More than 10 percent of Drug samples from Government sources Not of Standard Quality
New Delhi: Estimated 10.02% medicines of the sample of medicines from government sources tested by the government were found to be Not of Standard Quality (NSQ), the Minister of State for Health and Family Welfare recently informed the parliament.
The minister was responding to a question raised in the parliament asking whether the Government has conducted any survey into the quality of medicines being distributed in the Government hospitals
Responding to the question, through a written reply the minister informed that a nation-wide survey (2014-16) was conducted to assess the extent of Not of Standard Quality (NSQ)/Spurious drugs by drawing samples from both Government and private sources. Out of a total of 47012 drug samples drawn, 17.8 per cent samples were drawn from Government sources. The estimated percentage of NSQ and spurious drugs from Government sources were found to be 10.02% and 0.059% respectively.
The minister further informed in the survey report, recommendations for the role and responsibility of various stakeholders in addressing the problem of spurious and NSQ drugs in the country have been made.
Accordingly, the Government has taken various regulatory measures to ensure the quality of medicines distributed in the country. The report has also been shared with all the State Governments and Union Territories Administrations and they have been requested to take urgent remedial measures to improve the quality of drugs in the country including by way of taking legal samples of the same batches of drugs as were declared NSQ, for testing.
Drugs are assumed to be Not of Standard Quality if they do not meet the regulatory requirements for Standard Quality as defined under the Drugs and Cosmetics Act.
Under the same act, a drug is classified as Spurious if
(a) if it is manufactured under a name which belongs to another drug; or
(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or
(d) if it has been substituted wholly or in part by another drug or substance; or
(e) if it purports to be the product of a manufacturer of whom it is not truly a product