Governance, risk and compliance (GRC):Indian companies

January 30, 2009

Now the time has came when India’s listed companies start seeing importance of Governance, risk and compliance (GRC) management systems after what happened to Satyam.

Almost 90 per cent of India’s listed firms do not have a single system that rolls up the entire enterprise. They have multiple systems. If you don’t have one platform that can pull out the relevant data, the risk is much higher, MetricStream’s head of Asia Pacific Shankar Bhaskaran says.

Source: Deccan Chronicle

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Class III devices may require pre-market approval (PMA)

January 27, 2009

Medical device manufacturers may soon be required to submit all class III devices to the more stringent pre-market approval (PMA) process instead of the 510(k) pre-market notification process.

New devices must clear FDA pre-market review through either the 510(k) pre-market notification process, which determines whether a new device is substantially equivalent to another legally marketed device, or the PMA process, which requires the manufacturer to supply evidence that the device is safe and effective. The Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III devices.

Continue reading this story here HCPRO


Cars to hit Indian roads in 2009

January 22, 2009

fiat-ggrande-punto1. Fiat Grande Punto

Expected in May-June 2009, the car’s estimated price varies between Rs 500,000 and Rs 700,000.

It is a pemium hatchback/small-car that runs on both petrol and diesel.

The car will also be available with an Essesse kit, which boosts power to 135kW.

hyundai-santa-fe2. Hyundai Santa Fe

Expected in mid 2009, this SUVs price is estimated to be between Rs 23 and Rs 26 lakhs (Rs 2.3 to Rs 2.6 million). The car runs on both petrol and diesel.

The car will come in 2.2-litre, 148bhp diesel motor which might be tuned to suit Indian fuel quality.

maruti-suzuki-splash3. Maruti Suzuki Splash

Expected early this year, the car is estimated to be priced between Rs 400,000 and Rs 5,50,000. The styling is bold and is characterised by massive headlamps at the front.

The rear has an inward tilt to it.

A refined and fuel efficient 1.2L petrol and the 1.3L multijet (DDiS) diesel engines are planned for the car.

honda-jazz4. Honda Jazz

Expected in June-July this year, the car is estimated to cost between Rs 500,000 and Rs 600,000.

A Small segment, premium hatchback, to be available only in the petrol version, the car is expected to compete directly with the Skoda Fabia, the yet-to-be-launched Fiat Grande Punto and the Hyundai i20.

mahindra-xylo5. Mahindra Xylo

The Mahindra Xylo is Mahindras first attempt at building an multi-purpose vehicle. This MPV will compete directly with the Toyota Innova.

Priced between Rs 600,000 and Rs 800,000, this vehicle was launched in December 2008.

The Xylo has the same heart as that of the Scorpio, the 2.6 CRDe, as well as the 2.2 M-Hawk’s engine as options.

As Mahindra is using the same engine as the Scorpio, the vehicle’s cost is less than that of the Innova.

toyota-fortuner6. Toyota Fortuner

Expected early this year, the SUVs estimated price is between Rs 16 lakhs and Rs 18 lakhs (Rs 1.6 to Rs 1.8 million).

The car will be available in both petrol and diesel versions.

Source: Rediff


AdvaMed Updates Code of Ethics

January 13, 2009

Tightened Restrictions

The updated AdvaMed Code contains significantly tighter restrictions on manufacturer interactions with health care professionals (HCPs) than the current version of the Code. Key changes include:

Entertainment, Recreation, and Meals:

The updated Code contains an entirely new section providing that companies should not provide or pay for any entertainment or recreational events or activities for non-employee HCPs, including theater, sporting events, golf, or vacation trips. Under the updated Code, companies may continue to provide “modest” and “occasional” meals to HCPs when such meals are incidental to a bona fide presentation of scientific, educational, or business information.

Like the corresponding section of the PhRMA Code, the updated AdvaMed Code now calls for meals to be provided predominantly in an in-office setting. The AdvaMed Code provides an exception from this restriction in some circumstances, however, such as where the medical technology cannot easily be transported to the HCP’s place of business.

Gifts:

The updated Code includes a new prohibition stating that companies should not provide branded, non-educational, non-patient benefit items to HCPs, even if such items are of minimal value.

It permits companies to provide occasional modest items to HCPs that benefit patients or serve a genuine educational function, subject to a $100 cap. This provision largely parallels the recent changes to the PhRMA Code, but contains some differences, such as an exception from the $100 cap for medical textbooks or anatomical models used for educational purposes. The updated Code also makes clear that gifts to HCPs’ office staff should be treated the same as gifts provided directly to HCPs.

Third-Party Educational Conferences:

The updated Code removes Grand Rounds from the examples of permissible third-party educational conferences and states explicitly that the program sponsor should independently control content, faculty, and program materials.

Research Grants:

While the updated Code treats as acceptable grants for research leading to clearly defined goals, it states that companies should not provide “unrestricted” research grants. This change marks a significant difference from past industry practice.

Consulting Arrangements:

The updated Code provides, among other things, that compensation for consulting should represent fair market value for the services provided, be identified in writing in advance of providing the services, be based on the consultant’s expertise, and be unrelated to the volume or value of a consultant’s past, present, or anticipated business with the company.

Product Training and Education:

The updated Code clarifies that companies may cover HCPs’ expenses for travel to company sites to obtain training and education on medical technologies, but that such expense payments should be supported by objective business reasons. Because pharmaceuticals do not require the type of hands-on training that is needed to demonstrate the use of many medical technologies, the PhRMA Code contains no parallel provision.

New and Substantially Expanded Provisions

The updated Code addresses a number of device industry practices for the first time. These include:

Royalty Payments:

The updated Code provides that arrangements involving the payment of royalties to HCP consultants should comply with the Code’s standards for consulting arrangements; be entered into only where the HCP is expected to make or has made a novel, significant, or innovative contribution to product development; and be calculated based on factors that preserve objectivity of medical decision-making.

