India Faces Rising Threat of Spurious Drugs Amid Poor Pharmacy Monitoring

Poor monitoring of pharmacies makes this a possibility. Over 300 drug samples found substandard across India .

STAFF REPORTER

Guwahati: Even as there are frequent reports of sub-standard and spurious drugs being identified and flagged in the market by monitoring agencies, doubts persist whether such drugs are withdrawn from the market or continue to be sold by retailers.

Sources said the Central Drugs Standard Control Organisation (CDSCO) reviews quality of various medicines by collecting samples from the market every month, during which 200-250 samples are often found to be sub-standard or spurious.

Reflecting the gravity of the situation, over 300 drug samples were identified as NSQ and spurious across the country by CDSCO during routine regulatory surveillance in September this year. While the Central drugs laboratories identified 42 drug samples as NSQ, state drugs testing laboratories identified 288 such samples.

But, there is no guarantee that such drugs are withdrawn by the manufacturers or distributors. And the primary reason for this is that pharmacies dealing with such drugs are not properly monitored, especially those located in remote areas.

As per the normal procedure, once a drug of a particular batch is found to be not of standard quality (NSQ) or spurious, its manufacturer is informed. The manufacturer then intimates the distributor, who in turn asks the retailers to stop trading that particular drug and send it back to the distributor.

While this looks good on paper, doubts persist whether such drugs are withdrawn from the market, or they find their way to customers.

In Assam, there are approximately 3,000 registered pharmacies, and there have been reports in the past of spurious and fake drugs being seized from a few of them in remote areas.

Again, there are many pharmacies in the state operating without a qualified pharmacist, while there are instances of multiple pharmacies operating with the registration certificate of a single qualified pharmacist.

Further, there are weekly markets in rural areas of the state where medicines are sold openly, thus leaving little room for proper monitoring.

Given the circumstances, sources pointed out that there is ample room for NSQ and spurious drugs making it to the end users in Assam. However, sources said NSQ and spurious drugs could be identified from the print on strips, with the quality of print on the strips of such drugs being poor.

Such drugs, especially capsules and tablets, also generally chip or break easily, besides getting discoloured often, the sources added. However, all these specifications to detect a sub-standard or spurious drug are beyond the imagination of a layman who only compares the names of the drugs with the physician's prescription. Many spurious drugs even have almost identical names and looks with minor differences in spellings making it difficult for common people to distinguish them.      

The drug samples are identified as NSQ based on their failure to meet one or more specified quality parameters like strict quality, strength, purity, or identity specifications.

CDSCO and the state drug regulators declare drugs as NSQ based on laboratory testing done under the Drugs and Cosmetics Act, 1940.

CDSCO said the identification of NSQ and spurious medicines is carried out regularly in collaboration with state regulators to ensure that such drugs are identified and removed from the market.

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