India has over the past decade turned into an attractive destination for pharma and biotech research and development (R&D) activities. The foreign and multinational companies have now become complacent with India's stature as a hot destination for conducting clinical trials and are in a race to choose the best region available in the country for the same.
With several pharma and biotech units in its kitty, Hyderabad, which is located in the south central part of the country, was the favourite location for drug manufacturing and clinical/contract research till recently. But, presently pharma and biotech research players are shifting their focus to other regions like Himachal Pradesh, Sikkim, Delhi and other parts of the northern India to exploit existing opportunities in these regions.
Being an emerging market, northern India poses a number of unique hurdles forcing the companies to check their decision twice before entering into this lucrative region. As north India has become the most sought after market in theses days, there is a plethora of opportunities for pharmaceutical, contract research organisations (CROs) and biotechnology players. In this context, the key aspects to be learned about north India are:
● The key CRO players
● Regulatory environment
● The scenario of super specialty hospitals and pool of trained investigators
● Opportunities available for conducting clinical trials and contract research
Literally speaking, contract or clinical research organization (CRO) refers to a person or an organization, which is contracted to conduct clinical trials and other duties with the sponsor. India has a CRO market of around $300 to $500 million with northern India accounting for 10 per cent of it generating revenues of $40 million.
There are several strong reasons to consider north India as a frontrunner in the race of clinical research. Genetically diverse population, people who have not been exposed to many medications and diseases ranging from tropical to severe that are prevalent in the region are some of the factors that makes the region a sought after locale for clinical trials and other related activities. Also, All type of ethnic group dwells here enabling mixed patient pool for clinical trials.
Also, northern India is noted for its highly qualified and skilled doctors, super specialty hospitals, medical research centers for clinical studies and experienced CROs. Apart, the region provides the most cost effective clinical trials, that too with competitive infrastructure available.
Key CRO players
The USA-based i3, a group company of United Health Group, is the main multinational CRO operating in the country.
The company's focus areas include clinical trial project management, clinical trial data management and pharma human resource.
The country is also expected to see a rise in the number of domestic CROs in the near future.
With the meteoric rise of clinical research sites, now more and more sponsors are entering the northern India. When it comes to top hospitals in north India - AIIMS, Apollo, PGI-Lucknow, KGMC Lucknow, RP eye care center in Delhi, SMS in Jaipur, PGI in Chandigarh, Rajiv Gandhi Cancer hospital, Max hospital (cardiac and orthopedic care) and Fortis hospital - they are far established than hospitals in other parts of the country. Similarly, there is a couple of institutes, including PGI Chandigarh, Jamia Hamdard, Delhi Institute of Pharmaceutical and Research (DIPSAR), National Institute of Pharmaceutical Education and Research (NIPER), Institute of Clinical Research (India) ICRI and Central Drug Laboratories (CDL) Lucknow, offering well equipped human resources for clinical research activities.
Typically, when a new drug is discovered or even in stages of clinical research, Indian regulatory authorities tend to differ with international laws. But, of lately, India has pledged to abide by the international guidelines. And this is is the biggest quality that northern India encompasses, as major authorities are situated in this region. For instance, offices of Director Controller General of India (DCGI), Indian Council of Medical Research (ICMR), Directorate General of Foreign Trade (DGFT) and Department of Biotechnology (DBT) are located in northern India.
The major attractions of the region are:
● All types of climatic conditions
● Enough HR
● Presence of national regulatory authorities
● Educated and accessible manpower
● Presence of all type of ethnic groups leading to mixed patient pool
● Well connected to other parts of the world
● Low operational cost compared to other parts of India
● Optimal conditions to carry out research
● Availability of largest patient pool and biggest hospitals
Scope and potential
The region also offers several untouched fields - animal research and phase I/II study centers - to researchers to become avant-garde. Though, northern India possess more than 700 pharmaceutical manufacturing units, surprisingly no organization has so far come up with the business to dominate the field. Also, there is not even a single dedicated central lab facility available in north India. Apart, the area of toxicity study is one of the major areas, which has been overlooked so far in the region. In addition, there is a scarcity of medical writing facility in northern part of the country.
Dedicated clinical trial material manufacturing facility is still one area, which as a matter of fact remains missing not only in the northern India but also in the entire country. However, as we go comparing it with entire country, northern India holds a lot of potential with immense resources available for dedicated clinical trial material manufacturing facility.
(The author is managing director of Fermish Clinical Technologies Pvt. Ltd., Delhi)