. FOOD F OR TI FI CATI ON
Why in news?
• The Food Safety and Standards Authority of India (FSSAI) has recently released a report on food fortification.
Background
• Nearly 70% of people in India consume less than half of their recommended dietary allowance(RDA) of micronutrients. The deficiency of micronutrients is also known as “hidden hunger”.
• Fortification is being promoted through both open market and government schemes like ICDS,MDMS,PDS,etc.
Food Safety and Standards (Fortification of Foods) Regulations,
2018
• It has prescribed standards for fortification of various food products such as All fortified foods must not fall below the minimum level of micro nutrients.
• Quality assurance:
o Every manufacturer and packer of fortified food shall give an undertaking on quality assurance
o random testing of fortificants and fortified food
• Every package of fortified food shall carry name of the fortificant and the logo to indicate.
• The Food Authority shall take steps to encourage the production, manufacture, distribution, sale, and consumption
• In National Nutrition Strategy (Kuposhan Mukt Bharat), food fortification has been given a major thrust.
• FSSAI has operationalised standards for fortification of:
o wheat- flour-rice (with iron, Vitamin B12 and folic acid)
o milk & edible oil (with Vitamins A and D)
o double-fortified salt (with iodine and iron).
• It has also introduced the +F logo to identify fortified foods.
• It has also launched the Food Fortification Resource Centre (FFRC) to promote large-scale fortification of food across India.
What is food fortification?
• Food fortification is the deliberate addition of one or more micronutrients to food so as to correct or prevent a deficiency and provide a health benefit .
Some International experiences
• Salt iodization was introduced in the early 1920s in both Switzerland and the United States of America and has since expanded progressively all over the world.
• In Venezuela, wheat and maize flours have been fortified with iron has shown significant reduction in iron deficiency.
• In Morocco, fortification of double fortified salt showed improved results in reduction of anaemia.
• The concentration of just one micronutrient might be increased (e.g. the iodization of salt) or there might be a whole range of food–micronutrient combinations.
• Food fortification is a “complementary strategy” and not a replacement of a balanced &
diversified diet to address malnutrition.
Advantages of food fortification
• Health benefits:
o Elimination of micronutrient deficiency diseases like anaemia, goitre, xerophthalmia, etc. which are prevalent in India. For eg. according to the National Family Health Survey, around 50% of women and children in India suffer from anaemia.
o Food fortification can be used as an effective tool to counter vitamin D deficiency. (prevalent in more than
70% of Indian population).
o It reduces the risk of death from infectious diseases.
• Wide population coverage: Since the nutrients are added to staple foods that are widely consumed, it enable to improve the health of a large section of the population.
• Socio-culturally acceptable: It does not require any changes in food habits and patterns of people being targeted.
• Cost-effective:
o The Copenhagen Consensus estimates that every 1 Rupee spent on fortification results in 9 Rupees in benefits to the economy.
62 www.visionias.in ©Vision IAS
o Technology to fortify food is simple and easy to implement.
• Complements Food security: Nutritional security is much needed to reap the dividends of implementing the food security act.
Challenges
• Voluntary nature: Fortification continues to be voluntary rather than mandatory leading to limited efforts to fortify by state governments and private sector.
• Poor implementation by states: Although some states have adopted fortification in ICDS, MDMS and PDS, but due to lack of definitive policy guidelines, budgetary constraints, technical knowledge and logistic support, states have not adopted fortification in a holistic manner.
• Weaknesses of FSSAI: It lacks resources and manpower to effectively carry out its mandate.
• Lack of awareness: There is a lot of misinformation and ignorance about the usage and benefits of fortified food as of now.
Way forward
• Nationwide Implementation: Pan-India implementation of fortification via government schemes would amount to only an increment of 1 percent of the total budget allocated annually.
• Support to states: Merely issuing orders and notifications from Government of India will not suffice as state governments require hand-holding support and should sensitised about the benefits fortification and must be enabled to procure fortified staples in various programs.
• Ensure Standards: Compliance with FSSAI standards w.r.t macronutrient content and quality must be strictly enforced.
• Awareness: A mass awareness campaign about food fortification is needed to scale up demand from consumers in the open market.
• Promote food processing industry: It will go a long way in improving the nutritional value of staple food.
6.2. FI XE D DOSE COMBI NATI O NS (FD CS)
Why in news?
Recently, the Ministry of Health and Family Welfare in exercise of powers conferred by the Drugs and Cosmetics Act, 1940 has prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) and restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.
Background
• In 2016, the health ministry had banned 349 FDCs, claiming they were "unsafe" and "irrational" for consumption on the recommendation of Chandrakant Kokate committee (2015). However, the matter was contested by the affected manufacturers in various High Courts and the Supreme Court of India.
