US Biotechnology and regulatory framework

May 23, 2008

Biotechnology in the United States is regulated by at least five Federal agencies in a Coordinated Framework:

1. The Environmental Protection Agency (EPA)

2. Department of Agriculture (USDA)

3. National Institutes of Health (NIH)

4. The Occupational Safety and Hazard Administration (OSHA) and

5. To a small extent the Food and Drug Administration (FDA)

Major Laws that Empower Federal Agencies to Regulate Biotechnology
Law Agency
The Plant Protection Act USDA
The Meat Inspection Act USDA
The Poultry Products Inspection Act USDA
The Eggs Products Inspection Act USDA
The Virus Serum Toxin Act USDA
The Federal Insecticide, Fungicide, and Rodenticide Act EPA
The Toxic Substances Control Act EPA
The Food, Drug, and Cosmetics Act FDA, EPA
The Public Health Service Act FDA
The Dietary Supplement Health and Education Act FDA
The National Environmental Protection Act USDA, EPA, FDA
Source: Pew Initiative on Food and Biotechnology

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$80bn Indian mega-hub proposed

May 23, 2008

The Indian government is close to rubber-stamping an $80bn industrial hub near Vishakhapatnam (Vizag) which is expected to attract pharmaceutical companies to the region. A consortium of Mittal Energy Investments, Total SA and Petroleum Corp will be the anchor tenant at the mega oil, chemical and petrochemical hub following its $7.5bn investment.

Surrounding this will be numerous pharmaceutical and chemical manufacturing facilities, spread over the 603 sq km site.

The sheer scale of the site and the investment should ensure that it becomes a focal point for pharmaceutical activity within India. At this time it is unclear which pharmaceutical companies will be setting up in the region.

The operating in India the hub at Vizag should prove alluring to pharmaceutical companies owing to its scale plus the surrounding geography, culture and infrastructure.

Companies operating in the hub will be looking to utilise the large number of highly educated, English speaking graduates from the region’s educational establishments.

It is this workforce which has driven the rapid growth of Vizag from a small fishing village during colonial times to the industrial monolith it is today.

This industrial expansion has been supported by improvements in the region’s infrastructure.

Consequently, the hub will have excellent links by air, which have undergone rapid improvement in recent years. This has resulted in increased capacity for international airlines and permission for night flights. The city is also well connected to the rest of India by air and rail.

This should facilitate the movement of people to the hub, as well as the transport of goods to market. Vizag’s natural harbour will also play a vital role in dealing with exports, which are anticipated to be $13.6bn per annum.

Infrastructure at the hub itself is to be developed through significant governmental funding, with central government pumping in $1.2bn and the state, Andhra Pradesh, supplying $500m.

The sums of money involved signify the commitment of the Indian government to see the nation build on the impressive growth it has achieved in recent years.


What Foreign Companies Need to Know about Litigation in America before Entering the U.S. Market

May 23, 2008

Despite the beginning of the “credit crunch” and the collapse of the housing market, 2007 was a banner year for foreign direct investment in the United States, which ranked second, behind China, in the number of new and expanded foreign projects. Behind the bad news is a silver lining – the decline in the value of the dollar against other currencies currently makes investment in the U.S. extremely attractive. With its dynamic economy, deep capital markets and resilient consumer spending, the United States is likely to remain an irresistible target for foreign companies seeking new business opportunities, yet hurdles remain.

Selecting a Business Location

Good corporate legal strategy in America begins by planning ahead to ensure that, if and when litigation arises, it occurs on favorable terms.  In that regard, the most critical decision a business must make initially is where to locate its headquarters.  There are, of course, a host of issues that must be weighed when choosing where to locate any new business, such as taxes, regulations, access to an educated workforce and whether unions have a strong presence.  However, carefully choosing the location of the principal place of business can go a long way toward minimizing the consequences of litigation by guaranteeing that a forum, friendly to business, hears any future disputes.  Such jurisdictions typically have a negligible union presence and a strong governmental commitment to attracting foreign investment.  The judges are conservative and the juries are well-educated, sensible and stingy.

