India lays down the law on biologics

As biologics and biosimilars become more prevalent, India is laying down the law on how it expects manufacturers and distributors to handle the supply chain of the drugs, particularly given the country's great variations in temperature. And it's putting the safety burden on both distributors and manufacturers alike.

India's Central Drug Standards Control Organization (CDSCO) last week released its final guidance on good distribution practices (GDP) for biologic medicines, inPharma Technologist reports. 

"It shall be the responsibility of all parties involved in the distribution of biological products to ensure that the quality of biological products and the integrity of the distribution chain are maintained throughout the distribution process from the site of the manufacturer to the entity responsible for dispensing or providing the product to the patient or his or her agent," the guidance reads.

The new rules says that each entity must clearly lay out who is responsible to see that the drugs are kept safe along the supply chain and requires "validated temperature-control systems (e.g. thermal packaging, temperature-controlled containers, and refrigerated vehicles) shall be used to ensure that correct transport conditions are maintained between the distributor and customer."

To keep tainted drugs from reaching patients, the new guidance says there needs to be cooperation among regulators, manufacturers, distributors and law enforcement authorities. 

The stakes are high to cooperate. Manufacturing of biologics and biosimilars is expected to be a growth market. A number of contract manufacturers have opened biologics plants in preparation for the expected surge and some are pairing up to make the most out of biosimilars growth.

In a deal with Merck Serono, India's Dr. Reddy's ($RDY) won co-commercialization rights for the antibody biosimilars it develops for the oncology market in the U.S. That arrangement resembles a string of collaborations which have been struck in the past year, including between Amgen ($AMGN) and Watson Pharmaceuticals ($WPI) as well as Samsung and Biogen Idec ($BIIB). Analysts expect the biosimilars market to be large, but the financial threshold to enter it will be high. And now the Indian government wants to see stakeholders get along.

- read the inPharma Technologist story 
- here's the guidelines (PDF link)