Registration of cancer drug in one day raises eyebrows

By Don Asoka Wijewardena

The Health Ministry’s Cosmetic Devices and Drug Regulatory Authority (CDDRA) is alleged to have by passed a Consultant Oncologist and issued a license to the local agent of an Indian Drug Company in one day.

A senior official, at the Health Ministry’s Laboratory Services, said that Marks Healthcare (Pvt.) Ltd, the local agent for the Indian drug producer Panacea Biotech Ltd., had, on November 8, applied to the CDDRA for registration and a licence to supply a cancer drug named Paclitaxel (Protein Bound Particles for Injectable Suspension 100 mg (Pacliall). The CDDRA had on the day of receiving the application itself, without consulting the Consultant Oncologist, registered the agent and issued the licence. He said that when a local agents applied for registration and licences, they would normally have to wait for between six moths to one year to receive it but in this case the CDDRA had been unusually fast.

He said the file and documents on the drug would be sent to Oncologist Dr. Jayantha Balawardena on November 18 for evaluation and recommendation. But, the procedure was that the Consultant’s evaluation and recommendations should be sought before registering and issuing the licence for a drug.

He said that even in India the drug named Paclitaxel had to be placed on a six-month probation. But, in this case the CDDRA had flagrantly violated the procedure of registering and issuing the licence.

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