Since 1961, India’s drug controller has approved more than 1,200 combination drugs, according to a list published on the website of the Health Ministry’s Central Drugs Standard Control Organization (CDSCO), the national drug regulatory body. But many have also been licensed on the state level without the approval of the central government.
It wasn’t until 1988 that the definition of a “new drug” under Indian law was amended to expressly include the combination of two or more already approved drugs.
Peter Roderick, a lawyer and research fellow at Queen Mary University of London, said “it’s been clear since 1961 that if it’s a new drug, it needs central approval.” Roderick co-authored a Public Library of Science study on fixed-dose combination drugs in India that was published in May this year.
A drug regulatory official said the law has been clear since 2002. That year, an amendment to the statute explicitly stated that to make a new drug, a company required prior written approval of the central government in support of a state license application. Some pharmaceutical makers maintain the requirement wasn’t clear until 2012.
In 2007, the government tried and failed to get close to 300 state-licensed combination drugs withdrawn.
“Indian companies mastered the art of combinations,” said D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, a lobbying group for large pharmaceutical companies. “Certain excesses have taken place.”
In 2012, the government undertook another attempt to exert control over the FDC market. That followed a parliamentary report critical of the functioning of the CDSCO. The report also underlined the health risks posed by unapproved combinations.
“Many FDCs in the market have not been tested for efficacy and safety,” the committee reported.
On the threat of antibiotic resistance, the committee said that unauthorized FDCs “that pose risk to patients and communities…need to be withdrawn immediately due to danger of developing resistance that affects the entire population.”
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.