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Average failure ratio of drugs made in Gujarat low: State FDCA

In the backdrop of several pharma manufacturing plants in the country coming under the scanner of the US drug regulator, the food and drug control administration in Gujarat pointed out that the average failure ratio of drugs made in Gujarat was lower at 3.5 to 4% compared to an overall average of around 5-6%, highlighting better quality compliance.

Interestingly, no facility from the state has come under ban from the US Food and Drug Administration (USFDA) in the last one year, claimed senior officials in the Gujarat Food and Drug Control Administration (FDCA).

Gujarat has 40 USFDA approved plants. Around 20% FDA approved plants in the country are in Gujarat, and the state enjoys a similar share in terms of India's drug exports to the US.

The Gujarat FDCA conducts regular quality checks on randomly selected samples from the market. H G Koshia, commissioner of Gujarat FDCA said, "Of the 7,000 odd samples tested last year, the average failure ratio was in the range of 5-6%. Of this, drug samples made in Gujarat registered an average failure ratio of 3.5 to 4%, highlighting the fact that quality control mechanisms are well in order here."

In the wake of rising cases of quality control violations, the commissioner of USFDA, Margaret Hamburg is visiting India between February 10 to 18. Only recently the USFDA has banned Ranbaxy's Toansa plant from exporting to the US. Big pharma like Ranbaxy, Wockhardt, RPG Life Sciences, Aurobindo Pharmaand Strides Arcolab have received import alerts from the USFDA or approvals have been withdrawn from specific facilities. India is the second largest exporter of drugs to the US after Canada. During her visit, Hamburg is expected to meet the drug regulators from some of the Indian states.

The Bavla plant of Claris Pharmaceuticals had received a notice from the USFDA in November 2010 that barred the company from exporting products manufactured at its Bavla facility to US.

FDA investigators had found violations in the current good manufacturing practices (CGMP) regulations for finished products or pharmaceutical formulations at the Bavla site, and hence imposed a ban on exports. Finally, the issue got resolved around August 2012. In another case, Zydus Cadila's Moraiya facility in the outskirts of Ahmedabad had received a warning letter from the USFDA in June 2011, which was eventually revoked in July 2012.

Ever since the cases of FDA ban, the local drug regulator has upped its vigil. Koshia said, "We try to monitor facilities on a regular basis, and more than that, we are trying to create a culture of quality compliance in the state, such that even medium sized companies do not fail on compliance tests." As per the directives of the Drug Controller General of India directives, at present, local drug inspectors accompany USFDA officials when they visit plants for inspection.

Koshia would be giving a presentation on the scenario of the pharmaceutical industry in Gujarat before Hamburg in Delhi this week.

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