What’s in today’s article?

• Why in news?
• Russia-Ukraine war
• What is the Background of Russia-Ukraine conflict?
• Why Russia invaded Ukraine?
• What is the current status of Russia-Ukraine War?
• News Summary: Jeddah peace summit on the Russia-Ukraine war
• Key highlights of the speech delivered by NSA Doval
• India’s participation: what does it signify?

 

Why in news?

• Saudi Arabia hosted Ukraine, the U.S., some European countries and major developing countries, including India and Brazil, for peace talks on the Russia-Ukraine war.
• The aim of this summit was to reach an agreement on key principles for a peaceful end to Russia's war in Ukraine.

 

Russia-Ukraine War

What is the Background of Russia-Ukraine Conflict?

• Tensions between Ukraine and Russia escalated in late 2013 over a landmark political and trade deal with the European Union.
  • After the pro-Russian then-President, Viktor Yanukovych, suspended the talks weeks of protests in Kyiv erupted into violence. Soon, the then pro-Russian President was ousted.
• Russia responded by invading Crimea, which was a part of Ukraine, and annexing it in March 2014.
  • Russia invaded Crimea on the pretext that it was defending its interests and those of Russian-speaking citizens.
• Shortly afterwards, pro-Russian separatists in Ukraine's Donetsk and Luhansk regions declared their independence from Kyiv (capital of Ukraine).
  • They established their own autonomous state called Donetsk People's Republic in 2014.
  • Russia, in February 2022, recognised the independence of these two regions.
• Kyiv and Moscow signed a peace deal in Minsk in 2015. It was brokered by France and Germany. But it could not bring peace in the region.

• Later, in February 2022, Russian President Vladimir Putin declared war on Ukraine in a televised address.
  • He said the military action announced by Russia will seek to demilitarize Ukraine and came in response to threats from Ukraine.

 

Why Russia invaded Ukraine?

• Russia wanted a guarantee Ukraine can never join NATO
  • Russia's main demand was a commitment from NATO to end its further expansion into former Soviet republics — especially Ukraine. 
• Russia wants NATO arms out of Eastern Europe
  • Russia wants NATO to stop deploying its weapons and forces in countries in Central and Eastern Europe that joined the alliance after 1997.
• Russia wants a ban on NATO missiles within striking distance
  • Russia has nervously watched as NATO has demonstrated it can deepen its involvement in Ukraine — providing weapons and training.
  • NATO missiles on Ukrainian soil might pose serious threat to Russia’s security.
• Russia wants autonomy for eastern Ukraine
  • Russia says Ukraine must meet its obligations under 2015 agreements.
    • The peace deal, known as the Minsk agreements, was signed to end the fighting between Ukraine's army and pro-Russian separatists in eastern Ukraine.
    • The Minsk agreements also provided additional autonomy to the separatist Russian-speaking territories in the Donbas.

 

What is the current status of Russia-Ukraine War?

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Image caption: Current Status of Ukraine War

 

News Summary: Jeddah peace summit on the Russia-Ukraine war

• The two-day meeting on the Ukraine conflict was hosted by Saudi Crown Prince Mohammad Bin Salman and attended by top security officials of around 40 countries.
  • The current meeting follows an earlier meeting in Copenhagen more than a month ago to discuss the Russia-Ukraine conflict.
• While Russia did not participate, Ukraine was present at the meeting. India was represented by NSA Ajit Doval.

 

Key highlights of the speech delivered by NSA Doval

• Underlined the need for respect for sovereignty and territorial integrity by all states
  • He emphasised that respect for sovereignty and territorial integrity by all states must be upheld without exception.
  • He also said that efforts must be made to resolve the conflict and soften its consequences.
• Highlighted the challenges
  • The meeting confronts a two-fold challenge — resolution of the situation and softening the consequences of the conflict. 
  • Efforts must be directed on both fronts simultaneously and much more groundwork is needed to ensure this.
• A solution acceptable to all relevant stakeholders is needed to end the war
  • He said that several peace proposals have been put forward, and each has some positive points but none is acceptable to both sides. 
    • Ukrainian President Zelenskyy had proposed 10-point peace plan during last year’s G-20 summit.
    • China also came up with a 12-point-plan for the political settlement of the Ukraine crisis.
    • In June 2023, leaders of seven African countries, led by South African President Cyril Ramaphosa, visited Russia and Ukraine.
      • They proposed a 10-point proposal which suggested the recognition of Russia and Ukraine's sovereignty, and the release of prisoners.
  • The key question that needs to be addressed in this meeting is whether a solution acceptable to all relevant stakeholders can be found.
• Highlighted India’s approach
  • He said that India’s approach has been and always will be to promote dialogue and diplomacy. This is the only way forward for peace.
  • India has engaged both Russia and Ukraine since the beginning of the conflict at the highest levels.
    • While India has not explicitly condemned the Russian invasion of Ukraine, PM Modi had said this is not the era of war. 
    • India has also condemned the Bucha massacre, expressed concerns at the nuclear rhetoric by the Russian leadership.
    • In recent days, India condemned the collapse of the Black Sea Grain Initiative, where Russia walked out of the deal.
  • He also pointed out that the whole world and especially the Global South was bearing the brunt of the situation. 
  • New Delhi is providing both humanitarian assistance to Ukraine and economic assistance to its neighbours in the Global South.

