Government Bans 156 Fixed Dose Combination Drugs: A Major Crackdown on Irrational FDCs

What’s in today’s article?

• Why in News?
• Fixed Dose Combination (FDC) Drugs
• 156 fixed dose combination drugs banned

Why in News?

The Union Health Ministry has banned 156 fixed dose combination (FDC) medicines, citing "no therapeutic justification" and potential risks to patients. FDC drugs combine multiple active ingredients, which can be helpful for conditions like tuberculosis and diabetes but may also deliver unnecessary or harmful components. 

Fixed Dose Combination (FDC) Drugs: 

About

• Combination products, also known as fixed dose drug combinations (FDCs), are combinations of two or more active drugs in a single dosage form. 
• They are also referred to as cocktail drugs.
  • The Food and Drug Administration, USA defines a combination product as ‘a product composed of any combination of a drug and a device or a biological product and a device or a drug and a biological product or a drug, device, and a biological product’.
• It is widely accepted that most drugs should be formulated as single compounds. 

Acceptability 

• Fixed ratio combination products are acceptable only when –
  • The dosage of each ingredient meets the requirement of a defined population group and 
  • The combination has a proven advantage over single compounds administered separately in therapeutic effect, safety or compliance. 

Advantages of FDC Drugs 

• FDC formulations have unique advantages such as complementary mechanism of action, synergistic effects, better tolerability, elongated product life-cycle management, and cost savings.
• Use of FDCs is a rational approach for achieving optimal therapeutic benefits while minimizing pill-burden.

Challenges/Demerits of FDC Drugs

• There are increased chances of adverse drug effects and drug interactions compared with both drugs given individually.
• Unfortunately, many FDCs being introduced in India are usually irrational.
  • The most pressing concern with irrational FDCs is that they expose patients to unnecessary risk of adverse drug reactions.
• Irrational FDCs also impose unnecessary financial burden on consumers.
  • Medical practitioners who patronize such combinations could be the centre of controversy when subjected to litigation in consumer forums.
  • This is due to the fact that these combinations do not find mention in standard text or reference books and reputed medical journals. 
• Pharmaceutical manufacturers, however, continue to reap the benefits of huge sales, and therefore continue to promote combinations with vigour.

156 fixed dose combination drugs banned

• About the news
• The government has banned 156 fixed-dose combination (FDC) medicines, including antibiotics for fevers and colds, painkillers, and multivitamins, citing potential risks to human health.
• The Union Health Ministry issued a gazette notification under Section 26 A of the Drugs and Cosmetics Act of 1940, prohibiting the manufacture, sale, and distribution of these medicines.
• The ban follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB), both of which found no therapeutic justification for the ingredients in these FDCs.
• Key highlights
• The banned drugs include common combinations like anti-allergic medicines with nasal decongestants, antibiotics with acne creams, and migraine medicines with anti-nausea drugs. 
• Notably, the ban also includes the mefenamic acid-tranexamic acid combination and sildenafil with blood vessel relaxants. 
• This is the largest crackdown on FDCs since 2016 when 344 drugs were banned, a decision later upheld for 328 combinations in 2018. 
• Some pre-1988 drugs previously exempt from the ban are now included, which has surprised the pharmaceutical industry, raising concerns about the immediate withdrawal of these long-used products from the market.

Q1. Why did the Indian government ban 156 fixed-dose combination drugs?
 

The Indian government banned 156 fixed-dose combination drugs due to the lack of therapeutic justification and potential risks to patients, based on recommendations from an expert committee and the Drugs Technical Advisory Board.

Q2. What is the impact of the ban on the pharmaceutical industry?

The ban on 156 fixed-dose combination drugs has taken the pharmaceutical industry by surprise, raising concerns over the immediate withdrawal of long-used products and questioning the inclusion of pre-1988 medicines.