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Regulating Biologicals

E Kumar Sharma     April 3, 2019

It is often said that the future in healthcare is crucially linked to biotech-based products. Part of it is due the nature of diseases such as cancer where biotech-based drugs are becoming important and partly driven by a move towards personalised healthcare linked to individual body make-up.

It is, therefore, important when Drug Controller General of India (DCGI), S. Eswara Reddy, says the government wants separate regulations for biological products, including vaccines and other biotech-related products - all of which are currently clubbed with overall drug regulation.

The move is significant if the end purpose is to ensure effective regulations tailored for biological products with an eye on quality and to check erring manufacturers. In fact, only a few months ago, the DCGI dealt with a case of contamination in polio vaccine samples. The industry's larger concern, however, is over-regulation and inadequate monitoring due to shortage of man and machine.

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