Fixed-dose combination (FDC) Drugs & its Ban in India

What is Fixed-dose combination (FDC) Drugs :

Fixed-dose combination (FDC) that includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses & are in the spotlight currently due to government’s ban on them.

According to US healthcare provider IMS Health, almost half the drugs sold in India in 2014 were FDC, making it a world leader in combination drugs.

What is the logic behind FDC drugs :

The logic behind FDCs is to improve adherence, simplify therapy and/or to maximise benefit for the patient courtesy the added effects of the multiple medicinal products given together. The common drugs that will be affected by the ban are Saridon and D-cold total. The ministry of Health and Family Welfare has prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) with immediate effect. It has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.

 A government document titled ‘Policy Guidelines for Approval of Fixed Dose Combinations in India’, released in June 2013 had claimed that “FDCs have shown to be particularly useful in the treatment of infectious diseases like HIV, malaria and tuberculosis where giving multiple antimicrobial agents is the norm. FDCs are also of use in chronic conditions especially when multiple disorders often co-exist.”

For instance, several FDCs pack a combination of nimesulide and paracetamol and are sold under different brand names as an anti-pyretic, or medications to control fever. India reportedly boasts around 2,000 FDCs, four times more that what’s available in the US.

What makes FDC drugs Popular :

The one-word answer is cost. Instead of buying two, or more, separate medicines, a patient can buy just one FDC medicine to treat multiple illness symptoms, which typically works out easier on the wallet. Pharma companies, meanwhile, love them because it is far cheaper and quicker to combine existing active ingredients to make new products than to discover new medicines and manufacture them separately.

FDCs’ popularity in India is due to the reasons such as increased efficacy, better compliance, reduced cost and simpler logistics of distribution. FDCs have shown to be particularly useful in the treatment of infectious diseases like HIV, malaria and tuberculosis, where giving multiple antimicrobial agents is the norm. FDCs are also useful for chronic conditions especially, when multiple disorders co-exist.

Why Government banned FDC drugs :

The health ministry took this decision after the Drugs Technical Advisory Board recommended that “there is no therapeutic justification” for the ingredients contained in the banned FDC drugs and that these medicines “may involve risk to human beings”.

Health experts have long maintained that many FDC combinations in the market neither boast any advantage over individual drugs nor are safe. Simple logic dictates that chances of adverse drug effects and drug interactions can go up if medicines are combined instead of being taken separately. Apart from the fact that some of the drugs reportedly boast dangerous side-effects, unnecessary use of combination drugs makes the human body resistant to treatment.

Worryingly, published studies have long claimed that FDCs are often prescribed to cover up for diagnostic imprecision-likely making them extremely popular with quack doctors.

Hence, in a bid to stop the irrational use of FDCs, the Union Health Ministry on Wednesday banned the manufacture, sale or distribution of 328 varieties of FDC drugs for human consumption. The move will likely affect over 6,000 medicine brands.

“The banned FDCs account for about Rs 2,500 crore and represent only the tip of the iceberg. In our estimate, the market for unsafe, problematic FDCs in India is at least one-fourth of the total pharma market which is valued at Rs 1.3 trillion,” the All India Drug Action Network, a civil society group working on safety and access to medicines and one of the petitioners in the Supreme Court case, said in a statement.

Disadvantages of  FDC drugs :

FDC could be unsafe for consumption with potential health risk since the side effects of the combined product in FDC are different from those of its ingredients.

Sometimes the combination can come with risk that are not originally existed in the individual ingredients.

When an adverse reaction happens in a patient it is very difficult to identify which ingredients caused the reaction.

Many studies have pointed out that many of these combinations don’t have any advantages over individual drugs.

FDCs are famous, not because of its therapeutical effect, but because of the profits that are earned by the pharmaceutical companies due to the low production cost and high demand.

Why Government has not banned FDC drugs earlier :

To be sure, the latest ban on FDCs isn’t the first one. In 2007, the government ordered states to withdraw 294 combinations that were in the market without the approval of the central government. Drug companies and industry associations used legal means to push back the government’s order

Actually the health ministry has been gunning for “irrational” and “unsafe” FDCs for over two years now. In March 2016, the government had banned 344 FDCs, adding five more to the list subsequently, following a report submitted by the Prof CK Kokate committee.

But drug makers, including Pfizer, Procter & Gamble, Abbott, Glenmark, Sanofi, Wockhardt, Cipla, Lupin and Dr Reddy’s, had immediately moved various courts against the decision. The Delhi High Court alone had received over 450 petitions seeking a stay on the ban.

In December 2016, the Delhi High Court squashed the Centre’s decision, noting that it had acted on the advice of a ‘technical committee’, instead of consulting the Drugs Technical Advisory Board (DTAB) or the Drugs Consultative Committee. According to the bench, this violated the provisions of the Drugs and Cosmetics Act.

The health ministry had challenged this ruling in Supreme Court and, in December 2017, the latter directed DTAB to decide the fate of these FDCs.

Incidentally, the DTAB (Drugs Technical Advisory Board) has recommended restricted manufacture and sale of six other FDCs, subject to certain conditions based on their therapeutic justification. The SC also ruled that the government could not use the DTAB report to prohibit 15 of the 344 drugs in the original list as these have been manufactured in India since before 1988.

According to The Times of India, this exception covers several popular cough syrups, painkillers and cold medication with sales amounting to over Rs 740 crore annually. However, the apex court told the ministry that it is free to initiate a fresh investigation into the safety of these 15 drugs if it wants them banned.

How Pharma sector get affected by FDC drug ban :

The proposed government ban on over 340 combination medicine (fixed-dose combinations, or FDCs) will impact over 2 per cent  nearly Rs 2,900 crore  of the organised retail market, with popular cough syrups, painkillers and flu medicines like Phensedyl, Saridon, Sumocold, and Vicks Action 500  facing action. 

Large pharma companies have reportedly said that the impact is expected to be negligible since the FDCs in question are less than 2% of the pie. They added that over the last couple of years, they have either phased out such drugs or changed the combination.


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