Drug Regulator Halts Production At Maiden Pharma's Sonipat Unit

India’s national drug regulator and Haryana’s drug controller on Wednesday stopped all manufacturing activities at the Sonipat plant of Maiden Pharmaceuticals — the company at the centre of the contaminated cough syrup controversy.

Meanwhile, as the scare of “killer” cough syrups spread, the state food and drug commissioners have jumped into action and are testing samples from across brands to identify any contamination.

Sources in the Union health ministry confirmed that the Central Drugs Standard Control Organisation (CDSCO) and the state drug controller of Haryana have halted manufacturing at the Maiden Pharmaceuticals plant on grounds of deficiencies found in local inspection.

Maiden Pharma is under fire after the World Health Organization (WHO) last week raised red flags connecting cough syrups produced at Sonipat to the deaths of 66 children in Gambia. A team comprising Rakesh Dahiya, senior drugs control officer, Sonipat, and Sandeep Kumar and Devender Pratap Singh — drug inspectors from the CDSCO zonal office in Ghaziabad — inspected Maiden Pharma’s facilities on October 1 and 3.

The state drugs controller-cum-licensing authority based in Panchkula, Haryana, issued a show-cause notice on October 7 under Rule 85(2) of the Drugs and Cosmetic Rules, 1945, asking the firm why its manufacturing licence may not be suspended or cancelled. The company was asked to respond within seven days, failing which action would be initiated. There are two more days to go before the state licensing authority can decide to cancel or suspend the manufacturing licence altogether.

During inspection, the authorities found that batch numbers, expiry and manufacturing dates, and the name of manufacturer were missing from the invoices of propylene glycol, an ingredient used in cough syrups. The drug authorities noted that Maiden Pharma has not done quality testing of propylene glycol. The firm failed to produce the log books of equipment and instruments regarding manufacturing and testing for the drugs in question.

Centre forms expert panel to advise CDSCO

The Centre has also formed a committee to examine and analyse the adverse event reports, causal relationship and all related details shared by WHO. Government officials indicated that the panel — comprising Y K Gupta, vice-chairperson, Standing National Committee on Medicines, Pragya D Yadav, scientist, ICMR-National Institute of Virology, Pune, Arti Bahl, division of epidemiology, National Centre for Disease Control, New Delhi, and A K Pradhan, joint drugs controller, CDSCO — would recommend the future course of action to the CDSCO.

A government official revealed WHO had said that out of the 23 samples of products under scanner and which were tested, four were found to contain diethylene glycol and ethylene glycol. “WHO has not yet made available a certificate of analysis.

It has informed that it will be made available in the near future,” the official said, adding that the exact one-to-one causal relation of death has not yet been provided by the global body to CDSCO although the latter had requested it twice.

State FDAs jump into action

In the face of a growing scare of contaminated cough syrups, state FDAs have started random sampling of the medicines to detect any poisonous or contaminating element. The four cough syrups from Maiden Pharma were licensed only for exports, and not sold in India.

A K Jain, deputy drug controller of Uttar Pradesh, told <Business Standard> that the authority had instructed all field officers in the state to collect samples of cough syrups that contain glycerin or propylene glycol, the contamination of which leads to diethylene glycol and ethylene glycol poisoning. “We are also checking if there has been any pilferage of Maiden Pharma cough syrups in the Indian market, just to be doubly sure,” Jain said.

Southern states, too, stepped up their action.

“We have directed to stop the sale of all the products of Maiden Pharmaceuticals. As a precautionary measure, this has been followed. The reason for the measure is the deaths in Gambia,” said Sujith Kumar K, deputy drug controller of Kerala.

“All our supplies are through the Kerala Medical Services Corporation. Sale of whatever stock is left in the depots and other places has been stopped. We will sample the stocks and when the results are known, we will take action depending on that,” Kumar added.

Prescription drugs used to treat type-2 diabetes and over-the-counter painkillers manufactured by the company were detected as sub-standard during lab tests on at least five occasions in the last nine months. This included samples of tablets including a gastro-resistant aspirin, a calcium tablet and another for treatment of diabetes.

On the other hand, Deepak Jacob, managing director of the Tamil Nadu Medical Services Corporation, said that the state had no contracts with Maiden Pharmaceuticals.

Violations by Maiden Pharma

· Inspections found batch numbers, expiry/manufacturing dates, name of manufacturer missing from invoices of propylene glycol, an ingredient used in cough syrups

· Drug authorities said that Maiden Pharma has not carried out quality testing of propylene glycol

· The firm failed to produce the log books of equipment and instruments regarding manufacturing and testing for the drugs in question

· It had not done process validation and analytical validation for the drug products of its four cough syrups

· Issues with stability study of the four cough syrups. Inspecting team did not find the cough syrups charged/monitored in stability chambers

· However, the firm had submitted accelerated stability study data when seeking marketing authorisation (an indication of data being fudged)