain itu, peraturan tersebut juga dianggap menghambat proses perizinan dan investasi serta menghambat kemudahan berusaha. Dari jumlah tersebut terdapat 65 qanun Aceh yang ikut dibatalkan, yang terdiri dari 6 Qanun Provinsi dan 59 Qanun Kabupaten/Kota. Mengenai kewenangan siapa yang sebenarnya berwenang menguji Perda/Qanun tidak ada sebuah kesepakatan pendapat diantara para pakar.  Abstract: Qanun is a substitute for the term regional regulation that is specific to Aceh Province as a form of special autonomy. In the hierarchy of statutory regulations, Qanun is one of the statutory regulations whose ordering is under the Law. Because the qanun is a kind of legislation, the government has the authority to cancel it if the qanun is contrary to the provisions of the higher statutory regulations. In mid-2016, the Ministry of Home Affairs (Kemendagri) of the Republic of Indonesia canceled 3,143 regional regulations because they were considered to hamper regional economic growth and extend the bureaucratic path. In addition, the regulation is also seen as hampering the licensing and investment processes and hampering the ease of doing business. Of these, there were 65 Aceh qanuns that were canceled, consisting of 6 Provincial Qanun and 59 District / City Qanun. Regarding the authority of who actually has the authority to examine the Perda / Qanun there is no agreement of opinion among experts.

scholarly journals Nepalese Tax Structure: An Analytical Perspective

2018 ◽  
Vol 7 (1) ◽  
pp. 15-26
Author(s):  
Madhav Khanal
Keyword(s):  
Tax Evasion ◽  
Secondary Data ◽  
Tax Structure ◽  
Tax System ◽  
Doing Business ◽  
Indirect Taxes ◽  
Analytical Perspective ◽  
Ease Of Doing Business ◽  
The Government ◽  
The One

Tax is the major source of revenue for the government, and development of any country’s economy largely depends on the tax structure it has adopted. A Tax structure which facilitates easy business and leaves no chance for tax evasion brings prosperity to a country’s economy. On the other hand, tax structure that has provisions for tax evasion and the one which does not facilitate ease of doing business shows down the economic growth. Nepal has a well-developed tax structure. The power to levy taxes and duties is distributed among the three tiers of the Government, in accordance to the constitutional provisions. Nepali tax system has gone through many reforms but still it is very far from being an ideal one. Many problems like tax evasion, reliance on indirect taxes, black money and existence of parallel economy show that Nepali tax system requires some major reforms in the future ahead to address all this problem. This study is purely based on secondary data. Various figures are obtained from different sources of the government of Nepal. It is seen that there is major dependence on indirect taxes than the direct taxes.

Studying ‘Make in India’ from the Lens of Labour Reforms

2017 ◽  
Vol 42 (1) ◽  
pp. 1-19
Author(s):  
Kinjal Shukla ◽  
Maitreyi Purohit ◽  
Shubhra P. Gaur
Keyword(s):  
Developing Economies ◽  
Manufacturing Sector ◽  
Harvard Business Review ◽  
Domestic Investment ◽  
Doing Business ◽  
Ease Of Doing Business ◽  
The Government ◽  
Primary Focus ◽  
Key Aspects ◽  
The Impact

The contribution of the manufacturing sector in gross domestic product (GDP) has been a cause of concern, as India contributes only 16 per cent to the GDP in comparison to other rapidly developing economies, for example, the manufacturing sector of Thailand contributes 34 per cent to the GDP, China 32 per cent and South Korea 31 per cent. Currently, India stands at 134th position out of 189 economies under Doing Business Index. Its rank has also declined in the Global Manufacturing Index in comparison to the previous year. The Government of India in the year 2014 initiated a campaign titled Make in India to foster the growth of the manufacturing sector. In the initial phase of the campaign, the primary focus was on three key tactics namely reviving domestic investment, ensuring the ease of doing business and attracting foreign investors to invest in the manufacturing sector. The government later on realized that first there is a need to bring reforms in the decades old labour laws. This has urged the government to consider reforms in labour laws which will make Indian labour market more competitive in international market. The government has initiated these reforms by proposing certain amendments in the Factories Act 1948 and by including few provisions in the Labour Laws Amendment Act, 2011, and the Apprenticeship (Amendment) Act, 2014. The article attempts to analyze the impact of these reforms on success of Make in India campaign by studying the overall impact of these labour law reforms from employees and employers’ perspective and contribution of labour reforms in Make in India campaign by using the theory of structural change, fundamentals and growth given by Rodrik (2013b, Harvard Business Review). It also analyzes the impact of these reforms on two key aspects of the campaign, that is, focusing on job creation and skill enhancement.

scholarly journals PENGENAAN PAJAK PENGHASILAN ATAS PENGALIHAN HAK ATAS TANAH DAN/ATAU BANGUNAN YANG DIIKAT DALAM PERJANJIAN PENGIKATAN JUAL BELI DIHUBUNGKAN DENGAN EASE OF DOING BUSINESS (EODB) DALAM PERSPEKTIF KEPASTIAN HUKUM

2020 ◽  
Vol 1 (2) ◽  
pp. 172-190
Author(s):  
Nadhilah Mustika ◽  
Dewi Kania Sugiharti ◽  
Purnama Trisnamansyah
Keyword(s):  
Income Tax ◽  
Tax Avoidance ◽  
Legal Certainty ◽  
Tax Collection ◽  
State Revenue ◽  
Doing Business ◽  
Ease Of Doing Business ◽  
Legal Uncertainty ◽  
The Government

