39 out of 1221 drug samples not of standard quality

The Central Drugs Standard Control Organisation (CDSCO) has declared that a concerning amount, about three percent of the drug samples it has tested during the month of February, are not of standard quality. One particular sample has been declared as misbranded.

The drug regulator Central Drugs Standard Control Organisation (CDSCO) has tested a total of 1,221 samples of drugs, medical devices, and cosmetics during the month as part of its routine tests, out of which 1,181 samples were of standard quality, while 39 were declared as not of standard quality.

That includes a batch of Telma H tablets from Glenmark Pharma, a batch of ranitidine tablets IP 15 mg, one combination of telmisartan 40 mg and hydrochlorothiazide 12.5 mg tablets IP; and a batch of citrizine syrup IP 5mg/5ml – 60 ml from the public sector firm Hindustan Antibiotics Ltd. A batch of losartan tablets IP 25 mg from another public firm, Karnataka Antibiotics & Pharmaceuticals Ltd, has also failed the test, according to the Central Drugs Standard Control Organisation (CDSCO).

Of the total drug samples that failed, four were manufactured by a Telangana-based firm, Ortin Laboratories Ltd. Two were from Uttarakhand-based companies Bal Pharma Ltd and Cotec Healthcare Pvt Ltd, Tamil Nadu-based business Kaushik Therapeutics, Himachal Pradesh-based frim Pharma Force Lab, and Gujarat-based business Gurumangalam international each.

A particular batch of flupentixol and melitracen hydrochloride tablets manufactured by Jips Pharmaceuticals, the label of which had no address visible, was declared as misbranded.

The level of standard quality drugs among the total number of pills tested by the Central Drugs Standard Control Organisation (CDSCO) has been 2-3 percent for the last several months, showing the data.

A recent report quoting sources has said that the Central government is looking at keeping a tab on the companies that failed the quality tests more than twice last year, with plans to conduct surprise inspections in their manufacturing units. That is part of the government’s efforts to wipe out the country’s spurious and pure quality medicines, said the report.

In February, the Central Drugs Standard Control Organisation (CDSCO) declared that over two percent of the total drug samples it had tested during the month of January 22 in various Central Drugs Laboratories of India were not of standard quality. The Central Drugs Standard Control Organisation (CDSCO) had tested 1,227 drug samples during the said period; of these, the organization found 27 not of standard quality. The remaining 1,200 samples were of standard quality, it asserted.

Around 2.4 percent, that is, 33 samples out of the total 1,385 total drug samples it tested in December 2021, were found as not of standard quality. In November, it tested 1,102 samples and found 22 that were not of standard quality. Central Drugs Standard Control Organisation (CDSCO) found the remaining 1,080 samples to have standard rate as per the requirements of the regulations.

In October, Central Drugs Standard Control Organisation (CDSCO) found that a concerning 3.4 percent of the drug samples that the Central Drugs Standard Control Organisation (CDSCO) had tested across India were not of standard quality. Out of the 1,061 samples tested during that month, only 1025 turned out to be of standard quality.

The Central Drugs Standard Control Organisation (CDSCO) comes out with these lists every month of drugs, medical devices, and cosmetics that are not standard quality, spurious, adulterated, or just misbranded.

These test samples were drawn by various zonal and subzonal offices of the Central Drugs Standard Control Organisation (CDSCO) and then tested in the drug testing laboratories of the organization in Kolkata, Mumbai, Chandigarh, and Guwahati.