WHO issues alert on India-made syrup; says acted on info to make nations ‘aware’

New Delhi: The World Health Organisation (WHO) has stated that it acted on information and pictures of packaging it received from the Australian regulator Therapeutic Goods Administration and the affected countries, Marshall Islands and Micronesia, after issuing a medical alert regarding a cough syrup manufactured in India that is contaminated.

The WHO said in an email that the alert was only made to "ensure countries are aware and to protect their populations," despite the producer from Punjab claiming that it did not export syrups to the West Pacific countries, Indian Express reported.

When asked if the agency had verified the products' authenticity, the WHO spokesman responded, “In cases such as these, it can be possible for a third party to distribute to other countries. Our investigation is ongoing… I can’t speculate on the actualities of this case.”

The organisation stated that it was still obtaining data from the Australian authority regarding the number of samples taken from the two nations and the number of them that were found to contain an unacceptable level of the contaminants di-ethylene glycol and ethylene glycol. The WHO stated that it is awaiting details on any negative incidents or fatalities that may be related to the syrups from the affected nations.

“The products were sampled during planned market surveillance campaigns and analyzed by Therapeutic Goods Administration…. WHO cautiously issues Medical Product Alerts only after due diligence and receiving actionable information from those impacted,” the spokesperson stated. “In this case, WHO received information and photographs of packaging from Therapeutic Goods Administration and the impacted countries.”

The Central Drugs Standard Control Organisation (CDSCO), an Indian regulatory body, was informed on April 14 and April 24, according to the agency. On April 12, the WHO claimed to have contacted the manufacturer and stated marketer; "we await information from them."

Sudhir Pathak, MD of Punjab-based QP PharmaChem, said, “We have received no mails from WHO. How can we ignore any mail from them? We export drugs to many countries. I came to know of the issue only when CDSCO and state drug control officers came to our factory.”

He said that if all records had been thoroughly examined, the inquiry should not have reached his company. “We had sold the drugs for use in Cambodia. How did it reach Marshall Islands and Micronesia, and where were the samples picked up from? Ideally, in an investigation like this the regulator should ask the retailer where they got the medicine from, then reach out to the wholesaler and check who they imported [the medicine] from. Had this process been followed, they would have known that our company did not sell the drug.”

Pathak said, “When we export drugs, we send the permission granted to us in India, our own Certificate of Analysis, and testing done by a third-party lab along with the products. Without these documents, the customs of no country would let our products enter. So how did it enter these markets?”