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


Reliance MF told to withdraw ad

June 5, 2009

The Securities and Exchange Board of India on Thursday directed Reliance Mutual Fund and Reliance Capital Asset Management Ltd to withdraw the advertisement for their recently launched infrastructure fund, and also asked them to show cause why they should not be restrained from launching any new schemes.

Why Securities and Exchange Board of India issued the order?

The entities did not submit the advertisement to SEBI within the stipulated seven days from the date of issue of the fund offer, said the market regulator. The audio-visual was unintelligible and also lasted for less than the SEBI-mandated five seconds.

This leads to a situation where the investors are not able to take well-informed decisions, the SEBI order said.

Source: The Hindu Businessline


Pharma Code Revised and its changes, the revised Code has:

June 5, 2009

Among its changes, the revised Code:

Prohibits distribution of non-educational items (such as pens, mugs and other “reminder” objects typically adorned with a company or product logo) to healthcare providers and their staff. The Code acknowledges that such items, even though of minimal value, “may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues.”

• Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations. The Code also reaffirms and strengthens previous statements that companies should not provide any entertainment or recreational benefits to healthcare professionals.

Includes new provisions that require companies to ensure that their representatives are sufficiently trained about applicable laws, regulations and industry codes of practice – including this Code – that govern interactions with healthcare professionals. Companies are also asked to assess their representatives periodically and to take appropriate action if they fail to comply with relevant standards of conduct.

Provides that each company will state its intentions to abide by the Code and that company CEOs and Compliance Officers will certify each year that they have processes in place to comply, a process patterned after the concept of Sarbanes-Oxley compliance mechanisms. Companies also are encouraged to get external verification periodically that they have processes in place to foster compliance with the Code. PhRMA will post on its Web site a list of all companies that announce their pledge to follow the Code, contact information for company compliance officers, and information about the companies’ annual certifications of compliance.


eFiling of personal income-tax

June 4, 2009

Procedures

To facilitate eFiling, the board has notified new forms for the AY 2009-10. These return forms are available at http://www.incometaxindia.gov.in

While eFiling is mandatory for a company and a firm liable to audit under section 44AB of the IT Act, it remains optional for other categories of tax-payers.

The e-return has to be furnished at http://incometaxindiaefiling.gov.in

The department has further stated: “It is advisable, though not mandatory, to use a digital signature for electronically furnishing the return.”

If the return is electronically furnished under a digital signature, the tax payer would not be required to furnish the Form ITR-V with the department. Else, the assessee would be required to follow up the electronic transmission of the data by submitting Form ITR-V (as verification of the electronic filing of return).