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India prohibits 328 fixed-drug combination pharmaceutical products

Court allows continued sales of existing stock

by K. V. Venkatasubramanian, special to C&EN
September 23, 2018 | A version of this story appeared in Volume 96, Issue 38


India prohibited the manufacture, sale, or distribution of 328 pharmaceutical products containing combinations of drugs earlier this month. The Delhi High Court has now allowed sale and distribution of existing stock while the ban is challenged.

The government had banned the products in a notification issued Sept. 12, saying that they did not serve any therapeutic purpose. In a report issued in May, the country’s Drugs Technical Advisory Board called the combinations “irrational” and said they should be prohibited for posing risks to health.

Several combination product manufacturers are fighting the ban in court. They include Piramal Enterprises, which combines acetaminophen, propyphenazone, and caffeine into Saridon for headaches; Juggat Pharma, which markets the same combination as Dart for pain; and GlaxoSmithKline, which combines chlorpheniramine and dextromethorphan into Piriton for coughing.

The government already tried to ban many of these combinations in 2016. At that time, India’s Supreme Court asked the Drugs Technical Advisory Board to review the products and their justifications for use.

The All India Drug Action Network applauded the Drugs Technical Advisory Board’s conclusions. “It reinforces our constant demand for approval, and use, of only rational medicines in India,” the group, which advocates for equitable access to health care and medicines, said in a July statement. “Rationality needs to be demonstrated by safety, efficacy and therapeutic justification.”

The next hearing by the Delhi High Court is scheduled for Sept. 27.


Because of an editing error, this story initially misidentified the courts involved in the case. It was corrected on Sept. 24, 2018.


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