contaminated Cough Syrup
In a response to questions raised in Himachal Assembly by two MLAs – Kewal Singh Pathania and Vipin Singh Parmar to health department of the state, the house said a total of 1,683 samples had failed quality tests, till January 2024. Of this, 374 samples failed in the last one year.
In a written response to the MLAs, this February, the Himachal Pradesh Health Department said 374 drug samples failed tests in the last year.
The failed samples covered tablets, capsules, oral liquids, small and large volume parenteral (Injections), dry syrups, soft gelatin capsules, vaccines, among others including the therapeutic segments.
The list included older incidents involving samples of ‘Levolite M’ syrup and ‘Orvastin’ tablets of Morepen Laboratories. Product permissions were suspended for five days to five months, the list said.
A Morepen Laboratories spokesperson said, “Based on the findings we had recalled batches from the market. We followed guidelines laid down by the state authority. The issue currently stands resolved.”
The list of companies mentioned included Abbott, Acme (that makes Abbott’s Thyronorm), Alkem, Glenmark, Dr Reddy’s Laboratories, Cipla. Emails were sent to the companies and a response was awaited from them on the State’s findings.
Some of the samples mentioned in the list, across companies, are being challenged; had since been passed or was being further investigated, an industry-insider said. Some samples have been listed as “spurious” including Abbott’s ‘Phensedyl Cough Linctus’ , Glenmark’s Telma AM (blood pressure drug) tablets and Omeprazole (DelayedRelease), for example.
There are 38 drug controllers monitoring and inspecting the quality of medicines produced from the State. Besides Baddi, manufacturers are also based out of Barotiwala and Nalagarh, in Solan district. Sampels were also collected from Sirmaur and Una. Baddi is a major hub for manufacturers, including the pharmaceutical industry.
The recent list mentions Maiden Pharma – under Government scanner already for selling contaminated syrups – as a company under-investigation.
Some of the companies saw their licences being suspended for a period ranging for 7 days to 4 months, the government’s action taken report. In some cases, product permission has also been cancelled.
The 120-page list included companies like Kanha Biogenetic, Alventa Pharma, Admed Pharma, for example, who have been issued show-cause notices and “correspondence is currently under-way”, the list said.
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