The Central government is actively considering a proposal to test medications at government laboratories before they are sent to other countries in light of quality concerns being raised internationally for the cough syrups exported by Indian companies.
The Central Pharmaceuticals Standard Control Organisation (CDSCO), the top drug regulating body, has suggested testing the pharmaceuticals (finished products) at government labs before exporting, according to official sources.
The Directorate General of Foreign Trade (DGFT) will be the sole organisation that will approve the release of the consignment for export, according to the plan, once exporters have presented the certificates of analysis of the batches provided by accredited laboratories.
The Indian Pharmacopoeia Commission, Central Drugs Standard Control Organisation (CDSCO) labs, including RDTL (Chandigarh), CDL (Kolkata), CDTI (Chennai), CDTI (Hyderabad), CDTL (Mumbai), and RDTI. (Guwahati), as well as NABL-accredited drug testing labs of state governments, are proposing to test the analysis of the sample from the export consignment.
"The CDSCO has submitted that some government intervention was necessary to stop the low-quality cough syrups from entering the global supply chain from India," an official said.
References to quality problems with Indian companies' exported cough syrups have been received on a global scale. An official source claimed that references and media reports have also been found where cough syrups made by Indian firms and transported outside failed quality control testing.
Further, messages from the World Health Organisation (WHO) have been received. Department of Commerce (DoC), Ministry of External Affairs (MEA), and other organisations and departments with reference to such reports and outcomes.
"In conjunction with the states, the Government of India (GoI) has taken enforcement action after proactively identifying such establishments. On a case-by-case basis, punitive action under Indian law has also been taken, along with the closure of some plants and the cancellation of licences, according to the official source.
Sources claim that the Secretary of Pharmacy expressed worries over cough syrup quality issues in a letter on April 26 and claimed that this would negatively impact the nation's reputation as the "Pharmacy of the World."
The letter also recommended that the health ministry investigate the feasibility of maintaining a strict quality control requirement for cough syrup exports.
"The CDSCO has noted that solvents such propylene glycol and/or glycerine and/or sorbitol are required for the syrup-based formulations of cough compositions (cough syrups), due to the insolubility of the medications employed. Another person with knowledge of the situation claimed that di-ethylene glycol (DEG) and ethylene glycol (EG) are the most often used adulterants with these solvents.
The source also said that if used in large quantities, these adulterants can be fatal to the kidneys. Over the past eight months, concerns have been raised over the quality of medications produced by businesses with Indian headquarters.
Global Pharma Healthcare, based in Tamil Nadu, cancelled all of its eye drops in February after they were allegedly connected to eyesight loss in Americans.
Earlier, cough medicines made in India were thought to have contributed to the deaths of 66 and 18 kids in the Gambia and Uzbekistan, respectively, last year.