Central Drugs Standard Control Organisation(CDSCO) is determined to streamline the process of regulatory clearances and provide a robust environment for drug approvals in the country, according to Dr G N Singh Drugs Controller General of India (DCGI).
Dr Singh who was in Bengaluru in connection with the launch of the Karnataka Pharmaceutical Policy (KPP), said, “We are now working to create a simplified single window clearances for all drug licenses. The pharma industry has done its best for making its presence felt in the global market. Now it is the turn of the drug regulator to gear up and meet the needs of the industry.”
The CDSCO’s role to act as the competent authority to issue clearance certificate for compliance to good manufacturing practices (GMP) for drugs as per the requirements of European Union indicates its renewed focus to provide a more efficient environment, he said.
Appreciating the efforts of the Indian pharma industry’s to export to 280 countries and the vaccines to 150 nations the DCGI stated that it was the quality of Indian products that is driving the export efforts.
Some of the efforts that would lead to a transformation in the working processes would be to do away with the multi layer structure of the drugs control office at the Centre which is complicating the clearances for drug discovery approvals. This calls for decentralization of the state drugs control department across the country, said Dr Singh.
“In an age of new pharma and biotech entrepreneurs, there is need to update and modernize systems. This is where we see the need to amend Drugs and Cosmetics Act (D&C Act) and create an environment for the industry to be work in an efficient manner meeting the timelines,” stated the DCGI.
“CDSCO has embarked upon setting up of zonal offices and has seen the need for sub-zonal offices to further give the much needed support. Going by the performance of the state drugs control department and the industry in Karnataka, we are keen to set up a dedicated CDSCO office her,” he said.
Following the announcement of DCGI, the Karnataka health and family welfare minister Aravind Limbavali who was present at the occasion readily consented to allocate the required land for the same in the state .
The DCGI also interacted with the Karnataka Pharmaceutical Drugs Manufacturers Association (KDPMA) to understand the issues facing the units.