The Hindu Business Line : Combination drugs: Driven by science or commerce?

Mumbai, Nov. 12 You do not need a sten-gun to tackle an ant, is how a Mumbai-based doctor describes a combination medicine that packs, without compelling reason, several medicines into a single pill.

Take for instance, analgesic pill that combines paracetamol + diclofenac sodium + amoxicillin + cloxacillin + pantoprazole + lactic acid bacillus + serrapeptase. Was this seven-in-one pill backed by sound scientific reason or created with a commercial intent is a question that throws up as many answers as there are combinations in the drug.

Science vs. commerce

And therein lies the complexity of the fixed-dose combination (FDC) that combines multiple medicines in fixed doses, but in a single pill. A formulation that may be prescribed by good science or driven by commercial motives, observe doctors and pharma industry representatives.

The seven-in-one pill is one of the 120 “absurd” FDCs that the regulatory Drug Controller General of India (DCGI) has recently ordered off the market-place, even as another 150 combinations were slotted for review. This was part of a review of 294 combinations, an estimated Rs 3,000 crore market.

Doctors explain that a seven-in-one painkiller that combines a pain-killer + an NSAID (a non-steroidal drug that is anti-fever, inflammation and pain) + two separate antibiotics + a gastric reflux medicine + a medicine facilitating good bacteria + a protein, may be quite unnecessary.

Consumer concerns

Addressing worries of consumers who may have taken an FDC prescribed by a doctor only to be told now the combination is banned, a health ministry official familiar with the screening of FDCs told Business Line that an absurd FDC may be ineffective and not have the impact it promises.

Sometimes, FDCs may be useful, but need to be restricted in use. The unbridled prescription of such FDCs could be harmful, observes a doctor. For instance, gastro-intestinal FDC that combines ondansetron (used for chemotherapy-related vomiting) and omeprazole (an antacid). The drug has contra-indications in gastric-cancer patients, the doctor said, agreeing with the DCGI’s decision to reject this combination.

An FDC should combine medicines that are compatible and do not chemically negate each other’s effects, he said. Gastro-intestinal FDC Mebeverine (for irritable bowel syndrome — IBS) and anxiety drug Alprazolam may have a rationale, as gastro-enterologists feel IBS is related to anxiety, the doctor said. But the FDC has been banned.

Combining pain-killer paracetamol with anxiety drug alprazolam, however, is “non-sense”, the doctor says, agreeing with DCGI’s ban on the analgesic. Other rejected gastro-intestinal drugs include IBS drug dicyclomine with anti-ulcer drug ranitidine; drug dicyclomine with painkiller paracetamol and anxiety drug chlordiazepoxide.

These FDCs may have a rationale, but problems arise when the dosage of one of the medicines in the combination needs to be changed. This can be reviewed and changed if separate tablets were taken, observes the doctor.

Good FDCs

But combination drugs, as seen in the treatment of HIV/AIDS and tuberculosis, can be useful, the Health Ministry official said. It facilitates easy use, convenience, better tolerance and helps patients adhere to doctor’s instructions of taking medicines x-many times a day. Three-in-one HIV/AIDS pills reduce the patient’s pill-burden. The patient takes just two medicines a day instead of six.

But for consumers now trying to deciphering medicine labels, adding to their anxiety, the doctor suggests: Question your doctor if the medicine (combination or otherwise) is necessary, has side-effects and has a long-term impact.

Stay Order

The Confederation of Indian Pharmaceuticals Industry (CIPI) has got a stay order from the Madras High Court against the DCGI’s order in Puducherry. CIPI’s Mr T.S. Jaishankar told Business Line that companies had legally got their licences from the state regulatory authorities and some of the FDCs were in the market for over six years.

The CIPI was not against a review of FDCs, he clarified, but the screening needs to be done in a more scientific manner, he indicated. The industry is yet to get a copy of the HC directive.

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