August 20, 2020 11:03:24 am
A pharmaceutical manufacturer from Himachal Pradesh being investigated for selling a contaminated cough syrup allegedly purchased the solvent used in the medicine from an unlicensed trader and produced a “misleading” quality report of the finished drug, investigators have told the High Court of Himachal Pradesh.
The syrup, Coldbest-PC, was linked to the death of several infants in Jammu earlier this year after government analysts detected a poisonous impurity called diethylene glycol (DEG) in it. The impurity is believed to be present in the solvent used in the syrup.
The manufacturer Digital Vision stated in court that while purchasing three batches of the solvent from Ambala-based Thakur Enterprises, it had also received certificates of analysis regarding the chemical.
However, state drugs control authorities told the court that Thakur Enterprises did not possess a valid drugs licence
required to stock or sell the solvent propylene glycol. Thus, Digital Vision violated the Drugs and Cosmetics Act and Rules in purchasing it from an unlicensed firm, they stated.
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Digital Vision also contended in court that its quality control department analysed the syrup and issued a certificate of analysis to all its batches as they were found to be complying with standard norms and specifications.
Drug control officials countered that the firm had no facility for conducting the test for detection of DEG and had not actually conducted any such test. The analysis report of the firm “indicating compliance of norms relating to ethylene glycol and DEG was, therefore, misleading,” drug officials argued.
In response to the company’s contention that it had got the solvent tested and approved from a private lab in Delhi, drug officials said that the firm has not maintained the stock register for excipients as per law and has failed to produce any document/receipt for sending the raw material solvent to the lab in question. The report, thus, cannot be relied upon at this stage, officials said.
“At present, neither there is any proof of the solvent propylene glycol having been purchased from a duly licensed dealer/stockist nor there is any proof of the same having been tested for presence of commonly tested adulterant DEG before being put to use in different drug formulations,” the high court observed in its judgment.
Samples of Coldbest-PC from J&K, Himachal and Haryana tested positive for DEG at a central government lab in Chandigarh. The company has disputed these findings, but the state government disclosed in court that a government analyst in Tamil Nadu, where some syrup bottles were sold, has also detected DEG in the syrup.
The syrup, prima facie, cannot be said to be of standard quality, the court observed. Digital Vision has remained shut since mid-February on the orders of drug control authorities. However, except two syrups made by the same solvent, various other drug samples from the plant taken by officials had passed the quality tests.
The firm had moved the court against orders which stopped all manufacturing at its plant in Kala Amb and suspended the company’s manufacturing licences.
The court upheld the proceedings initiated against the company regarding the syrup Coldbest-PC, but set aside the licence suspension order, directing authorities to examine the entire matter afresh after considering the firm’s replies.
Till then, it has allowed the firm to resume making and selling drugs which do not involve the use of the contentious solvent propylene glycol.
Meanwhile, another cough syrup Cofset-AT made by the firm using the same solvent allegedly caused renal failure in a two-year-old girl in Baddi last month, following which officials tried recalling it from the market.
Drug inspector Lalit Kumar said that no bottle of the syrup has been returned to the manufacturer yet. He said 2,992 bottles of the batch in question were made in September last year and sold to a wholesaler in Ambala, from where they were dispatched to eight different distributors across the country and further sold to retailers.
Samples of eight pharmaceutical products and three hand sanitisers made in Himachal have been declared as ‘not of standard quality’ in the drug alert list released by the Central Drugs Standard Control Organization for the month of July.
Across the country, 35 samples failed the tests but none of them was declared spurious or misbranded.
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