Fixed Dose Combination Drugs: Why Govt Panel recommends ban on 343 medicine combos

Unnecessary Overuse, Dosage Mismatch, Lack of Backup Studies were some of the reasons cited by the report

New Delhi: An expert panel formed by an apex advisory board on drugs to review the "safety, efficacy and therapeutic justification" of 349 fixed dose combination (FDC) medicines, which were banned in 2016, has backed the Health Ministry's decision to ban the drugs, barring six of them.

The panel set up by the ministry has submitted its recommendations to the Drugs Technical Advisory Board (DTAB), which will forward the same to the health ministry soon, a government official said.

After reviewing the 349 FDCs, the panel had recommended that 343 of them should be banned, while the remaining six drugs be restricted or regulated. Hindu reports some of the reasons cited by the report submitted by the sub-committee as following

• Unnecessary Exposure- “For most FDCs, their use would lead to unnecessary overuse, and the patients would be exposed to risk of multiple ingredients when one would suffice,” the report stated


• Dosage Mismatch- This would result in toxicity or contrarily lack of any effect on the patient, the experts pointed out. “An inability to adjust doses of individual ingredients is especially risky, if an ingredient has narrow safety margin,” the report said.


• Lack of Literature: Most pharma companies have not generated data on their own, and the published literature they have submitted to justify the FDC is not epidemiologically relevant to India and relied on a few biased studies. Indications mentioned on the FDC drug packs were too broad and absurd, the report said.

Hindu adds that during the review, some pharma companies offered to alter the indication on the drug packs for the use of the drug, or carry out more studies in support of their FDCs, but the sub-committee struck such offers down. “They were advised to follow the Drugs and Cosmetics Act for new drugs,” the report said.

FDC means a combination of two or more drugs in a fixed dosage ratio. The banned FDCs include painkillers, anti-diabetic, respiratory and gastro-intestinal medicines.

Meanwhile, the All India Drugs Action Network (AIDAN) welcomed the DTAB sub-committee's report, saying it reinforced their consistent demand for approval, and use, of only rational medicines in India.

"Rationality needs to be demonstrated by safety, efficacy and therapeutic justification. None of the FDCs meet the criteria of a rational and safe drug. The people of India have been made the consumers of unsafe medicines for too long and this is one step towards rectifying the grave situation of a pharma market brimming with innumerable irrational FDCs," AIDAN said in a statement,

"Finally, we are appalled at the pharma industry's disinformation and claims that the recommendations of the sub-committee will deal a huge blow to it. We ask how an important action in favour of safe medicines can be construed as a 'blow' and object to such misleading propaganda," it added.

In 2016, the Health Ministry had banned 349 FDCs claiming they were "unsafe" and irrational for consumption. The move was estimated to affect around 6,000 medicine brands.

Hundreds of pharma companies moved the Delhi High Court against the move, following which the ban on the manufacture and sale of these medicines was lifted later that year.

The government then approached the apex court, which in December 2017 mandated that DTAB decide the fate of these FDCs.