Beware, you may be consuming sub-standard drugs!

Source: The Hitavada      Date: 04 Apr 2018 10:22:20


By Rajendra Diwe,

Beware! Are we consuming ‘not of standard medicines’, be they generic, branded, ayurvedic, homoeopathic or allopathic?

The recent report of the Comptroller and Auditor General of India about the performance audit on Food and Drugs Administration (FDA) which has covered test-check records for the period 2012-2017 revealed this serious issue. The report says, “FDA has no proper mechanism of recalling the ‘Not of Standard Quality (NSQ)’ or if it has, the delay in the entire process of collecting samples, sending for the tests to Drug Control Laboratories and on the basis of the analytical reports issuing orders to recall the medicines resulted in consumption of the NSQ drugs by the public.”

The Hitavada has procured the sample test reports of Public Analyst for the period January 1, 2018 to March 31, 2018. It is observed that during the period 129 samples have been declared by public analyst as NSQ. (January-50, February-43 and March-36).
The names of medicines listed in the reports when checked, it is found that there has been a long gap in the date of manufacturing, date of collection of sample and date of receiving the report.

The test record of six medicine samples collected and received by Nagpur Division has clearly indicated the fact.
For Example, Drug Inspector from Yavatmal had sent a sample of Providone Iodine in February 2018 to Public Analyst. The sample had Mfg Date: 25/4/2010 and Ex Date: August 2018. The report of Public Analyst dated March 31, 2018 has declared it as NSQ because of less content than label claim.

Do you think? A product
manufactured in 2010 remains on the counter for sale? This means, the consumers had already used the same.
In another case, a product named Tiger King Ayurvedic Capsules of which sample was collected by Drug Inspector of Wardha on November 8, 2017. The report of public analyst on March 28, 2018 has stated that it has no Ayurvedic medicine but Sildenafil Citrate (a drug for erectile dysfunction). Do you think, if a consumer gets quick response with this ‘Indian Viagra’, is it available on shelf for sale?

A multivitamin syrup named ‘Lycoptin M Syrup’ which has manufacturing date: May 2017 and Expiry October 2018. The sample of which collected by Drug Inspector from Nagpur on October 18, 2017. FDA Nagpur received Analyst Report on March, 27, 2018 that is after six months. The report has declared the syrup as NSQ because Vitamin A was 60 percent of the labelled amount and Vitamin C 53 percent of the labelled amount. Even FDA officials have no idea whether the product is on shelf or out of shelf.

Bhandara Drug Inspector on November 28, 2017 collected and sent samples of Mario-CV syrup (Amoxycillin+Clauvenic Acid) an antibiotic dry syrup for kids. The product has Mfg Date: February 2017 and Expiry Date:July 2018. The Analyst Report received on March 27, 2018 has revealed that it had Amoxycillin 67.78 percent of the labelled amount and the clauvenic acid is just 0.97 percent (no trace) than the labelled amount. This means the consumer had paid money for clauvenic acid which is not existed and less amount of Amoxycillin than the required dose. As the product is expiring in July 2018; when the FDA would act to recall the same? The question for which no one gets an answer.

Another product sample of ‘Panqub D tablets’ (Pantoprazole 40 mg Domeperidome 10 mg tablets) a brand of now a day Hot Cake for controlling acidity was collected by Drug Inspector in Bhandara on January 22, 2018. The product has Mfg Date: November 2016; and Exp Date: October 2018. Analyst has termed as NSQ on March 28, 2018 because of less contents of drugs than labelled amount. The consumers may have consumed the medicine for relief of their acidity.

Dika Tablets (Doaclofenac+Serratiopepdiase) a brand of pain killer having MfgDate: April 2017 and Exp date: August 2018. Sample was collected from Bhandara by Drug Inspector on October 24, 2017; Analyst report received on March 27, 2018 that is after six months stating 70.65 percent of Serratiopepdiase than labelled amount. One may think about the relief of pain of the patients who have consumed the same.

CAG audit report says, “ During 2012-2017, total samples tested by Drug Control Laboratories (DCL) in Maharashtra state were 26,437. Out of them 22,336 were found standard quality and 2,075 samples have been declared as NSQ. Surprisingly, in 2, 026 test reports (eight per cent) no opinion was given on the samples. 1,589 samples pertained to Ayurvedic drugs and 434 samples pertained to other than Ayurvedic drugs.”

“Test reports on the drugs tested were issued after 90 days from the date of receipt of sample in the DCLs, in 10,501 (40 per cent) samples tested the delay in
recalling Not of Standard Quality (NSQ) drugs resulted in consumption of the NSQ drugs by the public.
In 95 (25 per cent) out of 375 cases scrutinised in audit, more than 50 per cent of the NSQ drugs were already consumed before they were recalled. Of this, in 61 cases, the entire stocks of NSQ drugs were consumed and therefore could not be recalled.”

CAG has also raised a question about the ‘Standard Drugs’. It says, “The DCLs have no facilities for testing the microbial counts and advanced mechanism, then how they have declared the drugs as standard and safe?”