Maiden Pharma seeks to reopen Sonipat plant after DCGI clearance

Haryana-based Maiden Pharmaceuticals, which was in the eye of the storm after cough syrups manufactured at its Sonipat plant were linked to child deaths in Gambia, is looking to reopen the facility once it gets final clearance from the national drug regulator.

The state’s Food and Drugs Administration (FDA) has written to the Drugs Controller General of India (DCGI), requesting him to form a joint committee with central and state officers to inspect the plant. “We had raised questions on GMP (good manufacturing practices) compliance and sent a notice to Maiden Pharma. The company has replied, claiming it has taken action,” Manmohan Taneja, senior drugs control officer at Haryana’s FDA, told Business Standard. Now an inspection needs to be carried out to ensure that the plant is GMP-compliant, he added.

The drug authorities shut production at the Sonipat factory on October 12 after news about the Gambia deaths surfaced, with the World Health Organization (WHO) linking the “unacceptable” levels of diethylene glycol and ethylene glycol in Maiden Pharma’s cough syrups to the tragedy.

However, the DCGI has now said the cough syrups in question were found not to be contaminated, and met with government standards. 

The drug regulator, V G Somani, in his recent letter to Rogério Gaspar, director of regulation and prequalification, WHO, said that the statement issued by the global agency in October was “amplified by global media”, which led to a narrative being built internationally targeting the quality of Indian pharma products.

Maiden Pharma Managing Director Naresh Kumar Goyal told Reuters that the company would now request the authorities to reopen its factory. “But I don’t know what will happen. We are still waiting,” he was quoted as saying.

Health ministry sources, however, indicated that there was no immediate plan to allow Maiden Pharma to reopen its plant. “Only the samples were found not contaminated. The factory was closed on the grounds of non-compliance with GMP. Both are different from each other,” said a government source.

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The Haryana FDA halted production at Maiden Pharma’s site on October 12. A joint inspection by the state FDA and the Central Drugs Standard Control Organisation (CDSCO) had found 12 violations of good manufacturing practices at the facility.

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

Experts feel that the WHO should be cautious before naming any company or country in such a matter, which is yet to be causally linked.

Gagandeep Kang, microbiologist and professor at Christian Medical College, Vellore, said: “Of course, caution in naming companies and countries is completely correct, but there should also be agreement on timely follow-up and investigation on the part of producing countries.”

Public health and policy expert Anish TS said, “It’s not good that one is blaming a country or a company for these kinds of false allegations. Without having proper evidence, there is no point in blaming countries or communities, and companies. It does long-lasting damage to the image of the country and the industry.”

“In countries like Gambia, or any Asian or African countries for that matter, the quality control systems are questionable,” he added.