Amid the concerns over the potential health risks of four cough syrups manufactured by Maiden Pharmaceutical Limited, the Union Health Ministry has clarified that the drugs have not been sold in India.
According to the ministry, the company only has a manufacturer and export licence for the four medicines in question - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
Maiden Pharmaceutical Ltd has only exported them to The Gambia so far.
However, the company has sold other drugs in countries across Africa, South America and South East Asia including Algeria, Senegal, Nigeria, Cameroon, Kenya Tanzania, Laos, Vietnam, Thailand, Cambodia, the Philippines, Malaysia, Indonesia, Ecuador, Chile, Venezuela, Surinam and Paraguay, besides others.
?It is also present in Russia, Poland and Belarus.
The company has two directors -- Naresh Kumar Goyal and Vivek Goyal - and two manufacturing plants, one based in Sonepat and the other in Panipat. Its corporate office is at Netaji Subhash Place, Pitampura, Delhi.
Following the WHO alert, the Central Drugs Standard Control Organisation (CDSCO), the Drug Controller General of India (DCGI) and the Haryana State Drugs Controller have collected samples of four cough syrups for testing.
The samples, taken from the same batch have been sent to a Kolkata-based lab and the result of the tests is expected in the next few days.
"The samples (controlled samples of the same batch manufactured by M/s. Maiden Pharmaceuticals Ltd for all the four drugs in question) have been taken and sent for testing to Regional Drug Testing Lab, Chandigarh, by the CDSCO, the results of which will guide further course of action as well as bring clarity on the inputs received, to be received from WHO," a Health Ministry statement said.
On September 29, days before it made the alert public, the WHO had informed DCGI, the National Drug Regulator of India about the links between 66 child deaths in Tha Gambia and the four cough syrups.
The Health Ministry, however, said that the exact one-to-one causal relation of death has not yet been provided by WHO to CDSCO.
The CDSCO has asked WHO to share the report on the establishment of "causal relation to death" with the four cough syrups.
While it is good news for India that the cough syrups have not been sold in India, Dinesh S Thakur, a public health activist pointed out that Maiden Pharmaceutical Ltd. has a questionable track record when it comes to product quality.
Thakur pointed out that it has been reported for substandard products several times and was blacklisted in Bihar in 2011.
The company was one of 39 companies blacklisted by Vietnam in 2014 for violation of Quality Control Regulation and Drug Regulation.
The controversy is bad news for the pharma industry of India, which prides itself as the pharmacy of the world.
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