Directorate General of Health Services (DGHS) Office of Drugs Controller General (India) orders port offices to release all the consignments of imported Insulin formulations including consignments released on letter to avoid shortage of such lifesaving drugs.
DGHS has received representation from organisation of pharmaceutical producers of India (OPPI) wherein it has been stated that several consignments of Insulin formulations arc pending for release at various port offices due to delay in ongoing analytical testing at NIB, Noida. OPPI has been also stated that these Insulin formulations are life-saving products and may lead to shortage in the market due to delay in testing.
NIB has informed that during last 3 years, there has been no case of failure of imported Insulin formulations in respect of the quality parameters.
DGHS directed to release all the consignments of imported Insulin formulations including consignments released on letter of guarantee, subjected to the condition that the product shall comply with all the provisions of Drugs & Cosmetics Act 1940 and Rules, 1945 thereunder.
And in case if any released product will declared as not of standard quality by the NIB, the same shall be recalled from the market, notified by DGHS.
Further DGHS informed port offices that, "in this connection it is also directed to draw samples of r-DNA derived drugs in future, as per the risk-based criteria communicated to port offices."
