Drug Controller begins review of alarming findings on substandard drugs from a new pilot study

February, 2016  
A new pilot study conducted across two drug categories by academicians from the Department of Pharmacy, Jaypee University of Information Technology, Solan (Himachal Pradesh) has found high incidence of substandard drugs.
"Our idea was to only raise a question that if a pilot study has found this, then what about the rest of the drugs sold in the country?" says Ahmed Nawaz Khan, Assistant Professor and a co-author of the study. Although he and others have not approached the Indian drug regulator with their findings, he says: "The aim was to alert the regulator though our pilot study." The findings of the study were published in the Journal of Applied Pharmaceutical Science, December 2015. 
 
So, what is the Indian drug regulator doing about this, since the pilot study talks of as much as around 15 per cent substandard drugs in one case?

Official estimates put the figure at not more than 4.5 per cent. "This came as a news to us. It is a matter of investigation and we are looking into this. I have now put a very high level officer on the job to look into the matter," says G.N. Singh, the Drug Controller General of India. "We want to investigate the methodology adopted for this study and the test protocols deployed."

He is quick to add:  "We are open to revisiting and reviewing our estimates on substandard drugs, but we need to ensure the data arrived at is science-based and driven by the right methodology recognised nationally and internationally. I hope to get some preliminary findings on this in the next 15 to 20 days."

Explaining the methodology to sources, Khan, says: "Regulators normally collect random samples. We did not do that. For this pilot, I specifically sought samples of cheap drugs and we collected 32 samples of diclofenac sodium, a painkiller and 46 samples of amoxicillin trihydrate, an antibiotic. We found 15.62 per cent substandard for diclofenac sodium and in case of amoxicillin, 13.04 per cent were found substandard."

He also says this is a pilot study and therefore cannot be compared with the national level government estimates, which finds a total of around 4.5 per cent drugs substandard and involves thousands of products. "We have collected samples for two drugs and that, too, from north India. We picked up these samples from Delhi, Meerut, Saharanpur and Ludhiana," says Khan.

The DCGI, who has himself earlier been a Director of a Drug Testing Laboratory, says matters such as these need to be looked at closely as they impact public health and would also be a matter of concern not just for the local and national drug regulators but also for the 35 drug testing laboratories within the government sector and the 200-odd within the private sector, with about 75 of them ISO and NABL accredited. NABL is the National Accreditation Board for Testing and Calibration Laboratories, an autonomous body under the aegis of Department of Science & Technology, Government of India. Business Today