New Delhi: The central government has initiated a probe into whether contaminated batches of two cough and anti-allergy syrups manufactured by a Gujarat-based drugmaker were exported to other countries, ThePrint has learnt.
The Central Drugs Standard Control Organisation (CDSCO) in an alert issued in August said the concentration of Ethylene Glycol (EG) and Diethylene Glycol (DEG) in the two syrups manufactured by Ankleshwar-based Norris Pharma — Sylpro Plus and Trimax Expectorant — exceeded the acceptable limit. This was the first instance in recent years when the drug regulator issued a public alert on account of DEG and EG contamination in any drug.
Contamination of drugs with EG and DEG, beyond the acceptable limit, can be dangerous for humans and even fatal in some cases, especially in the case of children, according to the World Health Organization (WHO).
The CDSCO, based on random sampling of drugs as part of a nationwide quality assessment exercise, had declared a total of 48 drugs including the two syrups as not of standard quality (NSQ).
ThePrint reached Norris Pharma for comment via email but had not received a response by the time of publication. This report will be updated if and when a response is received.
A senior official in the CDSCO, however, told ThePrint Thursday, “Following the alerts, we investigated the case of Norris Pharma and it was found that the batches found contaminated were supplied in some states while the company also had tie-ups with a Mumbai-based exporter to export drugs outside India, to some African countries.”
The CDSCO in collaboration with other departments is trying to ascertain which countries received the contaminated drugs, he said, adding that “if necessary, batches in question may be recalled”. The Gujarat Food & Drugs Control Administration, on the other hand, said Norris Pharma’s factory in Ankleshwar has been closed pending further investigation.
ThePrint reached Drugs Controller General of India (DCGI) Rajeev Raghuvanshi via call but was told that he was unavailable for comment.
Also Read: Reporting faulty manufacture to annual audits: How govt wants drugmakers to improve quality
‘DEG or EG can be severely harmful’
The alert issued by CDSCO in August said Sylpro Plus syrup, which lists Cyproheptadine HCL and Tricholine Citrate as active pharmaceutical ingredients (APIs), was found to contain 0.243 percent DEG and 0.171 percent EG — as against the 0.1 percent WHO-prescribed limit for these solvents in any syrup.
Trimax Expectorant, the other cough syrup manufactured by Norris Pharma that made its way to the NSQ and lists Terbutaline Sulfate, Bromhexine HCL and Guaifenesin as APIs, was found to contain 0.11 percent EG but no amounts of DEG.
Dr H.G. Koshia, commissioner of the Gujarat Food & Drugs Control Administration, said a thorough assessment of the Norris Pharma manufacturing plant was carried out following claims of contamination in cough syrups manufactured by the drugmaker.
“We found gross violations of the GMP (Good Manufacturing Practices) norms and have ordered the plant shut till further orders,” he told ThePrint.
He added that quality testing of all dosage forms — syrups, tablets and capsules — is now being carried out, and emphasised that the percentage of NSQ drugs originating from Gujarat is now 2-3 percent, from about 10 percent found previously, about a decade ago.
A senior pharmacologist with a central government-run hospital in Delhi, meanwhile, said on condition of anonymity that cases of default contamination of liquid paediatric formulations with DEG have been reported in the past, mainly in low- and middle-income countries.
Glycerin or glycerol are organic solvents used in liquid oral medications such as paediatric cough syrups, paracetamol (anti-fever) suspension for children and sometimes in antibiotic syrups, he said.
He further explained, “However, manufacturers sometimes use DEG and EG, which are cheaper alternatives to glycerin, without appreciating the unacceptable risks involved…while glycerine is relatively safe for oral use, DEG or EG can be severely harmful.”
The case involving Norris Pharma came to light against the backdrop of at least five countries and the WHO flagging the supply of contaminated cough syrups by Indian drugmakers over the past year.
Last October, authorities in The Gambia alleged a link between cough syrups supplied by Haryana-based Maiden Pharmaceuticals and the deaths of at least 69 children. Two months later, authorities in Uzbekistan alleged that cough and fever syrups supplied by Noida-based Marion Biotech caused the deaths of at least 18 children. In August this year, WHO issued a medical alert saying three batches of cough syrup Cold Out, manufactured by Tamil Nadu-based drugmaker Fourrts — contained EG and DEG beyond permissible limits.
ThePrint reached Fourrts chairman S V Veeramani over phone for comment but had not received a response by the time of publication. This report will be updated if and when a response is received.
(Edited by Amrtansh Arora)
Also Read: ‘Does govt have the resources?’ Why pre-export testing of cough syrups may not plug all loopholes