- The Ministry of Health and Family Welfare prohibited the manufacture, sale or distribution of 156 fixed-dose combination (FDC) medicines.
- The Ministry has banned FDCs in accordance with the power enshrined under the Drugs and Cosmetics Act 1940.
- Banned FDCs posed risk to human beings whereas safer alternatives to the said drug are available.
- Banned FDCs include antibiotics, painkillers, and multivitamins such as Aceclofenac and Paracetamol.
What are Fixed Dose Combinations (FDCs) Drugs?
- FDCs refer to products containing two or more active ingredients also referred to as cocktail drugs used for a particular indication(s) (as per Drugs & Cosmetics Rule 1945)
- Active Ingredient is the biologically active component of a drug product (tablet, capsule, cream, injectable) that produces the intended effects.
- As per the Drugs and Cosmetics Act 1940, the FDCs are considered as New Drugs and the Central Drugs Standard Control Organization (CDSCO) issues approval.
Mostly FDCs are in combinations of cough, cold, and fever preparations; antimicrobials; vitamins and minerals etc
Rationale for Usage of FDCs
- Enhanced efficacy
- Cost-effectiveness
- Reduced pill burden
- Pharmacokinetic advantage
- Pharmacokinetics is defined as the study of absorption, distribution, metabolism, and excretion of drugs by the body
Issues associated with FDCs
- Lack of individual dose flexibility
- Unapproved and Banned FDCs
- Increased risk of Antimicrobial Resistance (AMR).
- Ethical concern
Steps taken by India for regulation of FDCs
- Drugs & Cosmetics (Amendment) Act, 2008 provides stringent penalties for manufacturers of spurious and adulterated drugs and certain offences have also been made cognizable and non-bailable.
- Testing capacities of Central Drugs Testing Laboratories under CDSCO are being constantly strengthened to expedite testing of drug samples in the country.
- Drugs and Cosmetics Rules 1945 amended in 2017: Providing that applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing License of oral dosage form of drugs.
A1 AND A2 MILK
- Recently, the Food Safety and Standards Authority of India (FSSAI) withdrew its direction to Food Business Operators (FBOs) do not market their milk and milk products in the name of A1 and A2
- Earlier, FSSAI stated that standards of milk as specified in Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 do not mention/ recognize any differentiation of milk on the basis of A1 and A2 types
- Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 has been enacted under the Food Safety and Standards Act 2006
Basis of the Classification
- A1 and A2 are genetic variants of Beta (ß)-casein protein. Casein (make 80 % of milk protein) is one of the two types of protein found in milk. The other one is Whey.
- Differentiation in both is linked to the difference in structure of amino acid sequence.
- Also, A1 evolved from A2 through natural mutation.
- Regular milk contains both A1 and A2 beta-casein, while A2 milk is unique in that it contains only the A2 variant.
- Studies of the National Bureau of Animal Genetic Resources (NBAGR) have confirmed that indigenous cows and buffaloes produce A2 milk.
| Comparison between A1 and A2 milk | ||
| Parameters | A1 Milk | A2 Milk |
| Nutrition | Higher fat content and calorie count | Higher protein content |
| Health benefits | Contains histidine (essential amino acids)
Histidine is used by body to produce histamine (enables the body to regulate its reaction to inflammation and allergies). As per studies, A1 milk cannot be digested well by some people and A2 is a better alternative for them. |
Contains proline (a non-essential amino acid).
It is an essential component of collagen and important for proper functioning of joints and tendons. |
| Source | Found predominantly in cow breeds that
originated in northern Europe e.g. Holstein, Friesian, Ayrshire, and British Shorthorn |
Present in milk from breeds native to Channel
Islands and southern France, including Guernsey, Jersey, Charolais, and Limousin cows. |
About Proteins
-
- These are large molecules made of amino acids. It is of two types-
- Essential amino acids: Cannot be made by the body. As a result, they must come from food.
- Non-essential amino acids: Can be synthesized in the body
- Proteins are the main structural constituents of the cells and tissues of the body. Muscles and organs are largely made of proteins
- These are large molecules made of amino acids. It is of two types-
- Proteins in Key Food Items
-
- Egg: Ovalbumin, ovotransferrin, ovomucoid, ovomucin etc.
- Fish: Myosin, tropomyosin and actomyosin
- Lentil: Globulin, Albumin, etc.
- Soybeans: Glycinin, Beta-conglycinin
- Almonds: Amandin
