The Central Drugs Standard Control Organisation (CDSCO) is set to become paperless within six months with completely shifting its services to online portal Sugam. The agency digitized 60-70 per cent of its services through Sugam portal so far.
In another six months we are planning to go completely electronic for all our services by doing away with requirement of any physical documents, said a senior CDSCO official.
With the launch of Sugam on November 14, 2015, firms can apply online for grant of registration certificates for import of drugs or import license of drugs in Form 10, under D&C Rules. They can also file online applications with respect to import registration and license of medical devices. Online submission has also been started for grant of approval to conduct bioequivalence studies for export purposes.
CDSCO has recently started process for online submission for clinical trial approval for Biologicals (Vaccines) on Sugam. Firms can request to test vaccine samples at CDL Kasauli and receive batch release certificate online. Firms can add their license details issued by State FDA’s on Sugam. They can submit online application for grant of approval for import and manufacture of new vaccine, registration and import license for vaccines, conducting clinical trial.
The agency is in process of starting online submission for clinical trial approval of new chemical entity. Over next three months, it will start online submission for FDC approval, grant of Certificate of Pharmaceutical Product to WHO GMP certified manufacturing units where inspections have been conducted, he informed.
Besides this, we have integrated all seven laboratories of CDSCO with Sugam and data related to samples of drugs tested in these laboratories will be uploaded on the portal from next month which will enable us to immediately alert the state drug controllers if poor drug quality is detected. It will eventually facilitate drug recall in a timely manner, he opined.
We have also developed database of drug retailers and wholesalers from ten states including Maharashtra, Goa, Gujarat, Puducherry, Delhi, Jharkhand which will soon be published on CDSCO website. The database proves to be effective in pan India drug recall, he stated.
Some states have started online process for grant of drug distribution and manufacturing licences. These portals are affiliated to CDSCO enabling it to get access to all the data generated through the system.
Apart from drug traders’ database, the agency is set to put in place a single platform containing data pertaining to manufacturing facilities in the country in a month. Efforts are being made to get states onboard so that software is provided to manufacturers who put their plants’ data in the software, said the official.
Recently the ministry of health and family welfare has notified Medical devices rules. The new rules will go into effect January 1, 2018. An authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under these rules, intending to import medical devices, will be required to make an application for grant of import licence for medical device to the Central Licensing Authority through an identified online portal of the ministry. The services of Sugam will be extended to application with respect to grant of import licence for medical device.
The agency will soon start online submission of drug samples by its drug inspectors for lab testing. The sample analysis report will be put online by the respective CDSCO laboratory. It will lead to reduction in time required in submitting the hard copy to the respective lab by drug inspectors and fast track the drug testing process. The initiative is a part of slew of measures initiated by CDSCO to make its services online, he said.
The main aim of this e-governance drive is to bring in transparency, accountability and competency in CDSCO which allows creating a real time platform and improve the safety and security programmes taken up by it.