Diabetes drug among 48 critical medicines that fail CDSCO quality test

Oct 05,2023

NEW DELHI : The drug regulator said it found 48 critical medicines, meant for domestic consumption, as “not of standard quality" in August. The samples were collected across the country.

Some of these drugs are: MOL-PCB syrup given to children for pain relief; Nifedipine sustain release tablets I.P. 20 mg used to treat hypertension, calcium and vitamin D3 tablets, and CyproheptadineHCl with tricholine citrate syrup which is given to children to treat anaemia, liver or digestive disorder.

Glimestar-M2 forte tablet, used for treatment of diabetes and made by the Mankind Pharma Ltd, also failed the quality check. The sub-standard drug sample was picked by drug inspectors in Mizoram.

“Around 1,166 total drug samples were collected all over the country out of which 48 were declared as not of standard quality," said a drug alert prepared by the Central Drugs Standard Control Organization (CDSCO), seen by Mint.

“We have controverted the analysis report of Govt. analyst and its under investigation. We had already conducted our own analysis on the control sample of the said product and found that the results were compliant with all prescribed parameters," a Mankind Pharma spokesperson said.

Queries sent to the health ministry spokesperson remained unanswered till press time.

The development follows several incidents of toxic Indian-made cough syrups causing the deaths of children in other countries. Many of these drugs are made by micro, small and medium enterprises, who are now required by law to comply with good manufacturing practices. India is the largest supplier of medicines to low-middle-income-countries.

“The CDSCO has registered medical device testing labs and in-vitro diagnostic labs to carry out tests or evaluation of such pharmaceutical items under medical device rules, 2017," said the official.

Source: Livemint