 

India’s participation: what does it signify?

• NSA Ajit Doval’s participation in the peace conference on Ukraine shows India’s willingness to step up efforts to end the war. 
• The fact it has raised its level of representation — up from the Secretary-rank official in June — reflects the sense of purpose on India’s side. 
  • In Copenhagen meet, where Ukraine was on the agenda, India was represented by MEA’ Secretary (West).
• As chair of G20, New Delhi is keen to have a consensus document at the leaders’ summit in New Delhi next month.

 

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Q1) What is the geographical location of red sea?

The Red Sea is a seawater inlet of the Indian Ocean, located between the northeastern African continent and the Arabian Peninsula. It stretches from the Gulf of Suez in the north to the Bab el Mandeb strait in the south. The Red Sea is bordered by countries such as Egypt, Sudan, Eritrea, Djibouti, Saudi Arabia, and Yemen. Its geographic coordinates roughly range from 12°N to 28°N latitude and 33°E to 43°E longitude.

 

Q2) Where is Copenhagen?

 Copenhagen is the capital city of Denmark, a country located in Northern Europe. Copenhagen is situated on the eastern coast of the island of Zealand (Sjælland in Danish), which is part of the larger Danish archipelago. It is separated from Sweden by the Øresund Strait.

 

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Source: Doval in Jeddah: Efforts must to resolve Russia-Ukraine conflict | The Hindu  | The Hindustan Times

What’s in today’s article?

• Why in News?
• What are the Good Manufacturing Practices (GMP) for Pharma Companies?
• Need for the Revised GMP
• What are the Major Changes in the GMP?
• Significance of the Revised GMP
• Concerns Raised by Pharma Industry and Way Ahead

 

Why in News?

• The Government of India recently directed all pharmaceutical companies in the country to implement the revised GMP, bringing their processes at par with global standards.
• Larger companies (turnover > Rs 250 crore) have been asked to implement the changes within six months, while medium and small-scale enterprises (turnover < Rs 250 crore) have been asked to do so within a year.

 

What are the Good Manufacturing Practices (GMP) for Pharma Companies?

• GMP is a system for ensuring that products are consistently produced and controlled according to quality standards.
• It is designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
• The World Health Organisation (WHO) has established detailed guidelines for GMP and many countries have formulated their own requirements for GMP based on WHO GMP.
• Others (such as the ASEAN, EU) have harmonised their requirements through the Pharmaceutical Inspection Convention.

 

Need for the Revised GMP:

• Poor quality of Indian manufactured drugs: There have been incidents where countries have reported alleged contamination in India-manufactured syrups, eye-drops, and eye ointments.
  • For example, the deaths of 70 children in the Gambia, 18 children in Uzbekistan, 3 persons in the US, etc., have been linked to these products.
  • Only 2,000 of the 10,500 drug manufacturing units in the country at present meet global standards, being WHO-GMP certified.
• A risk-based inspection found several deficiencies: For example,
  • Incoming raw materials not being tested before use,
  • Product quality not being reviewed,
  • Absence of quality failure investigation,
  • Infrastructure deficiency to prevent cross-contamination,
  • Faulty design of manufacturing and testing areas, missing qualified professionals, and
  • Poor documentation.

 

What are the Major Changes in the GMP?

• The revised GMP guidelines focus on quality control measures, proper documentation, and IT backing to maintain quality of medicines produced.
• The new guideline introduces pharmaceutical quality system, quality risk management, product quality review, and validation of equipment.
• This will mean companies will have to carry out regular quality reviews of all its products, verify consistency of the quality and the processes.
• It also suggests a change control system to evaluate all changes that may affect the production or quality of the product.
• The companies will also have to carry out stability studies as per the climate conditions.

 

Significance of the Revised GMP:

• It will bring the Indian industry on par with global standards, improving the quality of medicines available in India as well as sold in global markets.
• This comes at a time when India is promoting itself as the global manufacturing hub for generic medicines.
• The GMP-related computerised systems will ensure that there is no tampering of data related to the processes.
• Instituting the same quality across the industry will give confidence to regulators from other countries.

 

Concerns Raised by Pharma Industry and Way Ahead:

• It is the smaller companies who have to make drastic changes, as most bigger companies in India already follow the global GMP.
  • Therefore, at least 36 months would be needed to make the necessary changes.
• To help such companies, the department of pharmaceuticals has a scheme to provide credit-linked capital and interest subsidy for upgradation of MSME units.

 

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Q1) What is the World Health Organisation (WHO)?

Founded in 1948, WHO is the United Nations agency that connects nations, partners and people to promote health, keep the world safe and serve the vulnerable – so everyone, everywhere can attain the highest level of health.

 

Q2) Why is India called the pharmacy of the world?

India is hailed as the “Pharmacy of the World” owing to its high and efficient production of “global standard medicine” at affordable costs.

 

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Source: Revised manufacturing rules for drug firms: what changes, and why