IGMPI India

October 7, 2015

October 7, 2015

PAN Drugs receives warning letter from USFDA

USFDA has recently issued a warning letter to PAN drugs Vadodara based plant due to significant deviations from good manufacturing practices.

MHRA issues recall notice of Lacri-Lube eye ointment

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a recall notice to Allergen Limited. The recall notice relates to 5g and 3.5g pack sizes of

Another Import Ban for Polydrug Laboratories

USFDA (Food and Drug Administration) issues import ban for products manufactured by Polydrug Laboratories. It was issued on Sept. 11, 2015 for

Health Canada lifts its ban from two Apotex facilities in India

Health Canada has lifted its ban from Apotex two Indian facilities. Canada’s drug regulator reinspected the two plants in June and determined

33 drugs were found to be of not of standard quality during Surprise inspection

Recently Karnataka drug control department had conducted surprise inspections to pick up drug samples at random. The drug test labs have issued their result.

Vivimed Labs successfully completes USFDA inspection of its manufacturing facility

Vivimed Labs has recently successfully completed inspection of its API manufacturing facility in Spain. After the completion of inspection Vivimed said “the USFDA inspectors concluded

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First device for migraines gets FDA approval

FDA has announced that it has approved the first medical device that can relieve migraine headache. The machine, Cerena single pulse transcranial magnetic stimulation device had been under clinical trials. It has demonstrated in 201 patient clinical trial and has proved that it is effective in relieving migraine headache in 38% patients within a span of two hours and 34% were pain free within 24 hours.

As a part of the procedure, the patients had to hold the device at the back of their head and press a button for two pulses. Each pulse is 0.9 Tesla and the duration is less than millisecond each.

During the clinical trial, some patients were also treated with a fake device and those patients showed response in two hours in 17% cases and in 24 hours in 10% cases. However, the symptoms and complaints like oversensitivity to light, sound and nausea or vomiting, which are related to migraine, were not shown.