Exclusive : 'Substandard’ Medicines Production increasing in India

1
84

“Not of Standard Quality”  NSQ, is the drugs which are not complying to quality standard fixed by CDSCO

USFDA raised concerns many times on the quality and efficacy of medicines being sold in India.

Dated 25 February 2017, USFDA’S India director Mathew Thomas addressed in an annual conference of the forum that he had tested some of the drugs (sold here in India), and discovered that they were not of standard quality.

Now a days Central Drugs Standard Control Organization (CDSCO) are very active, aware and doing well as result frequently audits of Indian pharmaceutical manufacturing facilities to meet Schedule M requirement. Mostly plant audited by CDSCO from November 2016 to till date.

In spite of all efforts of CDSCO inspections, manufacturing of Substandard drug is still continued in India.

PharmaPathway collects the List of NSQs (“Not of Standard Quality”) drugs from CDSCO official website.

As compared to previous year, production of substandard medicine increased in country. Some of these drugs are manufactured by big brands such as Cipla, Cadila, Sanofi. These NSQs covers all category of medicine like painkillers, fever, cold constipation, loose motion, calcium and iron supplements.

As per sample pick up and analysis of these drugs these are not complying following test as cited ‘Description and particulate matter’, ‘Dissolution’, ‘Misbranded’ and ‘Disintegration’, ‘Volume of injection’, ‘Assay, ‘Bacterial Endotoxin’, ‘pH’ among others.

Year wise  data collection help us to understand the current scenario of increasing “Not of Standard Quality” drug

In 2015 – Total 161
Month No. of Drugs
January 10
February 17
March 14
April 09
May 15
June 19
July 7
August 6
September 17
October 14
November 18
December 15

 

In 2016 – Total 242 
Month No. of Drugs
January 25
February 27
March 18
April 17
May 18
June 17
July 13
August 20
September 15
October 22
November 29
December 21
In 2017 – Total 149 (till end of may)
Month No. of Drugs
January 18
February 17
March 60
April 23
May 31

 

These data  are stating the health of pharmaceutical Quality of drug.