Pharma News

IPA demands amendment of D&C Act, separate University for pharmacy in TN

 The Indian Pharmaceutical Association (IPA) has demanded to amend the Drugs & Cosmetics Act and Rules 1945 to make only the pharmacy graduates eligible to become expert staffs in the pharma manufacturing units. In the resolutions passed during the just concluded IPA Convention, the IPA also urged the government to expedite action to amend the Rules in such way that all regulatory positions in the country must be an exclusive area for experienced and qualified pharmacists.

NIPER Ahmedabad to introduce PG diploma course for medical devices sector in July, 2010

 The National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad, is all set to launch India's first dedicated course in medical devices segment from the new academic year starting from July, 2010. The institute is currently in talks with some of the major educational institutes conducting similar courses in the country for expert opinion and will finalise the curriculum soon, senior officials of the institute said.

Duty of regulatory agencies must be to prevent harm from unsafe drugs, Kim Huynh-Ba.

The primary duty of the regulatory bodies across the world is to prevent harm from unsafe drugs. In the United States, the law ensures that there shall be a written stability testing programme to assess the stability characteristics of drug products. Stability is the critical quality attribute of a drug product. Further it ensures the capacity of a drug substance, said Kim Huynh-Ba, Technical director of Pharmalytik, Newark in USA.

Several drugs to come under regulatory scanner as national pharmacovigilance programme to begin in April

Two H1N1 drugs - oseltamivir and zanamavir, the controversial sub-fertility drug letrozole, popular non-steroidal anti-inflammatory drug nimesulide, decongestant drug phenylpropanolamine (PPA), antibiotic drug gatifloxacine, chronic constipation drug tegaserod, type-2 diabetes drug pioglitazone and rosiglitazone have been selected for the first phase of national pharmacovigilance programme which will begin in select 40 medical colleges across the country from April this year.

FDA Approves New Somatropin Injection Pen for Growth Hormone Disorders

March 5, 2010 — The US Food and Drug Administration (FDA) has approved a prefilled somatropin (rDNA origin) injection pen (Norditropin FlexPro, Novo Nordisk, Inc) for the treatment of growth hormone disorders in adult and pediatric patients. The product, an updated version of the company's NordiFlex pen introduced in 2004, is expected to be available in the second quarter of 2010.

Haffkine Institute to establish BA/BE study centre soon

The more than 100-year old Haffkine Institute of Mumbai will soon establish a BA/BE study centre which will be useful to the pharma industry in India and abroad in getting a more authentic bioavailability and bioequivalence (BA/BE) study results. The government-controlled Institute has already started the process in this regard and is expected to be completed within a year's time.

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