The Central government is good to go to streamline the licensing procedure for blood product manufacture and import by clearing the way for online submission of applications. The move is expected to help firms overcome procedural delays and ensure ready availability of safe blood products across the country.
There are scores of companies that manufacture and import blood products including packed red blood cells, platelet concentrate, fresh frozen plasma, washed red cells, cryoprecipitate and granulocyte concentrate. Each blood component is used for a different indication and their separation maximizes 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 plan is to offer import license and registration renewal through the health ministry’s Sugam portal. Registration on the portal will become mandatory and the firms may also have to upload their historical data. We’ll hold a meeting of various industry stakeholders on September 6 to discuss the proposal. A final decision will be taken after weighing the suggestions of the industry,” a senior official at the Central Drugs Standard Control Organisation (CDSCO) told Pharmabiz.
The CDSCO’s attempt to offer more services online is crucial as the Union health ministry is striving to digitize key 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 (FDCs) and subsequent new drugs and introduced an online submission process. A digital declaration mechanism was also made mandatory for all firms licensed to manufacture medicines, a move that would help the government create the first national digital database for pharmaceuticals.
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.
“Any move to streamline the blood banking system and expedite licensing is a welcome step as many of these firms are currently functioning without proper approvals,” a health professional associated with the Indian Red Cross Society pointed out. The concern expressed is valid as 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 licenses.
The CAG has been observed the complete situation and found that the non-compliance of deficiencies by the blood banks, slow in doing inspection/re-inspection, and late in issuing renewal after satisfactory inspections were among the common reasons. And according to the report, in the absence of approved licenses, an audit could not derive assurance that these blood banks had the required manpower and infrastructure for their functioning.