Centre monitoring, taking updates from state regulatory agencies about Maiden Pharmaceuticals Ltd, its products
Oct 06, 2022
By Shalini Bhardwaj
New Delhi [India], October 6 : The Central government is continuously taking all the updates and monitoring State regulatory authorities under whose jurisdiction lies the drug manufacturing unit Maiden Pharmaceuticals Ltd whose products are under the World Health Organization's investigation.
"There is no supply of Maiden Pharmaceuticals Limited drugs in India, they only export their products. Still, if any guideline is issued by the Drugs Controller General of India we will follow those guidelines," said All India Organisation of Chemists and Druggists.
The drug regulators has collected the samples of cold and cough syrup from the manufacturing facility of Haryana-based Maiden Pharmaceutical in Sonipat, after WHO issued a medical alert and results are expected to come in the next two days.
According to Haryana Health Minister Anil Vij, "Central government officials are gathering complete information. The sample will be sent to Central Drug Lab in Kolkata. After reports come, stern action will be taken if anything wrong is found."
ANI team also visited at Maiden Pharmaceuticals Ltd's head office in Netaji Subhash Place in Pitampura in the national capital, but the office was locked and the company hasn't even responded to the e-mails.
"As per the tentative results received by WHO, out of the 23 samples tested, 4 samples have been found to contain Diethylene Glycol/Ethylene Glycol as indicated. It has also been informed by WHO that the certificate of analysis will be made available to WHO in the near future and WHO will share it with India. At the same time, the exact one-to-one causal relation of death has not yet been provided by WHO, nor have the details of Labels/ products been shared by WHO with CDSCO enabling it to confirm the identity/source of the manufacturing of the products," said official sources.
Dr Praveen Khilnani, Director of Pediatric Intensive Care and Senior Consultant, Pediatric Pulmonology and Critical Care, at Madhukar Rainbow Children's Hospital said that diethylene glycol is not illegal but it has a direct effect on kidneys and brain when consumed above a certain quantity.
"Diethylene glycol is not illegal. It is a preservative chemical to prolong the shelf life of medications and prevent decomposition in adverse temperate conditions and dissolves the components in cough syrup. It has a direct effect on kidneys and brain when consumed above a certain quantity (or in accidental overdose situations as it is part of anti-freeze and coolants for automobile industry and used as raw material in manufacture of polyester fibers) or excessive use of cough syrup which normally can cause side minor effects such as shakiness sedation, nausea dryness of throat but to my knowledge almost never resulted in any major mishap like kidney failure or brain injury in Indian cities," said Dr Khilnani.
Dr Dhiren Gupta, Senior Consultant of Sir Gangaram Hospital said, "Diethylene glycol contamination has occurred as it is used in medicinal products instead of a safer--but more expensive--diluent such as pharmaceutical grade glycerine. It is to make the product cheaper."
Dr Gupta further said that the time has come to focus on the quality of products produced by pharma companies as poor quality medicines not only harm the patients but can lead to mortality.
"This news gives a bad name to India and Indian pharmaceutical companies. We should introspect about our drug policies. Indian pharmaceutical market is cost driven industry and relies on quantity rather than quality. The time has come to focus on the quality of products produced by pharma companies. It will help domestic consumers also as now days government is focusing on generic medicines. Poor quality medicines not only harm the patients but can lead to mortality," he added.
WHO on Wednesday issued an alert over four India-made cough and cold syrups which are made by Maiden Pharmaceuticals in India. WHO has also notified that the same cough and cold syrups could be linked to the deaths of 66 children in Gambia.
