The Drug Controller General of India (DCGI) has enforced a ban on the manufacture and sale of Diclofenac injection as various concerns were raised over its impact on health. The license for the manufacture of Diclofenac sodium injection 75 mg/ml was cancelled by the orders of DCGI on 4 th July 2018. The DCGI also ordered the withdrawal of the drug’s stock from the market. This order came as one of the pharmaceutical companies claimed that highly purified diethylene glycol monoethyl ether present in diclofenac sodium 75mg/ml injection caused damage to the kidneys.
The Diclofenac Battle: The efficacy and safety of this additive diethylene glycol monoethyl ether came under scanner as it was not permitted for use in parenteral preparations. Taking an account of this use the DCGI and Health ministry were approached in 2015 to stop its sale. The investigations by government were in…