The Best Defense is a Good Offense

Locating a company in a “pro-business” jurisdiction also allows it to take advantage of the Declaratory Judgment Act (DJA), which authorizes courts to rule on any legal issue presenting an actual controversy between two parties.  Often, a party that wishes to initiate suit will first send the other party a “demand letter” explaining the nature of its legal claim and threatening to sue the other party unless it is paid an outrageous sum of money.

The Benefits of Arbitration over Litigation
To avoid litigation altogether, foreign businesses should also seriously consider including provisions mandating arbitration of any disputes by the American Arbitration Association (AAA) in their contracts.  Arbitration requires the parties to submit disputes to a neutral decision maker and expert in the substantive law, with the authority to issue a binding decision.  The principal advantage of arbitration is that it allows a company to avoid having a jury decide its case.  This can be a real benefit to any corporate defendant, especially when a foreign company faces off against a hometown entity or individual.

The Litigation Process
If all else fails and a company finds itself in court, this need not be cause for despair.  The American judicial system is designed to repeatedly test the merits of the plaintiff’s claims and to dispose of the case at the earliest opportunity.  Indeed, despite its reputation as a no-holds-barred litigious society, only 4.1% of all cases filed in federal court ever reach trial, with the rest being settled by the parties or dismissed by the court. Cases typically begin with the filing of a complaint in court followed by service of the complaint on the defendant.  If the complaint is defective on its face, the defendant may immediately move for dismissal.

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FDA Guidance: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

May 20, 2008

This guidance document provides recommendations to manufacturers, for using methods other than sterility testing to confirm container and closure system integrity as a part of the stability protocol for sterile biological products, human and animal drugs, and medical devices. This guidance document finalizes the draft guidance of the same title dated January 1998 (January 28, 1998, 63 Federal Register (FR) 4272).

The recommendations in the guidance document apply to both pre- and post-approval stability protocols for sterile biological products, human and animal drugs, including investigational and bulk drugs. For medical devices, the recommendations in the guidance document apply to stability protocols for those devices labeled as sterile. The guidance can be downloaded from the FDA website.

FDA Releases Information on Risk Evaluation and Mitigation Strategies (REMS)

May 20, 2008

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS. Some drug and biological products that previously were approved/licensed with risk minimization action plans (RiskMAPs) will now be deemed to have REMS. The FDA answers questions about Risk Assessment and Management Strategy, click here.

GMP Regulation for Medical Devices

May 20, 2008

Process validation is required by the medical device GMP Regulations, 21 CFR Part 820. Section 820.5 requires every finished device manufacturer to:

“…prepare and implement a quality assurance program that is appropriate to the specific device manufactured…”

Section 820.3(n) defines quality assurance as:

“…all activities necessary to verify confidence in the quality of the process used to manufacture a finished device.”

When applicable to a specific process, process validation is an essential element in establishing confidence that a process will consistently produce a product meeting the designed quality characteristics.

A generally stated requirement for process validation is contained in section 820.100:

“Written manufacturing specifications and processing procedures shall be established, implemented, and controlled to assure that the device conforms to its original design or any approved changes in that design.”

Validation is an essential element in the establishment and implementation of a process procedure, as well as in determining what process controls are required in order to assure conformance to specifications.

Section 820.100(a) (1) states:

“…control measures shall be established to assure that the design basis for the device, components and packaging is correctly translated into approved specifications.”

Validation is an essential control for assuring that the specifications for the device and manufacturing process are adequate to produce a device that will conform to the approved design characteristics

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Places near Bangalore / Bengaluru to go

May 20, 2008

1. Nandi Hills

It is the nearest hill station from Bengaluru and a good option for somebody looking to go for a long drive.

