US bans import of 30 generic drugs of Ranbaxy

September 17, 2008

The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy’s Dewas and Paonta Sahib plants in India.

The Warning Letters identify the agency’s concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy’s manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

The problems at these two Ranbaxy plants relate to deficiencies in the company’s drug manufacturing process. These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the American public are manufactured according to cGMP requirements. While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products. We will continue to monitor the situation.

Today’s announcement does not impact products from Ranbaxy’s otherplants which are not affected by today’s actions. FDA has inspected those facilities and, to date, they have met U.S. cGMP requirements for drug manufacturing.

The FDA recommends that consumers continue taking their medications manufactured by Ranbaxyand not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned about their medications should discuss their concerns with their health care professional.

Earlier today, the FDA informed Ranbaxy that until it resolves the deficiencies at each of these two facilities and the plants come into compliance with U.S. cGMP requirements, FDA’s drug compliance office will recommend denial of approval of any New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that list the Paonta Sahib or Dewas plants respectively as the manufacturer of APIs or finished drug products

Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States. The company makes a number of drug products.

The FDA Import Alert covers more than 30 different generic drug products (Drug List) produced in multiple dosage forms and dosage amounts ( i.e., 25 mg, 50 mg, and 100 mg) at these two locations.FDA has evaluated whether these actions would create any potential drug shortages in the United States, and has determined that other suppliers can meet market demand, with one exception. Because Ranbaxy is the sole supplier to the U.S. of one drug product, Ganciclovir oral capsules (an antiviral drug), to avoid creating a shortage of the drug, FDA generally will not detain shipments of this product, and plans to arrange for additional oversight and controls until the company resolves these manufacturing issues.

“With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality,” said Janet Woodcock, M.D., director, FDA’s Center for Drug Evaluation and Research (CDER). “The FDA has notified other agencies and health care professionals to make them aware of today’s actions so that they can take appropriate action and advise patients as needed.” The Warning Letters issued today document the results of FDA investigations at these two sites.

One Warning Letter addressed problems at Ranbaxy’s Dewas facility found during an inspection conducted by FDA in early 2008. During that inspection, FDA investigators documented significant cGMP deviations in the manufacture of sterile and non-sterile finished products and violations with respect to the manufacture and control of APIs. Specific areas of concern included the following aspects of the firm’s quality control program:

  • The facility’s beta-lactam containment program (measures taken to control cross-contamination), which appeared inadequate to prevent the potential for cross-contamination of pharmaceuticals;
  • Inadequate batch production and control records;
  • Inadequate failure investigations; (A failure investigation is done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence); and,
  • Inadequate aseptic (sterile) processing operations.

The second Warning Letter addressed the Paonta Sahib facility following an inspection at its Batamandi unit, also in early 2008.This inspection documented various cGMP deficiencies, including the following:

  • The lack of assurance responsible individuals were present to determine the firm was taking necessary steps under cGMP;
  • Inaccurate written records of the cleaning and use of major equipment;
  • Incomplete batch production and control records; and,
  • Inadequate procedures for the review and approval of production and control records for drug products.

Following the two inspections, FDA provided Ranbaxy with a separate list of inspectional findings for each of the facilities. In mid-April and May, Ranbaxy responded in writing to these findings in lengthy submissions to FDA. The agency then evaluated its findings, Ranbaxy’s responses, and the firm’s overall inspectional history, an evaluation that required substantial time due to the complex scientific and technical nature of both the identified deficiencies, particularly at the Dewas site, and the firm’s responses. Ultimately, FDA concluded that the firm’s responses were not adequate and that the Warning Letters were the appropriate regulatory response.

“Today’s actions are clearly warranted by the serious violations established by FDA’s investigations at these two sites,” said Deborah M. Autor, director, CDER’s Office of Compliance, FDA. “Until the company addresses these deficiencies, APIs and finished drug products from these plants will remain on the Import Alert, and we will not approve any Abbreviated New Drug Applications or New Drug Applications that list either of the two facilities as the manufacturer of APIs or finished drug products.”

This represents the second time in less than three years FDA has issued a Warning Letter to Ranbaxy. In 2006, FDA cited Ranbaxy for violations of U.S. cGMP at its Paonta Sahib facility.

The FDA will continue to work with Ranbaxy’s Dewas and Paonta Sahib plants to resolve these issues.
Consumers and health-care professionals can report adverse events to FDA’s MedWatch program at 1-800-FDA-1088; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or online, at the following Internet address: www.fda.gov/medwatch/report.htm

Source: FDA News


2,500 Lehman India employees’ fate uncertain

September 16, 2008

The fate of 2,500-odd employees working for investment banking giant Lehman Brothers in India remains uncertain following its parent company’s decision to file for bankruptcy protection in the United States.

Lehman said in a statement that its New York office intends to file for bankruptcy protection as it owes over $600 billion to lenders.

