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27 April 2010

State FDA lists 44 drug samples as not-of-standard drugs in March

Maharashtra Food and Drug Administration (FDA) has found 44 drugs not-of-standard-quality during its inspection in March 2010. Most of the not-of-standard-quality drugs were from tax-holiday states Himachal Pradesh and Uttaranchal. And every month, the number of sub-standard drug samples keeps increasing and firms from these two states have major share in this list.
27 April 2010

Work for vaccine production started in 2 PSUs, BCG Lab in Chennai yet to get green signal

Even as two of the three PSUs, CRI in Kasauli and PII in Coonoor, have run into action within two months of accepting the order of resumption of vaccine production from the Union Health Ministry on February 26 this year, the BCG Vaccine Lab in Chennai is still waiting for approval from authorities to commence operations, it is learnt.
27 April 2010

Glenmark's oral contraceptive gets FDA nod

Glenmark's US subsidiary Glenmark Generics has been granted approval by the United States Food and Drug Administration (FDA) for Norethindrone tablets 0.35mg—its generic version of Nor-QD. The product will be marketed under the trade name Heather and distribution is expected to start immediately.
26 April 2010

AIIMS to conduct conference on care of children born with cleft lip, palate & craniofacial anomalies

The All India Institute of Medical Sciences (AIIMS), New Delhi is hosting a conference on the care of children born with cleft lip, palate and craniofacial anomalies. The programme is part of the ninth Annual Conference of the Indian Society of Cleft Lip palate and Craniofacial Anomalies which is being held in New Delhi from April 23 to April 25.
26 April 2010

Indian pharma companies will become product companies, Reinhard Gluck, Cadila, India

The foremost challenge for any pharma company with biotech divisions or units in the Asian region is bringing out the product. We do not have too many products. However, I have been convinced that at least some Indian companies will do it.
26 April 2010

Liraglutide Superior to Sitagliptin When Added to Metformin for Glycemic Control

The addition of a glucagonlike peptide-1 (GLP-1) agonist in patients with inadequate glycemic control when treated with metformin alone resulted in significantly larger reductions in HbA1c levels when compared with the addition of a dipeptidyl peptidase-4 (DPP-4) inhibitor, a new study has shown.
26 April 2010

FDA Launches Campaign to Improve Infusion-Pump Safety

The US Food and Drug Administration (FDA) today unveiled an ambitious campaign to improve the safety of external infusion pumps, which have triggered 56,000 FDA adverse event reports linked to more than 500 deaths and 87 product recalls from 2005 through 2009, according to the agency.

The campaign mostly affects the makers of external infusion pumps, which may find FDA inspectors visiting their plants to ensure that safe manufacturing and testing processes are in place.
22 April 2010

IPA to conduct panel discussion on: how to handle expired drugs, next month

In the wake of the present expired drugs scam that plagued the entire pharma industry in Tamil Nadu, the Industry Division of the Indian Pharmaceutical Association plans to conduct a Panel Discussion on ‘How to Handle the Expired Drugs’. The programme will be conducted in Chennai in the first week of next month.
22 April 2010

3G technology to revolutionize Indian healthcare space: Vishal Bali

The introduction of 3G technology will change the face of healthcare delivery and the huge wave of 3G licenses and its impact on healthcare will be exponential. The availability of 3G bandwidth will enable video broadcast and data-intensive services telemedicine through wireless communications which will help accessibility of medical care to patients in far flung areas, said Vishal Bali, CEO Fortis Hospital.
22 April 2010

FDA warning to Propylthiouracil

April 21, 2010 — The US Food and Drug Administration (FDA) has added a boxed warning to the drug label for propylthiouracil about reports of severe liver injury and acute liver failure, in some cases fatal, that have been reported in both adult and pediatric patients who used this drug.

Notice of the warning was sent today in an alert from MedWatch, the FDA's safety information and adverse event reporting program.

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