New Delhi: The Central Drugs Standard Control Organization (CDSCO) and state drug controllers have directed a Madhya Pradesh-based drugmaker, suspected of supplying adulterated cough syrups to Cameroon, to halt manufacturing, the Centre informed Parliament Tuesday. Naturcold, the cough syrup supplied by Indore-based drugmaker Riemann Labs, was linked with the deaths of 12 children in Cameroon in March this year.
Responding to an unstarred question in the Rajya Sabha Tuesday, Minister of State (MoS) for health Bharati Pravin Pawar wrote: “In (the) case of Cameroon, a joint inspection was conducted by CDSCO, Sub-Zone Indore with SLA (State Licensing Authority), Madhya Pradesh at M/s. Riemann Labs., Indore and based on the findings the State Drugs Controller M.P. has directed the firm to stop the manufacturing activities (sic).”
This is the first instance of the central government conceding that action was taken in connection with cough syrup-related deaths in Cameroon.
The World Health Organization (WHO) had on 19 July issued a global medical product alert, based on a complaint received from Cameroon in March. At the time, the global health body emphasised that an analysis by a “WHO contracted and prequalified laboratory” found that the product contained “unacceptable amounts of diethylene glycol as contaminants”.
It added that the makers of Naturcold listed paracetamol, phenylephrine hydrochloride & chlorpheniramine maleate as active ingredients, and that a combination of these three is used to relieve symptoms associated with the common cold, flu, and allergic rhinitis.
The WHO further said that it found 28.6 percent concentration of diethylene glycol in samples of Naturcold as against the acceptable limit of 0.10 percent.
“The stated marketer of the affected product is listed on the product packaging as Fraken International,” the WHO alert said, adding that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) “confirmed that no such manufacturer exists in the UK”.
In response to a query by ThePrint, the WHO had said on 27 July that it was “still trying to determine the country of origin (of the drug mentioned in the alert)”.
“The packaging showed conflicting information. There is a UK address but the UK regulator confirms no such company is registered at that address in the UK,” the WHO told ThePrint.
“There is also a manufacturing code which appears to indicate the product was manufactured in India. Our investigations are ongoing and we have notified Indian authorities of this. We are waiting for their reply,” it added.
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Action against other drugmakers
In her written reply to Parliament, the Union MoS for health also said that so far the WHO has issued alerts and sought detailed information in connection with four cases of syrup products exported by India. These include cough syrups supplied to The Gambia, Uzbekistan, Marshall Islands and the Federated States of Micronesia, besides Cameroon.
In all these cases, manufacturing activities at units run by the drugmakers in question had been halted earlier following joint inspections by the CDSCO and state drug regulatory authorities, the government informed the House.
The reply also stated that on 22 May, the Union Ministry of Commerce & Industry issued a notification for an amendment in the export policy of cough syrups, making it compulsory for cough syrup manufacturers to procure a certificate of analysis from a government-approved laboratory before exporting their products with effect from 1 June.
(Edited by Amrtansh Arora)
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