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DAILY NEWS ANALYSIS

Monthly DNA

09 May, 2021

38 Min Read

PLI Scheme for the Food Processing Industry

GS-III : Economic Issues Government policies and interventions

PLI Scheme for the Food Processing Industry

Ministry of Food Processing Industries (MoFPI) has launched an online portal for ‘Production Linked Incentive Scheme for Food Processing Industry’ (PLISFPI). This Central Sector Scheme ‘PLISFPI’ will be implemented for the period from 2021-22 to 2026-27. It is a part of Prime Minister’s announcement of Aatmanirbhar Bharat Abhiyan.

Key Points

  • It will support creation of global food manufacturing champions commensurate with India's natural resource endowment and support Indian brands of food products in the international markets.
  • The scheme has two components,
    1. It will provide sales based incentives for manufacturing of four major food product segments - Ready to Cook/ Eat (RTC/ RTE) foods, Processed Fruits &Vegetables, Marine Products, Mozzarella.
    2. It will provide grants for undertaking Branding & Marketing activities abroad.
  • The sales based incentive would be paid from 2021-22 to 2026-27 on incremental sales over the base year. For the first 4 years, 5th & 6th years, base year would be 2019-20, 2021-22 & 2022-23 respectively.
  • Applicants will be extended grant @ 50% of expenditure on branding & marketing abroad subject to a maximum grant of 3% of Sales of food products or Rs 50 crore per year, whichever is less.

Beneficiaries

  • Applicants may be Proprietary Firm or Partnership Firm or Limited Liability Partnership (LLP) or a Company registered in India (or) Co-operatives (or) SME. They will apply only through online portal.
  • Category-I - Applicants are large entities who apply for Incentive based on Sales Exports, and Investment Criteria.
  • Category-II - SMEs Applicants manufacturing innovative/ organic products who apply for PLI Incentive based on Sales, their product uniqueness, level of product development etc.
  • Category-III - Applicants applying solely for grant for undertaking Branding & Marketing activities abroad, who will be selected based on the level of recognition of their Brand, sales, exports, etc.

Source: PIB

DCGI approves anti-COVID drug- BY DRDO & Clinical Trials

GS-III : S&T Health

DCGI approves anti-COVID drug- BY DRDO & Clinical Trials

GS-Paper-3: S&T - Innovation – UPSC PRELIMS – Mains Application

Context: An anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy’s Laboratories (DRL), Hyderabad.

An anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy’s Laboratories (DRL), Hyderabad.

Clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.

Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients. The drug will be of immense benefit to the people suffering from COVID-19.

  • Pursuing Prime Minister call for preparedness against the pandemic, DRDO took the initiative of developing anti-COVID therapeutic application of 2-DG.
  • In April 2020, during the first wave of the pandemic, INMAS-DRDO scientists conducted laboratory experiments with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad and found that this molecule works effectively against SARS-CoV-2 virus and inhibits the viral growth. Based on these results, Drugs Controller General of India’s (DCGI) Central Drugs Standard Control Organization (CDSCO) permitted Phase-II clinical trial of 2-DG in COVID-19 patients in May 2020.

DCGI

The Drug Controller General of India (DCGI) is the head of the Central Drugs Standard Control Organisation (CDSCO) in India.

  • CDSCO is the central drug authority in India.
    • CDSCO is a national level regulatory body under the Ministry of Health and Family Welfare.
    • The body is responsible for approving licenses for certain categories of drugs.
    • It is headquartered in New Delhi.
    • There are six functioning central drug testing laboratories under CDSCO.
  • The DCGI also establishes standards for the manufacturing, sales, import, and distribution of drugs in India.
  • The DCGI also regulates medical and pharmaceutical devices.
  • In case of any dispute with respect to the quality of the drug, the DCGI is the appellate authority.
  • The DCGI prepares and maintains the national reference standard for drugs.
  • He ensures that there is uniformity in the implementation of the Drugs and Cosmetics Act.
  • He is responsible for the training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions.
  • He is also in charge of the analysis of cosmetics received from the CDSCO as survey samples.
  • The DCGI is also the central licensing authority for medical devices which fall under the Medical Device Rules 2017.

