New Delhi, May 20
Amid quality issues being raised globally for the cough syrups exported by Indian firms, the Centre is actively considering a proposal of testing drugs at government laboratories before they are dispatched to other countries.
The apex drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO) has proposed testing the drugs (finished products) at government labs before exporting, official sources said.
According to the proposal, exporters will have to produce the certificate of analysis of the batches issued by authorised laboratories after which only the Directorate General of Foreign Trade (DGFT) will clear the release of the consignment for export.
The analysis of the sample from the export consignment is proposed to be tested at Indian Pharmacopoeia Commission, Central Drugs Standard Control Organization (CDSCO) labs viz.,L (Chandigarh), CDL (Kolkata), CDTI (Chennai), CDTI (Hyderabad), CDTL (Mumbai),I. (Guwahati)) and NABL-accredited drug testing labs of state governments.
“The CDSCO has submitted that some intervention from the government was necessary to stop the low-quality cough syrups from entering the global supply chain from India,” an official said.
References have been received over quality issues coming across globally for the cough syrups exported by Indian firms. References and media reports have also been noted where cough syrups produced by Indian manufacturers and exported have failed quality control testing abroad, an official source said.
Further, communications have been received from the World Health Organization (WHO). Ministry of External Affairs (MEA), Department of Commerce (DoC) and other organisations and departments regarding such reports and results.
“The Government of India (GoI) has proactively identified such units and has initiated enforcement action in coordination with the states. Certain plants have been shut down, licenses cancelled and punitive action under the Indian laws also has been taken on a case to case basis,” the official source stated.
According to sources, the Secretary (Pharma) in a letter on April 26 had also raised concerns about the quality failures of cough syrups exported stating that it will harm the national image of the country disproportionately as the “Pharmacy of the World”.
The letter also suggested the health ministry explore the possibility of keeping the export of cough syrups under mandatory quality check.
“The CDSCO has stated that the syrup-based formulations of cough compositions (cough syrups), because of the insolubility of the drugs used, require solvents like propylene glycol and/or glycerine and/or sorbitol. There are adulterants commonly used with these solvents where mainly di-ethylene glycol (DEG) and ethylene glycol (EG) are most common,” another source in the know of the matter said.
These adulterants are toxic to the kidney and cause deaths if used in high quantities, the source added.
In the last eight months, questions have been raised over the quality of drugs manufactured by India-based companies.
In February, the Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drop allegedly linked to vision loss in the US.
Before that, India-made cough syrups were allegedly linked to the deaths of 66 and 18 children in the Gambia and Uzbekistan, respectively, last year.