Govt forms expert panel to probe WHO claims on Maiden Pharma

New Delhi: In the wake of the claims of the World Health Organisation (WHO) on the deaths of 66 children in Gambia by consumption of 'adulterated' cough syrups from Haryana's Sonipat-based firm Maiden Pharmaceuticals, Union Health Ministry has on Wednesday formed a four-member expert committee to investigate the report sent by the WHO on the deaths of children in Gambia.

The development in this regard has come after a team of Central and state officials found that Maiden Pharma was manufacturing and testing drugs without adhering to the drug rules and in contravention of the various good manufacturing practices (GMP) requirements.

However, on the basis of findings of the team, the Haryana government has shut down all manufacturing activities of the company with immediate effect on Wednesday.

According to the Health Ministry order, a four-member expert committee has been set to examine and analyze the details of the reports/adverse events to be received from WHO in the matter. The committee will be headed by YK Gupta, who is vice chairperson, Standing National Committee on Medicines. Other members of the panel include Pragya Yadav, ICMR -NIV, Pune, Arti Bahl, division of epidemiology, NCDC, New Delhi and AK Pradhan, JDC(I), CDSCO.

According to the reports, Atlanta-based Atlantic Pharmaceuticals Company Ltd which has permission to export medicines to Gambia, ordered combined syrup bottles which were purchased from Maiden Pharmaceuticals limited.

"From the preliminary inquiry of Central Drugs Standard Control Organisation (CDSCO), it has been made out that Maiden Pharmaceuticals Ltd is a manufacturer licensed by the State Drug Controller for the product's 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," an official said, adding that Haryana-based drug making company has manufactured and exported these products only to Gambia.

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

"The CDSCO had requested WHO to provide relevant analysis/report indicating one-to-one causal relation of said deaths with the alleged adulteration of the drugs. The same is yet to be provided by WHO," the ministry stated in its order.

It further stated that on further follow up done by CDSCO with WHO, the certificate of analysis (COAs) of the sampled products, summary of the adverse events, etc has been shared by WHO on Tuesday. Further, the WHO has informed that they are in the process of taking forward the investigation.

"It is a usual practice that the importing country tests such imported medicines 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. In the present case, it is yet not clear whether these medicines were tested in Gambia before release," the official added.

On the issue, Haryana health minister Anil Vij told reporters that the samples of three drugs of the Sonipat-based pharmaceutical company, which were mentioned by WHO, have been sent to the Central Drug Laboratory in Kolkata.

"The report is yet to come. We will take action only after the report comes. After a joint inspection by Central and state officials, 12 violations were found in the manufacturing facility. It has been decided to shut total production.

We have sent a notice in this regard," he said.