Gujarat was the first state in the country to implement such a regulatory mechanism in around 2011-12. Here pharmaceutical stockists and druggists receive an SMS from the state FDCAs about non-standard quality (NSQ) drugs on the basis of test reports at the FDCA's drug testing laboratories. There are more than 27,000 pharmacy outlets in the state, and they can stop selling such unsafe drugs immediately after aberrations are detected in the batch.
Union minister of state for chemicals and fertilisers Mansukhbhai Mandaviya visited the Gujarat Food and Drugs Control Administration (FDCA) office a few days back. He, however, could not be reached for a comment.
Gujarat FDCA commissioner HG Koshia too confirmed the development and added that the Centre is keen to adopt the model and roll this out in the other states. "The minister also took interest in learning about the online drug licensing system that we have adopted for issuing product licenses," he added.
Any manufacturer can now apply for a product license online, the system would process the application and the license would be issued online as well. Once the process is complete, a system generated SMS would go to the applicant. Koshia claimed that such measures make the process of drug licensing speedy, as well as improve transparency and accuracy.
As for the SMS alert system for NSQ drugs that state FDCA had worked on it for three years and spent about Rs 30 lakh on development of software.
The National Informatics Centre (NIC) has developed the software for the FDCA.
The failure rate of drugs made in Gujarat, one of the leading pharmaceutical manufacturing hubs of the country, is lower compared to the national average. Koshia said that while the proportion of NSQ drugs is on the decline nationally, in Gujarat the ratio has been lower than the national average for the past few years.
"As against a national average of 5-6 per cent, the average failure ratio of drugs made in Gujarat is around 2.5-3 per cent," he said. NSQ drugs do not, however, mean that they are spurious or fake, only their quality standards are lower. Let's say if a particular drug takes 12 seconds for dissolution, a NSQ drug would take higher, may be 16-20 seconds.
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