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New Delhi
The Himachal Pradesh government has launched a probe through the local drug control office after 1,680 drug samples failed tests in the last three years.
Detailed findings on the samples taken from manufacturing units primarily in Baddi, are expected to be presented before the Assembly in July, sources told businessline.
In a response to questions raised in the Assembly by MLAs – Kewal Singh Pathania and Vipin Singh Parmar, 1,683 samples had failed quality tests, till January 2024. Of this, 374 samples failed in the last one year.
Baddi is a major hub for manufacturers, including the pharmaceutical industry. And the failed samples covered tablets, capsules, oral liquids, small and large volume parenteral (Injections), dry syrups, soft gelatin capsules, vaccines, among others. The therapeutic segments included drugs to treat allergies, thyroid, high blood pressure, cold and cough, to mention a few.
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.
“A probe is currently under-way and samples from various manufacturing facilities in Solan are being collected. Testing is being carried out. We are hopeful that a detailed report will be tabled in the next Assembly session scheduled in July,” Pathania said.
Older Probe
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.
374 failures in 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 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.
- Also read:Medication safety
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.
Pointers:
#1,683 samples had failed quality tests, till January 2024; 374 samples in the last one year.
# Samples largely from Baddi, a major hub for pharma manufacturers.
# Failed samples covered tablets, capsules, oral liquids, small and large volume parenteral (Injections), dry syrups, soft gelatin capsules, vaccines.
# Therapeutic segments included drugs to treat allergies, thyroid, high blood pressure, cold and cough.
# Maiden Pharma – hauled up for selling contaminated cough syrups – listed as “under-investigation”.
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