9 drugs produced in Himachal fail safety test

Tribune News Service

Ambika Sharma

Solan, November 16

Nine medicine samples manufactured by various pharmaceutical firms in Himachal Pradesh are among 50 drugs declared substandard nationwide by the Central Drugs Standard Control Organisation (CDSCO) in its monthly alert issued today.

The firms comprise Lifevision Healthcare DM Pharma, Salus Pharmaceuticals, Shiva Biogenetic Laboratories, Health Biotech, ANG Lifesciences India Ltd and Healcure Lifesciences from Baddi and Nalagarh; Pushkar Pharma in Kala Amb and Zee Laboratories, Paonta Sahib.

Used for common ailments

Paracetamol: Fever, moderate pain

Esolip-40: Gastro-resistant medication

Pantoprazole: Reduces stomach acid

B-complex: Treats vitamin deficiency

Ondasetron: For nausea during chemo

Montelukast: Given for mild asthma

Dicowin plus: Used to aid digestion

Cinafroz BR: Cough syrup

Midazolam jab: Used before surgery

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50drugs declared substandard nationwide in monthly alert

1,280 samples drawn by the regulator across India

As many as 1,280 samples drawn from various states by the CDSCO were tested, of which 1,230 cleared the safety test while 50 were declared substandard. These comprise paracetamol tablets used to treat fever and mild to moderate pain; Esolip-40, a gastro-resistant medication, and pantoprazole, which reduces stomach acid.

Also on the list are B-complex tablets, used to treat vitamin deficiency; ondasetron, prescribed for nausea and vomiting during cancer chemotherapy and radiation therapy; montelukast, given for mild asthma, and dicowin plus capsules, used to aid digestion. Cinafroz BR cough syrup and midazolam injection, used before surgery or a procedure, have also been declared unsafe.

Various reasons such as description, power of hydrogen (pH), presence of particulate matter, sterility, dissolution, fineness of dispersion and disintegration have been stated as the reasons for failure.

Navneet Marwaha, State Drugs Controller, said the batches declared substandard would be immediately withdrawn from the market. He said show-cause notices had been issued to all firms and the drug inspectors had been directed to inquire whether the conditions to issue licence were being adhered to. Further action as per the findings would be undertaken, he said.

Among the pharmaceutical units, Zee Laboratories (Paonta Sahib) had repetitively figured on the list. Assistant Drugs Controller (Paonta Sahib) Sunny Kaushal said actions such as suspension and withdrawal of product permissions had been taken over the past few months when the company’s samples failed.

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