A doctor in Mumbai did not prescribe regular cold medicine to a patient who went looking for cure for cold and cough.
The prescription was for a powerful antibiotic cocktail marketed in India by a unit of US pharmaceutical Abbott Laboratories. It is not approved for sale in major markets such as the US, UK, Germany, France, Japan and Australia. Medical experts say it doesn't make sense to prescribe the cocktail for cold symptoms. And a government-appointed panel in India recommended to the Health Ministry last year that it not be approved for sale here, citing lack of safety and efficacy data and a high potential for "misuse."
Under India's complex drug-approval regime, many pharmaceutical manufacturers have obtained permission from a single state to make new fixed-dose combination (FDC) drugs, like the Abbott one, and are selling them in other parts of the country without the approval of the central government.
India's top drug regulator is trying to shut down this avenue. "The first clearance of new drugs which anyone wants to market in India, that has to be given by the national regulatory authority," said GN Singh, the Drugs Controller General of India.
But inconsistent enforcement of the drug laws means that hundreds of FDC drugs are being sold in India without the approval of the central government. Policymakers have also now given pharmaceutical companies a chance to retroactively prove the safety and efficacy of these drugs, including the Abbott one.
Doctors and public health experts both in India and abroad say the proliferation and misuse of antibiotic combinations here may be contributing to antibiotic resistance, making India a potent incubator of so-called superbugs.
"Drug resistant strains spread globally," Ramanan Laxminarayan, Director of the Center for Disease Dynamics, Economics & Policy said. "They already have. It's very hard to regulate the movement of people."
Nearly half the drugs on the market in India last year were combinations. These include medications consisting of three different drugs apiece, doctors said. In the US, combinations made up 13.9% of drugs on the market, while in China the number was 14.4%, according to IMS Health. Last year, about 78% of combination drugs in India were sold by local firms, with multinationals making up the rest.
The manufacture and marketing of Zimnic AZ in India "is aligned with local regulations," said Varsha Chainani, Director of public affairs for Abbott in India. Chainani noted that more than 15 other companies in India are also manufacturing and marketing the same combination under different brand names.
"It would be inappropriate to comment in view of the pending evaluation," said Chainani, referring to the drug review currently being conducted by the Drugs Controller General of India. "Abbott will abide by the final outcome of the proceedings in this regard."
COMBINATION FEVER
Fixed-dose combination drugs like Zimnic AZ are used worldwide to improve patients' compliance in complicated courses of treatment for such conditions as HIV, tuberculosis and malaria. It's easier to get patients to take one drug than a number of different pills.
"FDCs are not bad," Sanjay Sikaria, Director of Suncare Formulations Private Ltd said. "Rampant misuse of these drugs is bad."
GN Singh, the Drugs Controller General, told Reuters that a government review of combination drugs currently under way would remove any irrational FDCs from the market. "Patient safety is of utmost importance to us," Singh said.
