Setting Up a Network of Action Research to Overcome Systemic and Cultural Issues

The world is changing faster than systems can keep up. This is seen in business, industry, education, health care, banking etc. The basic problem faced by managers is much the same across all of these ways of doing business: the owners and managers believe they see where the company needs to move but have difficulty explaining or motivating current staff to make the necessary changes. Sometimes management are up against cultural issues, and while they fully understand since they also come from those cultures, it is even more difficult because the change goes to the very fiber of their countries or ideals and yet are necessary if their organization is to survive. An example of this is seen in education in the Arab world where spokespeople such as her Majesty, Queen Rania Al Abdullah of Jordan and Crown Prince H.H. Shaikh Salman bin Hamad bin Isa Al-Khalifa of Bahrain actively pursue a dramatic change in education away from graduates who want and expect the government to hire them and to take care of them for the rest of their lives as has been the case for a very long time. In much of the world the government has always been the best employer and now economic pressures insist on a change to an entrepreneurial society, one that creates economic growth in the new knowledge based economic environment. Using this example, we see several complex layers of issues that need to be tackled simultaneously in order to bring about systemic change. These layers include:

  1. producing a cultural mind shift from being taken care of by the government to fast-paced entrepreneurial endeavors
  2. encouraging a shift from seeking only safety to being willing to take risks
  3. needing to incorporate the “soft” skills required in modern business into the standard curriculum
  4. providing professional development for teachers so that they can model these new skills, ones that they don’t currently have or understand
  5. finding the time to release all the staff for this training and this retooling while still continuing the work that is going on
  6. finding a way so that the change is embraced by the people rather than engendering resentment

As is true with most complex issues, facing these issues directly makes many experienced leaders and managers quail under the likelihood of potential failure. We have all seen reform efforts gone bad. Every new idea that does not get implemented properly, leaves behind it a residue of resentment and skepticism, eventually souring the entire culture of our working world. Many Western environments have seen this already, with employee morale dropping dramatically and productivity coming to a halt upon announcement of mergers, reorganization, etc.

The good news is that networked participatory action research (PAR) can overcome many, if not all, of these challenges. This article lays out the general format that can be used by leadership, in tandem with a good PAR facilitation, to develop teams of staff who will study the issues and develop solutions, taking ownership of the changes required by the complex situation rather than subtlety opposing all change.

How do you begin? The first step for management is to work what personal incentives can be used to encourage people to take on the extra work that is being asked of them. This is a common problem for businesses, nonprofits, and public administrators, who generally expect that this kind of work should just be done under the normal auspices of a person’s employment. We have found that incentives bring success and without them complex reforms of this nature are much more likely to experience a failure rate of somewhere around 50%. Here’s why. This PAR process will require that these teams work outside of their normal business day to gather data, have meetings to discuss actions and measurement, implement new steps, and measure their success. Consider them pilot projects in each of your major hubs of activity. If you were paying consultants to work out a pilot for you, you would pay them. In this case your own staff should be treated with the same respect you would give those consultants. The change in their attitude will seem remarkable. When you are asking them to step up as experts in what they do and help you redesign their own working environment to better meet the needs of outside pressures to change, to pilot new ideas, and you show them respect by paying them extra for their extra work, they are much more likely to give it their full attention.

What are you asking them to do? To participate regularly in an action research project and to write up the results in a final report that will be available to you for publication. This involves a discovery cycle where they analyze what needs to change in order to make your vision come true, present ideas as to which steps can be taken and measure the outcomes of those first steps, and then to come back and reflect with you on what they are finding. This will then start another round of discovery, measurable action, and reflection, a process which continues until you see real and sustainable change. In this manner they will take ownership of the changes you need them to make, feel transformed in their new roles, and, over time, you will be amazed at how much can be done, and what positive attitudes will develop. The requirement for a final report is a necessary capstone to this kind of change process. We have found that the two elements that create success are the incentives and the requirement for a final report that will be published. The first shows respect, the second sets a high professional standard.

What is the structure and timetable of this activity? Picture a central hub, with smaller circles attached to it through lines, and more lines making a web between the smaller circles. That is the general design of networked participatory action research to address complex change. First, small working groups are formed in each of the hubs of activity that need to address the change. For instance in education, you would bring together working teams that included Principals and key teachers from schools where the reform needed to be put in action. In business, the decisions of the online on where the reform needs to be put in action. So, if you’re strategic plan requires a retooling in some fashion across several working groups, you ask the heads of those working groups to select two or three partners and they form what we will call the local participatory action team.

