Relief for patients? Substandard medicines in retail shops just 3.2%, shows survey

Published: March 9, 2017 5:31 AM

The prevalence of not-of-standard-quality (NSQ) medicines at retail outlets across the country is 3.16%, while that of spurious drugs is a minuscule 0.0245%, according to the National Drug Survey 2014-16 of the Union ministry of health and family welfare.

According to the ministry, this is the largest-ever survey carried out by any country in the world to ascertain the quality of drugs. (Reuters)

The prevalence of not-of-standard-quality (NSQ) medicines at retail outlets across the country is 3.16%, while that of spurious drugs is a minuscule 0.0245%, according to the National Drug Survey 2014-16 of the Union ministry of health and family welfare.

While this is a cause for concern, officials said the findings refute the alarming data put out by the United States Trade Representative (USTR) in the latest edition of its Special 301 Report, which said “up to 20% of drugs sold in the Indian market are counterfeit”.

According to the ministry, this is the largest-ever survey carried out by any country in the world to ascertain the quality of drugs. Talking to FE, a senior official from the domestic pharmaceutical industry welcomed the report and argued that if India-made drugs are of questionable quality as suggested by the USTR, the country’s pharmaceutical exports would not have grown by leaps and bounds over the years.

“Pharma exports from India grew at an impressive 11.4% during 2015-16 when the total goods exports declined by 15.48%. The Indian pharmaceutical industry is valued at approximately $30 billion, and more than half of it is exported to different countries across the globe. The survey results comprehensively junk the notion that India is one of the chief producers of fake drugs in the world,” the official, asking not to be identified, said.

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Armed with the results of the new study, India could well challenge the US’s virtual campaign against Indian drugs, D G Shah, secretary general, Indian Pharmaceutical Alliance (IPA), said. “The survey findings fly in the face of USTR’s assessment of drugs manufactured in India,” Shah asserted.

Out of 69 different tests performed on the samples from retail outlets, 28 were found to be negative, with with non-compliance largely of dissolution and assay rather than of the substance as such.

The total number of non-compliance out of all tests of all samples from government sources was 1,177, of which, assay and dissolution accounted for 46.1%. The fact that the not-of-standard-quality drugs from government sources are 3.17 times higher than in the retail implies that there is something wrong in the existing procurement processes, the survey concluded.

Further, lack of uniform levels of enforcement may be leading to difference in the extent of NSQ in retail outlets and the government supply chain across different parts of the country.

Additionally, the NSQs are much higher in case of parenterals as compared with oral dosage forms and this aspect therefore needs special attention, the survey observed.

Interestingly, 98.51% of the samples drawn at the air or sea ports were active pharmaceutical ingredients (APIs) of which 91.87% were from China. And, a particular company from China alone accounted for 26.82% of APIs imported into India.

The survey said given this finding, strong measures to “upscale existing indigenous production capacity of APIs” are urgently needed. Industry sources point out deeper issues causing strong preference for cheaper Chinese API imports by the Indian manufacturers. Chinese API producers enjoy a huge cost advantage over their Indian counterparts in terms of easy access to land, energy, cheaper funds, relatively liberal environmental norms etc.

– Dibyajyoti Bhattacharjee

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