Regulatory affairs is a comparatively new profession which has developed from the desire of government to protect public health by controlling the quality, safety and efficacy of products in areas including pharmaceuticals, veterinary, cosmetics etc. Drug regulation history dates back long to first century BC where physicians in Egypt were required to administer their drugs in accordance with written laws. Regulatory affairs division is responsible for obtaining and maintaining licenses to market medicinal products. Apart from DCGI, different ministries such as DBT, MoEF, ICMR take care of clinical research and regulation in India.
India with her GDP 9.4% soaring is building itself as a scientific superpower country in the Asia-pacific region. The Indian pharma market is extremely competitive and all the world countries are eyeing India which boasts its competitive edge in research and development. It was not a surprise that India is now the third most popular location for R&D investment.
The face of Indian regulatory affairs is changing. The government of India is taking enormous steps to showcase India as the destination for multinational companies to conduct their global clinical trials in India. Pharma companies and CROs are keen looking on India since the development cost of a new drug is comparatively one -fifth of other developed countries.
Presently over 100 hospitals in India are actively engaged in clinical trials. There is lot of CROs functioning in India with niche technology and ICH-GCP trained investigators. According to the latest development, India may be allowing phase I clinical trials for the drugs discovered abroad soon. This is happened because of the huge improvements in the technical and other aspects of the clinical research industry in India.
The union health ministry of India is planning to review the Schedule Y of Drugs and Cosmetics Act in a bid to harmonise with that of ICH guidelines. The proposal of the same is to be approved by the Drugs Technical Advisory Board. The government is trying to remove the apprehensions in the minds of the multinational companies about the quality of the data and acceptance of such data by the world regulatory authorities and US FDA. The interesting and encouraging fact is that India has the highest number of USFDA-approved drug manufacturing plants outside the US.
Indian Council of Medical Research(ICMR) which is the apex body in India for the formulation, coordination and promotion of biomedical research has already released "Ethical Guidelines for Biomedical Research on Human Participants - 2006. The updated guidelines highlights about the various new topics such as terms of reference, training imparted to Ethics committee members, periodic and continuing review process during the clinical trial, the information need to be present in the patient information sheet, conflict of interest etc.
ICMR has already started a project with WHO on quality of informed consent in clinical trials in India. It has prepared a questionnaire which consists lot of new stuffs such as the type of consent taken whether it is verbal, place where the consent was taken, approximate time spent with participants to give information about the trial, approximate time given to each participant to reach a decision, etc.
The Union health ministry has to introduce this biomedical research and regulation bill to Parliament for its final approval to be converted into law. Once it becomes a law, it is mandatory for all medical institutions conducting human research has to get registered which in turn will encourage multinational companies to invest in India on clinical trials
Guidelines on import and manufacture of medical devices, cosmetics, probiotics, nutraceuticals, narcotics and psychotropic substances, veterinary products, homeopathic and other alternative medicines are been devised by the experts and soon they will be followed by the pharma companies.
Multinational companies who had not chosen India earlier due to lack of regulatory guidelines and approach for global clinical trials have now been ready to invest in India since India has already released its guidelines on global clinical trials. India now adheres to the TRIPS agreement and already it had entered the product patent scenario in 2005.
According to ASSOCHAM, the clinical trial market in India will be $200 million by 2007 and $1billion by 2010. The contract manufacturing market is expected to reach $900 million by 2010. Availability of heterogeneous population, highly qualified investigators, state-of the art hospitals are boosting the clinical research in India.
Service tax has been wavered off for the testing for new drugs in India by the government and this has positive feedback on the multinational pharma companies. WHO had already announced the expansion of its clinical trial registry platform to include trial registers from China and India. This is a major step for policymakers and scientists, who can now track local research activities, improve the quality of that research, and meet global standards for transparency in India and also the general public benefits by free access to a more complete picture of clinical research on diseases of interest in their own countries.
Union Minister of Steel and Fertiliser of India has urged the state governments to keep vigil on pharmaceutical firms on a regular basis to stop manufacture of spurious drugs The Union finance ministry, which is still holding up the proposal to withdraw tax exemption currently given to the contract manufacturers in excise-free zones, is likely to reopen the old files to cut down the excise duty on pharmaceutical products from the present 16 per cent.
The pharma industries which do not comply with the Schedule M will be closed soon as DCGI has already instructed state regulatory authorities to take the necessary action. Stringent measures like life imprisonment and heavy penalties against spurious drug manufacturers are on the anvil as government plans to bring two legislations in the ongoing session of Parliament.
The vibrant nature of Indian regulatory affairs is gaining rapidly the attention of world countries since India is turning to be the credible destination. As Indian regulatory affairs increase in complexity and scope, and globalization occurs within the field, there will be constant watch from the developed countries.
(The author is manager - Regulatory Affairs,PharmaLeaf India Private Limited, Bangalore)