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Substandard drugs in Indian domestic market comes down to 4.5% from 8%

Shardul Nautiyal, Mumbai
Tuesday, September 6, 2016, 08:00 Hrs  [IST]

Trends on sub-standard drugs based on a nation-wide study coupled with routine random- sampling exercises done over a period of one year reveals that presence of sub-standard drugs in India has considerably come down from 8 per cent to 4.5 per cent.

Routine sampling and tests of drugs by Central Drug Standards Control Organization (CDSCO) usually check the quality of drugs using parameters like dissolution and assay.

The decrease in trend has been the key highlight of a risk-based assessment done in the country based on a statistically designed system which shows similar trends existing globally in terms of circulation of sub-standard drugs in India. Sub-standard drugs in India is no exception if compared to the trends internationally in regulated and developed markets

Says Drug Controller General of India (DCGI) Dr G N Singh, “This is an encouraging trend when it comes to comparing Indian made generics with that produced in regulated markets. This will help us dispel the myth that India is a source of sub-standard drugs as compared to any other regulated market.”
Substandard drugs are medicines that are of lower quality because of poor manufacturing, quality control, storage or packaging practices. Such drugs are different from spurious drugs, which are mostly imitations of genuine drugs and are often conspicuously labeled to deceive the patient about the ingredients, effects or manufacturer.

“Proactive measures taken by the drug regulators have revealed these trends in terms of sub-standard drugs done through a statistically designed protocol,” adds Dr Singh.   

This comes at a time when 7 drug companies in India with substantial exposure to the US market, have also disclosed in the past two months that some of their manufacturing facility inspections have reached successful closure, signaling resumption of supplies and new product filings to the US.

Union health ministry’s pan India spurious drugs survey is also underway to assess for the first time complete testing of not-of- standard quality (NSQ) drugs as per Indian pharmacopoeia and other pharmacopoeias. Only 10 per cent of the samples were tested during the pan-India study done in 2009.

Compilation of field data based on 48, 000 samples is currently being done and final report is expected to be submitted to the health ministry in couple of months time.

For effective sampling of drugs by the drugs inspectors, around 224 molecules covering 15 therapeutic drug groups were assigned a unique sequence in the format developed through a statistical design. This ensured that the drug inspector can pick up samples only on the basis of statistical design and not on their own.

Around 1000 drug inspectors were trained to execute the pan-India exercise to implement the study in the most transparent manner. The analysis and testing is facilitated through a specialised AKS software which helps in offering field data on spurious and NSQ drugs online on a consistent basis in a seamless and flawless manner.

The survey was done in collaboration with Indian Statistical Institute (ISI), Kolkata and Hyderabad and National Sample Survey Organisation (NSSO). Central Drug Testing Labs (CDTL) in Chandigarh, Mumbai, Hyderabad, Chennai, Kolkata and Guwahati, state drugs testing labs at Gujarat, Karnataka Maharashtra and a lab at Indian Pharmacopoeia Commission (IPC), Ghaziabad are part of testing and analysis.


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