Tag Archives: improvement

India as a global pharmaceutical outsourcing hub: Some key advantages and the areas of improvement.

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All over the world, pharmaceutical research and development pipelines are gradually getting dried up. Lesser and lesser blockbuster drugs are now coming up from the ‘mind to the market’. Currently the average annual turnover of over 90% of patented drugs is around US $150 million each. At the same time regulatory requirements to obtain the marketing approval are becoming more and more stringent, spiralling the R&D costs of the innovator companies very significantly.
The name of the game:

In today’s perspective of the global pharmaceutical industry, ‘competitive efficiency’ in speed of implementation of various projects and optimizing costs of operations, can be easily considered as the ‘name of the game’.
Such competitive efficiency is as much essential for a relatively quick turnaround from ‘the mind to market’ of New Chemical Entities (NCEs) or New Molecular Entities (NMEs), to reducing manufacturing costs through various outsourcing opportunities and/or innovative application of technology and spreading geographical marketing operational network.

Towards this direction, ‘Business Process Outsourcing’ in R&D, manufacturing, clinical trials etc. is now gradually emerging as one of the most critical ways to achieve this important objective. It is expected that gradually outsourcing of specialized manufacturing like, biopharmaceutical and sterile manufacturing and specialized processes like, improvements in catalyst activity, will be gaining grounds.

India is emerging as a potential outsourcing hub:

India is fast emerging as a key player in the outsourcing business of the global companies, with its high quality facilities, world class services at a very competitive cost, in various areas of pharmaceutical business operations. India is not only a vibrant democracy, it has now a good Intellectual Property Rights (IPR) system in place and offers very significant cost advantages both in contract research and contract manufacturing space, as compared to many other countries.

Many Indian pharmaceutical companies are scaling up their capacities and investing in establishing more number of world class facilities. Currently India has over 100 pharmaceutical plants approved by the US foods and drugs administration. Incidentally this number is the largest outside the USA.

The key advantages:

India with its total pharmaceutical market size of around US $ 14 billion offers both value and cost arbitrage, which are as follows:

1. Familiarity with the regulatory environment and requirements of the developed markets

2. Extensive global operations in the generics business

3. World class facilities

4. Lower employee wages

5. Large number of young workforce

6. High capacity of skilled labour (350,000 engineers/year)

7. High quality of engineers, process chemists

8. Low communication barriers due to high levels of English

9. Speed of operation

10. Cost effective IT infrastructure, facilitating all key business processes

Contract research investment strategies of the global companies in India:

Most common investment strategy in the collaborative arrangement is risk-sharing outsourcing co-development of a NCE/NME. For example, Johnson & Johnson (J&J) signed an outsourcing agreement with Advenus Therapeutics of India in November 2008 with a contract value of US $ 247 million including milestone and royalty payments in the areas of inflammation and metabolic diseases. In this contract Advinus will be responsible for development upto ‘the proof of concept’ (Phase II a) and then J&J will take over till commercialization of the molecule.

Areas of improvements:

1. Biotech contract research as a whole

2. Economies of scale in manufacturing products like, recombinant proteins, small interfering Ribonucleic Acid (siRNAs), vaccines, antibodies etc.

3. Fully integrated service offerings in contract research and contract manufacturing

4. In genomics and proteomics research

5. Pre-clinical research

In all these important areas our neighbouring country China seems to score over India

Conclusion:

Availability of world class contract research and manufacturing facilities and the ability of the domestic pharmaceutical industry to deliver the agreed deliverables in a cost-efficient manner with desired operational speed, make India a potential contract research and manufacturing hub of the world.

India can expect to compete effectively in these areas with any other countries, including China, provided the improvement areas, as indicated above, are addressed with equal speed of action and with a missionary zeal.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Indian Patent offices (IPOs) have started showing improvement in their functioning; still lot of grounds to cover.

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Indian Patent offices are located, with four clearly specified jurisdictions, at New Delhi, Mumbai, Kolkata and Chennai.

Since last few years enough efforts have been made towards overall capacity building initiatives, training of personnel and digitalizing the huge databank of these offices, with wide scale application of information technology (IT). As a result the patent offices are now having almost a centralized database to provide online services to the users in various areas of their operations. Users are now having the facilities of not only online patent search, but also for online patent applications.

More extensive IT applications are required to achieve greater system efficiency and transparency:

However, to bring in more efficiency and transparency in the system, there is a need to introduce appropriate IT applications in all the transactional interfaces between the patent office personnel and the patent applicants.

Still there are lots of grounds to cover:

Following are the key areas which should be taken care of by the Controller General of Patents, Design and Trade marks (CGPDTM) to make the IPOs more efficient, transparent and effective:

1. The Patent Manual, which provides essential guidelines to the patent examiners to bring in uniformity in the patent application examination process, is long overdue.

2. Many patent applicants feel that there is a need to include the International Non-proprietary Names (INN) in the title of pharmaceutical patent applications by the IPO.

3. Inadequate bandwidth makes the IT system slow, reducing its operational efficiency.

4. Electronic-filing of patent applications has been introduced, but there is no facility of paying the fees online by credit card. This facility should be introduced to make it more convenient for applicants to file patent applications online, adding more speed to the process.

5. Electronic prosecution of patent applications should be introduced to make the patent prosecution virtually paperless and more efficient.

6. Despite new technological measures most patent officers and also the public in general are still following the traditional method of filing the patent applications due to the ease and authenticity of filing records. To encourage applicants to file applications electronically, incentives such as reduced fees may be offered to those who file their applications electronically.

7. The IPOs should digitize all the physical files lying with them, so that file histories of each application are available online.

8. The Patent offices should have designated centres to provide assistance to applicants for filing or prosecuting applications.

9. Clear guidelines to be issued for conducting pre-grant and post grant opposition proceedings. Presently they are being handled in an arbitrary manner.

10. In order to introduce an efficient system of patent prosecution, it is recommended that the IPOs adjust patent term to compensate patentees for any delay in the grant of the patent that reduces the term of the patent, when such delay is caused solely by the IPOs.

11. Decision making and its communication to all concerned to be made faster at the IPOs. A system to be instituted for issuing the operative part of the decision first, followed by details of the decision taken. These should be advertised immediately in the technical journal to close proceedings at the earliest. Delays are leading to increase in the waiting period for the grant of patents, even if the proceedings have been concluded (opposition or otherwise) attracting serial and frivolous pre-grant oppositions. Such delays are also preventing the patent applicants to get their grants. As a result they are unable to initiate infringement proceedings against infringers quickly, defeating the very purpose of the patent system.

12. The timeline for an application, which will be taken up for examination, needs to be clearly defined. Currently, there is no time-line defined for taking up the applications for examination.

Conclusion:

All concerned will feel happy, if the DIPP in general and the CGPDTM in particular take note of these suggestions and formalize a process within the IPOs to address these important issues.

Growing discontentment of the past, in several areas of operation within the IPOs, is now being effectively addressed. However, the system still warrants more capacity building to enable the IPOs provide world class services to the patent applicants. This process needs to be expedited to further enhance the credibility of the new IPR regime in India.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.