The Hindu Business Line : 40 fixed-dose-combination drugs may be off chemists’ shelves

Waiting for nod
Drug-makers worried about 1,300 FDCs approved only by State regulators and not the DCGI.
These medicines are set for a fresh review by State authorities in line with DCGI guidelines.

P.T. Jyothi Datta

Mumbai, Sept. 3

A prescription from the Centre may take some medicines off your doctor’s prescription. About 40 fixed-dose-combination medicines (FDC) are set to be removed from chemist shops, and another 1,300 combinations are to be reviewed, following a recommendation from the apex drug regulatory authority.

Four separate lists have been sent by the central Drug Controller-General of India (DCGI) to State regulators outlining combination drugs that have been banned; rejected by the Centre; approved by the Centre and finally, cleared only by the State and not the Centre. This is part of the DCGI’s exercise to screen the estimated Rs 3,000 crore FDC market.

On the DCGI’s list of 12 banned FDC’s are pain-killers, gastro-intestinal, orthopedic and central nervous system medicines. State regulators are also set to act on 34 rejected combination drugs, taking them off the market and withdrawing manufacturing licences, a Health Ministry official told Business Line.

But, causing heart-burn to drug-makers in the country is the list of 1,300 FDCs approved only by State regulators and not the DCGI. These medicines are set for a fresh review by State authorities in line with DCGI guidelines. Currently, the only FDCs off the hook are those cleared by the DCGI between 1971 and 2007.

On the banned list of FDCs, are painkillers combining paracetamol and anxiety-drug alprazolam or a paracetamol-analgin combine, for example.

The DCGI’s rejected list of FDCs include antibiotic combinations like ofloxacin and cefixime or anti-fungal/allergy drug combinations like flucanazole plus cetrizine (tablet). The underlying concern here is that drug companies may have got these combinations approved from some State regulator, despite being rejected by the Centre.

The 1,300 FDCs set for a review of their approvals span across therapeutic segments, including anti-microbials, dermatology, central nervous system, cardio-vascular, nutritional, gastro-intestinal, cough and cold and orthopaedics. Companies, including Alembic, Alkem and Aurobindo, Sun Pharma, Glenmark, Nicholas Piramal, Dr Reddy’s, Cipla, Indoco, GlaxoSmithKline, Merck, Morepen, Torrent, Elder, Unichem, Cadila, Intas, Ipca, Dabur, Lupin, Lyka and Zydus Cadila have drugs on this list.

Irrational combinations

Of this list, only irrational combinations will be removed after review and there will be no shortages, the official assured.

Some drug companies resort to irrational combinations to avoid price-control, he alleged.

Addressing consumer concerns, the official added, irrational FDCs were not unsafe, but they do not have the desired effect.

Combination medicines can be good too, like tuberculosis, HIV/AIDS and malaria drugs, he said.

Pharma industry officials counter that FDCs are sold only after getting approvals from the Centre or State. FDCs should be regularised, but based on scientific rationale and within a time-frame, they said.

Citing the poly-pill used in the UK for primary prevention of heart diseases, a Mumbai-based doctor observed combination drugs are here to stay. Only, the combination should be based on science and not commerce.

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