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CDSCO Eases Sampling Restrictions Of Insulin And Other R-DNA Derived Products

The organization of pharmaceutical producers in India(OPPI) informed the CDSCO about some insulin shipments pending testing and approval before their release from port offices.

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CDSCO Eases Sampling Restrictions Of Insulin And Other R-DNA Derived Products

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  1. CDSCO Eases Sampling Restrictions Of Insulin And Other R-DNA Derived Products The organisation of pharmaceutical producers in India(OPPI) informed the CDSCO about some insulin shipments pending testing and approval before their release from port offices. Following which, the authorities took up some important steps to ease this process of approval on port offices. Testing is an important step in the regulatory process for import of drugs in India, and hence this matter requires proper attention.

  2. What was the issue? According to the OPPI, many consignments of insulin formulations were pending for release at various port offices due to delay in analytical testing at NIB, Noida. OPPI also expressed concerns about the shortages of such life saving drugs on the market which will cause a negative impact on the local supply chain and health of people. It is important to note that all insulin and other r-DNA derived products have to be tested at NIB, Noida for compliance, before they can be released to the importers for sale in the local market. Upon deliberating over this issue, CDSCO directed the port offices to release all such consignments including consignments released on letter of guarantee. However, with subject to the condition that these products should comply with the provisions of the Drugs & Cosmetics Act, 1940 & 1945. Moreover, the Indian agent shall submit an undertaking that if found unfit by NIB, these products shall be recalled from the market.

  3. Furthermore, CDSCO also stated that samples of r-DNA based products(like insulin) shall only be drawn from batches when communicated to port offices based upon the risk criteria. One very important basis for CDSCO to approve these changes was a report from NIB. Which states that no insulin formulations imported in the previous 3 years were found unfit on the quality criteria. Impact of this decision This decision from CDSCO will have a very major impact on the import and sale for r-DNA based products. The prerequisite for sampling and testing of imported drugs causes a great delay between the import and sale. It was also a very pesky issue for importers as they had to deal with delayed supply causing a gap in the business process of expenditure and income.

  4. The elimination of the need for sampling will now facilitate quick movement of imported r-DNA products between the ports and the market.Thus ensuring that no shortages occur and the wholesalers are not deprived from good business opportunities. However, it is now the responsibility of the manufacturers and the local importers to ensure that the best quality product reaches the consumers.

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