Indian pharma industry: Ahead in adopting technological advancements

Indian organisations have to undertake value added exercises to make its mark in the pharmaceutical business, feels J Ramnivas

Yad yad acharati shreshta, tat tat deve itrojanaha Sayat pramanam kurute, lokotat anuvartate.

—Whatever great people do, others follow and techniques adopted by them are also adopted by others.

During the past decade, pharmaceutical organisations the world over have seen many technological upgradations and changes and India is no exception. In this transition period, India has stood as an undisputable leader to make a niche in the face of all technological changes and challenges.

Under these circumstances, Indian pharmaceutical organisations have followed the Darwin’s principle ‘‘Survival of the fittest’’ and have established a track record to overcome all these challenges. The Indian pharmaceutical industry today is in front rank of India’s science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology.

Playing a key role in promoting and sustaining development in the vital field of medicines, Indian pharma industry boasts of quality producers and many units approved by regulatory authorities in USA (US FDA), in Europe (like EDQM, MHRA etc.) in Australia (TGA), in Canada (TPD, HPB etc.) and in Japan. International companies associated with this sector have stimulated, assisted and spearheaded this dynamic development in the past 58 years and helped to put India on the pharmaceutical map of the world. Following are the challenges, which have been witnessed by the pharmaceutical sector during the last decade:

• Science based GMPs
• Advent of information technology
• Increasing regulatory requirements
• Drastic cost reductions
• Chemistry and manufacturing controls with innovated technologies
• Risk management
• Intellectual property rights.

There is a stark reality about we Indians that we stand united at the time of diversity. Accepting the ensuing technological challenges, we must show our preparedness to win the war of technology advancement in the pharmaceutical sector as we did in the past. There are a lot of factors which have made us look up with pride as and when we come across any kind of pressure in the technological segment.

The factors, which have proven advantageous to India’s growth and survival during this critical phase of technological development and transformation are listed below:

Competent workforce: India has a pool of personnel with high managerial and technical competence as also skilled workforce. It has an educated work force and English is commonly used. Professional services are easily available.

Cost-effective chemical synthesis: Its track record of development, particularly in the area of improved cost-beneficial chemical synthesis for various drug molecules is excellent. It provides a wide variety of bulk drugs and exports sophisticated bulk drugs.

Legal and financial framework: India has a 58 year old democracy and hence has a solid legal framework and a strong financial market. There is already an established international industry and business community.

Information & Technology: It has a good network of world-class educational institutions and established strengths in information technology.

Globalisation: The country is committed to a free market economy and globalisation. Above all, it has a 70-80 million middle class market, which is continuously growing.

Consolidation: 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.

Consolidating the position

If, the following steps are taken by Indian manufactures, it will help them to strengthen their position to transform themselves to adapt to the new technological challenges:

No compromise on quality fronts: Quality is that extra something, which the customer remembers long after the price is forgotten. Therefore, it must be the policy of all Indian pharmaceutical organisations to provide its customers with products and services, which exceed their requirements. All the organisations must abide at all times by quality systems and procedures in order to achieve the customer satisfaction and delight.

Right product-mix for sustained future growth: Indian companies need to attain the right product-mix for sustained future growth. Core competencies will play an important role in determining the future of many Indian pharmaceutical companies.

Merger and acquisition options: Indian companies, in an effort to consolidate their position, will have to increasingly look at merger and acquisition options of either companies or products. This would help them to offset loss of new product options, improve their R&D efforts and improve distribution to penetrate markets.

Research and development: Research and development (R&D) has always taken the back seat amongst Indian pharmaceutical companies. In order to stay competitive in the future, Indian companies will have to re-focus and invest heavily in R&Dm, to build on India’s existing strengths in manufacturing and distribution and substantially enhance the beginnings made in R&D. This will India one of the leading players in the global pharmaceuticals market.

Biotechnology and information technology: The Indian pharmaceutical industry also needs to take advantage of the recent advances in biotechnology and information technology. The future of the industry will be determined by how well it markets its products to several regions and distributes risks, its forward and backward integration capabilities, its R&D, its consolidation through mergers and acquisitions, co-marketing and licensing agreements.

Intellectual property rights and innovative process chemistry: Necessity is the mother of invention. When we think of invention, we always associate it with scientists who are working in advanced labs or highly educated people. We live today in the age of technology. Our economy is a knowledge economy today. It is not therefore surprising that Intellectual Property Rights (IPRs) have become a major issue in global trade negotiations. There are vigorous debates going on about amending the Indian Patent Act.

The degree of success that the Industry attains in these areas will be a direct function of the emphasis given to the development of a sound system of IPRs, Biological Sciences Research (particularly genomics and proteomics), Clinical R&D and Innovative Process Chemistry.

A concerted effort in R&D aimed at commercialisation of the products and processes utilising the existing natural resource of the country would provide economic benefit not only to the resource poor communities, but would also help the nation to compete in the international market.

Biotechnology can help India convert the biological wealth into economic wealth resulting in sustainable development.

Research focus of Indian manufactures should be on intellectual property management that includes: - Intensive product identification process that covers:

a) API complexity

b) Finished product complexity

c) Commercial potential of products

d) Cautious risk management

e) Dovetailing with different research groups

f) Development of value added products

g) Out licensing opportunity to global majors.

What others consider as a compulsion, we Indians have taken it as a challenge. There are multiple factors compelling the industry to explore newer technological avenues to cut cost and time, ensure operational efficiency, usher in world-class standards and work out innovative strategies to peg up bottom line.

A closer look at the technology profile over the past couple of years will prove that the Indian pharma industry has been shopping around for technology and skilled top-level manpower. Indian pharmaceutical organisations have to undertake value added excises with time to make their dreams come true to prove techno savvy in the pharmaceutical business by adopting the following horizons:

• Drive core growth by international generics
• Global generic business
• Critical mass in focused market
• Leveraging India advantage
• Build momentum of growth engines by specialty pharmaceuticals
• Brand building in developed markets
• Proprietary technology products
• Networking and alliances
• Secure future options by innovative research
• Expanding discovery research
• International clinical development
• Rx marketing

The writer is senior manager QA, Tonira Pharma Limited, Vadodara.

E-mail:jramniwas@tonira.com