Daily PT Capsule Mar 22

Daily PT Capsule UPSC Civil Services
Daily PT Capsule UPSC Civil Services

Historic Visit to Cuba by US President

US President Barack Obama is on  visit to Cuba, the first official visit of a US president since Calvin Coolidge in 1928.  In many ways, it represents the culmination of Obama’s approach to the island: a concerted effort to break down the decades-old US embargo and move toward normal relations.

The US embargo on Cuba has still not ended, it can only be done by US Congress. But what Mr.Obama has done is relaxation of  specific trade barriers and changed the American diplomatic approach that underpinned that embargo: treating Cuba as a pariah state, much like North Korea or Iran.

The new strategy is to work with Cuba rather than against it: to attempt to improve life in the country through negotiations and commercial ties rather than attempting to topple the communist government through isolation and economic pressure.

Mr. Castro, US President praised Mr. Obama’s recent steps to relax controls on Cuba as “positive,” but deemed them insufficient. He called anew for the U.S. to return its naval base at Guantanamo Bay to Cuba and to lift the U.S. trade embargo.


How has the US-Cuba relationship been? – Cuba and the United States restored diplomatic relations on 20 July 2015, which had been severed in 1961 during the Cold War. The United States, however, continues to maintain its commercial, economic, and financial embargo, which makes it illegal for U.S. corporations to do business with Cuba. Although the U.S. President, Barack Obama, has called for the ending of the embargo, U.S. law requires congressional approval to end the embargo.

Following the Cuban Revolution of 1959, bilateral relations deteriorated substantially. In 1961, the U.S. severed diplomatic ties with Cuba and began pursuing covert operations to topple the Communist regime.Moreover, the U.S. imposed and subsequently tightened a comprehensive set of restrictions and bans vis-à-vis the Cuban regime as retaliation for the nationalization of U.S. corporations’ property by Cuba. Meanwhile, several organizations, including a nearly unanimous UN General Assembly, have called for “an end to the United States’ decades-long economic, commercial and financial embargo against Cuba.

Source: The Hindu, Vox


Stay on ban on drugs

Delhi high court has stayed its order that lifted ban on fixed dose combination (FDC) medicines of some pharmaceutical companies. In an affidavit, the government said that lifting the ban would be “against public interest and patient safety”. It claimed that the pharma companies were interested only in profit.

On March 10, 2016, the Central Drugs Standard Control Organisation(CDSCO) issued a notification prohibiting the manufacture, sale and distribution of 344 Fixed Dose Combinations of drugs, popularly known as FDCs.

There have long been safety and efficacy concerns over FDCs in general and action against them had long been awaited. But the Delhi High Court granted an interim stay on the ban until March 21 to Pfizer, a similar injunction against the ban on Phensedyl (another cough syrup) and Vicks Action 500. The interim stay has been granted on the grounds that the drug has been marketed for 25 years and that the notification banning it does not disclose any “grave urgency”. The court’s order also records the alleged objection of the manufacturers that they had been denied a hearing before the ban was imposed.


What are Fixed Dose Combinations? – It is a drug includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses.

Initially, fixed-dose combination drug products were developed to target a single disease (such as with antiretroviral FDCs used against AIDS). However, FDCs may also target multiple diseases/conditions. In cases of FDCs targeting multiple conditions, such conditions might often be related — in order to increase the number of prospective patients who might be likely to utilize a given FDC product. This is because each FDC product is mass-produced, and thus typically requires having a critical mass of potentially applicable patients in order to justify its manufacture, distribution, stocking, etc.

Why have they been banned? – There have been safety and efficacy concerns regarding fixed dose combinations. Apart from it many FDCs were also allowed to enter the market illegally. State Drug Authorities issued manufacturing licences for such FDCs without obtaining Central approval from CDSCO. This contravenes Rules 122B (3) and 122D, read with Rule 122E of the Drugs and Cosmetics Rules, 1945.

These provisions explicitly include FDCs within the definition of a “new drug”. When applying for approval to a State licensing authority to manufacture a new drug, the applicant must also provide evidence that the Central licensing authority, CDSCO, has approved the drug.

What is the way forward? – There has been lack of clarity and communication between central and state authorities. There is a need to consider  a new law on pharmaceutical regulation in India.

Source: The Indian Express,The Hindu, Wikipedia

New medicine for drug resistant TB launched

Ahead of World Tuberculosis Day, Health Minister J.P. Nadda launched Bedaquiline — new drug for Drug Resistant TB — as part of the national programme. The drug will be introduced in 104 districts across five States.

The new class of drug is a diarylquinoline that specifically targets Mycobacterial ATP synthase, an enzyme essential for the supply of energy to Mycobacterium tuberculosis and most other mycobacteria.

Bedaquiline is being introduced at six tertiary care centres across India. These sites have advanced facilities for laboratory testing and intensive care for patients. Bedaquiline will be given to multi-drug resistant TB patients with resistance to either all fluoroquinolone and/or all second line injectables and extensive drug resistant TB.

The national programme will also benefit from the introduction of over 500 Cartridge-Based Nucleic Acid Amplification Test (CBNAAT) machines — a revolutionary rapid molecular test which detects Mycobacterium tuberculosis and rifampicin drug resistance, simultaneously. This test is fully automated and provides results within two hours. It is a highly sensitive diagnostic tool and can be used in remote and rural areas without sophisticated infrastructure or specialized training.


What is drug resistant TB? – Multi-drug-resistant tuberculosis (MDR-TB) is defined as a form of TB infection caused by bacteria that are resistant to treatment with at least two of the most powerful first-line anti-TB drugs,isoniazid (INH) and rifampicin (RMP).

Five percent (5%) of all TB cases across the globe in 2013 were estimated to be MDR-TB cases, including 3.5% of newly diagnosed TB cases, and 20.5% of previously treated TB cases.

Treatment of MDR-TB requires treatment with second-line drugs, usually four or more anti-TB drugs for a minimum of 6 months, and possibly extending for 18–24 months.

Source: TheHindu, Wikipedia


Tax panel recommendation on digital services

A high-level government committee has recommended a 6-8 per cent tax on several online services such as online advertising, cloud computing, website-hosting, digital platforms for sale of goods and services or download of software and applications, provided by a company not resident in India. Committee on Taxation of E-Commerce, set up by the Central Board of Direct Taxes (CBDT), recommended that payments of over Rs.1 lakh made by a resident individual or company to a non-resident enterprise will be covered by this levy.

The report was submitted to Finance Minister Arun Jaitley prior to the Budget, based on which he proposed a fee of 6 per cent to be levied only on online advertising and restricted to B2B transactions.Though the Budget proposal is to apply this levy currently only on online advertisements, more categories of digital goods and services may be added later.

The Committee’s recommendation is to impose this levy on sale of digital goods and services, including website hosting, cloud computing etc.


Why to impose a levy on digital goods? – The equalisation levy follows the Base Erosion and Profit Shifting (BEPS) report, endorsed by the G20 and OECD, which sought to put forth a global standard for taxing e-commerce. The issue with e-commerce is that the services are often provided by companies that have no office space in the country where the service is rendered and so are not subject to tax, providing them an advantage over domestic players. The other issue, that experts feel needs to be addressed, is based on whom the onus of payment of the levy will fall.

The committee has taken cognisance that putting the onus of payment of the levy on the payment gateways and authorised foreign exchange dealers can reduce the obligation on the service purchaser.

This levy is India’s attempt to tax the digital economy in a non-adversarial manner and at the same time demonstrate its commitment to the global BEPS project and of course to raise more revenues for the country.

Source: TheHindu

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