The Indian clinical research industry desperately needs a growth booster.
The Indian clinical research industry since the year 2005 has been a very traditional player driven by purely bioequivalence studies for off patent generic drugs on healthy human volunteers. The business of bioequivalence studies is by and large a "least" risk associated business. The business was also associated with guaranteed returns in its prime growth years post 2005 till 2009.
The business till 2007 was smooth and has been the source of the growth of the markets for CRO's who have been doing bioequivalence studies for Indian Pharmaceutical companies
Bioequivalence studies of US based Pharmaceutical /Pharmaceutical companies outside India have been the growth drivers of the Indian CRO market.
A similar story holds true for patient based clinical trial studies at specified, registered and recognized hospital sites.
However with the Indian government with an aim and effort to streamline laws in the country for clinical research has started applying brakes even on the routine submissions at the CDSCO.
As a result of the same, many existing clinical research units with proven track records are facing setbacks. Many key industry leaders have united together and voiced their concerns to the government bodies.
The government has reassured from its end that it will speed up the process but needs to be seen as to how long the wait will be. The government has said that it has detected "possible flaws" in the clinical research companies' pattern and process of conducting the clinical trials.
The Government has sent circulars to all major Indian CRO's and India Pharmaceutical companies to furnish data on adverse events and deaths in the clinical studies. The same is generally declared on a routine basis by all and has been forwarded to concerned committees of the CDSCO for further action plans. These committees after analyzing the details have suggested certain recommendations for the process. Some of the key recommendations have been:
1. Mandatory Registration of the ethics committee
2. Mandatory registration and filing of all adverse events in all clinical trials
3. Mandatory registration (on a yearly basis)of the facility where the trials are conducted
4. Stringent norms related to investigators and training of all relevant people for emergency activities during the occurrence of adverse events
5. Ensuring compliance to Schedule Y and ICH-GCP guidelines for the conduct of clinical trials
During the time the above norms have been outlined, most of the regulatory clearances/NOC certification processes have been kept slow or on hold for longer time than the stipulated period for approval.
As a result majority of the western clients have withdrawn their outsourcing business and decided that the clinical trials will be conducted in other emerging nations.
The countries which have gained because of the slowness of the Indian regulatory system are China, South Korea, Taiwan, Indonesia, Philippines, Thailand and Vietnam and are continuously on the gaining spree.