With the onset of new life threatening diseases and epidemics, there is a need for new vaccines and drugs to be rolled out besides making them accessible and affordable. In this context, experts advocate improvement of product quality and GMPs in the current global regulatory environment.
Experts also emphasize the pharma analysts role in drug delivery to utilize available molecules in the existing drug delivery system. This according to them is possible through a proper system driven quality management system. This is more relevant in the current context as larger molecules, biosimilars, proteins etc can prove to be expensive in the Indian scenario because of socio- economic conditions.
Issues related to quality management and pharma analysts role in drug delivery were deliberated on the occasion of 16th Pharmaceutical Analysts Convention organised by Indian Drug Manufacturer's Association (IDMA) held in the city from September 27 to 28, 2013 in Mumbai. Madhu Saghee, assistant manager, Quality Assurance and Compliance, Novartis India Ltd. and Dr V R Bhate, director, Analytical Systems, Mumbai were conferred Young Pharma Analyst Award - 2013 on the occasion.
While delivering his inaugural address, chief guest Dr B Suresh, vice chancellor, JSS University, Mysore and president, Pharmacy Council of India (PCI) said, "With India being one of the largest generic producers, new innovations is the need of the hour as the industry is evolving, ethically inclined and is known the world over as a provider of quality medicines at low cost."
India stands at the threshold of change as new regulations are also coming in the field of phyto-constituents under the Drugs and Cosmetics Act and for OTC products and cosmeceuticals.
Speaking on the occasion, Dr VG Somani, joint drug controller general of India, Central Drugs Standard Control Organisation (CDSCO) said, "There is a need for pharma analysts to develop skills in formulations and reverse engineering to help establish the product in the market. There is even greater emphasis on empowering the analysts role in the drug delivery system for the stability of the product."
Since India is a supplier of quality medicines at a low cost, India accounts for WHO's 80 per cent vaccine procurement. "Government is also working to meet the challenge which physicians are confronted with nowadays considering the fact that there are more than 80,000 formulations to be prescribed of different branded generics for the sake of patient safety," Dr Suresh concluded.
The two day convention covered topics like one word one pharmacopoeia, pharmaceutical process innovation for herbal products, modern quality systems, design and evaluation of controlled environments for contamination control.
Dr DBA Narayana, chairman, Herbal and Herbal Products Committee, Indian Pharmacopoeia spoke on Pharmaceutical Process Innovation for Herbal Products. A talk on Embracing Modern Quality Systems - moving from complacency to compliance was delivered by Madhu Saghee, Sharu Ragnekar, management educator, Ragnekar Associates gave a low down on the Concept of Documentation and Dr Raghunandan, associate professor, JSS University gave a lecture on Essential Quality Systems for Error Free Pharmaceutical Manufacture. Amongst the dignitaries, the occasion was graced by J L Sipahimalani, chairman, Quality Management and Technical Subcommittee, IDMA and Daara Patel, secretary general, IDMA.