Fixed-dose combination ban to hit retail pharmaceutical biz

MUMBAI: The proposed government ban on over 340 combination medicines (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. 

A final decision on the ban is expected soon by health ministry, even as an expert panel — the Drug Technical Advisory Board, or DTAB — earlier recommended these “irrational and “harmful” medicines should be taken off the shelves. 

An FDC contains two or more drugs combined in a fixed ratio, and made available in a single dosage form. They comprise around 50 per cent of the Rs 1.25-lakh-crore market (moving annual total, or MAT, June 2018), with only certain combinations being marketed “irrational” and “harmful”. 

Last year, the Supreme Court (SC) had asked the DTAB to review the matter and recommend which FDCs should be regulated or banned, following a protracted legal battle between the government and drug companies over the issue.

The banned combinations on the proposed list belong to several therapeutic areas like cough and cold syrups, gastrointestinal and anti-infective formulations, and dermatological medicines. The respiratory portfolio will bear the highest impact of 10 per cent, followed by anti-diabetic and anti-infective drugs, data culled from IQVIA, a leading technology-driven healthcare service provider said. 

Gastro-intestinal medicine Panderm+ (Macleods Pharma) is the most impacted brand at 8 per cent or Rs 233 crore in value terms in the banned category, followed by cough preparation Phensedyl Cough (Abbott). 

IQVIA general manager South Asia Amit Mookim said, “The popularity of combination drugs has been due to the convenience of reduced pill burden at an affordable cost. After the ban implementation, the doctors may now have to change their Rx (prescription) habit and prescribe multiple plain drugs, instead of writing one FDC, which may have a huge cost impact on the patients.
Further, retail pharmacists dispense medicines based on doctors’ prescriptions that mention the brand names. 

The banned FDCs are sold under multiple brand names, and looking into the combination of each such brand is an extremely complex process. Each pharmacy may have hundreds of brands with the same combination, and it will be difficult to identify the banned FDCs — which are given in pharmacological names — and eventually may pose a risk to the patients. 

Therefore, the industry will have to educate and create awareness among pharmacists for effective and safe implementation of the ban.”

Further, industry experts say the market may see new launches, with newer formulations or a tweak in molecules, going forward — particularly where they are hit most. 

 Among the banned formulations, impact from top five molecules, brands, and companies is fairly high, while over 60 per cent of the banned molecules are triple combinations and more. The highest impacted market segment is Pioglitazone + Metformin + Glimepiride, followed by cough preparation market and Clobetasol + Ofloxacin + Ornidazole + Terbinafine.

In a surprise move in 2016, the government had banned over 340 FDCs, after which the ban was legally contested. The Delhi high court, which had heard a majority of petitions against the move, ruled in favour of industry, arguing the government had not gone through the statutory bodies which decide these matters. The government appealed the matter in the SC, which in turn asked the sub-committee of the DTAB to submit its recommendations.