The Central Drugs Standard Control Organisation (CDSCO) is in the process of strengthening the functioning mechanism of its administration including its nomenclature. The office is also working in revamping the Drugs and Cosmetic Act 1940 and planning to launch the Sugam Version II, informed Dr S Eswara Reddy, Joint Drugs Controller, CDSCO.
He also said, “We are in the process of developing a single portal for approval application, however, post the submission of the application it will be directed to respective State licensing authorities for approval. It will bring more transparency into the system as well as speed up the process. We are also coming up with Version II of the Sugam portal. To give priority to innovation and research, the CDSCO has also come up with a public relation office.”
He also added that the CDSCO is also making a list of Government facilities for R&D and innovation and will be making the list available on the CDSCO website so that any innovator can use the Government facility for R&D purpose.
Acknowledging the need for a single department dedicated for the pharma industry for research approval, he informed that recently an interim meeting chaired by the Secretary of MoH&FW was organised with the CDSCO officials to address the issue.
He also mentioned that the industry doesn’t like the test license but unlike developed countries, in India, we do not have the mechanism to monitor medicines consumption of each gram. There are high possibilities that the researched formulation gets commercialised, therefore, the insistence on research approval. Overall, the objective is to ensure ease of doing business along with ease of doing research.
Summing up, he said that if a company already has a research license then its application automatically gets approved online based on its previous application/s.