The Indian pharmaceutical industry should turn their attention to invent new drugs from molecule levels and each manufacturing unit should try to become invention centres, opined Dr APJ Abdul Kalam, former President of India.
Inaugurating the 64th Indian Pharmaceutical Congress (IPC) at SRM University at Kattankulathur in Tamil Nadu, the former President said there is vast potential for the Indian pharmaceutical sector which encompasses the industry and the academic institutions. India will become the leader in the world in the production of generics before long, he expressed the hope.
Addressing the gathering, Dr Kalam said one among all the tablets used in any part of the world is an Indian made. It shows that Indian pharmaceutical industry can dominate the global market. For this, the researchers in the pharmaceutical sector should attempt for inventing new drugs by utilizing all the capabilities of the industry and the academia. He advised the captains of the industry to involve the pharmacy academic institutions in the country in the endeavour of drug invention as partner in drug development and clinical research.
Quoting the introduction of the anti-malarial drug ‘Synriam’ by Ranbaxy in collaboration with Department of Science & Technology, Dr Kalam said all the industrial pharmacists and researchers must follow the step taken by Ranbaxy as a model and concentrate on inventing new drugs. According to him if the Indian pharma industry has to keep pace with the changes in the international scenario of customer needs, the pharma industrialists in the country have to take a paradigm shift.
“We have to look beyond process development capabilities towards new drug research with adequate attention to quality, costs, and time dimensions. We need Intellectual Property Rights (IPRs) capabilities for drug discovery research, new drug delivery systems, state-of-the-art packaging systems, automation, flexibility in manufacturing, and reliability of products. To minimize quality defects, we must change our mindsets for measurement from percentage to Six Sigma and improve process capabilities using statistical tools for consistent quality.”
Dr Kalam, who launched the Pharma Vision 2020 programme in 2003, said currently India has one million pharmacists and pharmaceutical scientists. Seventy-five per cent of this human resources is involved in distribution and retailing of drugs in community and hospital sectors. Fifteen to twenty percent of the balance is employed in the areas of manufacturing, quality control, R&D, regulatory, and in academia. The remaining five-10 per cent goes for higher studies or migrates to other countries.
He told the pharmacists that there is ‘the Open Source Drug Discovery’ (OSDD) programme, a CSIR led team India consortium with global partnership, to provide affordable healthcare to the developing world. The factor that affects the developing world is the discouragement of market forces in developing drugs for infectious diseases like tuberculosis, malaria etc. by research based pharmaceutical companies. “In the wake of the discouraging market forces we need to explore new models of drug discovery. This is where OSDD offers a promising new model,” Kalam added.
The Open Source approach has been successfully adopted in software and collaborative approach is known in science. Launched on September 15, 2008, OSDD has more than 4500 registered users from over 100 countries and more than 150 projects on TB drug discovery. OSDD offers a model of open innovation in pharmaceutical research as it concurrently carries out research in many areas of drug discovery. One of the OSDD projects which has made a big impact is the collaborative annotation of the bacteria causing TB, namely Mycobacterium tuberculosis (Mtb).
To be internationally competitive, the former president said “We should incorporate courses in regulatory jurisprudence so that newer legislations, domestic as well as international, are understood and implemented with utmost care and speed. Our courses must include exposure to guidelines issued by International Conference on Harmonization (ICH), Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Generic Clearance Procedures for pharmaceutical products. Also, for submissions of technical dossiers for exports, we must familiarise students with regulatory specifications of international agencies and with our national book of standards for drugs, the Indian Pharmacopoeia, and other similar international compendia.”
Regarding the promotion of professional services of pharmacists, he said continuing education should be made as a pre-requisite for all the budding pharmacists. Pharmacy colleges can have a collaborative programme with pharma industries and hospitals for designing an appropriate continuing education course. They must also be prepared to check the menace of spurious and sub standard drugs. For this continuous evaluation and updation of educational programmes is required with the introduction of molecular biology, biotechnology, nanotechnology, pharmaco-genomics, pharmaco-vigilance, pharmaco-economics, pharmaco-epidemiology, and a host of tools like molecular modelling, combinatorial chemistry, high throughput screening, etc., Dr Kalam said.
The president of the 64th IPC, Dr K Chinnaswami made the presidential speech. Drugs Controller General of India (DCGI), Dr G N Singh, Pharmexcil Director General Dr P V Appaji, Pharmacy Council of India president Dr B Suresh, Tamil Nadu Drugs Controller G Selvaraj, APTI president Dr Y G Yeole, etc. shared dais with the chief guest.
Local organising committee Chairman SV Veeramani welcomed the gathering and J Jayaseelan, LoC secretary proposed vote of thanks.