What Deflation could lead to?

June 19, 2009

The rate of inflation, as measured by the wholesale price index, has turned negative for the first time in three decades. The widely watched WPI fell to -1.61% in week ended June 6. This makes India possibly the only country with a negative inflation rate, though a number of European countries are nearing zero levels.

But unlike in Europe, where demand has been contracting, India isn’t facing a deflation as industrial output remains positive and the inflation rate measured by the consumer price index (CPI) still stands around 8% and shows no signs of a let-up.

Bankers are divided over whether a negative inflation rate will prompt the RBI to cut its benchmark policy rates. With negative inflation, real interest rates (net of inflation) in the money market are high.

Source: Timesof India


Deflation

June 19, 2009

What is deflation?

Deflation is a decrease in the general price level of goods and services.

Factors responsible for Deflation !

  1. The supply of money goes down.
  2. The supply of other goods goes up.
  3. Demand for money goes up.
  4. Demand for other goods goes down.

Quality System Inspection Technique (QSIT) :FDA

June 18, 2009

According to the FDA, 30% of the 10 most frequent observations in Form 483s issued for QSIT inspections are related to CAPA, and 50%  are CAPA-related for non-QSIT inspections.

See webinars which can help device makers to ensure quality standards

  1. CAPA – The Heart of Your Quality System
  2. CAPA systems in Post Marketing Surveillance
  3. Root Cause Analysis for CAPA Management (Shutting Down the Alligator Farm
  4. How CAPA and complaint handling should interact in Medical Device – Simplification of the processes is often needed to preserve their effectiveness
  5. Preparation of a corrective action/preventive action plan (CAPA) in Drug Safety/Pharmacovigilanc

Tight Regulation Over Cigarettes: Got Approved

June 15, 2009

More than four decades after the surgeon general declared smoking a health hazard, the Senate on Thursday cleared the final hurdle to empowering federal officials to regulate cigarettes and other forms of tobacco for the first time.

The Congressional Budget Office has estimated the new law would reduce youth smoking by 11 percent and adult smoking by 2 percent over the next decade, in addition to reductions already achieved through other actions, like higher taxes and smoke-free indoor space laws.

Law gives power to FDA:

  • Law would give the F.D.A. power to set standards that could reduce nicotine content and regulate chemicals in cigarette smoke.
  • The law also bans most tobacco flavorings, which are considered a lure to first-time smokers.
  • The law would also tighten restrictions on the marketing and advertising of tobacco products.
  • Colorful ads and store displays will be replaced by black-and-white-only text.

Beginning next year, all outdoor advertising of tobacco within 1,000 feet of schools and playgrounds would be illegal.

What Cigarette Makers required to do:-

Cigarette makers will be required to stop using terms like “light” and “low tar” by next year and to place large, graphic health warnings on their packages by 2012.

Source: The New York Times


FDA revises ICH Q8 guidance

June 11, 2009

The FDA has revised its guidance on ICH Q8, adding an annex that clarifies the original document and adds the principles of quality by design (QbD).

The US Food and Drug Administration’s (FDA) guidance states that different drug delivery methods will have varying CQAs, such as adhesion properties for transdermal patches, but raw materials such as excipients and intermediates are common factors.

Using the framework devised by the International Conference on Harmonisation (ICH) the guidance details the importance of identifying CQAs and using knowledge of them to guide product and process development.

Source: in-pharmatechnologist


Vermont Gov. Jim Douglas signed a bill toughest controls in the country on financial relationships between doctors and industry

June 11, 2009

The bill imposes more restrictions on gifts from pharmaceutical and medical devicemaker firms to doctors, and demands more detailed financial disclosure of consulting and research contracts between the two parties.

Law Allow

The law does allow, however, for free drug samples; distribution of peer-reviewed academic, scientific or clinical articles or journals serving a true educational function; or financial support for med students, residents and fellows to attend educational or policymaking get-togethers.


Dawood’s brother Anees shot at in Karachi: Report- Hindustan Times

June 5, 2009

Notorious underworld don, Dawood’s brother Anees Ibrahim has been fatally shot at last night in Karachi according to a TV Report.

He was attacked by a group of armed Baluch men near Al Habib bank ATM in Karachi, and was injured in the ensuing exchange of bullets. Around a dozen bullets were reportedly fired at him. There is no updates on his condition so far.

Anees has been wanted in India for a series of criminal charges including 1993 Mumbai serial blasts.

Source: Hindustan Times.com