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Growing from strength to strength
AD Pradeep Kumar & Gireesh Babu | Thursday, August 26, 2010, 08:00 Hrs  [IST]

A century old pharma hub of India, Gujarat, which is at the forefront of the pharmaceutical industry in the country, has carved out a significant portion of the country's pharma share, registering growth across all segments including generics and research and development and other life sciences.

The state, which accounts for about 42 per cent share of India ’s pharmaceutical turnover, 22 per cent in drug exports and produces about 40 per cent machinery for pharma sector, has around 3,553 registered units and provides employment to more than 50,000 people.

Gujarat pharmaceutical industry has evolved into an innovation-driven, knowledge focused, growth oriented industry. Over the years, it has moved forward at quick pace and attained a significant position in the global pharma industry. Gujarat is fast developing into an ideal location for global research. Further the upcoming dedicated pharma SEZs will also give a booster shot to drug manufacturing as a whole.

The main hubs of pharma-based activities clustered in and around Ankleshwar, Ahmedabad, Vadodara and the Bharuch-Vapi-Valsad belt are home to many domestic and international pharma and biotech companies.

While the Gujarat government is doing all it can to ensure complete support to the pharma industry, the most notable of this is the government's setting up of pharma clusters in Gujarat. The proximity of related industries in close clusters helps cut down logistics involved.

Says Dr R S Joshi ,Executive Secretary , IDMA Gujarat “The growth of pharma industry in Gujarat is due to quality conscious manufacturers, pro-active government and the cooperation of FDCA. In Gujarat, almost all the units are Schedule M compliant. After getting Schedule M, majority of the units have already obtained WHO-GMP Certificates.”

“In Gujarat there are 5 AC-GET projects coming up exclusively for pharma industry. We are getting constant inquiries from other parts of India for setting up units in Gujarat. Pharma industry growth in Gujarat is due to entrepreneurial skill, modern infrastructure facility and supported by around 100 pharmacy colleges”, adds Dr Joshi.

According to Chirag Doshi, Vice President IDMA Gujarat,"Gujarat has an established manufacturing base of formulation and bulk drug and capturing global market to become a global pharmaceutical hub. Emerging SEZs is likely to create a pharma growth as per international standards that will compete in global market. The availability of well developed chemical industry will boost the high growth of pharma sector which could make Gujarat a strong sourcing base for global companies. Gujarat has highly qualified specialists in the field of urology, oncology, etc”.

Having more than 40 per cent CROs in the country, Gujarat has played a great role in the growth of pharma R&D sector of the country. Gujarat is also a main hub of pharmaceutical machinery manufacturing. While Gujarat is a dominant force in the India's pharmaceutical sector ,the next logical step is to acquire global leadership. Gujarat has world class management acumen, IT solutions, well-established allied industries and entrepreneurial mindset, opines Doshi.

The state which has been a focal point for investors, industry, researchers and even the national drug regulators is now diversifying into the medical devices segment. If things work out according to the plans of the central, state governments and the industry, the state will soon lead the medical devices industry, which is comparatively in a nascent stage at present in the country.

The Department of Pharmaceuticals (DoP) under the central ministry for chemicals and fertilisers with support of the Gujarat state government, is developing a medical devices cluster in the state to promote medical devices industry and innovation in the country. However, availability of adequate manpower in the segment may pose a challenge for the growth of the cluster. In order to meet this challenge, the Ahmedabad chapter of National Institute for Pharmaceutical Education and Research (NIPER) has initiated a course for students in the segment.

To keep abreast of the times, the drug regulator in the state is equipping itself with latest gadgets for monitoring and controlling the industry. The Food and Drug Control Administration (FDCA), Gujarat, is the first state to take up an e-governance project seriously, and to come out with on-line issuance of sales licenses and other certificates like the CoPP. The e-governance project is at a mature stage. The administration is currently able to monitor the day- to-day activities of its regional officers and compile a database of the pharma industry in the state. A project to issue product licenses, which will virtually complete the e-governance programme in the FDCA, is on trial now, according to FDCA officials.

The FDCA is also planning to set up a laboratory to test quality of medical devices notified by the Drug Controller General of India as drugs. This is reported as the first of its kind initiative from a state drug regulator in the country. The administration is also expected to receive technical support from the Indian office of the US FDA on the latest developments in the segment. In order to expand the manpower for testing and related processes and setting up almost six more regional offices to carry out its responsibilities, the regulator is expected to induct 60 more drug inspectors soon.