Product Evaluations and Demonstrations:

The updated Code provides that products may be provided to HCPs free of charge for evaluation in clinical use, including single use consumables and multiple use capital equipment, to assess the appropriate use and functionality of devices and determine whether to purchase or recommend the product under evaluation. The Code also states that companies may provide non-sterile demonstration products or mock-ups to HCPs for HCP and patient awareness purposes. The Code establishes limitations on the numbers of such products provided for evaluation and demonstration purposes, sets forth documentation standards, and contains provisions relating to the length of the evaluation period.

Reimbursement Support and Health Care Economic Information:

The updated Code substantially expands the current Code’s provisions on reimbursement support, stating that companies may provide accurate and objective information on product reimbursement so long as the information is timely and complete. In addition, the expanded provisions clarify that companies may collaborate with HCPs, patient groups and organizations to advocate for government and commercial payor decisions to cover medical technologies and assist HCPs with obtaining favorable patient coverage decisions. Additionally, the updated Code states that medical technology companies may provide accurate health care economic information to HCPs. Because the revised Code also clarifies that the term “HCP” includes persons who do not provide medical services directly, such as group purchasing organizations, practice managers and purchasing agents, this provision would allow companies to provide healthcare economic information to such decision makers.

Source: Ropes & Gray LLP


Wipro’s clarification on World Bank ban

January 13, 2009

wiproThe grim environment in the IT industry turned grimmer on Monday with Wipro Technologies disclosing that in June 2007, the World Bank had banned it from bidding for its contracts till 2011 because the company had offered shares to the bank’s employees during its US IPO in 2000 which the bank termed “improper benefits”.

Impact of news


The disclosure, which pushed the Wipro stock down by nearly 10% on the Bombay Stock Exchange, came after the World Bank decided to publish names of all companies that it had barred from contracts.

The bank has also barred Hyderabad-based Megasoft Consultants for a period of four years on the grounds that it “participated in a joint venture with bank staff while conducting business with the bank”.

Wipro’s clarification

Wipro said the offer of shares to employees and clients, including World Bank employees, was part of the directed share program (DSP) approved by US stock market regulator SEC. The DSP has the objective of involving employees and customers with the public offering to expand Wipro’s recognition and brand, the company said.


“All participants in the program including the World Bank CIO and another employee who took shares in the names of their wives, signed a statement that their purchase did not violate any ethics or conflict of interest policies of their company, Senapathy said. He said the shares offered were at market price, not discounted, and that some customers had declined the offer because it con flicted with their company’s policies

Inadequate Disclosure


Wipro stock plummets by 12% in early trade and ends the day losing 9.3% of its value at Rs 227.35


In the process Azim Premji, promoter of the company, loses Rs 2,705 crore in one day Premji holds 79.37% stake in the company as per data on BSE website

Source: TimesofIndia


Is that right time to think over Corporate governance seriously by Indian Companies

January 8, 2009

Yes would be the answer of most the Corporate today by seeing what happened to Satyam. Most of the Indian corporate accept that loopholes must be plugged in regulation, audit and governance to restore the confidence of the stakeholders in corporate firms.

Increased focus on directors’ and executives’ role and responsibilities requires systematic frameworks for implementing critical corporate governance principles on ethics, code of conduct, compensation, financial policy, and financial reporting. Moreover, organizations are looking for sophisticated corporate governance solutions to enable them to set business priorities and develop risk management strategy to ensure business performance.

Here where the companies like MetricStream,ComplianceOnline,Approva,Certus Software,IBM,Sai global plays important role.

Attend Live | On- Demand Webinar from ComplianceOnline to know more on Corporate Governance

Source: MetricStream | ComplianceOnline


Fall of Satyam from day one till the date

January 8, 2009

satyam11. December 16: Satyam gets board’s approval for acquisition of Maytas Infrastructure and Maytas Properties for $1.6 billion.

2. December 17: Defers Maytas’ acquisition on stiff investor resistance.

3. December 18: Schedules board meet for the proposal of buyback of shares on December 29.

4. December 18: British mobile solution provider Upaid files a law suit against Satyam in a district Court in the US over Maytas deal.

5. December 24: World Bank bans Satyam for 8 years on charges of data-theft.

6. December 25: Satyam objects to World Bank’s statements; asks Bank to apologise to the company or face legal action.

7. December 25: Mangalam Srinivasan, non-executive and independent director resigns from board.

8. December 27: Postpones board meeting to January 10, 2009 to consider buyback of shares.

9. December 27: Promoters disclose that their entire holding in Satyam pledged with institutional lenders since 2006.

10. December 28: Two independent directors – Krishna G Palepu, Vinod K Dham – resign from the board.

11. December 29: M Rammohan Rao, another independent director, resigns from board.

12. January 1: Satyam-Upaid case hearing over the Maytas deal in Texas court on January 7.

13. January 2: Promoter holding in Satyam drops to 5.31 per cent from 8.27 per cent after sale of pledged shares by lenders.

14. January 5: Satyam brings up old report by research firm Forrester complimenting company’s innovation strategy.

15. January 6: IL&FS Trust company sales 2.45 crore shares of Satyam pledged to institutional investors by the promoters

16. January 6: Raju family holding in Satyam falls to 3.16 per cent after sale of pledged share by lenders

17. January 7: Satyam Chairman Ramalinga Raju sends letter to board tendering his resignation and admitting to fraud in accounting books.

18. January 7: Satyam Managing Director B Rama Raju also resigns.

19. January 7: DSP Merrill Lynch terminated its advisory engagement with company.

Source: Rediff