The CDSCO is responsible for the following:

  • Drug approval under the Drugs and Cosmetics Act.
  • Conducting clinical trials. Setting standards for drugs.
  • Quality control over drugs imported into the country.
  • Coordinating activities of the state drug control organisations.
  • Registration of foreign manufacturers of drugs and medical devices whose products are to be imported into the country.
  • Grant of licences to import drugs by Government hospitals or Medical Institutions for the use of their patients.
  • Recommend banning of drugs considered harmful or sub-therapeutic under section 26A drugs and Cosmetics Act.

  • The DRDO, along with its industry partner DRL, Hyderabad, started the clinical trials to test the safety and efficacy of the drug in COVID-19 patients.
  • In Phase-II trials (including dose ranging) conducted during May to October 2020, the drug was found to be safe in COVID-19 patients and showed significant improvement in their recovery.
  • Phase II was conducted in six hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country. Phase-II trial was conducted on 110 patients.

No clinical trials-for new drugs

  • Union Ministry of Health and Family Welfare has allowed waivers on conducting trials for new drugs in India in case the drug is approved and marketed in countries specified by — the Central Drugs Standard Control Organisation (CDSCO).

Regulation

  • New drugs approved for use in select developed markets will be automatically allowed in India provided global trials included Indian patients.
  • This waiver would also extend to drugs that receive these marketing approvals even while a trial is underway in India.
  • Data generated(clinical trial) outside the country will be acceptable.
  • Providing post-trial access of the drugs to the patients that require it have been defined for the first time.
  • It removed a clause in the clinical trials that mandated the sponsor (the entity initiating the trial) to pay 60% of compensation upfront in case of death or permanent disability of a patient.
  • Now companies will pay the total amount once it is proven that the injury occurred because of the trial.
  • Compensations in cases of death and permanent disability, or “other” injuries to a trial participant will be decided by Drug Controller General of India(DCGI).
  • It removed regulations on tests conducted on animals in case of drugs approved and marketed for more than two years in well-regulated overseas drug markets.

Significance of New Rules

  • It will end the unnecessary repetition of trials and speed up the availability of new drugs in the country.
  • It will lower the cost of drugs.
  • It will improve the ease of doing business for drug makers.

Criticism of new regulations

  • India is a country of vast ethnic diversity and most of the trials are done in the West. There is need of bridging trials for ethnically diverse populations to check drug suitability population.
  • Waiver should be only for drugs required urgently for national emergency.
  • Proving injury due to the trial is problematic and it is prone to manipulation.

  • In efficacy trends, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints. A significantly favourable trend (2.5 days difference) was seen in terms of the median time to achieving normalisation of specific vital signs parameters when compared to SoC.
  • Based on successful results, DCGI further permitted the Phase-III clinical trials in November 2020. The Phase-III clinical trial was conducted on 220 patients between December 2020 to March 2021 at 27 COVID hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu.
  • The detailed data of phase-III clinical trial was presented to DCGI. In 2-DG arm, significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence (42% vs 31%) by Day-3 in comparison to SoC, indicating an early relief from Oxygen therapy/dependence.

The similar trend was observed in patients aged more than 65 years. On May 01, 2021, DCGI granted permission for Emergency Use of this drug as adjunct therapy in moderate to severe COVID-19 patients. Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country.

Conclusion

The drug comes in powder form in sachet, which is taken orally by dissolving it in water. It accumulates in the virus infected cells and prevents virus growth by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique. In the ongoing second COVID-19 wave, a large number of patients are facing severe oxygen dependency and need hospitalisation. The drug is expected to save precious lives due to the mechanism of operation of the drug in infected cells. This also reduces the hospital stay of COVID-19 patients.

Phases of CLINICAL TRIALS

Clinical trial is a long and careful research process which is conducted in a step-by-step exercise usually comprising of the following phases:

  • Phase-0/Pre-clinical testing: The clinical trial often starts in a laboratory with the scientists finalising their ideas. If they are convinced, they start with animal testing. After all the things seems to be working well, the research on humans is needed.
  • Phase-1: It is the first study conducted on people in the clinical trial process. Here, the healthy participants (a small number) are given a fixed dosage and are watched closely. The aim of the study is to find the safest dose and the best treatment that can be given. It identifies side effects and studies how the dose works with other medicines or food.
  • Phase-2: In this phase, the study builds upon the results of Phase-1. It further tests the safety of drug along with its effectiveness. Here, more participants are involved. Now either all the participants are given the same experimental dose or sometimes the participants are divided into groups and given different treatment doses to compare. This phase can last for several years.
  • Phase-3: In this phase, the participant size is in hundreds to thousands. Here, tests are conducted to find if the treatment is better than the standard treatment available. It then compares side effects, survival rate and quality of life between the two. This phase runs over a long period of time.
  • Phase-4/ Post-marketing trials: In this phase, the participant size is in thousands. The studies are conducted only after the treatment has been registered with the drug regulator. This is usually done by pharmaceutical companies that manufacture the product. The study helps to identify how well the treatment is working when used widely. The long-term benefits and risks are also monitored. It further looks for the other uses of the drug or treatment other than intended ones.

