Flooded with complaints that “sub standard” diagnostic kits are entering the country from China, a three-member delegation will audit and inspect manufacturing units in China.
India gets a major chunk of imported diagnostic kits from China. “However, with complaints that the imported diagnostic kits are not of standard quality, it has been decided for the first time to carry inspection on the units producing diagnostic kits in China,” said a senior official.
As part of its efforts to ensure quality products entering India earlier in May last year, the ministry had sent a delegation to China for auditing and inspection of drug manufacturing plants. The decision was taken after several import licenses were cancelled failing to comply with Good Manufacturing Practices (GMP).
About 60-70 per cent of the bulk of drugs comes from China. The delegation inspected five pharma companies in China then. “While, there were no major irregularities found in the drug manufacturing units. The registration of one of the units was cancelled after it did not allow the inspectors to audit,” added the official.
This time, the inspectors are expected to inspect about six diagnostic manufacturing units. Officials say that following the complaints of sub standard quality drugs and diagnostic kits from China, the ministry has already written to the Chinese Food and Drug Authority (FDA) that some Chinese drug firms that export bulk drugs to India are expected to not complying to GMP. “The FDA on the other hand asked us to carry out inspections. Following which the decision was taken. The inspection will help us know whether the manufacturing units are adhering to the GMP or not, so that further action can be taken,” added the official.
The ministry has plans to extend the inspection proves to all manufacturing sites situated abroad. The team is expected to visit Italy after the delegation comes from China.