The Diamond Jubilee edition of Indian Pharmaceutical Congress (IPC) 2008 hosted by the Indian Pharmacy Graduates Association (IPGA) commenced in New Delhi highlighting the need for better regulatory system in pharmaceutical and pharmacy education sectors in compliance with the global requirements.
In the inaugural function, held at the Netaji Subhas Institute of Technology, the experts from regulatory, industry and academia pointed out the need for reviewing and revising the current trends in pharmaceutical regulation to upgrade the current regulatory standards for a better place in the global pharmaceutical industry.
The fast growing pharmaceutical industry in India poses a challenge to the Indian regulators to cope up with the increase in volumes as well as new innovations in science and technology and the regulatory system should be overhauled in order to catch up with the situation, said Dr M Venkateshwarlu, former Drug Controller General of India (DCGI) and the president, Indian Pharmaceutical Congress Association (IPCA) in his presidential address.
On behalf of IPC, he requested the government to create an independent autonomous regulatory agency to initiate recognition of all Contract Research Organisations (CROs) and to introduce regulations to monitor the activities of CROs to ensure quality of services to the overseas customers, which in turn will help the Indian outsourcing industry to grow better.
The government should also define the regulatory requirements for CROs and introduce an accreditation system by agencies like Pharmaceutical Export Promotion Council (Pharmexcil) and facilitate free import and export of samples meant for test and analysis. He also urged the government to introduce concepts of Dossier and Drug Master Files for the grant of marketing authorization for drug products. There should be clear and relevant definitions for terms like 'new drug' and 'medical device' and the margins for wholesaler and retailer should be fixed, he added.
"The pharmacy education has a major role in this fast growing pharmaceutical sector and there is an immediate need to evaluate and regulate the mushrooming of educational institutes offering short-term courses in clinical research. The curriculum for pharmacy education requires regular review to impart training to the graduate and post graduate students of pharmaceutical sciences and continuingly apprising them for new developments in science and technology," said Venkateshwarlu. He also suggested that there could be a concept of add-on courses relevant to the pharmacy profession.
Addressing the 5000 plus audience as the Guest of Honour of the inaugural function, Malvinder Mohan Singh, chief executive officer, Daiichi Ranbaxy averred that with the capabilities of Indian pharmaceutical sector, the industry which is known as the destination of generic drugs will become the destination of innovation in next 12 years. The Indian companies need a combination of innovation and generic drug production to get to the top of the global pharmaceutical industry, he added.
The pharmaceutical sector in India is undergoing tremendous changes in various fields and the drug regulation and pharmacy education are accepting the challenge with new upgradations, said Dr Surinder Singh, DCGI, in his welcome address. "The recent introduction of Pharm D course, with the most updated curriculum for pharmacy education, is one such example of change in regulations on par with international norms," averred Singh.
Various awards on pharmacy and pharmaceutical industry were presented to the experts in pharmacy education, industry and regulatory authority, on the occasion. The function also honoured leaders from all the five affiliates of IPCA, the Indian Pharmaceutical Association (IPA), Indian Pharmacy Graduates Association (IPGA), All India Drug Control Officers Confederation (AIDCOC), Association of Pharmacy Teachers of India (APTI) and Indian Hospital Pharmacists Association (IHPA). The three day conference will discuss the need for change in regulation and pharmacy education to excel pharmaceutical services in healthcare. The Pharmaceutical Expo 2008 organised by Federation of Indian Chambers of Commerce and Industry (FICCI) is also concurrently held in the institute.