Daily PT Capsule Mar 31

By   April 2, 2016
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Cabinet promulgates ordinances for Enemy Property and Uttarakhand

The Union cabinet on Wednesday 30th March promulgated two ordinances to amend the Enemy Property Act and to to authorise expenditure beyond April one in Uttarakhand which is under President’s Rule.

This comes in the wake of the Cabinet Committee on Parliamentary Affairs (CCPA) recommending proroguing the Budget session of Parliament, a rare development, followed by the seeking and receiving of Presidential assent. This has enabled the government to recommend the promulgation of the two ordinances in what would have otherwise been the middle of the session.

The ordinance for amendments in the 48-year-old Enemy Property Act was promulgated in January 2016. The Bill to replace the ordinance was passed by the Lok Sabha on March 9 after the government rejected demands by some Opposition parties that it be sent to the Standing Committee. However, it could not be cleared by the Rajya Sabha where the government is in a minority and the Enemy Property (Amendment and Validation) Bill, 2016, was eventually sent to a Select Committee.

In the case of Uttarakhand the central government believes that the Budget and Appropriation bill have not been passed and therefore this means that no money can be withdrawn from the State Consolidated Fund from April 1. And since Uttarakhand was under President’s Rule the Cabinet has recommended an Appropriation Ordinance for Uttarakhand, so that valid withdrawal of the government revenue can be done.

Analysis

What is proroguing of the session? – A legislative session is the period of time in which a legislature, in both parliamentary and presidential systems, is convened for purpose of lawmaking. Prorogation is  to discontinue a session of (a parliament or other legislative assembly) without dissolving it.

Source: TheHindu, Wikipedia

Clinical Trials norms eased

Health Ministry has amended the Drug and Cosmetics Act, exempting clinical trials conducted at academic institutions from taking the hitherto mandatory permission from the Drug Controller General of India (DCGI). The latest amendment to the D&C Act follows recommendations by the Professor Ranjit Roy Choudhury Committee, which had suggested that academic research should be approved by the Institutional Ethics Committees.

The once booming clinical trials in India came under the Supreme Court scrutiny in 2013, after at least 370 deaths were attributed to Serious Adverse Events (SEAs) during such trials. In September 2013, the apex court ruled that no new clinical trials be permitted until the regulatory mechanism was reformed.

Analysis

What is the need for easing such norms? – The initiative will help to create a system in which research and innovation are not caught in red tape. This is part of the government’s ease of regulation reforms. Many students test existing drugs and their study is delayed because of permissions required from the DCGI. Now, their institutions’ ethics committees are authorised to allow them, which should nurture an environment of research in the country.

What are the possible risks of such a move? – Public health experts say the move is a setback for those working towards a safer, more transparent clinical trials regime. Although the element of risk is lower but ethics committees need to be independent. It will depend on the institutions how they use it, which leaves a huge loophole.

Source: TheHindu

India-EU FTA discussions in Brussels

On 30 March 2016, the European Union(EU) hosted in Brussels the 13th EU-India summit. Discussions focused on trade and investment, energy and climate, water, migration and foreign and security policy.

Leaders at the summit adopted a joint statement, reaffirming their commitment to strengthen the EU-India strategic partnership. The two countries made an attempt to revive the stalled negotiations for the India-EU Broadbased Trade and Investment Agreement (BTIA).

Analysis

What is India’s interest? – Given the contribution of the service sector to GDP (57 percent), India is seeking improved market access in services. India’s interests lie in Mode 1 of the BTIA, which covers information technology enabled services (ITES), business process outsourcing (BPO), and knowledge process outsourcing (KPO), and Mode 4 which covers movement of skilled professionals like software engineers.

Improved market access in Mode 4 will allow skilled professionals such as software engineers to temporarily reside and work in EU countries. The barriers to Mode 4 include work permits, wage-parity conditions, visa formalities and non-recognition of professional qualifications.

India also seeks a data secure status from the EU, as the high cost of compliance with existing EU’s data protection laws and procedures renders Indian small and medium enterprises (SMEs) un-competitive.

What is EU’s interest? – The EU’s demands in India’s Mode 3 services includes further liberalization of FDI in multi-brand retail and insurance, and presently closed sectors like accountancy and legal services. The European banks have been eyeing India’s relatively underutilized banking space. However, the surrender of banking licenses by Goldman Sachs, Morgan Stanley and UBS shows that the burden of priority sector lending and financial inclusion have dissuaded foreign banks from entering India’s market.

India’s intellectual property regime (IPR) is another impediment. Any commitment over and above the WTO’s Trade Related Aspects of Intellectual Property Rights (TRIPS) will undermine India’s capacity to produce generic formulations. It is feared that data exclusivity protection measures (which allow pharmaceutical companies to exclusively retain rights to their test results for a certain period) would delay the supply of Indian generic medicines. That explains India’s opposition to the proposal. European pharmaceutical companies are wary of India’s patents law which prevents “ever-greening” – a provision that allows companies to renew patents on old drugs by making incremental changes.

Source: TheHindu, TheDiplomat

New Defence Procurement procedure for boosting native industry

The government unveiled the Defence Procurement Procedure on Mar 28. It has laid out the process for acquisition of equipment for the Indian Army, Navy and Air Force.

MoD constituted a Committee of Experts to recommend suitable amendments to DPP-2013. The target was to facilitate ‘Make in India’ in defence manufacturing and also simplify/rationalise various aspects of procurement. DPP-2016 evolved as a document that covers the operational context, acquisition categories and plans under various ‘Buy’ or ‘Make’ categories, procedure for defence-ship-building and also the Fast-Track procedure. Concept of strategic-partnerships is proposed to be clearly defined.

A new category for indigenously designed, developed and manufactured equipment has been added.  Acquisition schemes are broadly classified as, ‘Buy’, ‘Buy and Make’, and ‘Make’. ‘Buy’ is further categorised as ‘Buy (Indian indigenously designed, developed and manufactured— IDDM)’, ‘Buy (Indian)’, and ‘Buy (Global)’. ‘Buy Indian or IDDM must have at least 40% indigenous content. ‘Make’ portion of the contract has to be minimum 50%. ‘Buy (Global)’ is outright purchase of equipment from foreign vendors and the Government to Government route may be adopted.

Buy & Make’ essentially is initial procurement of equipment in Fully Formed (FF) state followed by indigenous production through Transfer of Technology (ToT).

Under the new policy, top priority to acquiring weapons will be given to Buy (Indian — IDDM) followed by Buy (Indian), Buy and Make (Indian), and Buy and Make (Global); the last priority will be given to Buy (Global) category.

Ministry of Defence will also spell out 15 years Long Term Integrated Perspective Plan (LTIPP), the 5 years Services Capital Acquisition Plan (SCAP) and Annual Acquisition Plan (AAP) for clarity.

A new “penalisation provisions” policy will replace the reflexive “blacklisting” of arms vendors suspected of wrongdoing with a more appropriate range of penalties.

The ‘Make’ procedure will see the government reimbursing 90% of the development cost.There is also greater assurance for defence industry to recover its costs. After successfully developing a prototype, if the vendor does not get an order, even his 10% expenditure would be refunded.

Analysis

What will be the impact on industry? – Introduction and according the highest priority to indigenously designed, developed and manufactured procurement, DPP 2016 would definitely spur more design development activities within the country and contribute towards the much higher indigenous content and finally creating a vibrant domestic defence industrial base.

The new policy also allows the Defence Acquisition Council to take a “fast-track” route to acquire weapons which would help in overcoming the shortages in our armed forces.

Source: TheHindu, Livemint

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