As a succession process to the e-governance initiatives of the Central Drugs Standard Control Organization (CDSCO), the Chennai-based south zone office of the central drug regulator has made the process of receiving applications and issuing certificates for ‘Export NoC’ online from October.
This is the second phase of high-tech operations introduced by the south zonal office to help the industry, and that too first in the country, through its online application portal, ‘Sugam’, launched in last year. Sugam portal is a high-tech e-governance system which was introduced by DCGI Dr. G N Singh towards facilitating regulatory-industry relations.
While briefing Pharmabiz about the operational process of the portal, Dr S Manivannan, deputy director of drugs control in Chennai CDSCO, said all the activities for Form level licensing were made operational within two days of its launching in last year. Now, we have entered into the second stage of the high-tech revolution in the CDSCO with online activities for the ‘Export NoC’. He hopes that this development will largely help the pharma manufacturers, traders and exporters in Tamil Nadu, Pondicherry and Kerala.
The online process for ‘Export NoC’ became live on October 6, and the office received four applications on October 9. All applications were processed on the same day and issued licences on the next day. The DDC said his office has stopped receiving any application in hard copy and the licenses are certified by digital signature. He further said Chennai CDSCO office is the first zonal office in the country that has made this remarkable thing within a short time.
In last year, the operations of the portal started on June 15 and receiving and issuing of Form 11 licences started on the next day itself.
Elaborating on the activities of the central regulatory office, Dr. Manivannan said CDSCO is mainly concentrating on four regulatory approvals such as issuing dual use licences (for import of chemicals and pharmaceuticals), issuing NoC in Form 29 for manufacturers, ‘Export NoC’ and Form level licensing. Out of these, Form level licensing were started online through Sugam portal in last year, and the ‘Export NoC’ has been made applicable now. The remaining two approvals will be made online by December.
To a question he said the office of Chennai CDSCO is transparent in all spheres of activities and also in coordinating with state drugs control department. The industry and trade sector show a healthy cooperation towards the central regulator’s office.
When asked about the CDSCO’s coordination work in the state, S. Sivabalan, director of Tamil Nadu drugs control department, said very good support is getting from the central office for coordination work and immediate action is taken on all files.
Responding to the new initiatives of the CDSCO in Chennai, the Kerala state drugs controller, Revi S Menon, said no file from Kerala is pending with the central office in Chennai. The DDC is giving full support to all regulatory activities that require the cooperation of CDSCO.
Commenting on industry side, the chairman of Tamil Nadu Pharmaceutical Manufacturers Association, J Jayaseelan said no industrial unit is facing any kind of difficulty in clearing a file from the CDSCO office. A healthy industry-regulatory relation is maintained in between the regulator’s office and the industry leaders.
Source : www.pharmabiz.com
Published on: October 17, 2017