Sunday, November 11, 2018

SEP 18 ST 1 2 FF FDCS

. 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.

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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.

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•   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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