With a rising number of allegations against made in India cough syrups in various countries, the government has imposed new conditions for export with effect from June 1. However, there is no change in free export status.

“The export of ‘cough syrup’ under ITC (HS) Codes falling under the Heading 3004 shall be permitted subject to the export sample being tested and production of Certificate of Analysis (CoA) issued by any of the laboratories with effect from June 1, 2023,” said a notification issued by Directorate General of Foreign Trade.

The CoA should be issued by either Indian Pharmacopoeia Commission (Ghaziabad), CDL (Kolkata), CDTL (Chennai), CDTL (Mumbai), CDTL (Hyderabad) RDTL (Chandigarh) or by RDTL, (Guwahati).

Testing can also be done by any NABL-accredited State Drugs Testing Laboratory.

What do the ‘alerts’ say?

This development has taken place after the World Health Organization (WHO), last month, issued another alert for an India-manufactured contaminated cough syrup sold in the Marshall Islands and Micronesia.

This is the third such alert within seven months for contaminated cough syrups produced in India, with the previous cases having been identified in the Gambia and Uzbekistan.

The alert asks people to not use the syrup and regulators to increase surveillance of supply chains. It also asks manufacturers to test raw materials used in syrups such as propylene glycol, sorbitol, and glycerine/glycerol before using them in a medical formulation.

Earlier cases

In January, WHO issued a warning against the use of two India-made cough syrups linked to the deaths of at least 20 children in Uzbekistan.

Authorities said that the alert referred to two substandard (contaminated) products, identified in Uzbekistan and reported to WHO on December 22, 2022.

Substandard medical products are products that fail to meet quality standards or specifications and are therefore “out of specification”.

In October last year, WHO issued an alert on four substandard products, identified in Gambia and reported in September 2022.

The alert said that the four products are Promethazine Oral Solution, Kofexmalin Baby Cough SyrupMakoff Baby Cough Syrup, and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India).