How do you look at the process of drug development in the country?
Clinical trials are critical for development of new drugs. With increasing disease burden and emergence of new variants of diseases, some of which are specific to India, trials become all the more important.... Development of new drugs for India-specific diseases is possible only through local research and clinical trials.
Besides, for us, it is important that drug development should be undertaken in an efficient and cost-effective manner while ensuring the rights, safety and well-being of trial subjects.
India has developed enormous capabilities in chemical synthesis, analysis and formulation development. India is one of the leaders in development of complex biological products such as pentavalent vaccine, pneumococcal vaccine, influenza vaccine, measles vaccine, rotavirus vaccine and hepatitis B vaccine. India has developed capabilities at a commercial scale to develop and produce rDNA products such as insulin, monoclonal antibody and blood products like albumin, which are produced at substantially lower costs. Medicines and vaccines developed in India are exported to more than 200 countries, including the US and Europe. We are working on vaccines for chikungunya and Zika virus.
How is the government planning to make clinical trials effective, quick and safe?
India-specific diseases need focused attention. At the same time, the government has been concerned about the infringement of the rights of patients and other trial participants. Keeping this in view, the Indian government has made it mandatory to provide for medical management and payment of compensation, which is not present in any other country. The effort has been to ensure patients’ rights and safety and that there is no compromise in terms of the rigour of the trial.
India is the largest producer of drugs in the world. But new drugs take a lot of time to reach India. Why?
The clinical trial application processing was getting delayed. The government has carried out a careful analysis of the problems and issues involved and rationalised the processes. By doing so, it has been ensured that there is ease of doing business and the rights and welfare of participants in such trials are not compromised.
How are you planning to address the shortage of trained manpower in the regulatory sector?
India does not have a major deficiency of manpower in this area. However, it would be necessary to augment their skill sets. A series of training programmes of regulatory officials and experts involved in the approval of clinical trials and new drugs have been conducted to streamline the approval process.
During the last two years, major steps have been taken to enhance the regulatory capacity and a scheme for strengthening it has been approved at a cost of Rs 1,750 crore.
Indian researchers say it takes months to get approval to conduct trials in India. Many a time, they fail to participate in global studies.
The government has taken a number of measures to promote the conduct of scientific and ethical trials in the country. In January last year, 25 panels, comprising nearly 350 experts for different therapeutic areas from government medical colleges and institutions, were approved. It helped in evaluation of applications of new drugs and clinical trials in a time-bound manner without compromising the quality of review.
Audio-visual recording of informed consent process is now mandatory only in case of vulnerable subjects in clinical trials of new chemical or molecular entity. Only audio recording is required in anti-HIV and anti-leprosy drugs....
An IT-enabled system for online submission and processing of clinical trial applications will be operational in a few weeks.
