Made in Gujarat: Share of non-standard quality drugs lower than India average

The percentage of NSQ drugs in the state has been in the range of 2-2.5% as compared to an all-India average of 5-6%

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. The percentage of non-standard quality (NSQ) drugs out of the random drug samples collected from the market is low, the state drug controller pointed out.

Over the past five years or so at least, the percentage of NSQ drugs has been in the range of 2-2.5% as compared to an all-India average of 5-6%.

Gujarat is also one of the leading states when it comes to collecting samples for testing for quality as well as spurious or fake drugs. In 2014-15 the Food and Drug Control Administration (FDCA) had collected 11,704 samples for testing while in 2013-14 it was 10,452 samples, and in 2015-16 it was 7,192 samples taken up for testing. In comparison, other leading pharma manufacturing hubs like Maharashtra collected 4,502 samples for testing in 2015-16.

Of the total samples tested, percentage of NSQ samples manufactured in Gujarat was at 2.08% in 2015-16 and 2014-15, while it was higher at 2.52% in 2013-14 and around 2.33% in 2012-13. Compared to this, the percentage of NSQ samples that were manufactured in other states  were at 3.25% for 2012-13, 3.32% in 2013-14, 2.49% in 2014-15 and 2.79% in 2015-16.

This is out of the samples collected in Gujarat. Senior state government officials pointed out that the all-India average for NSQ drugs was around 5-6%. 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.

"We are one of the leading states when it comes to collection of samples for testing, and we are also ramping up our efforts to crack down on spurious and fake drugs," said H G Koshia, commissioner, Gujarat FDCA. The FDCA has started a mobile drug testing laboratory and has recently cracked down on six cases of spurious drugs some of which were manufactured in Himachal Pradesh and bordering Rajasthan.

Year	No. of Samples received	Samples Tested	Samples of Std Quality	NSQ Samples	% of NSQ samples made in Gujarat	% of NSQ samples from other states
2012-13	9257	6832	6455	381	2.33%	3.25%
2013-14	10,452	9713	9146	567	2.52%	3.32%
2014-15	11,704	11,300	10,784	516	2.08%	2.49%
2015-16	7192	7500	7135	365	2.08%	2.79%
Source: Food and Drug Control Administration, Gujarat

Failure Ratio of Drugs
Year	National Average	Gujarat
2009-10	11%	9%
2010-11	7.11%	5%
2011-12	10.50%	6%
Source: FDCA, Gujarat