Indian pharma majors fail drug test

NEW DELHI: Medicines made by Indian pharmaceutical companies including Cipla, Pfizer, Dr Reddy’s, Lupin and Sun Pharmaceuticals among others have failed quality

NEW DELHI: Medicines made by Indian pharmaceutical companies including Cipla, Pfizer, Dr Reddy’s, Lupin and Sun Pharmaceuticals among others have failed quality tests conducted by the drug controller general of India (DCGI), the apex drug standards body.

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DCGI has launched an aggressive inspections drive against over 200 drug makers after testing 60,000 drug samples from across India under its not of standard quality (NSQ) survey. The names of the drugs were not revealed. The list of companies also include Mankind Pharma, Macleod sand Wockhardt.

The firms, which are allegedly selling low-quality medicine sand non-compliance to manufacturing norms, have been sent letters for the upcoming inspections. “Letters have been dispatched to all firms whose samples were found ‘not of standard quality’, while at many firms inspections have also begun. In the first phase, we have selected over 200 companies ,” GN Singh, DCGI told HT.

However, Cipla, Abbott and Sun Pharma denied receiving a letter from the DCGI.

Products of Cipla and Pfizer, as per DCGI sources, were observed to have maximum variations.

“We want India to be known as the cheapest but a high-quality generic drug producer in next 3-5 years,” Singh said.

The move has come after the string of quality lapses found by international regulators including US Food and Drug Administration and United Kingdom’s Medicine sand Healthcare Products Regulatory Agency(MHRA) in Indian medicines.

Regulatory raps from global agencies started with Ranbaxy Laboratories, now part of Sun Pharma, which had to stop supplies after the US FDA pointed out major violations in drugs produced at its Indian plants.

Later many companies including Wockhardt and Lupin have been sent regulatory notifications.