The government of India has prohibited manufacture, sale and distribution of 344 Fixed Dose Combination (FDC) drugs that are likely to involve risk to human beings (when safer alternatives to the said drugs were available). It has issued a gazette notification to this effect on March 10.
An expert committee said these drugs were found to have no therapeutic justification and the same was officially communicated to the Drug Control Administration (DCA) of Telangana on Monday, said Drug Controller, Dr. Akun Sabharwal.
Complete withdrawal
Following the advisory, Assistant Directors and Drug Inspectors of the DCA have been instructed to recall/ensure complete withdrawal of the said FDC drugs from the market with immediate effect and inform to the head office the quantity recalled, on a daily basis.
Also, the Telangana State Chemist and Druggist Association has been asked to inform their members to recall the drugs and refrain from sale and distribution of the same.
The Organisation of IDMA, Pharmaceutical Manufacturing Association, Bulk Drug Manufacturing Association have been requested to inform their members too, about this. A press release said the Indian Medical Association was also asked to inform it’s members not to prescribe these drugs.
A list of prohibited FDCs has been uploaded on the DCA website dca.telangana.gov.in under the head ‘Circulars’.