Source: PIB

National Programme for Organic Production-Organic agriculture

GS-III : Economic Issues Agriculture

National Programme for Organic Production-Organic agriculture

GS-Paper-3: Economic - Agriculture – UPSC PRELIMS – Mains Application

Agricultural and Processed Food Products Export Development Authority (APEDA) has sourced finger millet and barnyard millet from farmers in Himalayas (Uttarakhand) for exports to Denmark. These millets were exported to Denmark after meeting the organic certification standards of the European Union (EU).

Organic Food

Organic farm produce means the produce obtained from organic agriculture, while organic food means food products that have been produced in accordance with specified standards for organic production. According to FSSAI,’organic agriculture’ is a system of farm design and management to create an ecosystem of agriculture production without the use of synthetic external inputs such as chemical fertilisers, pesticides and synthetic hormones or genetically modified organisms.

At present, organic products are exported provided they are produced, processed, packed and labelled as per the requirements of the National Programme for Organic Production (NPOP).

  • The NPOP or the Participatory Guarantee System for India (PGS-India) is a top- down mechanism run by the APEDA under the Ministry of Commerce for certifying general exports.
  • The NPOP came into inception in 2001 under the Foreign Trade (Development and Regulations) Act, 1992.

Organic Food Regulatory System

  • Food Safety and Standards Authority of India (FSSAI) is the food regulator in the country and is also responsible for regulating organic food in the domestic market and imports. FSSAI had notified the existing certification system through Food Safety and Standards (Organic Foods) Regulations in 2017.
  • National Programme for Organic Production (NPOP)
    • NPOP grants organic farming certification through a process of third party certification.
    • It involves the accreditation programme for Certification Bodies, standards for organic production, promotion of organic farming etc.
    • It is implemented by Agricultural and Processed Food Products Export Development Authority (APEDA), Ministry of Commerce and Industry.
    • The NPOP standards for production and accreditation system have been recognized by the European Commission, Switzerland and USA as equivalent to their respective accreditation systems.
  • Participatory Guarantee System for India (PGS)
    • PGS is another process of certifying organic products.
    • The certification is in the form of a documented logo or a statement.
    • It is implemented by the Ministry of Agriculture and Farmers’ Welfare.
    • The organic farmers have full control over the certification process. PGS certification is only for farmers or communities that can organise and perform as a group. Individual farmers or groups of farmers smaller than five members are not covered under PGS.
    • PGS is applicable on on-farm activities comprising of crop production, processing and livestock rearing, etc.
    • Off-farm processing activities such as storage, transport and value addition activities by persons/agencies other than PGS farmers away from the group are not covered under PGS.
  • Organic foods are also required to comply with the requirements of labelling of FSSAI in addition to that of NPOP or PGS-India.

Significance - The NPOP certification recognized by the EU and Switzerland enables India to export unprocessed plant products to these countries without the requirement of additional certification.

  • It also facilitates export of Indian organic products to the United Kingdom even in the post Brexit phase.
  • It has also been recognized by the Food Safety Standard Authority of India (FSSAI) for trade of organic products in the domestic market.
  • Organic products covered under the bilateral agreement with NPOP need not to be recertified for import in India.

Agricultural and Processed Food Products Export Development Authority (APEDA)

  • This authority, which was established under the APEDA Act, 1985, functions under the control of Ministry of Commerce and Industry.
  • It has been mandated with the responsibility of export promotion and development of the scheduled products viz. fruits, vegetables and their products, meat products and poultry products, dairy products, etc.,
  • It has been entrusted with the responsibility to monitor import of sugar.

