In order to develop own molecules to drugs, the regulatory authority for clinical trials and granting approvals for introduction of new drugs need to be made more efficient in the country, said Dr A P J Abdul Kalam, President of India, while unveiling the historic Pharma Vision 2020 charter as part of the 55th Indian Pharmaceutical Congress (IPC) in Chennai.
Talking to an audience of over 1,000 from the pharmaceutical industry and allied sectors at the Sree Ramachandra Medical College, Chennai, the President said it was time that we develop a molecule to drug in the country, though we have enough manpower. However, we need to organize ourselves to attain global standards. This could be done by obtaining approvals from dynamic health councils and with partnership from pharmaceutical industries in India and abroad to develop the process of converting of a molecule to a drug, as this involves different technologies to work together like pre-clinical trials, phase I, Phase II, pharmacologists, bioinformatics etc.
The probability of a molecule to fail at the fag end of the process could be one reason for the lack of our country not able to bring about this conversion, involving factors like economics and timeframe for development and risk of high failure, said the President.
Elaborating the challenges and opportunities for Indian pharma industry, the President said our specific aim should be to develop drugs for cancer, diabetes and immunomodular compounds. In the present scenario of globalisation where the West is looking forward to cut cost of production and without compromising on quality, India should leverage the scope of biotechnology. Streamlining of procedural methodologies in obtaining permission etc. has to help in rapidity of such developments, rather than getting lost due to regulatory formalities. Though the governmental agencies reflect to such a mood, industries are yet to convince of such action, especially biotechnology. Governmental agencies should work together to achieve this, especially in the area of drug discovery to production.
Commending the Indian pharma sector for its excellent growth over the years with various support statistics, the President said India could become the first in production of drugs from the current fourth place in the world, by increased R&D investments, manufacturing of drugs with high quality, cost effectiveness, availability world over and higher market penetration. Indian companies have been making rapid strides in the field of biotechnology. Recombinant DNA technology in addition to the production of Hepatitis B vaccine was being put to use for making rDNA Insulin by two Indian companies. Companies have developed cost effective processes for Interferron besides working on newer vaccines and diagnostic kits. In the developed Indian Vision 2020, healthcare is an important area, with the aim of promoting affordable and accessible healthcare. The expert team has identified three major diseases TB, HIV and water-borne diseases. It is also important to harness the possibilities of IT to take healthcare to the masses. It has become relevant to pharmaceutical research. For example, Human genome project, which requires huge data to be created, has given way to the development of bioinformatics. Pharma education and research institutes should be keen to study and develop the area of information technology, particularly bioinformatics and deploy it widely to make use of it in the pharma sector.
He said the Indian drug industry should aim to gather 20 per cent of the world market by year 2020, and must identify all the missions, which would make drug production in India first in the world. Research and drug design, development and acceptance for introduction was a big mission, and pharma companies should understand designs to drug development and marketing, and a creative leadership was imperative, said Dr Kalam.
The salient features of the Pharma Vision 2020 document were introduced by P D Seth, President of Indian Pharmaceutical Association. The function was also participated by S S Vanagamudi, Chairman, Local Organising Committee, IPC, V V Venkatachalam, Chancellor, Sree Ramchandra Medical College, Radha Venkatachalam, Registrar, Sree Ramachandra Medical College & Deemed University etc.