The Central Drugs Standard Control Organisation (CDSCO), as part of its efforts to promote e-governance, has decided not to accept physical applications for approval of new drugs, fixed dose combinations (FDCs) and Subsequent New Drugs (SNDs). All applications should be mandatorily filed on Sugam, an online portal developed by the health ministry. The new rule will come into force on June 22.
The CDSCO is planning to offer all its services online through Sugam portal in a phased manner. The latest phase, a module for new drugs, FDCs and SNDs, was launched in April to further reduce time and transaction cost.
The CDSCO’s bid to offer services online is crucial as the Union health ministry is striving to digitise information key to healthcare to enable interoperability and exchange of data in the country. The Drugs Technical Advisory Board has recently agreed to a CDSCO proposal to make a declaration mechanism mandatory for all firms licensed to manufacture medicines in India. The move will help the regulator create India’s first national digital database for pharmaceuticals.
The central regulator aims at making it mandatory for all drug makers to upload the details of their manufacturing licenses and list of products on ‘Sugam’. The state licensing authorities can easily verify it by checking the inputs on the site. Once it is made mandatory, all the manufacturers will be putting details of their facilities and products regularly in the database.
The database would come in handy for the drug manufacturers and consumers alike as it provides 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 latest in a slew of measures adopted by the CDSCO to boost ease of doing business in the country. 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 seeking information regarding regulatory requirements.
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Autor(en)/Author(s): Arun Sreenivasan
Quelle/Source: Pharmabiz, 18.06.2018
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