• The Drugs Technical Advisory Board on a direction from
Drug regime in India
• Drugs are regulated by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945.
• Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, is the authority that approves new drugs for manufacture and import.
• State Drug Authorities are the licensing authorities for marketing drugs.
• Drugs Technical Advisory Board (DTAB): It is the highest statutory decision-making body under the Union Health ministry on technical matters. It is constituted as per the Drugs and Cosmetics Act, 1940.
Supreme Court, formed Nilima Shirsagar committee to review the safety, efficacy and therapeutic justification of 344 fixed dose combination (FDC) drugs. The committee also recommended the continuation of the ban along with other observations such as:
o FDCs were formulated without due diligence, with dosing mismatches that could result in toxicity.
o Pharma companies whose products were under scrutiny provided “irrelevant” data that relied on biased
studies and almost 95%, failed to prove safety, rationality and compatibility of these FDC.
o Experts believe combination drugs to be unsafe because unaware physicians can prescribe wrong dosage that can in turn make human body resistant to treatment.
o Over the years, India has become a "dumping ground" for irrational FDCs that are not approved in other countries for consumption.
63 www.visionias.in ©Vision IAS
• The DTAB in its report recommended that there is no therapeutic justification for the ingredients contained in
328 FDCs and that these FDCs may involve risk to human beings.
• Market size of the banned drugs is estimated to be around Rs 20-22 billion and will impact the country’s top
drugmakers.
About FDC
• An FDC is a cocktail of two or more therapeutic drugs packed in a single dose. Several cough syrups, painkillers and dermatological drugs in India are FDCs.
• Benefits: They are known to offer specific advantages over the single entity preparations, such as increased efficacy, and/or a reduced incidence of adverse effects, possibly reduced cost and simpler logistics of distribution relevant to situations of limited resources
• Cheaper for consumer: patient can buy just one FDC medicine to treat multiple illness symptoms.
• Good For Business: For pharma companies, FDC's are cheaper and easier to combine existing active ingredients to make new products than to discover new medicines. They are also not covered under the ambit of price control regime.
• According to All India Drugs’ Action Network (AIDAN), the market of unsafe, problematic FDCs in India is at
least one fourth of the total pharma market valued at ₹1.3 trillion
Why in news?
• The Food Safety and Standards Authority of India (FSSAI) has recently released a report on food fortification.
Background
• Nearly 70% of people in India consume less than half of their recommended dietary allowance(RDA) of micronutrients. The deficiency of micronutrients is also known as “hidden hunger”.
• Fortification is being promoted through both open market and government schemes like ICDS,MDMS,PDS,etc.
Food Safety and Standards (Fortification of Foods) Regulations,
2018
• It has prescribed standards for fortification of various food products such as All fortified foods must not fall below the minimum level of micro nutrients.
• Quality assurance:
o Every manufacturer and packer of fortified food shall give an undertaking on quality assurance
o random testing of fortificants and fortified food
• Every package of fortified food shall carry name of the fortificant and the logo to indicate.
• The Food Authority shall take steps to encourage the production, manufacture, distribution, sale, and consumption
• In National Nutrition Strategy (Kuposhan Mukt Bharat), food fortification has been given a major thrust.
• FSSAI has operationalised standards for fortification of:
o wheat- flour-rice (with iron, Vitamin B12 and folic acid)
o milk & edible oil (with Vitamins A and D)
o double-fortified salt (with iodine and iron).
• It has also introduced the +F logo to identify fortified foods.
• It has also launched the Food Fortification Resource Centre (FFRC) to promote large-scale fortification of food across India.
What is food fortification?
• Food fortification is the deliberate addition of one or more micronutrients to food so as to correct or prevent a deficiency and provide a health benefit .
Some International experiences
• Salt iodization was introduced in the early 1920s in both Switzerland and the United States of America and has since expanded progressively all over the world.
• In Venezuela, wheat and maize flours have been fortified with iron has shown significant reduction in iron deficiency.
• In Morocco, fortification of double fortified salt showed improved results in reduction of anaemia.
• The concentration of just one micronutrient might be increased (e.g. the iodization of salt) or there might be a whole range of food–micronutrient combinations.
• Food fortification is a “complementary strategy” and not a replacement of a balanced &
diversified diet to address malnutrition.
Advantages of food fortification
• Health benefits:
o Elimination of micronutrient deficiency diseases like anaemia, goitre, xerophthalmia, etc. which are prevalent in India. For eg. according to the National Family Health Survey, around 50% of women and children in India suffer from anaemia.
o Food fortification can be used as an effective tool to counter vitamin D deficiency. (prevalent in more than
70% of Indian population).
o It reduces the risk of death from infectious diseases.
