MEDICAL WRITING:AN EXPANDING MARKET IN INDIA

Medical writing services are gaining momentum as sponsor companies look for faster and more efficient ways to bring new drugs to the market. With regulations becoming more stringent, appropriate documentation of the safety and efficacy of new molecules is becoming increasingly important.

As the market for health care products is growing, the demand for health care information is also increasing and consumers, patients as well as physicians, demand more information regarding products.

Thus, effective medical writing is crucial both before a drug gets regulatory approval as well as during the marketing stage. As long as the drug development pipelines are full or increasing, medical writers will continue to play an expanded role in pulling together and writing regulatory submissions.

Ø Why Outsourcing?

Pharmaceutical companies are now opting to outsource in order to meet deadlines, maintain high quality and/ or reduce the cost. Outsourcing to companies that have staff with medical background and technical knowledge of the regulations increases the speed of work. The demand for high quality documents is also increasing as the difference between poor-quality and high-quality medical writing can mean the difference between a speedy drug submission and approval, and a rejection.

Although the pace of drug development is constantly increasing, most individual companies do not have many regulatory submissions and reports. For the companies that have an occasional regulatory submission, maintaining a medical writing team is challenging and can be a drain on resources. More companies are opting to outsource medical writing so that they can obtain quality services in a cost effective manner.

High mobilization rate in the pharmaceutical industry poses a big challenge to the development and maintenance of a medical writing department in huge pharmaceutical companies. Further, the bulk of medical writing tends to be piled towards the beginning or the end of the clinical studies, whereas in between medical writing department tends to have idle staff waiting for work. Company-employed medical writers have a propensity to share insular views that companies have regarding their own products. On the other hand, by outsourcing, these companies get an added advantage of the range of experience and unbiased attitude that freelance writers can provide.

Ø Outsourcing medical writing to India

Globally, pharmaceutical companies are turning to India in order to tap the medical writing potentials of the country. A large number of qualified and experienced professionals, cost effectiveness and wide use of English are some of the advantages that make India a dream destination for outsourcing medical writing.

India has a pool of qualified, talented and experienced medical scientists. India, each year, produces approximately three million graduates, 700,000 post-graduates and 1500 PhDs in the scientific stream. This includes around 18,000 medical graduates passing out from 200 medical schools. Many Indian professionals have thorough knowledge of good clinical practices(GCP), drug development, experience with basic and clinical sciences and good writing skills. Many of them also possess industry experience and consequently know how to put together reports and analyze safety data.

Further, English is the primary language of these professionals and they can communicate and produce good quality, scientific documents just like their American and British counterparts. An interesting fact is that according to some estimates, 15% of the scientific population of pharma and biotech companies in US is of Indian origin.

Further, due to cost advantages and competitiveness, India is being considered as a destination for medical writing and other CRO services that are needed for the growth of the biopharma segment. Indian professionals have already made their mark in Information Technology and Medical Tourism and now the world is looking at us to be a partner in Clinical Research and Medical Writing.