The Drugs Controller General of India (DCGI) has cautioned against the consumption of Abbott’s antacid Digene Gel citing safety concerns. The US-based drugmaker has recalled several batches of the medicine manufactured at its Goa facility.
The DCGI has advised doctors and healthcare professionals to carefully prescribe and educate their patients to discontinue the medicine’s use and for reporting of any ADRs (adverse drug reactions) arising due to consumption of the said product.
What is the role of DCGI?
• The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General (India), is the central authority for regulating the quality of drugs marketed in the country under the Drugs and Cosmetics Act, 1940.
• The mission of CDSCO is to safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.
• Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority are major functions of CDSCO.
• The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 have entrusted various responsibilities to central and state regulators for regulation of drugs and cosmetics. It envisages uniform implementation of the provisions of the Act and Rules made there under for ensuring the safety, rights and well being of the patients by regulating the drugs and cosmetics.
• CDSCO is constantly striving to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.
• The CDSCO, with its headquarters in New Delhi has six zonal offices, six sub-zonal offices, seven Central Drugs Testing Laboratories and nine airport & 18 sea port offices (including inland container depots).
