DCGI asks states to report instantly warnings given to Indian companies by foreign regulatory bodies

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The Drug Controller General of India (DCGI) has asked, yet again, the state drug controllers to report to him instantly the cases of alerts and restrictions by other countries issued against the Indian manufacturers and also instructed the state licensing authorities to hold inspections in such cases.

This is the third time that the DCGI is writing to the states on the same issue. Earlier, the office of the DCGI had written on June 26 and December 11 last year with the same instruction. But the states have failed to do so, prompting him to send instruction again.

“It is observed that in spite of warning/prohibition issued by various international regulatory authorities like US FDA, MHRA etc. to the Indian manufacturers, this office has not received any such information from you,” the notice by the DCGI said.

“The matter is serious in nature and therefore, you are once again requested to direct all the drug manufacturers in your state/union territory to bring all such matters to the notice of DCGI as well as the state licensing authority (SLA) concerned so that immediate action in the matter could be taken to ensure the quality, safety and efficacy of the drugs marketed in the country,” the letter said.

The DCGI also asked the SLAs concerned, in such alerts are issued, to inspect the manufacturing facilities to verify compliance to the provisions of the Drugs and Cosmetics Act and rules especially with regard good manufacturing practice.

In the earlier letters also the DCGI had asked SLAs to direct all the manufacturers that “as and when the issues relating to compliance to GMP and other aspects in manufacturing of drugs are raised and actions like restrictions and alerts are issued by any foreign regulatory authority in respect of drugs manufactured in India and exported, the details of the same should be brought to the notice of the DCGI immediately.”

Source : PharmaBiz


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