Stringent testing protocols in place for export of Indian cough syrup samples

22 December 2023 | News

Mandatory for all cough syrup manufacturing companies to submit samples of each batch for testing before exporting

image credit- shutterstock

image credit- shutterstock

In a proactive measure to ensure the safety and efficacy of Indian cough syrup meant for export, 445 batches of cough syrup samples from various manufacturers across India have been dispatched to multiple laboratories nationwide for rigorous testing.

The Central Drugs Standard Control Organization (CDSCO) disclosed that, as of December 20, 2023, drug testing laboratories in India have received a total of 445 batches of cough syrup samples. These samples will undergo thorough testing, scrutinizing parameters such as toxicity, efficacy, and safety. Only after clearing these stringent tests and obtaining safety certification will the respective manufacturing companies be authorized to export their cough syrup globally.

The decision to intensify testing procedures comes in the wake of a recent incident in Gambia, Africa, where infants experienced adverse effects, leading to fatalities after the administration of Indian cough syrup. This unfortunate incident drew global attention, prompting concerns about the reputation of the Indian pharmaceutical industry. The World Health Organization even issued alerts and blacklisted certain pharmaceutical companies.

In response to these challenges, the CDSCO has amended its standard regulations. It is now mandatory for all cough syrup manufacturing companies to submit samples of each batch for testing before exporting to global markets.

As part of this initiative, 83 batches from Maharashtra are being tested at the Central Drug Testing Laboratory (CDTL) in Mumbai, 12 batches at CDTL Hyderabad, 57 batches at the Regional Drug Testing Lab in Chandigarh, and 132 batches at IPC Ghaziabad. Additionally, 67 batches have been sent to various state laboratories, including Food and Drug Lab Gujarat, Jammu, Kerala, and Bhopal. The remaining 97 batches are undergoing testing at private drug testing facilities.

Only after receiving clearance from these laboratories will the concerned manufacturers obtain approval for exporting the cough syrup to the global market, ensuring a heightened level of scrutiny and safety in the pharmaceutical export process.


Amguth Raju


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