Gambia deaths: Pharma firms suspect human error, negligence

Mukesh Tandon

Panipat, October 13

Days after the World Health Organisation (WHO) flagged four syrups produced by Kundli-based Maiden Pharmaceuticals, some pharma industrialists also suspected human error and negligence in the quality control department of the company before dispatching the medicines to Gambia, where 66 children died.

Lessons to be learnt

Samples’ test report will clear the errors behind the suspected cough syrups, but it is a big mistake at the end of any pharmaceutical company, and others need to learn a lesson from the entire issue. A pharma firm owner

The state Food and Drug Administration (FDA) Department has stopped the entire production of the Maiden pharmaceuticals after it found 12 flaws during the joint inspection of the plant at the HSIIDC, Kundli.

An owner of a pharmaceutical company, however, said samples’ test report would clear the errors behind the suspected cough syrups, but it was a big mistake at the end of any pharmaceutical company, and others have to take a lesson from the entire issue.

Meanwhile, the Haryana Pharmaceutical Manufacturers Association (HPMA) said if samples which had been sent by the regulators at Central Drugs Laboratory at Kolkata failed the laboratory test, the association would not stand with the company.

A firm owner said manufacturing drugs and medicines was not an easy job. The industrialists as well as the company staff had to be extra vigilant during the manufacturing process as it was a matter of human life, he said. Three layers of checking system was mandatory before releasing a batch of any medicinal product in the market, he said.

Firstly, the raw material is checked at the entry level, where after testing, the impurities are removed, and then it enters the production division, he said. The production manager checks the batch before releasing and the product has been sent to the quality control department after proper assessment by the quality control department, it has been sent for final checking to the quality assurance manager and after getting clearance from the quality assurance manager, the products’ batch is released to the market, either in domestic or global market, he added.

Vikas Pruthi, general secretary, HPMA, said Maiden Pharmaceuticals was a member of the HPMA and it would be too early to comment on its status over the deaths of children in The Gambia.

The regulators have sent the samples and we would have to wait for the results, he said. Conspiracy behind the issue could not be ruled out as some countries, China and European nations, also want to malign the image of India at the international level, Pruthi claimed.

RL Sharma, president, HPMA, said the Indian pharma industry was the fastest-growing industry in the global market and India was at the third position in the world for exporting medicines globally.