Dr. BR Jagashetty on Accountability in Drug Sampling Norms

New legal guidelines for sampling medicines, cosmetics and medical devices by drug inspectors of central and state drug control agencies will bring much-needed accountability. This is a good step, and good things will happen in India, said Dr BR Jagashetty, former National Adviser (Narcotics Control) to the Union Health Ministry and former Karnataka State Narcotics Controller.

Similarly, I prepared and published the most important guidelines for Karnataka in 2009 on a range of traders, consumers, government pharmacies, etc., including animal products and cosmetics, says Dr. Jagashetty.

This current DCGI circular mandates that all data on non-standard quality (NSQ) and adulterated drugs be uploaded to the CDSCO website along with the analysis report submitted by federal government inspectors. This will provide opportunities for the work being done by the recruiting team, he said.

However, the main problem arising from these legal guidelines is that CDSCO lacks agents and funds despite the appointment of drug inspectors. For example, there are many drug inspector posts available in Karnataka. The situation is similar in other countries, he said.

According to the guidelines, each drug inspector collects at least ten samples per month, nine samples of APIs, additives and dosage forms, and a sample of cosmetics and medical devices without information on veterinary drugs. There was also talk of establishing a supply chain to the manufacturer for all samples taken, a process involving dispensary workers who are currently missing, Dr Jagashetty said.

It was also noted that the NSQ report containing a copy of the test report in Excel sheet format should be uploaded to the CDSCO website on or before the 10th of each month on or before line 9, but it does not indicate its need. It is to be uploaded to the DC State Department website. "It's available, but it's different," he said.