Samples failing repeatedly, Baddi unit told to stop manufacturing
In a move aimed at stopping pharmaceutical firms habitually defaulting on adhering to quality norms, the State Drugs Administration has begun issuing stop manufacturing directions. The move is intended to curb supply of substandard drugs.
One such firm, Baddi-based Captab Biotech, unit-II, Jharmajri, has been directed to stop manufacturing of large volume injection or infusion drugs owing to repeated failure of its injection samples and non-compliance of manufacturing norms pertaining to Good Manufacturing Practices (GMP).
The unit has been prohibited from manufacturing and sale of any drug by the State Drugs Controller Manish Kapoor in orders issued in April. “A joint inspection conducted from March 17 to March 19 by the state and central drug authorities had found serious flaws in the compliance of GMP norms. Show cause notices were also issued to the unit management to ensure compliance of flaws pointed out during the inspection but they were not rectified within the given time,” informed Dr Manish Kapoor, State Drugs Controller, Baddi
“Keeping in view serious manufacturing flaws, it was decided that large volume manufacturing of parenterals (injectables) could not be permitted for non-compliance of the Drugs and Cosmetics Act, 1940 in view of patient safety,” remarked Dr Manish Kapoor, who added that promoting quality drug manufacturing is their key concern.
The firm has been directed to stop manufacturing drugs falling under manufacturing licence form 28D pertaining to large volume parenterals, sera and vaccines.
It was found to be habitually defaulting in adhering to quality parameters as its various drug samples have been repeatedly figuring in the monthly drug alerts issued by the Central Drugs regulator. In May alone, eight batches of its saline injections, used commonly for fluid replenishment, were found containing bacterial endotoxins and they also failed the sterility test. Both are considered serious flaws hitting the quality and affecting patient safety.
Pharma experts say that endotoxins can contaminate injectable medications posing a risk of fever and inflammation. Properly formulated and sterilised injectable products are required to strictly adhere to endotoxin limits to ensure patient safety. Maintaining sterility ensures patient safety and prevents adverse reactions like infections or sepsis.
Notably, keeping in view large number of substandard drugs figuring in the monthly alerts the drug authorities are conducting risk-based inspections on habitual offenders. In April alone 24 per cent drugs in the national alert pertained to Himachal and this comprised a large number of injection samples.
Risk-based inspection was also conducted at Captab Biotec after repeated drug samples failed quality parameters.
The regulatory authorities have been specially targeting injection samples from various states, including Himachal after serious defects have been detected in lab tests.
Himachal Tribune