CDSCO accepts applications for new drugs from June 22 | SND and FDC
The CDSCO (Central Drugs Standard Control Organization), as a major aspect of its efforts to promote e-governance, has chosen not to acknowledge physical applications for approval of new drugs, fixed-dose combinations (FDCs) and Subsequent New Drugs (SNDs). All applications ought to be compulsorily documented on Sugam, an online portal created by the health ministry. The new run will come into force on June 22.
The CDSCO is planning to offer all of its services online through Sugam portal in a planned manner. The most recent stage is a module for new drugs, FDCs and SNDs, was launched in April to additionally reduce time and transaction cost.
The CDSCO’s offered to offer services online is significant as the Union health ministry is striving to digitize data key to healthcare to empower interoperability and exchange of information in the nation. The Drugs Technical Advisory Board has recently agreed to a CDSCO proposal to make a declaration mechanism compulsory for all organizations authorized to make medicines in India. The move will enable the regulator to make India’s first national digital database for pharmaceuticals.
The central regulator has made an objective in making it mandatory for all drug makers to upload the details of their manufacturing licenses and a list of products on ‘Sugam’. The state licensing authorities can easily verify it by checking the inputs on the site. When it is made compulsory, all the manufacturers will put points of interest in their facilities and products regularly in the database.
The database would prove to be useful for the drug manufacturers and consumers alike as it gives details of licenses issued for manufacturing sites and drug formulations by state FDAs along with a list of approved wholesalers and retailers.
The move is the most recent in a huge number of measures adopted by the CDSCO to help simplicity of working together in the nation. The Drug Controller General of India has recently opened a public relations office at the CDSCO headquarters which can be approached by innovators and start-ups looking for data with respect to regulatory requirements.