Leading medical experts have expressed shock and concern at the disappointing state of adverse drug monitoring system in the country causing sales of huge number of irrational combinations. They felt that uncontrolled greed of pharmaceutical companies is the main reason for flooding the market with such products.
The experts cautioned that all such products cannot be taken out of the market as many companies depend on them as their `bread and butter.' The companies would try to retain the same brand and change the combinations if the authorities ask them to withdraw an existing irrational drug combinations, they pointed out.
Terming it as a `social evil like dowry which cannot be eliminated,' Dr C D Tripathi, head of pharmacology at the Safdarjung Hospital and Vardhman Mahavir Medical College in Delhi, blamed it largely on the avarice of the pharmaceutical companies.
Calling for a strong ADR system, Dr Anoop Mishra, director of Fortis Hospital and a member of National Pharmacovigilance Advisory Committee, said there was no foolproof system in the country even after 60 years of Independence to check the menace.
While acknowledging that many of the FDCs were effective, Prof Umesh Kasra, Professor of Medicine at the Safdarjung Hospital, called for a careful approach by the clinical practitioners. The experts were speaking at a recent workshop on irrational combinations here organised by the Health Essayists and Authors League (HEAL).
``Nimesulide is combined with paracetamol so that a patient who requires just paracetamol, a relatively safe medicine, is made to consume a more dangerous drug like nimesulide which is banned in several countries. Similarly many antibiotics are available as FDCs and many of them are irrational,'' Dr Tripathi said.
Combination pills have now become the largest selling brands in the anti-pain, inflammation and fever category. As is evident, there is no synergism when two drugs acting on the same enzyme are combined, the experts felt.
The use of irrational combinations would increase the risk of side effects as they have not gone through the post-marketing trials besides, they being costlier. The selling of irrational FDCs would promote the culture of self-medication, they said.
"It is like a miss and hit therapy. Alarmingly there is not proper register with the States or with the Centre about the number of FDCs in the market. So far no effort was taken up to study on them,'' Dr Tripathi said.
Type B side effects and bizarre reactions that cannot be predicted from the pharmacology of the drug molecules can only be detected by post marketing surveillance of the medication. This requires at least 30,000 people to be treated with the drug to be sure that an adverse reaction with incidence of one in 10,000 is not missed. But that is not being done in the country, Dr Anoop Mishra said.