However, it highlighted that no other Lehman Brothers’ US subsidiaries or affiliates, including its broker-dealer and investment management subsidiaries, are included in the filing.

The filing for Chapter 11 bankruptcy protection, which allows a company to restructure while creditor claims are held at bay, was made in the US Bankruptcy Court in the Southern District of New York by the investment bank’s holding company, Lehman Brothers Holdings Inc.

Source: Rediff


New EC GMP regulations for radiopharma

September 16, 2008

Revised good manufacturing practice (GMP) requirements for the production of radiopharmaceuticals have been published by the European Commission (EC).

The updates to the annex are intended to make it compliant with GMP Part II, which laid out additional requirements for actives substances used as starting materials.

In addition the EC has sought to bring the regulations up-to-date with advances in the manufacture of radiopharmaceuticals.

An initial draft was published for public consultation in December 2006. This process has now been completed and

Dead Line:

Companies have until March 1 2009 to become compliant with the new requirements.

The regulations are broken down into subcategories including quality assurance, personnel, production and documentation. These are intended to provide the necessary regulation to prevent cross-contamination, the spread of radioactive material and ensure the quality of the product.

Quality assurance is particularly important in the manufacture of radiopharmaceuticals as the half-lives of some mean they need to be administered shortly after production. Consequently there is not enough time to test the product.

To maintain high standards the regulations insist on rigorous record keeping and for the principles of qualification and validation to be applied, details of which can be found here.

AIM:

Underlying all the regulations is the need for accurate, up-to-date documentation of procedures.

What manufacturers must establish:

1. Manufacturers must establish specifications for raw materials, labelling and packaging materials, critical intermediates and the finished radiopharmaceutical.

2. Specifications must also be put in place for any piece of equipment that could critically impact on the quality of the finished product.

3. The cleaning, sanitisation, sterilisation or maintenance of equipment should be documented to show the product name, batch number, date and time of the activity and signature for the persons involved in these activities.

4. Documents must be kept for a minimum of three years, unless a different timeframe is specified by national laws.

Retention to ensure accountability extends to keeping sufficient samples of each batch of bulk formulated product for at least six months after expiry of the finished medicinal product.

Samples of starting materials, excluding solvents gases or water used in the manufacturing process must be kept for at least two years after the release of the product. This period can be shortened if the material has a period of stability of less than two years.

Annex 3, the complete document covering GMP requirements for the manufacture of radiopharmaceuticals, can be found here.

Source: Outsourcing Pharma


Tips to protect your WiFi from hackers

September 15, 2008

It could any one of us. Wake up one morning to discover that the Indian Mujahideen has hacked into our Internet account and sent out a chilling mail claiming responsibility for a terror attack on the nation.

Source: Rediff

  1. Disabling the SSID broadcast. To some extent this makes it difficult for the hacker to detect the presence of a WiFi access point.
  2. Enable MAC address filter. Each network interface has a unique MAC address, by filtering it, one can to an extent control which machines can use the access point.
  3. Turn on WPA/WEP encryption. This ensures that traffic between a legitimate machine and an access point is not readable.
  4. Change default admin passwords for access points.
  5. Ensure access points are placed securely. In the centre of a room/office etc to minimise its signal strength outside the office

Even after following the above precautions, your WiFI account could be compromised and hence, the things to look at are:

  • Monitor usage of the access point. Have a clear inventory and knowledge about the position of each access point.
  • Monitor the usage of the Internet link, to know what traffic is going out. For example, some corporate block e-mail providers like yahoo or hotmail. Hence, even if the access point is compromised, the hacker may not be able to use public e-mail systems.
  • Consider a specific security policy for wireless networks. For example, most companies primarily use wired networks in the office as the primary media. Access points are used in common areas like conferences rooms etc. Hence, strict policies can be deployed on wireless networks as compared to wired networks.


Risk Evaluation and Mitigation Strategy (REMS) for Certain Drugs and Biologics

September 5, 2008

The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a Federal Register notice published today.

Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug. The manufacturers of the 25 drugs and biologic products identified in today’s notice must submit to the agency a proposed REMS by Sept. 21, 2008.

Effect

The user fees that will help support implementation of the Risk Minimization Action Plans … and the penalties, starting at $250,000 and potentially reaching $10 million, that can now be imposed for failure to adhere to drug safety provisions … are why it’s crucial for you to attend the Risk Management and Drug Safety Summit.

Source: FDA


Google Chrome (BETA) for Windows

September 5, 2008

Google Chrome is a browser that combines a minimal design with sophisticated technology to make the web faster, safer, and easier.

Features:

  1. One box for everything
    Type in the address bar and get suggestions for both search and web pages.
  2. Thumbnails of your top sites
    Access your favorite pages instantly with lightning speed from any new tab.
  3. Shortcuts for your apps
    Get desktop shortcuts to launch your favorite web applications.

Click here to Download Chrome (BETA) – the new browser from Google

Source: Google