A major drug alert for August 2024 has been released by the Central pharmaceuticals Standard Control Organization (CDSCO), which states that more than 50 regularly used pharmaceuticals, such as paracetamol, anti-diabetes pills, and calcium and vitamin D3 supplements, have been categorized as “not of standard quality.” Given that India is a significant global supplier of pharmaceuticals, this news brings to light persistent worries about the quality of drugs made in the nation.
The notice notes that several companies, including Alkem Laboratories, Hindustan Antibiotics Limited, Hetero Labs Limited, Karnataka Antibiotics and Pharmaceuticals Ltd, Nestor Pharmaceuticals Ltd, Priya Pharmaceuticals, and Scott-Edil Pharmacia Ltd., are involved in the manufacturing of the medications in question. As part of its initiatives to guarantee that the general population has access to safe and effective treatments, the CDSCO publishes a list of these drugs once a month.
Notable examples of the pharmaceuticals that were highlighted are antibiotics like Amoxicillin and pills containing potassium clavulanate, as well as high blood pressure meds like Telmisartan and Atropine Sulphate. According to the Indian Pharmacopoeia (IP), the quality problems found vary from failures in the “dissolution test,” which gauges how rapidly a medicine dissolves in the body, to failures in the “Assay” and “water” tests. Certain medications had labels designated as spurious, suggesting they might be fake or improperly made; other medications had problems with volume homogeneity, which could compromise the accuracy of the dosage.
By randomly testing samples every month and taking necessary action against manufacturers found to be in violation of norms, the CDSCO highlights its dedication to monitoring drug quality. Since that these medications are used to treat a wide range of illnesses, it is imperative that the public continues to have faith in the healthcare system.
Concerns exist, meanwhile, over some state drug licensing bodies’ noncompliance. According to the CDSCO report, data pertaining to the August 2024 Not of Standard Quality (NSQ) Alert has not been supplied by a number of states, including Andhra Pradesh, Arunachal Pradesh, and Tamil Nadu. The lack of reporting may make it more difficult to guarantee the efficacy and safety of medications that are sold.
All things considered, the CDSCO’s conclusions underscore the necessity of strict regulatory monitoring in India’s pharmaceutical industry and stress the significance of upholding strict standards to safeguard public health. In order to solve these quality concerns and guarantee that all pharmaceuticals supplied to the general public fulfill the necessary safety and efficacy criteria, ongoing enforcement and monitoring are required.
SOURCE :
THE HINDU
