India's Central, State Drug Regulators Need To Work Together: WHO Chief Scientist On Gambia Deaths

To remain a leader in generic medicines and vaccines space, India must prove that 'we have a very strong regulatory system', WHO Chief Scientist Dr Soumya Swaminathan said.

Dr Soumya Swaminathan, Chief Scientist at the World Health Organization (WHO), has said the death of 66 children in Gambia, reportedly after consumption of four Indian-made cough syrups, is a serious issue. She said the drug regulators working separately at central and state levels should harmonise their operations, according to a PTI report.

Swaminathan was in Pune Thursday to attend the annual general meeting of the Developing Countries Vaccine Manufacturers Network (DCVMN). Speaking about the WHO report that linked the death of 66 children in Gambia to the Indian-made cough syrups, she said on the sidelines of the meeting: "Certainly, the government is in touch with WHO as WHO actually provided the report based on the investigation which was done to prove that it was because of the diethylene glycol contamination. It is a very serious issue and it has to be taken very seriously."

In India, she was quoted as saying, there are central as well as state-level drug regulators, and that there is a need to harmonise their operations.

“There are no mechanisms where regulators of different states can actually work together, do the inspections on each other's products," Swaminathan said, as per the PTI report.

She said India is a leader in the generic medicines and vaccines space, and it is important for the country to prove that "we have a very strong regulatory system".

Cough Syrup Contents Toxic To Humans, WHO Had Said

WHO had earlier this month issued a medical product alert after the 66 deaths in the Gambia.

In its report, the health agency announced that cough syrups made by Sonipat-based Maiden Pharmaceuticals Limited in Haryana contained diethylene glycol and ethylene glycol that are toxic to humans. 

"Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants," WHO said in the alert.

The cough and cold syrups were Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

The Union Ministry of Health Affairs had later said samples of the same batch manufactured by Maiden Pharmaceuticals for all four drugs were sent for laboratory testing, and that the results would "guide further course of action as well as bring clarity on the inputs received/to be received from WHO".

The ministry also said the products were only for exports, and not sold in India. “These 04 drugs are not licensed for manufacture and sale in India. In effect, none of these four drugs is sold domestically,” the statement read.