The potential of nutraceuticals and herbal drugs have been identified widely worldover and global market for them is estimated at $85 million, said Dr M Venkateswarlu, deputy drugs controller (India), west zone, Mumbai, presenting his views on the Indian pharma industry- global opportunities and challenges.
The revenue of global pharma industry in the year 2002 has been $400 billion, with growth rate up to eight per cent. There has been increased cost in R&D. ICH aimed at harmonizing USP, EP, and JP had been very effective, and the harmonization is in its advanced stage.
In the country, revenue of pharma industry is Rs. 22,000 crore, whereas annual growth of the industry is 10 per cent. The contribution of biotech industry is Rs. 250 crore and pharma industry’s exports account to Rs. 10,000 crore with a growth rate of 20 per cent.
In India, the focus is on discovery of new chemical entities, new drug delivery systems, clinical research, formulations development, contractual work, custom synthesis etc. Collaborative R&D is emerging. The strength of the Indian industry lies in the ability to reduce costs and remove impurities. In clinical research too, the country has immense strength, he said.
In the services sector, we should try to exploit the areas such as analytical method development and validation, clinical data management (Novartis and Pfizer has data management centres in India), production of anciliary equipment and materials, manufacture of primary and secondary packing materials.
Challenges for the pharma industry include harmonization of legislations, upgradation of legislation. Entrepreneurs should overcome their resistance to change. The ambience of GMPs should change in the country, especially with regard to facilities and data generation, and concepts of validation, annual product review, process analytical technique, out of specification, out of trend, good automated manufacturing practices have to be understood. The companies should look at GMP more objectively, not merely for certificates.
The industry also has to face challenges such as developing an effective logistics system, simplification and maintaining transparency in procedures, upgradation of curriculum and facilities of colleges and universities for pure and applied sciences like DNA mapping and pharmacogenomics. Integration of IT with biotechnolgy and production technology will also be very vital.
Other key challenges will be standardization of herbal and nutraceuticals, GCP and GLP in clinical trials, maintaining brand equity, regulations for biogenerics, registration of generic products in US etc,. India has to create awareness that, the country’s herbal drugs and nutraceuticals comply with world standards and should aggressively enter into generics production.