Once these small teams are formed, (becoming the smaller circles in our imaginary diagram) you bring them together on a regular basis, facilitate their understanding of action research, their understanding of the challenges your wider organization faces, and what is expected of their individual subgroups. Then their team goes back to their area and proceedings with a cycle of action research. This includes discovering what is the currently in the way of the change and measuring it. Then they come back to the hub for another day’s work as you facilitate their next steps which include designing and planning the implementation that will begin to create the change you desire. Because they are held to a standard that requires later reporting, each step along the way as measured, and as the process continues as they grow in their professional understanding of the scientific approach to problem solving and change.

The timetable starts with management assigning the work to their managers and the managers choosing their teams, then these teams or hubs of activity come together with the facilitator to learn about action research and to plan the rest of the change effort. The will be meeting as a larger group for one full day about every two months for approximately one year after the first meeting. In total, and including initial planning and final celebration, the facilitated group meets for 8 – 10 working days. The teams will put in about three times that much effort in their local context. We have studied groups using this design and have found consistently transformational results – both from the teams in the hubs of activity and in the total organization as a whole. Generally a year of facilitated activity and another year where the people involved in the initial teams disseminate what they have learned and engender change in their local environments will demonstrate remarkable differences. The following quotes participants at the end of this design demonstrate the results you might expect in your organization.

The cycles of participatory action research have certainly given us exciting results. Motivation in our organization is an ongoing research topic, and we realize that we have a duty to pass on this information to the entire community. We all need to raise our expectations as to our ability to achieve better results, but we have proven to ourselves that we are up to the task.

The action research process has pushed all of us to continue to refine our practice of acquiring usable information. As we went through this cyclical process, we gained clarity on the data needed to be most helpful to those we work with and our employers. Everyone assisted by seeking information and we created an environment where all were successful. The process supported us and caused us to grow beyond out wildest dreams. While at time frustrating, it also creates an effective model for successful implementation of change.

Future articles will discuss the facilitation issues and other specifics of the design.

Why Would a Focus Group Facilitator Be Necessary?

When a business decides to launch a new product, it must invest millions of dollars in order to bring the product to the market. These dollars are spent primarily on research and development (R&D) and there is no guarantee that these dollars will ever be recouped. If the product is a complete flop, it will lose millions of dollars and cripple the company’s finances. For this reason, many companies use focus groups to determine how consumers feel about a specific product before producing and releasing it. Companies that bring together a group must hire a facilitator to lead the group’s discussion. This article takes a look at how group think works and what role a group facilitator plays.

A focus group is a form of qualitative research in which a set of consumers who match the target demographic are asked their opinions and attitudes to a specific idea, product, or service. The group facilitator asks participants a wide range of questions and participants are able to interact with other group members. Ideally a focus group will sustain a conversation and all participants will feel that they can speak freely. This free exchange of ideas allows the company to get the most honest reaction to a proposed product, service, or marketing campaign.

There are three phases of focus group planning that a group facilitator will have to complete. He or she will complete work before, during, and after the focus group. This professional will actually start working right after the company decides it is time to hire a facilitator. The group leader will help plan the event by identifying objectives for the discussion, determining a location and group of participants based on the objectives and the target market, and finally he or she will develop a script. This script will include an opening section that explains how the event will work, a section with open-ended questions that spur conversation, and a closing section that thanks the participants.

Once planning is completed, the group facilitator will conduct the focus group. He or she should record the session either with a voice recording or a video, with participants made aware that they will be recorded. The facilitator will follow his or her script during the session, but an experienced professional will know when to ask spontaneous questions. He or she will also focus on getting full answers, keeping the discussion on-track at all times, and making sure that every participant is given the chance to speak. The group facilitator will also keep an eye on time so that all questions are addressed.

When a business decides to hire a facilitator, it will also have help dealing with the results of the focus group. The group facilitator will use his or her notes and the recording of the session to create a written summary. This summary can then be analyzed to determine whether a product or service is ready for the market, or if a marketing campaign needs to be retooled before the product or service is released.

Companies that hire a facilitator to lead their focus groups will minimize the occurrence of costly product or service flops.

Group Facilitators Create Results by Encouraging Attendee Participation

Getting a group of people to work together with the purpose of achieving a common goal is often an obstacle for businesses. Facilitators may be incorporated into a workshop as a way to encourage positive participation in the workplace. Group facilitators help all participants with applying practical skills, problem resolution, and productivity issues. When the goal of a session is to put all these items to better use in future team collaborations, the process is commonly called a facilitated workshop. These sessions are advantageous any time a business is attempting to manage organizational changes.

