Reports have emerged that the well-known antacid syrup Digene Gel from Abbott India is currently undergoing a voluntary recall process. This decision sprung from isolated complaints from customers regarding unusual odor and taste. In response to these complaints, the Drugs Controller General of India (DCGI), part of the Central Drugs Standard Control Organisation (CDSCO), has advised healthcare practitioners to be mindful when administering Digene Gel to patients.
About Digene Gel
Digene Gel is a widely used antacid syrup aimed at alleviating symptoms related to acidity. These symptoms include heartburn, stomach discomfort, multiple types of abdominal pain, and gas. The core function of this antacid relies on basic compounds such as magnesium hydroxide which effectively neutralize stomach acid.
The Concept of a Drug Recall
A drug recall is a precautionary measure whereby a drug is withdrawn from the market by a pharmaceutical company or regulatory authority due to various safety or quality concerns that could potentially harm patients. However, it’s important to note that India presently lacks any legislation that specifically allows for the recall of entire batches of substandard drugs, posing a significant challenge in this field. Establishing a comprehensive Drug Recall Law in India is thus a pressing need to ensure that whenever a drug batch is found to be of substandard quality, it is immediately and completely withdrawn from the market.
About Central Drugs Standard Control Organization (CDSCO)
The Central Drugs Standard Control Organization (CDSCO) acts as the central drug authority, playing out functions assigned to the Central Government under the Drugs and Cosmetics Act, 1940. CDSCO operates from six zonal offices, four sub-zonal offices, and thirteen port offices, with additional laboratories under its jurisdiction. The key activities of CDSCO encompass exercising regulatory control over drug imports, approving new drugs and clinical trials, convening meetings of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), and giving approval to certain licenses as Central License Approving Authority.
The Role of the Drugs Controller General of India
The DCGI holds a pivotal role as the head of CDSCO. The responsibilities of the DCGI include approving licenses for specific categories of drugs including blood and blood products, IV fluids, vaccines, and serum in India. Moreover, the DCGI maintains the standard and quality of manufacturing, selling, import and distribution of drugs in India.
Last Modified: February 22, 2024