Health Minister attributes lack of inspections to the recent deaths linked to contaminated cough syrup.
Tamil Nadu’s Health Minister, Ma Subramanian, recently asserted that the Central Drugs Standard Control Organisation (CDSCO) had not conducted any inspections in the state for six years. This statement comes in the wake of a tragic incident where 22 children died after consuming a cough syrup named Coldrif, which was manufactured by Sresan Pharmaceutical Manufacturer in Kanchipuram.
The deaths of these children, who had been suffering from common illnesses like fever and cold, raised significant concerns about the quality of the syrup. Reports indicated that after consumption, the children exhibited symptoms such as vomiting and difficulty in urinating. The first death occurred on September 2, and similar cases were noted in other states, including Rajasthan.
Subramanian highlighted that it is mandatory for drug inspectors to perform annual inspections of all drug manufacturing units. In response to the deaths, he mentioned that two state drug inspectors had been suspended due to their failure to conduct necessary quality checks on the drugs produced by Sresan Pharmaceutical. He further emphasized that central drug inspectors are supposed to inspect manufacturing facilities across the country every three years, yet no inspections had taken place in Tamil Nadu during the past six years.
The minister expressed frustration over the situation, questioning where the blame should be placed given the lack of inspections from the central authority. The alarming reports of child fatalities prompted immediate action, and the Tamil Nadu Drugs Control Department initiated inspections following information received from Madhya Pradesh about potential contamination of the cough syrup.
Tests conducted by the state revealed the presence of diethylene glycol in the syrup, a harmful chemical known for its potential health risks. This prompted a swift response from authorities, leading to an order to halt production of the syrup on October 3 and the issuance of a show-cause notice to the manufacturer. Notably, the permissible limit for diethylene glycol as an impurity is only 0.1%, and its presence in any amount poses significant safety concerns.
Despite the allegations against the Tamil Nadu government regarding the inspection shortfalls, Subramanian pointed out that the All India Anna Dravida Munnetra Kazhagam (AIADMK), which was in power at the time, should address these issues. He also mentioned that the state’s drug inspectors are required to conduct periodic inspections at all pharmaceutical manufacturing units and that meetings are ongoing to ensure compliance.
The recent events have led to further scrutiny, with Madhya Pradesh Chief Minister Mohan Yadav accusing the Tamil Nadu government of not cooperating with the investigation into the child fatalities. Subramanian countered this assertion, stating that the arrest of the pharmaceutical company’s owner was made possible due to the state’s proactive measures in identifying contamination.
On October 2, inspections revealed that samples of Coldrif were substandard, and a subsequent analysis confirmed dangerously high levels of diethylene glycol. As a precautionary measure, the Delhi government has now banned the sale and distribution of the syrup, advising the public against its use due to health risks. The formulation has already faced bans in several other states, including Tamil Nadu, Madhya Pradesh, and Kerala, among others.
