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Registration, licensing process for blood products to go online from Sept 26; e-filing of application on Sugam portal made mandatory
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Arun Sreenivasan, New Delhi
September 22 , 2018
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The licensing process for blood product manufacture and import in the country will go online on September 26. The Central Drugs Standard Control Organisation (CDSCO), which had held a meeting with various industry stakeholders earlier this month to discuss the plan, has also decided not to accept physical applications for registration and import of blood products from next week.
The national drug regulator will launch an exclusive module to facilitate digital submission of applications for registration of blood products such as packed red blood cells, platelet concentrate, fresh frozen plasma, washed red cells, cryoprecipitate and granulocyte concentrate on its e-governance portal ‘Sugam’.
Each blood component is used for a different indication and their separation maximises the utility of one whole blood unit. While these life-saving products are key to the treatment of hemophilia, hepatocellular carcinoma and other serious liver diseases, they need specific storage conditions and constant monitoring of the industry is imperative to ensure safety and therapeutic efficacy.
The move to make registration process online is expected to help domestic manufacturers and importers reduce procedural delays and ensure ready availability of safe blood products. “Registration on the portal is made mandatory and the firms may also have to upload their historical data,” a senior CDSCO official said.
The CDSCO’s attempt to offer more services online is crucial as the Union health ministry is striving to digitise healthcare information to enable interoperability and data exchange. In June, the regulator had stopped accepting physical applications for approval of new drugs, fixed dose combinations and subsequent new drugs and introduced an online submission process. A digital declaration mechanism was also made mandatory for all drug firms, a move that would help the government create the first national digital database for pharmaceuticals.
Healthcare professionals have been batting for steps to simplify licensing procedures and regulate blood bank system as many of these firms are found to be functioning without proper approvals. A recent report by the Comptroller and Auditor General of India (CAG) has revealed that nearly half of the 68 government and private blood banks in Delhi have been functioning without licences.
The CAG observed that “non-compliance of deficiencies by the blood banks, delays in conducting inspection/re-inspection and delays in issuing renewal after satisfactory inspections” were among the reasons for such a situation. “In the absence of valid licences, an audit could not derive assurance that these blood banks had the required manpower and infrastructure for their functioning,” the report had stated.
The Indian blood banking system is controlled by central and state drug control authority under Drug Controller General of India while National AIDS Control Organisation acts as a facilitator to transfusion services on behalf of the health ministry. The average annual blood collection in the country is around 7-8 million units. The availability of safe blood is crucial as the country is facing a shortage of blood and blood components.
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