After issuing a medical alert for an India-manufactured cough syrup being contaminated, the World Health Organization (WHO) has said that it acted on information and photographs of packaging received from Australian regulator Therapeutic Goods Administration and the impacted countries — Marshall Islands and Micronesia. With the Punjab-based manufacturer stating that it did not sell syrups to the West Pacific nations, WHO, in an email to The Indian Express, stated that the alert was issued only to “ensure countries are aware and to protect their populations.” Asked whether the agency ascertained that the products were genuine, the WHO spokesperson said, “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 actualities of this case.” The agency said it was still gathering information from the Australian regulator on the number of samples collected from the two countries and the number found to have unacceptable quantity of the contaminant di-ethylene glycol and ethylene glycol. The WHO said it is awaiting information on any adverse events or deaths potentially linked to the syrups from the impacted countries. “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 agency said the Indian regulator — Central Drugs Standard Control Organisation (CDSCO) — was alerted on April 14 and 24. The WHO said it reached out to the manufacturer and stated marketer on April 12 and “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 the query should not have reached his company had all documents been inspected properly. “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?” Pathak had previously said that the contamination could have been a result of Cambodian buyers diluting it with other solvents, or someone selling spurious drugs under his firm’s name.
