78 drugs fail safety test, 40 manufactured in Himachal Pradesh

Tribune News Service

Ambika Sharma

Solan, January 23

More than 50 per cent of the drug samples declared substandard in the monthly alert issued by the national drugs regulator today pertain to pharmaceutical companies in Himachal.

Drug controller’s post vacant in state

• HP Govt hasn’t appointed a new drugs controller after the incumbent retired on Dec 31
• As a result, regulatory works are suffering and instructions issued by CDSCO haven’t been communicated to firms firms to face action
• Manish Kapoor, Deputy Drugs Controller, said the firms in the list of failed drug samples would be examined for shortcomings and action would be taken

As many as 40 of the 78 drug samples in the list released by the Central Drugs Standard Control Organisation (CDSCO) pertain to firms in Kala Amb, Paonta Sahib, Baddi-Barotiwala-Nalagarh belt and Sansarpur Terrace in Kangra.

Of the 1,008 drug samples tested nationally, 930 were found of standard quality while 78 failed to adhere to the quality parameters.

The failed samples included eight samples of various batches of heparin sodium injections manufactured by Baddi-based Alliance Biotech. The presence of particulate matter was cited as the key reason. Five samples of the Kanha Biogenetic firm at Baddi also figure in the list. All samples pertain to calcium carbonate with vitamin D3 tablet where the assay content, which is responsible for the efficacy of a drug, was found lacking.

Overall, 25 drug firms are under the scanner from Kala Amb, Paonta Sahib, Baddi-Barotiwala and Sansarpur Terrace in Kangra. At least three firms figured multiple times in the list with several of their drug samples found lacking the requisite quality.

Manish Kapoor, Deputy Drugs Controller, said two units of Kanha Biogenetic were closed after “stop manufacturing” was ordered over a month ago. Compliance regarding various shortcomings was still awaited.

He said a majority of these firms had been examined in risk-based inspections and new firms which appeared in the list today would be examined for shortcomings and further action.

Commonly used drugs like montelukast sodium and levocetirizine dihydrochloride tablets, telmisartan tablets, pregabalin tablets, cyproheptadine HCl and tricholine citrate syrup, sodium valproate tablet, ampicillin capsules, amoxycillin trihydrate capsules, ascorbic acid +zinc capsules, trypsin, bromelain and rutoside trihydrate tablets, ambroxol hydrochloride, terbutaline sulphate, guaiphenesin and menthol syrup were among those which figured in the list of substandard medicines.

They are used to treat common ailments like allergy, asthma, hypertension, epilepsy, to revive appetite, stop bacterial growth, for blood clotting disorder, to relieve pain and inflammation due to trauma, surgery, cough, bronchitis and gastric problem.

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