Agencies Issue Statement on Basel II Advanced Approaches Qualification Process

July 9, 2008

The federal banking and thrift agencies today issued an interagency statement outlining the qualification process for banking organizations implementing the new advanced capital adequacy framework known as Basel II.

The process consists of three major stages:

  1. Adoption of an implementation plan
  2. Completion of a satisfactory parallel run and
  3. Advancement through three transitional periods.

Attachment (622 KB PDF)

Staff errors costing UK pharma firms millions, report warns

July 9, 2008

UK pharmaceutical companies are paying a hefty price for errors made by their staff, new research has unveiled.

Losses are estimated at $46.8m (£23.9m, €29.8m) a year [1], with 85% of pharmaceutical companies reporting exposure to impaired reputation in the last 12 months due to employee misunderstanding.

Impact on businesses of employee misunderstanding, specifically among the

  1. Pharmaceuticals
  2. Banking
  3. Petrochemical, and
  4. Transportation sectors.

According to the report, both UK and US employees are costing businesses $37bn (£18.7bn, €23.53bn)[2] every year because of a lack of understanding.

One UK pharmaceutical company surveyed for the white paper learned an expensive lesson when ‘a procurement error resulted in significant production downtime. A dedicated production facility could not function without a chemical catalyst. This oversight left us with no option but to shut down production.’

Company was affected by

  1. Poor procurement practice (18%)
  2. Industrial tribunal settlements (17%) and
  3. Personal injury (11%).

Nine out of ten pharmaceutical companies said employee misunderstanding increased exposure to injuries to their personnel or the public, and loss of sales (96% over the past 12 months. Plus, around 89% said they had been exposed to reduced productivity and 85% cited impaired reputation.

The Association of the British Pharmaceutical Industry estimates that 73,000 people are employed directly by the sector

Drug cos want govt to review price control on key brands

July 9, 2008

Drug majors including Ranbaxy, Pfizer, Glaxo and Eli Lilly have approached the government asking for a review of the drug price regulator’ decision to impose price control on their key brands which include cough syrups, antibiotics, pain killers, ulcer treatments and pills for male impotence.

The major MNC brands now under the ministry’s examination include Pfizer’s Bendryl Couph Syrup and Caladryl lotion for itching and Eli Lilly’s Human Insulin.

Cadila Pharma’s anti-ulcer medicine Ranitidine, Ranbaxy’s pain killer Pentazocine and antibiotic Roscillin, anti-bacterial Cilanem and impotence drug Caverta, Pfizer’s medicine for irritation and itching Caladryl lotion are also believed to be under the government’s review.

Source: Economic Times

India lets pharma fight compulsory licenses

July 9, 2008

India’s patent office has decided that drugmakers should be able to have their say before the country grants compulsory licenses, which allow domestic generics makers to export copies of patented medicines to countries that don’t have the ability to make the drugs needed to combat a public health crisis.

The patent office on July 4 dismissed a petition filed by Natco Pharma opposing the patent office’s move to seek the opinion of Pfizer before granting a compulsory licence to Natco. The application seeks granting a compulsory licence to manufacture and export generic version of Pfizer’s patented cancer medicine, Sunitinib, to Nepal.

The application was made under Section 92 (A) of the Patent Act and the Patent Rules, 2006, which allows the government to permit or issue compulsory licence to local manufacturers to export patent medicines to the countries, which do not have the capability to manufacture such medicines.

Since such licences are meant to be issued at the time of public health crisis, the Patent Rules do not spell out in detail the modalities of issuing them. Natco had argued that inviting patentee (Pfizer) to appear at the hearing to contest the grant of compulsory licence was not required under the patent law.

The patent office, however, felt that the arguments of the patentee shall be helpful in deciding the terms and conditions for granting such a licence and may also be helpful in avoiding the abuse of the provisions of Section 92 (A).

Source:The Business Standard

U.S., Vietnam Ink MOU on Device, Drug Safety

July 9, 2008

The U.S. and Vietnam have signed a three-year, renewable memorandum of understanding (MOU) to enhance the safety of medical devices and drugs traded between the two nations.

The MOU is the culmination of discussions between HHS Secretary Mike Leavitt and senior Vietnamese officials that began a few months ago as part of the new import-safety strategy created last November by a U.S. Cabinet-level Interagency Working Group on Import Safety.

The agreement with the Vietnamese specifically calls for cooperation in the following areas:

  • Information sharing — the governments will exchange information on laws and regulations, guidance documents and training for postmarket safety surveillance of products;
  • Workshops and training — the governments will conduct workshops on training that concerns medicinal products; and
  • Best practices in clinical trials — HHS and the FDA will cooperate with Vietnamese officials on training in good clinical practice and the regulatory inspection of clinical trials.

The working group’s proposals included creating incentives to ensure that foreign manufacturers exporting products into the U.S. meet agency standards and allowing the destruction of medical products refused admission into the country to prevent their re-importation. Expedited destruction would apply to refused products that are valued below a given threshold or pose a certain level of risk to humans or animals.