India’s apex drug regulatory agency Central Drugs Standard Control Organisation, after initiating the system of checks on cough syrups for exports, is considering a proposal to relax the rule for certain countries, News18 has learnt. The regulator is likely to waive the requirement of testing batches of cough syrups for manufacturers exporting to the USA, UK, Canada, EU, Japan, Australia, Singapore, Republic of Korea, and Switzerland.
Last year, the Centre decided to put in a system of checks at government laboratories before exporting cough syrups. The move was driven by multiple allegations levelled by importers of Indian medicines, especially cough syrups — including Uzbekistan, the Gambia, Marshall Islands, and Micronesia — where made-in-India syrups were found contaminated with toxic diethylene glycol (DEG) and ethylene glycol (EG). On May 22, the government announced the amendment of the Foreign Trade Policy, 2023, related to the export of cough syrups.
Now, the CDSCO has received a proposal from industry stakeholders requesting exemptions from testing requirements.
“Representation has been received from stakeholders requesting for exemption of testing. The matter was examined by CDSCO,” according to a 44-page long presentation accessed by News18. “In case the manufacturers are exporting to the USA, UK, Canada, EU, Japan, Australia, Singapore, Republic of Korea and Switzerland, the requirement of testing at the prescribed laboratory may be waived.”
It further said that “if cough syrup is manufactured in a plant or section approved by the regulatory agencies of the listed countries for any product, such cough syrup may also be allowed to be exported to any country without testing at the prescribed laboratory”.
News18 reached out to Health Secretary Apurva Chandra and Rajeev Raghuvanshi, the drug controller general of India, who heads CDSCO, for comments. However, they did not respond to text messages.
300 Batches of 7,000 Failed: Latest Data
While at one end the CDSCO is considering lowering checks, the presentation also showed that more than 300 batches of cough syrups out of 7,000 tested were found ‘not of standard quality’ on various parameters, including the contamination of toxic diethylene glycol and ethylene glycol.
It said “353 batches out of 7087 were tested in the last year”… which “were declared as Not of Standard Quality (NSQ) for various parameters such as DEG/EG, assay, microbial growth, pH, volume etc”. The government started testing the batches starting May 22, 2023, and the data is till July 14, 2024.
The presentation shows that 4,009 batches were analysed at CDSCO’s labs of which 223 were found NSQ for all parameters. Similarly, 861 batches were analysed at state labs and 84 were found problematic, while 2,217 batches were tested at private labs but 46 were found problematic.
Presence of DEG, EG Matter of Concern: CDSCO’s Analysis
The presentation on page 44, titled “data analysis”, said: “9 failed in DEG/EG which are a matter of concern.” It added: “As per the investigations carried out, the reason for failure in the DEG/EG are as follows: failure to test to the propylene glycol bulk for DEG or EG, unsecured supply chain and in one case the firm stated that the peak of the DEG might be placebo peak”.
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