A facilitation expert is included to remove existing barriers and to assist with goal achievement. Workshops help employees become motivated and create interaction that promotes a productive environment. Working relationships are improved due to the sense of belonging these professionals provide during the process. Many techniques are used throughout the building session to ensure it is a success.

How Do Facilitator Techniques Increase Collaboration?

The techniques applied by facilitators are an attempt to encourage each individual to constructively participate along with the rest of the group. A professional will first identify the objectives to be accomplished through the workshop. Flexibility is important in regards to participant schedules and goal achievement. If the facilitator is too focused on time or rushes into deliberations too quickly, less successful results will follow throughout the session.

Games are a common tool used before a meeting commences because it removes tension from the atmosphere. When individuals have to work together to win a game, they often have an easier time opening up and becoming comfortable around each other. These little breathers also promote teamwork, communication, and compromise.

Complex problem solving where the resolution is broken down into small pieces may be another used technique. Facilitators present the problem on a large scale and then break it into smaller manageable components. A section of the problem is assigned to each group so they can come up with a solution. By removing the intimidation of a big issue, the entire team is able to solve the complex problem. Some participants are not as willing to take part in the workshop. A facilitator typically identifies social unrest to provide additional encouragement to contribute to the group.

Visual tools are another tactic used during the facilitation process. Participant numbers are often limited to ten people because this count ensures all attendees are involved. Techniques vary based on the personal style of the professional and the overall objective of the workshop.

Group facilitatorsmust be self-aware, friendly, communicative, and open to provide needed results. Any business can set up a workshop to improve team work or decision making abilities. Some services provide a program for this type of facilitation designed to include one or many series of workshops. A company can also set up their own event and locate a facilitator to assist with developing a team building or staff enhancement session. Businesses often find these processes to be more rewarding when a qualified professional is used. With a little research, any type of collaborative session should be a success.

Impact of Product Patent on FDI in Indian Pharmaceutical Industry

An Ordinance on Patents (Third) Amendment was promulgated by the Government on December 26, 2004 to make the Indian patents law WTO compliant and to fulfill India’s commitment under TRIPS to introduce product patent protection for Drugs, Food and Chemicals with effect from January 1, 2005.

An overview of Indian pharmaceutical industry

The Indian pharmaceutical industry, with US$4 billion in domestic sales and over US$3
billion in exports, is showing satisfactory progress in terms of infrastructure development, technology base and product use. The industry now produces bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing processes and has also developed excellent ‘good manufacturing practices’ (GMP) compliant facilities for the production of different dosage forms. The strength of the industry is in developing cost-effective technologies in the shortest possible time for drug intermediates and bulk actives without compromising on quality. This is realized through the country’s strengths in organic synthesis and process engineering.
The focus under the R&D effort is to encourage development of new molecules. A provision of Rs. 150 crore has been made under the Pharmaceutical Research & Development Support Fund. A Drug Development Promotion Board under the Department of Science & Technology has also been set up for the utilisation of this fund. Feasibility of setting up a Mega Chemical Industrial Estate in the country with world class infrastructure facilities is also being studied. For the first time in many years, the international pharmaceutical industry is finding great opportunities in India. The process of consolidation, which has become a generalised phenomenon in the world pharmaceutical industry, has started taking place in India.

The pharmaceutical industry, with its rich scientific talent and research capabilities, supported by Intellectual Property Protection regime, is well set to take a great leap forward. As regards product patents for
drugs, an amendment to the Indian Patents Act has been carried out through the Patent (Amendments) Ordinance, 2004 on December 26, 2004. The Ordinance amends the Indian Patents Act, 1970 for the third time with a view to introducing product patents for drugs, food and chemicals. Apart from manufacture of drugs, the product patent regime will help the pharmaceutical industry to tap outsourcing of clinical research. By participating in the international system of IPR protection, India, with its vast pool of scientific and technical personnel, and well-established expertise in medical treatment and health care, has unlocked vast opportunities in both exports and outsourcing and has the potential to become a global hub in the area of R&D based clinical research. The Patent Ordinance also provides adequate safeguards to protect the interest of the domestic industry, and the citizen from any increase in prices of drugs.