About APEDA: http://apeda.gov.in/apedawebsite/organic/index.htm

Source: PIB

Methane Emissions- Global Methane Assessment & Climate Change

GS-III : Biodiversity & Environment Climate Change

Methane Emissions- Global Methane Assessment & Climate Change

GS-Paper-3: Environment and climate change – UPSC PRELIMS – Mains Application

“Human-caused methane emissions must be cut by 45 per cent to avoid the worst effects of climate change, a new United Nations report has said

Such a cut would prevent a rise in global warming by up to 0.3 degrees Celsius by 2045, the report added. It would also prevent 260,000 premature deaths, 775,000 asthma-related hospital visits annually, as well as 25 million tonnes of crop losses. Human-caused methane emissions are increasing faster currently than at any other time since record-keeping began in the 1980s.

Methane

Methane is a gas that is found in small quantities in Earth's atmosphere. Methane is the simplest hydrocarbon, consisting of one carbon atom and four hydrogen atoms (CH4). Methane is a powerful greenhouse gas. It is flammable and is used as fuel worldwide. Methane is produced by the breakdown or decay of organic material and can be introduced into the atmosphere by either natural processes – such as the decay of plant material in wetlands, the seepage of gas from underground deposits or the digestion of food by cattle – or human activities – such as oil and gas production, rice farming or waste management.

Impact of Methane: Methane is 84 times more potent than carbon and doesn’t last as long in the atmosphere before it breaks down. This makes it a critical target for reducing global warming more quickly while simultaneously working to reduce other greenhouse gases. It is responsible for creating ground-level ozone, a dangerous air pollutant.

*** The report was released by the Climate and Clean Air Coalition and the United Nations Environment Programme (UNEP)

Key points

  1. Carbon dioxide levels have dropped during the novel coronavirus disease (COVID-19) pandemic. However, methane in the atmosphere reached record levels last year, according to data from the United States National Oceanic and Atmospheric Administration.
  2. The report said this was a cause of concern as methane was an extremely powerful greenhouse gas. It was responsible for about 30 per cent of warming since pre-industrial times.
  3. However, cutting methane emissions can rapidly reduce the rate of warming in the near term as the gas broke down quickly, the report said.
  4. Governments worldwide were aspiring to reduce methane. For instance, the European Commission adopted the European Union Methane Strategy in October 2020. It outlined measures to cut methane emissions in Europe and internationally.
  5. Human-caused methane emissions are increasing faster currently than at any other time since record-keeping began in the 1980s.

Major Sources

Fossil Fuel: Oil and gas extraction, processing and distribution accounted for 23% of methane emissions in the fossil fuel sector. Coal mining accounted for 12% of emissions. The fossil fuel industry had the greatest potential for low-cost methane cuts, up to 80% of measures in the oil and gas industry could be implemented at negative or low cost. About 60% of methane cuts in this sector could make money as reducing leaks would make more gas available for sale.

Waste: Landfills and wastewater made up about 20% of emissions in the waste sector. The waste sector could cut its methane emissions by improving the disposal of sewage around the world.

Agriculture: In the agricultural sector, livestock emissions from manure and enteric fermentation constituted for roughly 32% and rice cultivation 8% of emissions. Three behavioural changes — reducing food waste and loss, improving livestock management and adopting healthy diets (vegetarian or with a lower meat and dairy content) — could reduce methane emissions by 65–80 million tonnes per year over the next few decades.

Reduction Potential

Europe: Greatest potential to curb methane emissions from farming, fossil fuel operations and waste management. The European Commission had adopted the European Union Methane Strategy.

India: Greatest potential to reduce methane emissions in the waste sector.

China: Mitigation potential was best in coal production and livestock.

Africa: Its potential to reduce methane emission was in livestock, followed by oil and gas.

Benefits
Human-caused methane emissions must be cut by 45% to avoid the worst effects of climate change.

Such a cut would prevent a rise in global warming by up to 0.3 degrees Celsius by 2045. It would also prevent 260,000 premature deaths, 775,000 asthma-related hospital visits annually, as well as 25 million tonnes of crop losses.

However, cutting methane emissions can rapidly reduce the rate of warming in the near term as the gas broke down quickly.

Climate and Clean Air Coalition

Launched in 2019, It is a voluntary partnership of governments, intergovernmental organizations, businesses, scientific institutions and civil society organizations committed to protecting the climate and improving air quality through actions to reduce short-lived climate pollutants.

**India is a member of the coalition.

United Nations Environment Programme: The UNEP is a leading global environmental authority established on 5th June 1972.

