Updated on 31 October 2012
There has been increase in the number of tainted drugs that reach the customers. To avoid such instances, the guideline presses on the point that there needs to be better cooperation among regulators, manufacturers, distributors and law enforcement authorities. It is also stated that all biological product distributors shall establish and maintain quality system. The guideline urges the documented quality policy describing the overall intentions and requirements of distributors regarding quality.
There have been a number of collaborations in the past, for instance in August this year, Dr. Reddy's won the co-commercialization rights for antibody biosimilars that Merck Serono develops for the oncology market in the US. This new guideline is expected to help boost such collaborations by further streamlining the process of distribution of biologics products and to make sure proper instructions are in place for the manufacturers till the product reaches the customers. To read the complete CDSCO guidelines in .PDF format, click here.