Health/Governance
Indian Certification of Medical Devices (ICMED) Plus Scheme launched

Relevance IN - Prelims ( about ICMED + ICMED plus + about QCI) + Mains ( GS II government policies and interventions + Health Sector + governance - transparency)
What's the NEWS

• The Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the ICMED the Scheme that had been launched for Certification of Medical Devices in 2016.
• The ICMED 13485 PLUS, as the new scheme has been christened, will undertake verification of the quality, safety and efficacy of medical devices.
• The ICMED 13485 PLUS Scheme was launched digitally by the Quality Council of India

The ICMED 13485 PLUS

• ICMED 13485 Plus has been designed to integrate the Quality Management System components and product related quality validation processes through witness testing of products with reference to the defined product standards and specifications.
• This is the first scheme around the world in which quality management systems along with product certification standards are integrated with regulatory requirements.
• This scheme will be an end to end quality assurance scheme for the medical devices sector in India.
• This scheme provides the much-needed institutional mechanism for assuring the product quality and safety.
• It will go a long way in assisting the procurement agencies to tackle the challenges relating to the menace of counterfeit products and fake certification.
• This will also help in eliminating the circulation and use of sub-standard medical products or devices of doubtful origin that could prove to be serious health hazards.
• ICMED Plus, one of the recent initiatives by the QCI, help in assuring the quality in medical devices.

Medical devices regulation

• While pharmaceuticals are regulated in India, it is an irony that medical devices were not regulated till 2017 which make for a sizable investment in the healthcare system.
• Association of Healthcare Providers (India) will encourage implementation of ICMED Plus among its members and stake holders
• Many organizations around the world have succeeded by reducing regulatory compliance through voluntary efforts.
• It would be in the interest of India manufacturing sector, if the DCGI starts using Certification bodies for verification of compliance in the medical devices.
• ICMED Plus launch has demonstrated a strong commitment by the medical devices manufacturers in India to not only provide medical devices products to consumers in India, but also compete globally by adopting global best practices for medical devices and enhancing the value for the end users.

Regulatory gap

• It existed in India prior to 2017 and the next 23 months of transition will continue to have regulatory gaps.
• To fill such gaps in the medical devices Industry, it is essential that ICMED Plus scheme, be recognized as a pre-requisite to show compliance by manufacturers under MDR-2017 and to reduce the load on regulators, ICMED Plus certification should be considered as deemed compliance for one year under MDR-2017.

Know! more about ICMED ( genesis)

• To fill the regulatory vacuum in quality certification space for medical devices in the country, the Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) rolled out a voluntary quality certification scheme for medical devices.
• The Scheme is intended to enhance patient safety, and provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers.
• This move is also intended to significantly eliminate trading of sub-standard products or devices of doubtful origins, a widespread and injurious phenomenon in the Indian market.
• Indian medical device industry is required to fulfil Indian regulatory requirements of ICMED including IMDR2017.
• This scheme is focused on assessment of those specific Indian regulatory requirements and enhance compliance level.

Quality Council of India

• The Quality Council of India, an autonomous body set up by the Ministry of Commerce and Industry, Government of India jointly with the Indian Industry represented by the three premier industry associations i.e. Associated Chambers of Commerce and Industry of India (ASSOCHAM), Confederation of Indian Industry (CII) and Federation of Indian Chambers of Commerce and Industry (FICCI), to establish and operate national accreditation structure and promote quality through National Quality Campaign.
• Quality Council of India (QCI) is registered as a non-profit society with its own Memorandum of Association and is governed by a Council with equal representations of government, industry and consumers.
• The Council plays a pivotal role at the national level in propagating, adoption and adherence to quality standards in all important spheres of activities including education, healthcare, environment protection, governance, social sectors, infrastructure sector and such other areas of organized activities that have significant bearing in improving the quality of life and wellbeing of the citizens of India.

Defence
Maiden Indian Navy - European Union Naval Force (EUNAVFOR) Exercise in Gulf Of Aden

Relevance IN - Prelims ( about EUNAVFOR) + Mains ( GS II bilateral relations + regional and global grouping)
What's the NEWS

• Indian Naval Ship Trikand, mission deployed for Anti-Piracy Operations, is participating in the maiden IN - EUNAVFOR Joint Naval Exercise in the Gulf of Aden commencing today.
• A total of five warships from four navies are participating in the exercise on 18th and 19th June 2021.

Know! more about the exercise

• The two day exercise will see high tempo-naval operations at sea, including advanced air defence and anti-submarine exercises, cross deck helicopter operations, tactical manoeuvres, boarding operations, underway replenishment, Search & Rescue, Man Overboard drills, and other maritime security operations.
• Ships of the four navies will endeavour to enhance and hone their war-fighting skills and their ability as an integrated force to promote, peace, security and stability in the maritime domain.
• Concurrently, a virtual "Information sharing Exercise" is also being conducted between the Indian Navy Information Fusion Centre - Indian Ocean Region and Maritime Security Centre-Horn of Africa on 18 June 21.
• EUNAVFOR and the Indian Navy converge on multiple issues including counter piracy operations and protection of vessels deployed under the charter of World Food Programme (UN WFP).
• Indian Navy and EUNAVFOR also have regular interaction through SHADE (Shared Awareness and De-confliction) meetings held annually at Bahrain.
• This engagement showcases increased levels of synergy, coordination and inter-operability between IN and EUNAVFOR.
• It also underscores the shared values as partner navies, in ensuring freedom of seas and commitment to an open, inclusive and a rules-based international order.
  

