Single-dose drugs are getting increasingly hard to find in India as drugmakers bypass the national government and get a state regulator to approve their fixed-dosage combinations (FDCs), many considered by experts to be "irrational" and dangerous if they combine antibiotics.
With just one state's approval, drugs are marketed throughout the country, often for a wide variety of indications, all without the central government's approval. Many FDCs are antibiotic cocktails that have earned India the sobriquet of "incubator of superbugs," bacteria that have evolved resistance to just about all the world's antibiotics.
An in-depth report by Reuters traced the life of Zimnic AZ, Abbott ($ABT) India's combination of two antibiotics, cefixime and azithromycin, which the news service said is being prescribed for more than a dozen indications, including the common cold. Each API alone is toxic with side effects and putting them together in one pill doubles their toxicity, reporters were told.
India's health ministry and agencies responsible for regulating pharmaceuticals have attempted for years to stop the practice of marketing FDCs without approval by the central government but so far have been unsuccessful. In India, each state has its own drug regulator and they don't always follow the same approval process.
Abbott's Zimnic AZ, manufactured by Indian drugmaker Akums Drugs & Pharmaceuticals in the state of Uttarakhand, has competitors that use the same combination even though they fight the same bacteria. Neither company responded to queries about the drug, but an Abbott India spokesperson said it "is aligned with local regulations."
|Drug Controller General of India G.N. Singh|
The Drug Controller General of India (DCGI) has refused to approve the cefixime-azithromycin combination, saying the combination was not appropriate. No other of the world's major drug markets has approved the combination.
Still, the regulator is reviewing the drug as part of a process to have FDC makers with only a state's approval get national approval. Since it has been unable to shut down the process of getting state approvals before national in order to get FDCs on the market more quickly, the DCGI has invited companies to submit those drugs for review.
One official said more than 3,000 different brands of FDCs are under review at the national level. That is in addition to the 6,200 it has already reviewed this year, as many as 20% of them considered "irrational." Only 40% of the total received approval, for that and other reasons.
Some industry defenders of the practice said a state approval process was just as good as the national one, and the national one takes longer. And, they said, physicians in India like combinations because it is easier to get patients to take one medicine than several.
India, where 70% of drug sales are for FDCs, has also been criticized for failing to collect data on drug reactions. Last year, it contributed only 37,800 suspected cases of adverse reactions to the World Health Organization databank, compared with 785,000 cases in the U.S. and 214,000 in China, which, as does India, has more than a billion people.
Multinational drugmakers produce only 22% of India's FDCs. The other 78% are sold by local drugmakers.
As for Abbott India, more than a third of its total sales of $1 billion last year came from FDC sales, according to IMS Health.
- here's the story from Reuters