After WHO alert on its cough syrups, Haryana firm asked to halt production, faces licence cancellation

The Haryana government has ordered the halting of drug manufacturing at the Sonipat unit of Maiden Pharmaceuticals, asking it to explain within a week "many contraventions" found during a recent inspection, or face suspension or cancellation of license.

The order to halt production came days after the World Health Organization (WHO) potentially linked four cough syrups manufactured at the facility to the deaths of 66 children in African nation of The Gambia.

After the WHO alert, samples of the four cough syrups manufactured by the firm was sent to the Central Drugs Laboratory in Kolkata on October 6 for examination.

Vij said a joint team of the state and the Centre inspected the unit during which it found 12 violations or deficiencies. "Taking cognisance of this, the state government has ordered to halt the drug production in this unit."

He further said the report of the cough syrup samples are yet to arrive from the Central Drugs Laboratory in Kolkata. "Depending on what it says, we will take further action," he said.

A show cause notice issued to the company says the firm could not produce a log book of equipment and instruments used to manufacture and test the drugs in question. 

Batch numbers of potentially dangerous chemicals which were acquired for the manufacture of cough syrups have not been mentioned.

The chemicals include Propylene Glycol, Sorbitol Solution, and Sodium Methyl Paraben. 

According to a notice issued by the Haryana Drugs Controller following the inspection of the firm's plant, Maiden Pharmaceuticals Limited did not perform quality testing of propylene glycol, the raw material used for making one of the formulations.

"The firm has not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol," said the notice.

The showcause notice issued on October 7 stated, "The inspection of your firm was conducted by a team comprising senior officials from CDSCO (Central Drugs Standard Control Organisation) and Haryana Drugs Controller Authority to conduct the necessary investigation for following drugs manufactured by you."

"During inspection many contraventions were detected. You are hereby served with the show cause notice rule 85(2) of drug rules, 1945 as to why your manufacturing license may not be suspended or cancelled," it said.

The state authority had asked the firm to respond within seven days, failing which it said ex-parte -- done with respect to or in the interests of one side only or of an interested outside party -- action will be taken against the company as per the drugs act.

Among the 12 "violations" highlighted by the state drugs regulator was that the batch number of propylene glycol, sorbitol solution and sodium methyl paraben used in the making of the drugs in question were not mentioned in the certificate of analysis report.

The firm has not performed process validation and analytical method validation for the drug products in question, according to the authority.

Besides, the complete plant is found under renovation and the firm failed to produce the log books of equipment and instruments regarding manufacturing and testing for the drugs in question, the notice read.

The batch number, manufacturer name and manufacturing date and expiry date were not found maintained on the purchase invoices of excipients including propylene glycol.