To reach Nandi Hills take the Hyderabad highway (NH7/Yelahanka Road) from Bengaluru. After 38kms along the highway, couple of kms past Devanahalli, you can see a road going to the left towards Nandi Hills. There is a sign board there and you should not miss it, if you are careful. After another 10kms you will reach a T-junction, from where you should take a left. 4 more kms, it is one more right turn followed by a ghat road leading to Nandi Hills.The place offers a nice bird’s eye view from the top. An early morning drive to the hills, in time for the sunrise, is an exciting option.

2. Sangam

Sangam is the confluence of Rivers Kaveri (Cauvery) and Arkavathi. One more nice picnic spot along Kanakapura Road (NH209) formed around River Kaveri.

To reach Sangam by taking a 33km deviation to the left, soon after Kanakapura, along NH209. A big arch is placed there to tell you the route. About 16kms from Kanakapura you will reach a junction, to the right of which is Cauvery fishing camp. Go straight for Sangam. The last five kms to Sangam is an enjoyable drive through the ghat roads, with picturesque hills all around you. Water is not so deep at Sangam and is very clean, in spite of the huge crowd generally found here. But the surroundings is filled with litter and plastic. Its a pitty that a place like this is not kept clean.

3. Sivanasamudram

Sivanasamudram (aka Sivasamudram) is a nice waterfall near Malavalli, Mandya district. The waterfall is around 50meters tall on River Kaveri (Cauvery) and is a beautiful sight, especially during monsoon. To reach Sivanasamudram, take the NH209 (Kanakapura road) and continue till Malavalli, past Kanakapura. Around 10kms past Malavalli, along NH209 (Kollegal road), you can spot a board to your left, indicating a 4km detour to Sivanasamudram.

4. Talakkad

Talakkad (Talakad/ Talakadu/ Talakkadu), situated in the banks of Kaveri (Cauvery) is known for its sand dunes and the temples buried underneath. River Kaveri flows very shallow here and is ideal to take bath and play around. Talakkad is in Mysuru (Mysore) district. To reach there, take the NH209 (Kanakapura road) past Malavalli. Soon after Malavalli, there is a T junction, with road on the right going towards Mandya/Mysuru. Take the left and continue in NH209, towards Kollegal. About some 5kms before the detour for Sivanasamudram, there are sign boards indicating Talakkad, 22 kms to the right.

5. Bannerghatta National Park

Located 22 kms from Bengaluru city, along the Bannerghatta road, this is a good place to visit. Just about 10kms from IIMB campus, Bannerghatta national park is probably the easiest place, where you can spot wild animals like lions and tigers roaming freely in something resembling a forest. These animals are kept in fenced containment and safari is arranged to see them. There is also a zoo in the national park premises where you can have a look at a variety of animals. An Elephant joy ride or safari is also possible.

A major drawback with the place is that it is more of a zoo than a national park and lacks a wild feel. Also, the animals kept in cages paints a sorry figure. Still, some of the tigers/lions kept in fenced containment looks healthy, offering a rare experience.

6. Big Banyan Tree (Ramohalli)

18 Kms. from Bangalore on the Mysore Road. The famed Big Banyan tree spread over nearly four acres is located here. The tree has an awe-inspiring appearance and consists of a vertical root system forming a pleasant complex. Age of this massive tree is around four hundred year.

7. Muthyala Maduvu (Pearl Valley)

44 kms from Bangalore via Brigade Road-Hosur Road-Anekal. A picturesque picnic spot with a waterfall which is 300ft. high. There is a Traveller’s Bungalow 6 kms from Anekal Town on the Hosur Road. For reservations contact Block Development Officer, Anekal.

8. Kolar Gold Mines

120 kms from Bangalore. Kolar is as rich in history as it is in gold. The gold mines here are the deepest mining pits in the world, reaching down to a depth of about 10,000 feet below the surface of the earth. The Secratary, Kolar Gold Mining Undertaking, K.G.F., may be contacted for permission to visit the mines. Bharat Earth Movers factory is also situated here.

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