In a major policy shift, the Union government has decided to enforce mandatory testing for Indian-made cough syrups before exporting them.
The decision comes after some of these syrups were linked to the deaths of numerous children in The Gambia and Uzbekistan.
According to a notification issued on Monday, 22 May, any cough syrup intended for export must possess a certificate of analysis issued by a government laboratory. This requirement will come into effect from 1 June.
The Ministry of Commerce and Industry issued the notification, stating, “Cough syrup shall be permitted to be exported subject to the export sample being tested and production of a certificate of analysis.”
India, known as the largest exporter of generic medicines, suffered a blow to its reputation when the World Health Organisation (WHO) found toxins in cough syrups manufactured by three Indian companies.
Deaths of children
The syrups manufactured by two of these companies were held responsible for the deaths of 70 children in The Gambia and 19 children in Uzbekistan last year.
It is yet to be determined whether testing will also be mandatory for cough syrups sold in the domestic market. No notification has been issued in this regard.
The notification identified six government-run laboratories for testing purposes: Central Drugs Laboratory (CDL) in Kolkata, Central Drug Testing Laboratories (CDTL) in Chennai, Mumbai, and Hyderabad, and Regional Drug Testing Laboratories (RDTL) in Chandigarh and Guwahati.
Additionally, the government stated that testing could also be conducted at state drug testing laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL).
Related: WHO impacted image of India pharma after Gambia deaths: DCGI
Tough measures
During tests conducted in India on cough syrups manufactured by Maiden Pharmaceuticals Ltd, no toxins were found, according to the government. However, it was discovered that several drugs produced by Marion Biotech, whose syrups were associated with deaths in Uzbekistan, contained contaminants.
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It should be mentioned that the government and regulatory bodies — CDSCO and DCGI — held a meeting with state regulators a few months ago in Hyderabad to discuss the exported syrup that has been held responsible for the death of children.
Later, the Drug Controller General of India (DCGI) submitted a proposal to the Ministry of Health and Family Welfare (MoHFW), suggesting mandatory testing of all cough syrups intended for export in government laboratories.
The proposal recommended that a Certificate of Analysis from one of the approved labs must be obtained for each batch of cough syrup for export clearance.
Superficial move, say critics
“While recognising that recent incidents have brought disrepute to India — particularly related to syrup-based and paediatric formulations — the focus of the proposal has been narrowed down to exclusively cover cough syrups,” said Malini Aisola of All India Drug Action Network.
The government has implemented the DCGI’s proposal by mandating government laboratory-issued Certificates of Analysis (CoAs) for export.
“This move appears to be in response to the negative publicity the country has received. It aims to provide some reassurance to the international community, presenting the image of taking action,” Malini said.
“However, it could be viewed as a superficial measure that fails to address the underlying issue of weak regulations in the country, which allows unscrupulous manufacturers to exploit the global market. While this intervention is a strategic and limited political step, long-term sustainable solutions require comprehensive regulatory reforms in India,” she added.
She added that it may not be realistic or necessarily justified to demand that India apply the same rigorous measures to each batch of cough syrup leaving its borders, especially if those batches already comply with the regulatory requirements of other jurisdictions.
“However, it is important to acknowledge and criticise the Indian government’s cover-up in the case of the Gambian children’s deaths and its defiance of the WHO. The response in the case of incidents in Uzbekistan garnered significant unwanted international attention, which the government was unable to handle,” she said.