• Wide population coverage: Since the nutrients are added to staple foods that are widely consumed, it enable to improve the health of a large section of the population.
• Socio-culturally acceptable: It does not require any changes in food habits and patterns of people being targeted.
• Cost-effective:
o The Copenhagen Consensus estimates that every 1 Rupee spent on fortification results in 9 Rupees in benefits to the economy.
62 www.visionias.in ©Vision IAS
o Technology to fortify food is simple and easy to implement.
• Complements Food security: Nutritional security is much needed to reap the dividends of implementing the food security act.
Challenges
• Voluntary nature: Fortification continues to be voluntary rather than mandatory leading to limited efforts to fortify by state governments and private sector.
• Poor implementation by states: Although some states have adopted fortification in ICDS, MDMS and PDS, but due to lack of definitive policy guidelines, budgetary constraints, technical knowledge and logistic support, states have not adopted fortification in a holistic manner.
• Weaknesses of FSSAI: It lacks resources and manpower to effectively carry out its mandate.
• Lack of awareness: There is a lot of misinformation and ignorance about the usage and benefits of fortified food as of now.
Way forward
• Nationwide Implementation: Pan-India implementation of fortification via government schemes would amount to only an increment of 1 percent of the total budget allocated annually.
• Support to states: Merely issuing orders and notifications from Government of India will not suffice as state governments require hand-holding support and should sensitised about the benefits fortification and must be enabled to procure fortified staples in various programs.
• Ensure Standards: Compliance with FSSAI standards w.r.t macronutrient content and quality must be strictly enforced.
• Awareness: A mass awareness campaign about food fortification is needed to scale up demand from consumers in the open market.
• Promote food processing industry: It will go a long way in improving the nutritional value of staple food.
6.2. FI XE D DOSE COMBI NATI O NS (FD CS)
Why in news?
Recently, the Ministry of Health and Family Welfare in exercise of powers conferred by the Drugs and Cosmetics Act, 1940 has prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) and restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.
Background
• In 2016, the health ministry had banned 349 FDCs, claiming they were "unsafe" and "irrational" for consumption on the recommendation of Chandrakant Kokate committee (2015). However, the matter was contested by the affected manufacturers in various High Courts and the Supreme Court of India.
• The Drugs Technical Advisory Board on a direction from
Drug regime in India
• Drugs are regulated by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945.
• Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, is the authority that approves new drugs for manufacture and import.
• State Drug Authorities are the licensing authorities for marketing drugs.
• Drugs Technical Advisory Board (DTAB): It is the highest statutory decision-making body under the Union Health ministry on technical matters. It is constituted as per the Drugs and Cosmetics Act, 1940.
Supreme Court, formed Nilima Shirsagar committee to review the safety, efficacy and therapeutic justification of 344 fixed dose combination (FDC) drugs. The committee also recommended the continuation of the ban along with other observations such as:
o FDCs were formulated without due diligence, with dosing mismatches that could result in toxicity.
o Pharma companies whose products were under scrutiny provided “irrelevant” data that relied on biased
studies and almost 95%, failed to prove safety, rationality and compatibility of these FDC.
o Experts believe combination drugs to be unsafe because unaware physicians can prescribe wrong dosage that can in turn make human body resistant to treatment.
o Over the years, India has become a "dumping ground" for irrational FDCs that are not approved in other countries for consumption.
63 www.visionias.in ©Vision IAS
• The DTAB in its report recommended that there is no therapeutic justification for the ingredients contained in
328 FDCs and that these FDCs may involve risk to human beings.
• Market size of the banned drugs is estimated to be around Rs 20-22 billion and will impact the country’s top
drugmakers.
About FDC
• An FDC is a cocktail of two or more therapeutic drugs packed in a single dose. Several cough syrups, painkillers and dermatological drugs in India are FDCs.
• Benefits: They are known to offer specific advantages over the single entity preparations, such as increased efficacy, and/or a reduced incidence of adverse effects, possibly reduced cost and simpler logistics of distribution relevant to situations of limited resources
• Cheaper for consumer: patient can buy just one FDC medicine to treat multiple illness symptoms.
• Good For Business: For pharma companies, FDC's are cheaper and easier to combine existing active ingredients to make new products than to discover new medicines. They are also not covered under the ambit of price control regime.
• According to All India Drugs’ Action Network (AIDAN), the market of unsafe, problematic FDCs in India is at
least one fourth of the total pharma market valued at ₹1.3 trillion
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