Impact of product patent on Indian Pharma industry

With a regulatory system focused only on process patents, helped to establish the foundation of a strong and highly competitive domestic pharmaceutical industry which in the grip of a rigid price control framework transformed into a world supplier of bulk drugs and medicines at affordable prices to common man in India and the developing world. Introduction of product patents will, however, mark the end of a golden age for IPI (Indian Pharmaceutical Industry). The new regulations will reshape the landscape of IPI forcing significant changes and divide within the industry.

A look into organization of pharmaceutical producers of India (OPPI) directory shows only 300 units out of 10,000 registered companies are in the organized sector. While process patent helped to flourish IPI into a world-class generics industry, product patent regime will filter the best from the pack and would be favorable to players with built-in scientific and technical resources. The impact of the new regulations will not deter the Indian pharma majors as they are already doing roaring business in the very countries where these patent laws are strictly in force.

Export markets increasingly drive IPI: in a turnover of US$5 billion, exports constitute $3.2 billion and the industry is poised to grow to $25 billion by 2010. The share of IPI in world pharmaceutical market is 1.0% (ranks 13th) in value and 8% (ranks 4th) in volume terms. The global market for generic drugs is estimated at $27 billion (2001) and the expiry of patents on drugs will be worth $80 billion (2005) offers a huge opportunity to IPI. India today has the largest number of US Food & Drug Administration (FDA) approved drug manufacturing facilities outside the US. In addition, Drug Master Files (DMFs) filed by Indian companies with the FDA is 126 higher than Spain, Italy, China and Israel put together. DMF has to be approved by FDA for a drug to enter the US market.
Research & Development (R&D) is a key to the strength of pharmaceutical industry especially in the product patent period. The global pharmaceutical industry spent $30.4 billion (2001) on R&D. The R&D expenditure (as a percentage of turnover) by the IPI is low (1.9%) when compared global giants (1016%). With transition into the new regime many Indian companies are mobilizing their resources war chest with an increase in their R&D budget. Government of India (GOI) encouraged the R&D in pharmaceutical companies by extending 10 year tax holiday to this sector. Besides, planning commission has earmarked $34 million towards drug industry R&D promotion fund for the tenth plan.

FDI in India was low in prior Product Patent era. Why?

Bringing a new drug into the market costs a company an average of about $800 to $900 million. Some estimates show that patient recruitment and medical personnel account for nearly 70 per cent of the clinical costs that are required to bring a drug to market. The less expensive means to raise research productivity is outsourcing research to low cost havens such as India and China. The global pharmaceutical outsourcing market stands at $10 billion (2004). Pharma multinationals have maintained a low-key presence in Indian market due to absence of product patents and rigid price controls. Pharmaceutical industry did not receive significant foreign direct investment (FDI). From August 1991 to December 1998 this industry accounted for a meager 0.44% of the total FDI. Introduction of product patents will see multinationals strengthening their presence in the country. The second largest population in the world, a growing economy and rising income levels makes Indian market difficult to ignore. Global companies would be reluctant to invest in a country where there is no IPR protection. Eli Lilly (world’s 7th Largest Pharma Firm) has its clinical research focus in the country and had spent considerable amounts over the last 2-3 years. But we would be only maintaining the quantum and will not expand even though there is huge potential. Global companies face the same frustration.

So the main activity of the company in the country would be to introduce products from the parent pipeline.mIn the domestic market, the share of Indian companies has steadily increased from around 20 per cent in 1970 to 70 percent now. Ranbaxy Laboratories is the market leader in terms of revenues followed by Cipla and Dr Reddys Laboratories. Glaxo is the only multinational to figure among the top ten pharma companies in India. In India, 97 per cent of drugs are off patent and are manufactured by a vast number of companies. The key therapeutic segments include anti-infectives, cardio vascular and central nervous system drugs. Anti-infective comprise the largest therapeutic segment in India, accounting for about 26 per cent of the market.

Globally, pharmaceutical industry grew at a compounded annual growth rate of 9.1 per cent in the last 23 years to $491 billion propelled by a string of innovative blockbusters. Multinationals were reshaped by mergers and acquisitions as a way of fattening their research pipelines. This at best represents a short-term solution. With a slew of brand name drugs losing patent protection in the next few years and the pressure building for pharmaceuticals to cut price, these giants find themselves under immense strain to find new drugs and reduce price.

So, from the above discussion it’s very evident that before any proper IPR regime specially in the absence of “Product patent” in India it was not a judicious decision for the international Pharma companies to invest here in India. FDI cap was raised from 74% to 100% in 2001 only but we didn’t find any change in the pattern of FDI in Pharma Sector.

Impact after 2005?

