| is rapidly becoming one of the best-considered | | | | 4. Many of the issues regarding patent protection and |
| settings for global pharma’s drug research | | | | intellectual property rights are settled. India is |
| and development (R&D). Many factors have | | | | compliant with the Trade Related Intellectual Property |
| contributed to this outsourcing attraction, namely: | | | | Rights Act (TRIPS). It holds a first-class |
| highly-skilled doctors, trained paramedical staff, and a | | | | data-processing infrastructure for biostatistics and |
| strong research infrastructure. | | | | bioinformatics, and huge generic drug-manufacturing |
| Pharmaceutical consulting firms attribute the growth | | | | facilities. |
| in pharma sales to transitional disease profiles, bigger | | | | All of these are critical aspects for R&D costs, |
| access to medicines, and growing public health | | | | which have dramatically been increasing for the past |
| programs, and if the Indian economy keeps on | | | | few years. It is vital to streamline the development |
| growing, the local pharmaceutical market will | | | | process as much as possible. Even though there are |
| experience a huge transformation in the years to | | | | no language barriers, US pharma-related companies |
| come, reaching the top 10 around the year 2015. This | | | | desiring to get established in India will have to invest |
| will definitely have an impact on the global pharma | | | | a great deal in education, given that 70% of the |
| industry in regards to R&D. | | | | population lives in rural areas and the poor go to the |
| Previous estimations have valued India’s | | | | public system for preventive and inpatient care. |
| research market between $600 million to $1 billion | | | | However, many of these patients also get involved in |
| dollars, and global clinical trials performed in this | | | | clinical trials for their urgent healthcare needs. |
| country are expected to continue growing | | | | Despite its many strengths, India presents challenges |
| importantly in the next few years. | | | | as well: |
| There are various reasons as to why India is such a | | | | 1. There are just about 500 GCP-trained investigators |
| desired location for research and development: | | | | with experience in clinical trials. India has considerably |
| 1. The amendments made in the past regarding the | | | | fewer physicians and beds than the world average. |
| schedule Y of India’s Drugs and Cosmetics | | | | However, these are expected to double in the |
| Act of 1942, have turned the country into an | | | | coming years due to private investment. |
| attractive location for new trials. This amendment | | | | 2. CRO’s must have a well-structured IT |
| permits parallel trial conduct in India simultaneously | | | | system and a strongly-supported workflow strategy |
| with the rest of the world, eliminating, thus, the | | | | to back up the access to information in real time, and |
| phase delay experienced before. | | | | the monitoring, clinical liaison, and business |
| 2. India is expected to be the most populated | | | | development functions to control studies happening in |
| country by 2035, turning it into the youngest one. It | | | | other Indian sites. |
| holds 20% of the world’s population under | | | | 3. CRO’s may have to hire more personnel to |
| 24. | | | | manage rural sites and create a database of prime |
| 3. This country has a varied patient population in | | | | Indian investigators for indications and therapeutic |
| regards to race, culture, and economic level; and | | | | areas, in order to meet international regulatory |
| many are inexperienced about treatment. They are | | | | standards. |
| less prepared to deal with pneumonia, Hepatitis B, | | | | If you enjoyed this article, please feel free to post it |
| diabetes, or cancer, thus, the more patients, the | | | | to your site or blog and forward this link to your |
| higher recruitment quota. Shorter recruitment | | | | friends. Have a great day! |
| timelines prevail in India and patients’ | | | | Don't forget to visit our blog. |
| compliance is higher. | | | | |