India- A Strong Pharma Destination
India has become the most sought after destination globally for drug research and development. Of the many factors which have contributed to this effect, the most important ones are that India possesses a vast reservoir of talented work pool consisting of highly-skilled doctors and scientists, trained paramedical staff and research assistants, and infrastructure which is updated from time to time with advance in technology. The reasons attributed towards the transformation of the Indian pharmaceutical industry in recent years and the consequent growth in sales turnover is due to the transition experienced in the pattern and profiles of various diseases, increasing access to medicines, rise in number of public health programs and growth of the Indian economy.
India: an attractive destination for research and development
India is considered to be a very attractive destination for research and development processes. Some of the reasons are explained below:
1. Amendments carried out in the schedule Y of the Drugs and Cosmetics Act of 1942 has succeeded in transforming India into a highly preferred location for carrying out new clinical trials. The amendment permitted the parallel conduct of a trial in India along with trials conducted in other parts of the world simultaneously, thereby avoiding the phase delay which had been experienced previously.
2. The ever growing population of India makes it certain that India will become the most populated country by the year 2035. This will also mean that India would become a country with the highest population of young people as it currently holds the distinction of having 20% of the entire world’s population below the age of 24.
3. India also boasts of a diverse patient population owing to different race, culture, economic level, and lack of experience regarding treatment of diseases such as diabetes, pneumonia, cancer or Hepatitis B. Therefore, the higher the number of patients, the higher is the recruitment quota.
4. Most of the issues with respect to protection of patents and intellectual property rights are resolved. India complies with the Trade Related Intellectual Property Rights Act (TRIPS). India possesses a commendable infrastructure with respect to data-processing for both biostatistics and bioinformatics, as well as huge facilities for manufacture of human generic drugs at a large scale.
Strong points of the biotechnology sector in India:
Biotechnology is the newest entrant into the pharmaceutical industry in India and is capable of helping India enter into the domestic and international investment arena. India is an emerging market which is preferred by the United Kingdom Trade & Investment, due to the recent developments in the biotechnology sector in India, indicating huge business prospects for the UK Biotechnology & Pharmaceutical sector.
The following factors contribute towards making Biotech companies an indispensable part of the Indian pharmaceutical industry:
• Large work force of talented and dedicated scientists and engineers.
• Cost effectiveness of the manufacturing process.
• Rise in number of national level research laboratories which provide employment to thousands of scientists and research scholars; medical colleges, and professional colleges which offer degrees and diplomas in various life science subjects.
• The dynamic and ever evolving industry of medicines and pharmaceuticals.
• The rich biodiversity offered by the human gene pools in India are much sought after by scientists dealing with genomics.
• India offers exciting conditions for clinical trials, research and manufacture.
All the above mentioned factors are critical aspects which need to be taken care of for the maximum streamlining of the development process to ensure minimum R& D costs.
Factors which pose a challenge to the Indian pharmaceutical industry:
GCP-trained researchers with prior experience of clinical trials number to around 500, which are not enough to carry out the entire research and data processing work. The task of channeling talent to ensure the optimum use to obtain maximum output is where India falters. Indian institutes have been able to provide a strong scientific work pool but have failed in providing scientific leaders. The need to maintain balance of course content with trained staff to provide students who are employable and possess industry skills is not fulfilled at present in Indian universities.
It is imperative that clinical research organizations(CROs’) must possess an IT system that is well-structured and a workflow plan which is supported strongly to ensure simultaneous back up and information access in real time, screening, clinical liaison, as well as business development to monitor and regulate control studies taking place in other Indian clinical test sites. The CRO’s might hire more workers to supervise trials in rural areas and maintain a database of eminent Indian researchers involved in research or therapy in order to comply with the international regulatory norms.
India has to focus on the aspect of translation of research proposals into projects which are commercially viable. However, most of the research institutions are ill-equipped to tackle such innovative scientific research. Support is required by India to translate such research ideas into economically viable projects to generate revenue.
Lacking public-private initiative is another cause of concern for the life science scenario in India. Existing public-funded bodies are not industry friendly in India. At the same time, the Indian industry in their quest for collaborative partners, tend to limit their search within Indian public funded organizations bodies and prefer opportunities abroad.
The Indian industry is hesitant to take up risks. This is due to reluctance by investors and banks to fund biotech projects. The need to compete at the international level makes it necessary for India to constantly upgrade technology which makes investment or funding at early stages of the proposal or idea critical.
India is slowly gaining recognition as an important clinical trial destination. India has been recently added to the group of 6 countries namely the US, UK, Canada, China and South Korea, who have succeeded in indigenously decoding the human genome. Certain advantages that Indian pharma companies possess with respect to international pharma companies is that of management of clinical data, drug discovery and cost effectiveness of manufacture.
Other encouraging changes that promote the growth of biotech sector in India include the fact that India is one of the highly favored destinations for collaborated R&D, contract research, bioinformatics, and clinical research trials due to the increasing compliance with international regulatory standards such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and current Good Manufacturing Practice (cGMP).