Deaths in Gambia due to India-made cough syrups: Centre takes steps to curb damage, Haryana firm remains non-operational

There was a stir in Haryana on Thursday after four Indian-made cough syrups were blamed for the deaths of 66 children in The Gambia. Health Department teams from Delhi, Sonipat and Chandigarh raided the pharmaceutical factory located in Sonipat.

India’s National Drug Regulator i.e. CDSCO also started investigating the matter. In the initial investigation of CDSCO, it has been found that the medicines of Maiden Pharma, which are controversial, were approved by the State Drug Control Authority of Haryana.

The central and state teams collected samples on October 1 and 3, a day after the WHO formally issued a medical product alert regarding four cold and cough syrups and cautioned that they could be linked to acute kidney injuries and deaths of the 66 children, a joint inspection of the pharmaceutical company was conducted on Thursday.

Health Department teams led by Haryana Drug Controller Manmohan Taneja took samples that are still under investigation.

Sonepat-based senior drug inspector Rakesh Dahiya said five samples were collected in the last one week and were sent to the Central Pharmaceutical Laboratory in Kolkata for testing. At the same time, Haryana Health Minister Anil Vij said that all the four syrups were prepared only for export. It was not sold in India.

Vij also said that strict action will be taken against the company and its owners, if the samples of Meiden Pharmaceuticals fail to meet the standards.

The Union Health Ministry said the exact “one-to-one causal relation of death” has neither been provided by the UN health agency nor the details of labels and products been shared by it with the Central Drugs Standard Control Organisation (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products.

The ministry in a statement said on September 29 that WHO informed DCGI that it is currently providing technical assistance and advice to Gambia, where children have died and where a contributing factor, is suspected to be the use of medicines that may have been contaminated with Diethylene glycol or Ethylene glycol (in some of the samples it was claimed to have been confirmed by further analysis conducted by WHO).

The CDSCO took up the matter immediately with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of M/s Maiden Pharmaceutical Limited, Sonepat is located.

Further, a detailed investigation was launched to ascertain the facts/ details in the matter in collaboration with State Drugs Controller, Haryana, the statement said.

“From the preliminary enquiry of CDSCO, it has been made out that Maiden Pharmaceutical Limited, Sonepat, Haryana is a manufacturer licensed by the State Drug Controller for the products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup under reference, and holds manufacturing permission for these products for export only. The company has manufactured and exported these products only to Gambia,” the statement said.

It is a usual practice that the importing country tests these imported products on quality parameters, and satisfies itself as to the quality of the products before the importing country decides to release such products for usage in the country.

As per the tentative results received by WHO, out of the 23 samples of the products under reference which were tested, four samples have been found to contain Diethylene Glycol/ Ethylene Glycol.

It has also been informed by WHO that the certificate of analysis will be made available to WHO in near future and WHO will share it with the Indian Regulator which is yet to be done.

The exact one to one causal relation of death has not yet been provided by WHO to CDSCO, the statement said.

As a robust National Regulatory Authority, CDSCO has requested WHO to share at the earliest with CDSCO the report on the establishment of causal relation to death with the medical products in question etc.

The State Drug Controller had given licenses to the said Company only for export of these four drugs namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup. Further all these 04 drugs were manufactured only for exports by M/s. Maiden Pharmaceuticals Limited are not licensed for manufacture and sale in India. In effect, none of these four drugs of M/s. Maiden Pharmaceuticals is sold domestically in India.

“The samples (controlled samples of the same batch manufactured by M/s. Maiden Pharmaceuticals Limited for all the four drugs in question) have been taken and sent for testing to Regional Drug Testing Lab, Chandigarh by CDSCO, the results of which will guide further course of action as well as bring clarity on the inputs received/ to be received from WHO,” the statement said.