Central and state drug regulators have initiated the process of assessing the quality of commercially available cough syrups sold in India after the World Health Organization issued a medical product alert for four such India-made medicines in connection with children’s deaths in The Gambia.
The Central Drug Standard Control Organisation zonal office in Hyderabad, in a letter marked top priority, has asked cough syrup manufacturers to test samples of the raw materials used in their medicines. They were asked to provide the CDSCO with the method of analysis and the specifications of diphenhydramine hydrochloride, ammonium chloride, sodium citrate and menthol – medicines used to relieve cough – in their products.
The drug inspector urged the manufacturers to treat the matter as most urgent.
Also read: Haryana regulator raises red flag over glaring lapses at Maiden Pharma plant
Asked if the Drug Controller General of India has called for samples of commercially available cough syrups to be tested across the country, a senior CDSCO official in the Delhi office said drug controller general VG Somani told state drug regulators in a letter on October 10 to follow the Indian Pharmacopoeia Reference Standards for testing the quality of drugs.
The standards set by the Indian Pharmacopoeia Commission pertain to the identity, purity and strength of drugs that are imported, manufactured for sale, stocked or exhibited for sale or distributed in India.
Presence of contaminants
The Centre said that the four cough syrups made by Maiden Pharmaceuticals, based in Sonipat, Haryana, that were allegedly responsible for the deaths in The Gambia were manufactured once and meant only for export. The medicines were identified as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
According to the WHO, lab analysis of each of these products confirmed that they contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. Consumption of these ingredients beyond a limit can cause symptoms including acute kidney failure and may be fatal, especially for children with low body weight.
Also read: Indian pharma company under fire for Gambia child deaths has a history of selling substandard drugs
Still, several state drug controllers have ordered samples of cough syrups sold in the market to be tested to ensure that the raw materials used comply with the prescribed standards.
The Karnataka drug regulator asked pharma companies to analyse samples of glycerin and propylene glycol that they use. It asked them to submit the certificate of analysis of glycerin and propylene glycol procured in the past one year within seven days.
“The state government has directed all manufacturing units to procure solvents like glycerin and propylene glycol complying with pharmacopoeial standards,” the Karnataka regulator said in a circular.
According to an official of the Maharashtra Food and Drug Administration, the state drug regulator has directed sample checks of all oral liquid solutions in light of the deaths in The Gambia.
“The drug inspectors are directed to collect samples and test if any of the samples have unacceptable amounts of diethylene glycol and ethylene glycol,” the official said. Maharashtra has 1,000 pharmaceutical units, of which 20-25 percent are oral liquid manufacturers.
Also read: Kerala halts sale of drugs made by Maiden Pharma under fire for children's death in Gambia
The drug controller of Uttar Pradesh issued an alert to see if there has been “any pilferage of Maiden Pharma cough syrups” in the state.
“We have sounded an alert to all officials on ground to look for the products by Maiden Pharma. The field staff has been told to collect samples of cough syrups that contain glycerin or propylene glycol,” AK Jain, deputy drug controller of Uttar Pradesh, told Moneycontrol.
Tamil Nadu, Kerala
The drug regulator in Tamil Nadu too has ordered the collection of samples of cough syrups and paracetamol to check for contamination with propylene glycol, which causes diethylene glycol and ethylene glycol poisoning.
“We have ordered samples to be drawn from different places in the state for the analysis of raw material which was found in the four cough syrups sold in The Gambia,” director of the Tamil Nadu Drugs Control Department PV Vijayalakshmi told Moneycontrol. She said no drug manufactured by Maiden Pharmaceuticals has been supplied to the state.
In Kerala, the drug regulator has halted the sale of Maiden Pharma’s products and the government is carrying out raw material analysis.
“Drug inspectors in Kerala have been instructed to draw samples from across the districts and send them for quality tests. Only after the government labs confirm the quality of the available drugs will the company be permitted to continue sales,” Kerala state drug controller PM Jayan told Moneycontrol.
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