© Reuters. FILE PHOTO: Ebrima Sagnia prays at the graveside of his 3-year-old son Lamin in Old Yundum, Gambia, November 1, 2022. Lamin died of Acute Kidney Injury in September 2022. To match Special Report HEALTH-COUGHSYRUP/ REUTERS/Edward McAllister
NEW DELHI (Reuters) -India will make tests mandatory for cough syrups before they are exported, a government notice showed on Tuesday, after Indian-made cough syrups were linked to the deaths of dozens of children in Gambia and Uzbekistan.
Any cough syrup must have a certificate of analysis issued by a government laboratory before it is exported, effective June 1, the government said in a notice dated May 22 and shared by the health ministry on Tuesday.
India’s $41 billion pharmaceutical industry is one of the biggest in the world but its reputation was shaken after the World Health Organization (WHO) found toxins in cough syrups made by three Indian companies.
Syrups made by two of these companies were linked to the deaths of 70 children in Gambia and 19 in Uzbekistan last year.
“Cough syrup shall be permitted to be exported subject to the export sample being tested and production of certificate of analysis,” said the notice issued by the trade ministry.
The health ministry did not immediately respond to a query on whether testing would be required for cough syrups sold in the domestic market.
The notice identified seven federal government laboratories where samples could be sent for testing, in addition to other state laboratories certified by a national accreditation body.
Indian tests of cough syrups made by Maiden Pharmaceuticals Ltd, linked to the deaths of children in Gambia, found no toxins but contaminants were detected in many drugs made by Marion Biotech, whose syrups were linked to deaths in Uzbekistan.
Reuters reported last week that India was considering a change to its pharmaceutical industry policy, including increased testing of cough syrups as well as of raw materials for drugs. The companies deny any wrongdoing.
The health minister and federal and state regulators also held a brainstorming session in the southern city of Hyderabad earlier this year “to find a solution to exported cough syrups that killed children,” a document from the prime minister’s office dated May 15 showed.
India has recently made it compulsory for exporters of cough syrup to conduct stringent tests prior to overseas shipment. This decision was taken after the deaths of six people in Jordan, who reportedly overdosed on the cough syrup made in India.
The Indian government has announced that each batch of the cough syrup intended for export will be tested and certified at accredited laboratories. This will guarantee that the products sold in foreign countries adhere to the safety standards and standards of quality set by the Indian Drug Regulatory Authority (DRA).
The mandatory tests will initially cover the finished formulations, with the authorities determining if the syrup contains any toxic substances, before certification. Also, the identity tests will be conducted to guarantee that the batch of drug complies with the formula specified for the particular drug. In addition, tests will be conducted for the label claims, which means that the amount of the active ingredient in the formulation needs to meet the claim.
The overdose attributed to a cough syrup manufactured in India has led to trade sanctions and posed a question mark over the safety and quality of Indian drugs. The series of tests being made compulsory for cough syrup exporters will not only raise the standards of the manufacturing process, but will also reassure foreign customers about the safety and efficacy of the products.
It is expected that the stringency of tests, along with the threat of prosecution, will lead to improved standard of medicines released, both for domestic and global use.