The pro-active nature of the state government is a major factor for the growth of pharma industry in Gujarat. The much acclaimed Vibrant Gujarat editions have ensured supply of adequate land for the industry to expand infrastructural facilities. Signing deals with the government at the summits have helped in easing land procurement and infrastructure for the industry. The government is also planning to conduct roadshows on various segments including the pharma and biotech in the last quarter of 2010 for identifying the needs of the industry to be addressed in the Vibrant Gujarat Summit 2011.

Gujarat is also home to some of the premier pharma education and research centres in India. The very fact that the number of pharmacy colleges in the state has increased from around seven a decade back to around 85 last year and to 100 in the current academic year is a pointer to the fast growing pharma education in Gujarat.

The pharma education in Gujarat is growing at a scorching pace. While the undergraduate courses are facing a glut situation where the availability of seats are far outnumbering demand, a similar situation may soon happen for post graduate courses also. This will enable the industry and the academia to meet the manpower needs of the state, which is considered as one of the fast growing hub for pharma and allied industries in the country,according to experts.

Gujarat , which is also known as a pharma machinery hub, has a strong backbone comprising the allied sector and consequently it has played a major role in the success of the pharmaceutical sector. Gujarat has the highest number of pharma machinery manufacturers in the country and manufacturing almost all types of machines which are required by the industry.

Pharma machinery industry is one of the largest business sector in Gujarat. IDMA - Gujarat State Board (GSB) and Indian Pharma Machinery Manufacturers Association (IPMMA) has always supported each other and are also working together on many projects as development of pharma machinery.

Says Rajesh Shah, president of Indian Pharma Machinery Manufacturers Association (IPMMA), “the future prospects for the pharma machinery in Gujarat seems to be very bright having wide scope of development with the infrastructure availability and support from the Gujarat government”.

“Gujarat is emerging as one of the largest state when it comes to pharma machinery. Gujarat already accounts for the production of around 45 to 50 percent of India's pharma machinery business”, he adds.

However the prominence of Gujarat had been impacted when Baddi of Himachal Pradesh emerged as a major investment destination offering a number of tax sops. This had led to several units being closed down in Gujarat as many companies moved to Baddi. As the tax honeymoon has came to an end, companies started coming back from these special zones to Gujarat.

Gujarat is also fast emerging as a hub for Contract Research Organisations (CROs), as 40 per cent of India's CROs are in Gujarat.As Gujarat is already a pharma hub having a significant number of the pharma companies engaged in New Chemical Entities (NCE) development, it provides with a readily available customer base for CROs based in the state. Earlier, the CROs have been primarily catering to the in-house requirements of the parent companies, but now they have started offering services to other Indian as well as MNC pharma companies looking to outsource clinical research activities, thus increasing their demand and need in the market.

Further CROs too have been benefited from this ready-to-use infrastructure in terms of uninterrupted power supply, roads, low start-up costs and trouble free labour etc. These are some of the factors that have significantly contributed to the growth of CROs in the state.

Apart from this,the state was also the first to undertake pre-clinical safety and toxicology studies in India. The state is home to more than 20 well established CROs, and the numbers are increasing as many more companies keen on entering Gujarat.

The trends clearly forecast a strong growth for the biotech industry in Gujarat. The specific areas of thrust would be biopharma, agri-biotech and marine biotech. The Gujarat State Biotechnology Mission (GSBTM) is putting in continuous efforts for attracting more skilled manpower, supporting the industry in various matters including development of infrastructure and technical support. The increased focus of traditional pharma companies on biotech would also drive the growth of the sector.

Driven by new enterprise and innovation in recent years, biotechnology sector in Gujarat is witnessing persistent growth. Besides agricultural biotechnology, other related areas that hold promise are diagnostics, vaccines, stem cell, animal healthcare and clinical trials.

Gujarat has a bright future in the field of pharma, including some key areas like contract manufacturing, manufacturing of new dosage forms, manufacturing of rDNA based products, bio-pharmaceuticals, APIs, ayurvedic preparations, medical devices and clinical research and development.

For becoming a leading global player in the pharmaceutical industry, the state should continue with current growth-oriented policies that have helped it achieve this mark and acquire capabilities required for operating in the global market place.

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