CDSCO approves Form 11 in ONE DAY! – SUGAM Portal Magic

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Encouraged by the Union government’s initiatives towards facilitating regulatory-industry relations, the south zonal office of the Central Drugs Standard Control Organization (CDSCO) in Chennai has kicked off the online issuance of licences and approvals following the introduction of the CDSCO’s high-tech online application system, known as ‘Sugam’.

Dr S Manivannan, the deputy director of drugs control at Chennai CDSCO office has claimed that the high-tech system has operated first in Chennai zone.

“We received applications on June 15, which was the deadline given for online application, we processed the same on the next day, June 16, and issued approval for Form 11 on 17th itself. This is a major achievement as far as both the industry and the regulator’s office are concerned,” he told Pharmabiz.

Form 11 is for grant of licence to import drugs for the purpose of examination, test or analysis. The DCGI has made it mandatory with effect from 15.06.2016.  This is issued online by the DDC at the zonal offices. The first such operation was held in Chennai office.

He said the operation of ‘Sugam’ portal is part of the e-governance facility of CDSCO and it is an initiative for enhancement of services to high-tech facilities and Chennai office is the first one to start within the entire country.  Previously, a minimum of five days time would be taken for processing and issuing approvals or licences.

Prior to the introduction of the online solutions in south India, the DDC has called for a stakeholders meeting at his office in which all the Tamil Nadu based pharma manufacturers, especially importers and exporters, attended. R Chandrasekhar, deputy director at CDSCO headquarters in New Delhi was the chief guest. IDMA Tamil Nadu state board president J Jayaseelan and secretary T Satheesh were also present on the occasion.
 
While explaining the benefits of the Sugam portal, the DDC at the CDSCO, New Delhi said the online solution offers advantages for patient community, industry people and for the regulatory staff on various things.

Jayaseelan said this high-tech facility would provide better and quick services to the pharma manufacturing companies and other associating business firms. The people of the industry can reduce their travel cost, better use their time and speed up the operations. Earlier, a manufacturer has to go to the CDSCO office several times for submission of applications, tracking the status of submitted applications and receiving licences. The online facility is a onetime solution for all the problems.

Dr Manivannan said he received only one application from Tamil Nadu as the people are now getting to know about it. When asked whether his office has given information to the manufacturers in Kerala, he said there is no big manufacturing company in Kerala. When the DDC’s response was taken to Kerala Pharmaceutical Manufacturers Association (KPMA), Purushothaman Nampoothiri, its president, said the CDSCO office is not giving any attention to Kerala companies.

Source: 1, 2

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