Pharma News - DCGI bars Pregna Intl from manufacturing medical device 'Tcu 380Ag' in6 violation of D&C Act "D3"

Ramesh Shankar, Mumbai Wednesday, August 06, 2014, 08:00 Hrs  [IST]

The drug controller general of India (DCGI) has barred the Daman-based pharma company Pregna International from manufacturing the medical device 'Tcu 380Ag' (intra uterine contraceptive device) for violation of D&C Act as the company did not obtain manufacturing license from the DCGI office as the product was a new drug. It may be noted that manufacturing of a new drug without permission from the office of the DCGI is in contravention to Drugs and Cosmetics Act and Rules thereunder, DCGI said in his order said. “You are therefore directed to submit reasons for manufacturing the said new drug without approval to this directorate at an early date so that further action may be taken in this matter. In case you are still marketing the drug in the country, you are hereby asked to surrender the license for the said product under intimation to this office”, DCGI Dr GN Singh in his order said. The DCGI has also directed the drug controller in Daman to cancel the license (product permission) granted to manufacture the device and take necessary action accordingly. The permission to manufacture the new drug/device 'Tcu 380Ag' was given to Pregna International by the drug licensing authority in Daman. This is to inform you that the above said drug/device falls under the category of 'New Drug' under Rule 122E of Drugs and Cosmetics Rules, 1945. Therefore, for its manufacture, all the applicants should submit application in Form-44 of Drugs and Cosmetics Rules to this directorate with requisite fees along with necessary documents for grant of approval, the DCGI in his directive to drug licensing authority in Daman said. “It may please be noted that grant of license without permission from the office of licensing authority under Rule 21(b) i.e. DCGI is in the contravention to Drugs and Cosmetics Act and Rules made thereunder as well as this causes loss of revenue to the central government. Therefore, in the interest of public health, you are required to cancel the license (product permission) granted to manufacture the said new drug/device and take necessary action”, the DCGI further said in his directive to drug licensing authority, Daman.