Ban 343 irrational FDC medicines, say experts

A government appointed expert panel has recommended banning 343 irrational FDC or Fixed Dose Combination medicines that got a life-line from the court after Health Ministry banned its sale almost two years ago.

Another six FDC medicines were allowed by the panel to be used for specific indications and in specific quantities.

Headed by Nilima Kshirsagar, chair in Clinical Pharmacology at Indian Council of Medical Research, the committee was formed by the Drugs Technical Advisory Board on the advice of the Supreme Court, which wanted a review of the Health Ministry's 2016 decision.

"The sub-committee noted that most appellants (companies manufacturing these medicines) had not generated safety and efficacy data of their own for their FDC. The published literature they provided to justify the FDCs was not relevant because epidemiological data is not from India. They also relied on a few biased studies,” the panel said in the executive summary of its report, a copy of which is available with DH.

The panel found that indications (symptoms indicative of a disease) mentioned by the companies were too broad, absurd and vague. Use of most of the FDCs would lead to unnecessary overuse of a drug and the patients would be exposed to the risk of multiple ingredients when one would suffice.

In FDCs where there is a dosing mismatch among the ingredients, using those medicines would result in toxicity or lack of efficacy. Many companies claimed safety by quoting OTC (over the counter) products in the UK or US market, ignoring the lacunae in the OTC system.

The Supreme Court in December 2017 asked the central government to make arrangement for experts to examine 349 fixed dose combination (FDC) medicines to find out if there is any “therapeutic justification” for their manufacture.

Tip of iceberg

“The FDCs under scrutiny account for approximately Rs 2,500 crore in sales and represent only the tip of the iceberg. In our estimation, the market of unsafe, problematic FDCs in India is at least one fourth of the total pharma market valued at Rs 1.3 trillion,” commented Malini Aisola from All India Drug Action Network, a non-government organisation and one of the petitioners before the Supreme Court.

While 344 medicines were banned by the Union Health Ministry on the recommendation of an expert panel, headed by C K Kokate, vice chancellor of KLE University, Belagavi, five more drugs were added to the list when the matter reached the court.

Pharmaceutical companies got a reprieve from Delhi High Court, but the central government went on appeal to the Supreme Court.

The list of 344 drugs include popular cough syrups, analgesics and antibiotic combinations. One of the prohibited drugs is the fixed dose combination of Chlopheniramine Maleate and Codeine syrup sold under the popular cough syrup brand Corex, manufactured by Pfizer.