ABSTRAK Salah satu komponen penilaian yang dapat mempengaruhi indeks kemudahan berusaha atau Ease of Doing Business (EoDB) dalam proses pengalihan hak atas tanah dan/atau bangunan adalah pembayaran pajak. Namun ketentuan pajak penghasilan atas pengalihan hak atas tanah dan/atau bangunan yang diatur di dalam PP No. 34 Tahun 2016 menyebabkan perubahan waktu terutang dan berpotensi menghambat kegiatan bisnis properti yang dilakukan oleh pengembang. Penelitian ini bersifat deskriptif analitis dengan menggunakan pendekatan yuridis normatif. Hasil penelitian menunjukkan urgensi pemerintah dalam menetapkan pengenaan Pajak Penghasilan (PPh) atas Pengalihan Hak atas Tanah dan/ Bangunan yang diikat dalam Perjanjian Pengikatan Jual Beli (PPJB) adalah untuk mencegah terjadinya penghindaran pajak dan sebagai sarana mempercepat pemasukan negara. Pengenaan PPh dalam pengalihan hak atas tanah dan/atau bangunan yang masih diikat dalam PPJB Bertahap tidak mencerminkan asas kesederhanaan dalam pemungutan pajak dan merupakan suatu penyimpangan norma perpajakan yang menimbulkan ketidakpastian hukum, yaitu bagi pengembang selaku pelaku usaha. Kata kunci: Pajak Penghasilan, Perjanjian Pengikatan Jual Beli (PPJB), EoDB, Kepastian Hukum ABSTRACT One component of the assessment that can affect the Ease of Doing Business (EoDB) index in the process of transferring rights to land and / or buildings is tax payment. However, the income tax provisions on the transfer of rights to land and / or buildings as stipulated in PP No. 34 of 2016 cause changes in the time owed and potentially hamper property business activities carried out by developers. This research is analytical descriptive using normative juridical approach. The results of the study indicate the urgency of the government in determining the imposition of Income Tax (PPh) on the Transfer of Land and Building Rights that are bound in Sales and Purchase Agreement (PPJB) is to prevent tax avoidance and as a means of accelerating state revenue. Imposition of Income Tax in the transfer of rights to land and / or buildings that are still bound in Gradual PPJB does not reflect the principle of simplicity in tax collection and is a deviation of tax norms that cause legal uncertainty, for developers as business actors. Keywords : Income Tax, Sales and Purchase Agreement (PPJB), EoDB, Legal Certainty

Indonesia’s new shipping decree would harm business

2018 ◽  
Keyword(s):  
Dwell Time ◽  
Crude Palm Oil ◽  
Content Type ◽  
Trade Reforms ◽  
Doing Business ◽  
The World ◽  
Ease Of Doing Business ◽  
The Government ◽  
To Come ◽  
Port Infrastructure

Subject Indonesia's new shipping decree and ease of doing business. Significance Darmin Nasution, the coordinating minister for economic affairs, last month chaired a meeting to discuss strategies for improving Indonesia’s position in the World Bank’s Ease of Doing Business rankings. Trade Minister Enggartiasto Lukita announced in February that a new shipping decree requiring Indonesian rather than foreign vessels to export coal and crude palm oil, due to come into effect later this month, would be enforced only after the government and shipping sector were “ready”. Impacts Besides initiating regulatory and trade reforms, Jakarta will seek to reduce bureaucratic obstacles. New customs regulations may help to reduce cargo ships’ ‘dwell time’ in port. Expanding port infrastructure will be key to Indonesia’s vision of being at the fulcrum of a global ‘maritime axis’.

New Saudi visa rules will struggle to spur investment

2019 ◽  
Keyword(s):  
Saudi Arabia ◽  
Positive Impact ◽  
High Grade ◽  
Middle Income ◽  
Content Type ◽  
Business People ◽  
Doing Business ◽  
Residency Status ◽  
Ease Of Doing Business ◽  
The Government

Subject New residency rules in Saudi Arabia. Significance The government began rolling out in June a scheme that will enable expatriates to acquire privileged residency status, on payment of a fee. The scheme is aimed at high-grade professionals and business people, with a view to providing them with greater incentives to invest in property and business ventures. Impacts The move will have a marginally positive impact on perceptions of the ease of doing business, but much will depend on how it is implemented. The measure will reinforce the trend towards reducing the predominance of non-Saudis at the lower end of the labour market. If the residency permits do stimulate the housing market, it might also drive up prices for middle-income Saudi home-seekers.

scholarly journals Implikasi Omnibus Law Terhadap Hak Konstitusional Atas Lingkungan Hidup Yang Sehat

2021 ◽  
Vol 18 (1) ◽  
pp. 195
Author(s):  
Ahmad Gelora Mahardika
Keyword(s):  
United States ◽  
Sustainable Development ◽  
South Korea ◽  
Environmental Protection ◽  
The United States ◽  
Constitutional Rights ◽  
Healthy Environment ◽  
Doing Business ◽  
Ease Of Doing Business ◽  
The Government

One of the goals of the formation of the omnibus law is to increase the index of ease of doing business in Indonesia, which is currently far behind other countries. One effort that was then carried out by the government was to cut down a number of permits, one of which was an environmental permit, namely the obligation to complete EIA and UKL-UPL documents. However, this regulation is actually contradictory to the spirit of sustainable development (SDGs) which development must be in line with environmental protection. The action also has the potential to violate Article 28H paragraph (1) of the 1945 Constitution which requires the state to ensure the protection of citizens' constitutional rights to a clean and healthy environment. Especially in countries that have the highest business ease indexes, such as Denmark, South Korea and the United States, the issuance of EIA documents is mandatory and is carried out strictly. Therefore this article will try to look at the implications of the omnibus law for citizens' constitutional rights to a clean and healthy environment.

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