Major Reports: Emission Gap Report, Global Environment Outlook, Frontiers, Invest into Healthy Planet.

Major Campaigns: Beat Pollution, UN75, World Environment Day, Wild for Life.

Headquarters: Nairobi, Kenya.

Functions: It sets the global environmental agenda, promotes sustainable development within the United Nations system, and serves as an authoritative advocate for global environment protection.

India Initiative

Seaweed-Based Animal Feed: Central Salt & Marine Chemical Research Institute (CSMCRI) in collaboration with the country’s three leading institutes developed a seaweed-based animal feed additive formulation that aims to reduce methane emissions from cattle and also boost the immunity of cattle and poultry.

India Greenhouse Gas Program: The India GHG Program led by WRI India (non-profit organization), Confederation of Indian Industry (CII) and The Energy and Resources Institute (TERI) is an industry-led voluntary framework to measure and manage greenhouse gas emissions. The programme builds comprehensive measurement and management strategies to reduce emissions and drive more profitable, competitive and sustainable businesses and organisations in India.

National Action Plan on Climate Change: The National Action Plan on Climate Change (NAPCC) was launched in 2008 which aims at creating awareness among the representatives of the public, different agencies of the government, scientists, industry and the communities on the threat posed by climate change and the steps to counter it.

Bharat Stage-VI Norms: India shifted from Bharat Stage-IV (BS-IV) to Bharat Stage-VI (BS-VI) emission norms.

Source: DTE

PRAYAAS Scheme

GS-III : Economic Issues Government policies and interventions

PRAYAAS Scheme

The Employees’ Provident Fund Organisation (EPFO) sent the pension payment orders to the retiring employees under the Employees’ Pension Scheme, 1995 through the “PRAYAAS” initiative. PRAYAAS is an initiative of the EPFO to disburse pension payment orders on the very day of retirement/ superannuation.

Source: TH

Model Insurance Villages

GS-III : Economic Issues Government policies and interventions

Model Insurance Villages

The Insurance Regulatory and Development Authority of India (IRDAI) has come out with the concept of Model Insurance Villages (MIV). The idea behind the MIV concept is to offer comprehensive insurance protection to all the major insurable risks that villagers are exposed to and make available covers at an affordable or subsidised cost.

  • Such MIVs are expected to tackle losses due to natural calamities like floods and earthquakes. There’s no catastrophe insurance in India now.
  • The concept would be implemented in a minimum of 500 villages in different districts of the country in the first year and increased to 1,000 villages in the subsequent 2 years. It will be implemented for 3 to 5 years.
  • Every general insurance company and reinsurance company accepting general insurance business and having office in India needs to be involved for piloting the concept.
  • In order to make the premium affordable, financial support needs to be explored through NABARD, other institutions, CSR funds, support from the government and reinsurance companies.
  • This is to ensure that families and their property, and crops get cover and the entire village community participate in the initiative.

Source: PIB

State Disaster Response Fund

GS-III : Disaster and Disaster management Disaster management act

State Disaster Response Fund

The Centre has released the first instalment of the State Disaster Response Fund (SDRF) for 2021-22 to all the States, in the wake of the second wave of COVID-19. Normally, the annual exercise of the release of the first instalment is usually done in June, as per the recommendations of the Finance Commission.

  • As a special dispensation, the Department of Expenditure, Ministry of Finance, at the recommendation of the Home Ministry, has released in advance the first instalment of the Central share of the SDRF.
  • Since Delhi is a Union Territory, the fund is released by the MHA and is included in the Union Budget.
  • State Disaster Response Fund (SDRF) has been constituted under Section 48 (1) (a) of the Disaster Management Act, 2005, based on the recommendations of the 13th Finance Commission.
  • It is the primary fund available with the State governments as part of their response to the notified disasters to meet expenditure on providing immediate relief to victims.
  • The Centre contributes 75% of the allocation for general category States and Union Territories and 90% for special category States (northeastern, Sikkim, Uttarakhand, Himachal Pradesh, Jammu and Kashmir).
  • The annual Central contribution is released in two equal instalments as per the recommendation of the Finance Commission.
  • The allocation to each State depends on its population and utilisation of such funds in the previous financial year.
  • The SDRF is audited by the Comptroller and Auditor General of India (CAG) every year.

Source: PIB

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