Testing of drugs from some nations eased
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Synopsis
The government has decided to reduce the frequency of testing for drugs imported from certain countries, provided their samples have not failed quality tests in the past five years. Random sampling will be conducted periodically, and any failed samples will lead to increased testing. New sources must undergo compulsory testing.
New Delhi: The government has decided to reduce the frequency of testing for drugs imported from countries such as the United States, Australia, Japan, Canada and from the European Union, provided their samples have not failed quality tests in the past five years.
In such cases, the frequency of sampling is to be reduced to any one consignment in two years or to any one consignment in sequential 20 consignments, whichever is earlier, according to new guidelines issued by the Central Drugs Control Organisation (CDSCO).
To ensure that quality drugs enter the country, random sampling of any one consignment in six months or of any one consignment in sequential 10 consignments, whichever is earlier, is to be done, as per the guidelines. If the sample of any product fails the quality test, then sampling has to be done on subsequent five consecutive consignments of the product.
If the product is from a new source, it has to compulsorily undergo testing. In case the product fails the quality test, the importers will be given the option to have the goods either reshipped to the country of origin or have them destroyed in the presence of assistant drugs controller or a customs officer.
To ensure better quality products, the CDSCO has started undertaking surprise inspections of pharmaceutical units in the country.
The government has come out with a document to provide guidance to port officers to take appropriate decisions for monitoring quality at the port of import based on a risk-based approach.
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