India a signatory to the WTO resolution on TRIPS Agreement India was thus committed to recognising product patents by amending The Indian Patents Act 1970. As per the minimum standards mentioned in the TRIPS agreement, patent shall be granted for any inventions, whether products or processes, in all fields of technology provided they are new, involve an inventive step and are capable of industrial application without any discrimination to the place of invention or to the fact that products are locally produced or imported. Accordingly, now patents will have to be granted in all areas including pharmaceuticals and the effective period of protection is for twenty years from the date of filing the application. With the implementation of TRIPS agreement by most of the developing countries by 2005, a stronger patent regime or product patents will be uniformly applicable on the pharmaceutical innovations among the member countries of the World Trade Organisation.

The implications of TRIPS for the pharmaceutical sector are that: patents will be granted both for products and processes for all the inventions in all fields of technology; the patent term will be twenty years from the date of the application (compared to the seven years under the 1970 Act), which is applicable to all the member countries and thus rules out all the differences in the protection terms prevailed in different countries; patents will be granted irrespective of the fact whether the drugs were produced locally or imported from another country; though the grant of the patent excludes unauthorized use, sale or manufacture of the patented item, yet there are clauses which provide manufacturing or other such rights of the patented item to a person other than the patent holder. In the case of a dispute on infringement the responsibility (to prove that a process other than the one used in the patented product has actually been used in the disputed product) lies with the accused rather than with the patent holder (in the 1970 Act, the responsibility is with the patent holder). This is the broad framework, which will guide the pharmaceutical industry of India in the WTO regime ( i.e. post 2005 period).

In order to increase the global prospects of the pharmaceutical industry in the post 2005 period, the Central Government has fixed the deadline of December 2003, to comply with the Good Manufacturing Practices set by World Health Organisation. Since this is mandatory for all the units, it means incurring expenditures that could range from Rs. 15 lakhs to 1 crore per unit. In some cases, it would involve shifting to new premises altogether. A few units might exit from business because of this. As contract manufacturers it is essential that both the parent unit and the loan licensee meet these requirements in cases where the production is meant for exports. While these standards improve the quality on par with international standards, it will also act as potential entry barriers for new firms to enter.

The strength of the Indian pharmaceutical industry is in reverse engineering. Such units by utilising the provisions under compulsory licensing, exceptions to exclusive rights and the Bolar exception should aim at producing the generic version of the patented product and those that are nearing patent expiry. Such firms should also be engaged in research leading to new drug delivery mechanisms and in identifying new uses of existing drugs. In this context, it is also essential to protect the innovations that have been introduced by the technology spillovers. It is suggested that in order to develop domestic innovations, developing countries require utility models or petty patents. These petty patents can be available for a shorter period of time for process innovations made over an existing product. The TRIPS agreement leaves members to introduce such legislation, as there are no specific rules on this subject. Such patents will encourage the small firms.

One of the concerns regarding product patents is the access to patented products. Some of the provisions within the TRIPS agreement clearly indicate that price controls could be imposed on the patented products. However, exemptions from price controls has been suggested by the government for the products that are produced domestically using the domestic R&D and resources and are patented in India. Such exemptions will keep the prices high and make access to the drugs difficult. It appears that `who patents the product’ matters more for the government than what is patented. In the recently concluded Doha meeting, a separate declaration on the TRIPS agreement has clarified that members have the right to grant compulsory licence in the area of pharmaceuticals and that they have the freedom to determine the ground upon which such licenses are granted, which can have a considerable impact on the availability as well as on their prices. However, the amendments made by the Government of India, make the procedures very cumbersome which needs to be revised in the third amendment to the Patents Act. While parallel trade in pharmaceutical may facilitate access to medicine, yet compulsory licence will be the only course of option to facilitate flow of technology and R&D. Scherer and Watal (2001) suggest that tax concessions should be provided to the pharmaceutical manufacturers to encourage them to donate the high technology drugs to the less developed and developing countries which is a viable option.

A majority of the population does not have access to the essential medicines (most of which are off patent) either in the government or private health care systems because they are not within their capacity to reach. Now that the percentage of drugs under price control has been reduced drastically it is essential to keep the prices of the essential drugs under check, especially those concerning the common diseases.

Currently only a handful of pharmaceutical firms in India invest in R&D which needs to be improved. The Pharmaceutical Research and Development Committee (1999) has suggested that a mandatory collection and contribution of 1 per cent of MRP of all formulations sold within the country to a fund called pharmaceutical R&D support fund for attracting R&D towards high cost-low-return areas and be administered by the Drug Development Promotion Foundation. The domestic universities and other academic institutions can play the role of research boutiques or contract research organisations (CRO), which can supply the technical know-how and manpower. Units that already have such facilities can also function as a CRO for other firms.