Defence
P11356 PROJECT

Relevance IN - Prelims ( about Project 11356)
What's the NEWS

• Keel of the second frigate of additional follow-on ship of Project 1135.6 for the Indian Navy was ceremoniously laid on 18 Jun 2021 by Vice Chief of Naval Staff.
• The ships under construction at Goa Shipyard Ltd (GSL) are part of indigenous shipbuilding program being executed under Inter Governmental Agreement with Russian Side for construction of two advanced frigates for the Indian Navy.
• The contract was signed on 25 January 2019 between Ministry of Defence and Goa Shipyard Limited. Keel Laying is a major milestone activity in the construction of any ship symbolising formal commencement of the construction process.
• Keel for the first ship was laid on 29 Jan 2021. The first ship would be delivered in 2026 and second ship subsequently after 06 months.
• It was for the first time that these vessels, with such technological complexity, were being constructed indigenously at GSL and marked an important milestone in our journey towards Atma Nirbhar Bharat and Make in India initiative.
• A large number of major equipment are being substituted with indigenous equivalents, in addition to use of significant indigenous build material.
• The entire hulls of the ships are also being built with indigenous steel.

Environment
India and Bhutan sign MOU for developing cooperation in the areas of Environment

Relevance IN - Prelims ( about the MoU highlights) + Mains ( GS II bilateral relations)
What's the NEWS

• India and Bhutan inked an MoU for developing cooperation between two countries in the area of environment.
• The MoU was signed virtually by Minister of Environment, Forest and Climate Change Prakash Javadekar from the Indian side and Minister of Foreign Affairs and Chairperson of the National Environment Commission

Know! the MoU highlights

• The MoU will open new vistas of bilateral co-operation in the area of climate change, waste management etc.
• India wants to engage with Bhutan on environmental related issues including climate change.
• The MoU is a platform to further enhance Indian and Bhutanese partnership and support, exchange best practices in areas like prevention of Air Pollution, Waste Management, Chemical Management, Climate Change, etc.
• It also provides the possibility to have joint projects in areas of mutual interest.
• The MoU will also strengthen technological, scientific and management capabilities and expand the areas of cooperation in the field of environment to promote a mutually beneficial partnership between the two countries.

Health
National Sickle Cell Conclave
Relevance IN - Prelims ( about Sickle cell disease )
What's the NEWS

• The Minister of Tribal Affairs, virtually inaugurate the Second National Sickle Cell Conclave on ‘Sickle Cell Disease'
• The Conclave is being held to mark the World Sickle Cell Day observed on 19thJune 2021 every year.

Know! more about the conference

• The Conclave is being organised by Ministry of Tribal Affairs, GoI , in collaboration with the Federation of Indian Chambers of Commerce & Industry (FICCI), Novartis, Apollo Hospitals, Piramal Foundation, GASCDO and NASCO.
• Sickle cell disease (SCD), which is the most prevalent inherited blood disorder, is widespread amongst many tribal population groups in India, posing a considerable health burden in several states.
• The disease in India is prevalent predominantly in Jharkhand, Maharashtra, Madhya Pradesh, Chhattisgarh, western Odisha, eastern Gujarat and in pockets of the Nilgiri Hills in north Tamil Nadu and Kerala.
• The flagship event will bring together top government officials, stakeholders including Ministry of Tribal Affairs, FICCI, Novartis, Apollo Hospitals, Piramal Foundation, GASCDO, NASCO as well as experts/clinicians to discuss ways and means to enhance awareness, prevention and management initiatives -- especially among women and children -- along with recent advances in SCD management.
• The program will include a panel discussion featuring leading clinicians, advocates and policy makers who are focused on delivering high-quality healthcare to people living with SCD.
• The conclave will visualize a roadmap for streamlining guidelines and for effective management of sickle cell disease through Continuum of Care approach in India.

Sickle cell anemia

• It is one of a group of disorders known as sickle cell disease.
• Sickle cell anemia is an inherited red blood cell disorder in which there aren't enough healthy red blood cells to carry oxygen throughout your body.
• Normally, the flexible, round red blood cells move easily through blood vessels.
• In sickle cell anemia, the red blood are shaped like sickles or crescent moons.
• These rigid, sticky cells can get stuck in small blood vessels, which can slow or block blood flow and oxygen to parts of the body.
• There's no cure for most people with sickle cell anemia. But treatments can relieve pain and help prevent complications associated with the disease.

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