Even as some half hearted efforts are on in the country to weed out irrational combination drugs from the market, experts in the medical field have called for a comprehensive review of all the combination drugs available in the country on the lines of the US FDA action way back in 1970.
Experts are of the view that the need of the hour is a thorough review of all the combination drugs in the country like the Drug Efficacy Study Implementation embarked upon by the US FDA in 1970. The study found that 50 per cent of drugs in the market then were combination drugs. Alarmingly, only 45 of 1200 combination drugs assessed then were rated effective.
With the fixed dose combinations ruling the domestic market in India, the experts feel that a comprehensive study is overdue to assess the efficacy of these FDCs, as was done in the United States long back.
"Even after 60 years, we could not do a comprehensive attempt to study the number of combination drugs and irrational drugs. There is no record with the state and the Centre authorities on the number of irrational FDCs," regretted Dr C D Tripathi, head of Pharmacology in Safdarjung Hospital and Vardman Mahavir Medical College in Delhi.
According to the estimates, about Rs 25,000 crore is spent by Indians to buy drugs a year and 50 per cent of the FDCs in the market are irrational. Thus on an average, an Indian family is spending Rs 1000 per year on irrational combination drugs, pointed out Dr Tripathi.
India has banned just 79 FDCs since 1983, and all of them were ordered to be taken out following similar bans in other countries. Of the total new drug approvals of 101 in 2006, as many as 36 were granted to combination drugs, according to the official statistics.
Out of the total 232 drugs approved during 2005, the number of combination drugs was 36. In 2004, 21 out of the total 89 approvals were for combination drugs. When two or more drugs are combined, the mixed medicine is deemed to be a new product and under Sec 122 (E) of the Drugs and Cosmetic Act, it should have approval from the DCGI.
Meanwhile, even though some efforts are on to weed out the irrational combination drugs from the market, a serious review of the entire spectrum of huge number of combination drugs in the market looks a distant possibility, thanks to the insufficient monitoring and regulatory mechanism.
The pathetic situation in India is that any combination drug is not put through a post marketing surveillance of medication. This requires at least 30,000 people to be treated with the drug and their data analysed to be sure that an adverse reaction with an incidence of one in 10,000 is not missed. But this does not happen in the country.
The authorities often blame it on the lack of data to take action against any combination drug and the lack of a proper mechanism with sufficient number of personnel is the major hurdle in the drive. Hence, the experts have called for a comprehensive study of all the combination drugs in the market.