In the post TRIPS era, the government will have to probe in to factors that contribute to the widening gap between the proposed FDI and the actual FDI and rectify these bottlenecks. Similarly the difference between the number of patents filed and the patents granted calls for a detailed analysis to figure out where the Indian firms are lacking.

Governments at various levels should take active part in disseminating knowledge about the IPRs and the possible strategies that can be adopted by the industry. This will remove some of the impediments. Lessons should be drawn from the Chinese experiences where systematic efforts were taken to educate the bureaucrats, policy makers and the industry about the WTO and product patents in the pharmaceutical industry. India will have to strengthen the patent examination process and speed up the processing procedures. This will help in checking the products that may enter the country utilising the import monopoly route provided by the EMR. Besides a strong institutional and judicial framework will have to be set up for monitoring the prices, to prevent infringement and trade dress cases of patented products respectively.

As far as India’s pharmaceutical industry is concerned, various options are possible in the WTO regime. These are to: (a) manufacture off patented generic drugs, (b) produce patented drugs under compulsory licensing or cross licensing, (c) invest in R&D to engage in new product development, (d) produce patented and other drugs on contract basis, (e) explore the possibilities of new drug delivery mechanisms and alternative use of existing drugs, and (f) collaborate with multinationals to engage in R&D, clinical trials, product development or marketing the patented product on a contract basis and so on. Besides these strategies, India’s strength lies in process development skills. This expertise utilised within the WTO framework with emphasis on quality standards will provide India a competitive advantage over other Asian countries.

To conclude we can anticipate more FDI nature of investment in India in the field of Pharma Sector?

It’s a question which requires more time to be answered, but we can draw inferences from the facts & data discussed above. As from the above discussion it is obvious that Pharma industry is high investment seeking industry, & the other most important fact about it is that it require enormous R&D. The new Patent regime brings both opportunities and challenges to the domestic pharma industry. Even larger Indian companies lack the financial muscle to be major international player in basic R&D, that involves discovery of new chemical entities (NCEs). They would be helped by the government’s decision not to restrict patenting to NCEs. The Patent Ordinance issued recently defines the term patentability as per the TRIPS guidelines but does not exclude patenting of incremental inventions like new drug delivery systems, polymorphs etc, brightening the chances of Indian companies to benefit from the patent regime, but it may act as a disincentive for the international Pharma firms to invest in India.

Again if we look at the patent amendment act there are certain provisions of this Act which are discouraging the FDI in Pharma sector like

1. Deletion of the provisions relating to Exclusive Marketing Rights (EMRs) (which would now become redundant), and introduction of a transitional provision for safeguarding EMRs already granted.

2. a) Conditional grant of patent (Section 47) : Empowers the Government to import, make or use any patent for its own purpose. For drugs, it also empowers import for public health distribution.

3. Revocation of patent in public interest (Section 66): Empowers the Government to revoke a patent where it is found to be mischievous to the State or prejudicial to the public.

4. Grant of compulsory licence (Sections 82 to 94): Chapter XVI deals with the general principles and circumstances for grant of compulsory licences in order to protect public interest particularly public health and nutrition. These provisions check the abuse of patent rights. They can be invoked if the reasonable requirements of the public with respect to patented inventions have not been satisfied, and the patented invention is not available for public at a reasonably affordable price, and if the patented invention is not worked in the territory of India. Section 92 of this law provides for action in case of national emergency, extreme urgency and public non-commercial use, and can be invoked without the grace period of 3 years from grant of patent.

5. Use of invention for the purpose of Government [Sections 100 & 101]: Compliments Section 47.

6. Acquisition of invention and patent for public purpose [Section 102]: Empowers the Government to acquire a patent to meet national requirements.

7. Bolar provision [Section 107 (A) (a)]: Facilitates production and marketing of patented products immediately after expiry of the term of patent protection by permitting preparatory action by non patentees during the life of the patent.

8. Parallel import [Section 107 (A) (b)]: Provides for import so that patented product can become available at the lowest international price.

These provisions are basically public interest provisions but these are anti FDI in nature because in a sector of high investment & high uncertainty every investing firm need complete protection & patronage but here it is not guaranteed.

So we can anticipate that product patent is going to have a very little impact on the FDI scenario in a country like India.