Drug regulatory body seeks lists of cough syrup manufacturers from states, to launch joint audits

In the wake of deaths due to contaminated cough syrups, the Central Drugs Standard Control Organisation (CDSCO) has asked all state governments to submit a list of cough syrup manufacturers, following which the regulatory authority will conduct a joint audit of all the firms.

The government officials said that Tamil Nadu-based Sresan Pharmaceuticals, which manufactures Coldrif cough syrup that contained toxic components, was issued a manufacturing licence by the state government in 2011. The license was renewed in 2016. However, Central authorities were not in the loop.

“The firm was not in the Centre’s radar. It is a small firm. The state audit has itself made 364 critical observations in which 38 were critical. Now state governments’ have been asked to submit a list of cough syrup,” an official said.

Nineteen samples of cough syrups were examined, of which 13 were done by the Madhya Pradesh government and six by CDSCO.

“We analysed six samples, of which all were found clean; 13 were analysed by the state government, of which initially three did not have any toxins,” official said.

The sample of Coldrif that Tamil Nadu tested showed 48.6 per cent diethylene glycol (DEG).

“Once the Madhya Pradesh government learned that Coldrif was the largest consumed cough syrup and since the manufacturing firm was located in Tamil Nadu, the state government was requested to test. They conducted the site inspections,” an official said.

CDSCO had asked the Tamil Nadu government to initiate criminal proceedings against the Sresan firm.

CDSCO has informed the World Health Organisation (WHO) that DEG has been detected in at least three cough syrup medicines. However, none of the contaminated cough syrups that led to the deaths of children were exported from India to other countries, CDSCO told WHO.

Police on Thursday arrested S Ranganathan, owner of Sresan Pharmaceutical. Over 20 children have died after consuming the cough syrup.

In Rajasthan, officials said that children have died due to acute encephalitis syndrome and not due to the cough syrup.

CDSCO will also come up with a slew of regulations in a week so that no death occurs owing to the cough syrup. Officials said that no state so far has fully complied with the Corrective and Preventive Action (CAPA), guidelines which were introduced for ensuring safety standards in pharmaceutical products.

“So far, 18 state drug control authorities have onboarded the Online National Drugs Licensing System (ONDLS), which is aimed at streamlining drug licensing and regulatory compliance. More will come. After this, firms like Sresan Pharmaceuticals, which escaped Centre’s radar will be caught if its licence gets renewed,” sources said.

ONDLS is a digital, single-window platform for processing various drug-related licences in India.