As the prestigious Indian Pharmaceutical Congress (IPC) rides its way back into the heartland of pharma regulations with a fitting theme in its diamond jubilee year pulling thousands from different walks of broad pharmaceutical spectrum towards the national capital from December 12 to 14, a few thoughts on `quality' are rightly set to take the center-stage.
At a time when Indian pharmaceutical industry, with its varied hues, has stamped its credentials across the global arena by the width and quantum, need and efforts for harmonisation of regulations in consonance with international norms in the pharma sector in general and pharmacy profession in particular will be the key topics enveloping the conference. Rightly, its theme `Pharma Vision 2020: Regulations for better healthcare' will spur these attempts as industrialists, academicians, research workers, working pharmacists, pharmacy practitioners, drug regulatory authorities, health professionals, students and international delegates will be milling the venue - the Netaji Subhash Institute of Technology, Dwarka.
"The Indian pharmaceutical industry for the last six years focused itself in facility oriented and manufacturing processes. The industry needs to set up a higher bench-marking for this purpose and make the initiative matching with the product quality. The industry also has to achieve the total quality of medicines reaching the customers. The 60th Indian Pharmaceutical Congress is going to debate and work out on a plan and submit a report to the government, to improve and harmonize Indian Drug Regulations with the global regulations like ICH & WHO,'' president of 60th IPC Dr M Venkateswarlu sums it up.
The event is going to be very significant, not just for its theme and venue, but for its size too. The organisers, the Indian Pharmaceutical Congress Association (IPCA) in general and host body Indian Pharmacy Graduates Association (IPGA) in particular, have been working overtime over a year and the time has come finally to unfold the organising skills to make it a huge success. ``All preparations have been completed perfectly. We have made elaborate arrangements. It is going to be one of the biggest of the sort with over 8000 delegates enrolled for the event,'' says local organising committee secretary A K Nasa. The last IPC, held in Varanasi and marked by loose-nit arrangements, had around 5000 delegates.
After the recent terror attacks in Mumbai, which forced the postponement of CPhI India, cast a shadow over the event, the organisers have left nothing to the chance. Sufficient arrangements have been made for the safety and security of the massive event. And to the cheer of the organisers, no cancellations especially by the international delegates happened so far.
The organizers, Indian Pharmaceutical Congress Association (IPCA), is a federation of five national pharmaceutical associations as its constituents - is the apex body representing Indian Pharmacists working in various capacities in pharmaceutical industry, R &D, quality control, quality assurance, academics, drug control departments, hospitals, community pharmacy and marketing. It has a total strength of more than 20,000 professionals and pharmacists. The five constituents are Indian Pharmaceutical Association (IPA), Indian Pharmacy Graduates Association (IPGA), Indian Hospital Pharmacists Association (IHPA), Association of Pharmacy Teachers of India (APTI) and All India Drugs Control Officers Confederation (AIDCOC). IPC is held in different parts of the country hosted by a local committee. This year IPGA is hosting the conference.
Right Place,Right Theme
Delhi has been the seat of regulations, obviously being the national capital. But over the years, it has assumed significance as a meeting place for the academia, regulators and industrialists in the pharma sector. That makes again the event very special this time, as the conference comes back to the city after seven years. As expected, the response has been overwhelming going by the size of registration and profile of the expected participants. And at the right place, the right theme is going to be deliberated now.
The IPC, the largest congregation of experts and practitioners, aims to disseminate knowledge and facilitate exchange of new ideas amongst the members of pharmacy profession. Presentations will be made during the Congress on pharmaceutical technology, medicinal chemistry and phytochemistry, pharmacognosy, indigenous drugs and herbal formulations, pharmacology and toxicology, bio-pharmaceutics, pharmacokinetics, drug metabolism, pharmaceutical analysis and quality assurance, biotechnology and bio-therapeutics, hospital and clinical pharmacy, pharmaceutical education , professional pharmacy and regulatory affairs in pharmacy, GMP and TQM, the organizers said.
But again, the word `quality' will be making the most resonances in this meet. ``The quality of medicines plays a major role in the health care of patients. The definition of 'quality' focuses on improved safety and monitoring of pharmaco-vigilance. The quality of drugs can be divided into quality of pharmaceutical equivalence and quality for therapeutical equivalence,'' explains Dr Venkateswarlu.
Nationally and internationally the quality of drugs is evolved through GMPs, GLPs and GCPs at various stages of drug development processes. These generally cover design of facility with a capability of preventing contamination and cross-contamination. For this purpose, there are guidelines for manufacturing practices and good laboratory practices. Regarding the product quality, there are well-established guidelines for proving therapeutic equivalence through clinical trials and bioavailability centres. The end quality of a product reaching the patients shall ensure a facility and process quality as per GMP guidelines and pharmaceutical equivalence through clinical trials. So it is essential for pharma industry to establish systems and procedures to achieve pharmaceutical facility, qualification and the process oriented GMPs, he says, while reiterating that the congress will spend lots of time on all these aspects.
``Expecting to bring the experts from pharmaceutical profession all over the globe, the theme of the conference is chosen to bring out the excellence in pharmacy practices. The theme of the congress is quite appropriate in present scenario. Wide ranging topics from scientific, regulatory and technology to professional practice will ensure wide coverage to meet the sectoral interests of all,'' according to DCGI Dr Surinder Singh, who is the chairman of the local organising committee.
In recent years, the profession of the pharmacy has shown exponential growth. In the current changing global scenario, harmonisation of regulations in conformance with international norms and practice is need of the hour. This becomes imperative as India is a member of WTO and is also a country with the largest number of drug manufacturing units approved by US FDA outside US. Introduction of Pharm D programme under the Pharmacy Act is an example of regulatory changes in line with international norms, he says.
"The conference will bring together national and international experts on regulations, health management and healthcare professionals, to discuss opportunities and challenges for healthcare reforms in India. The conference will provide opportunities for speakers and participants to engage in a conversation about the major regulatory issues and challenges related to new drug discovery, clinical trials, medical devices, pharmacovigilance, GCPs and GMP guidelines etc. and their possible solutions. This will ensure in providing government with advice and alternative approaches to influence its reformation programme so as to develop a new system of affordable health care in our country,'' he adds.
The DCGI is also planning to unveil a regulatory roadmap ``CDSCO vision: 2020'' at the conference, detailing on the key areas to be restructured and finally evolve the drug control organisation into a world-class mechanism. On his part, he is planning to initiate an industry-wide debate on the key points of the roadmap at this IPC. It will spell out the mission and goals of the CDSCO, along with the strategies to achieve these goals, with the milestones mentioned.
Pharma Expo
Pharmceutical Expo 2008, being organised by FICCI along with the IPC, will again bring opportunities for companies to display and demonstrate their products and services not only to the delegates of the congress but also to the business visitors coming from Delhi and neighboring states like Haryana, Punjab, Jammu & Kashmir, Uttar Pradesh, Uttarakhand etc. which are also witnessing a tremendous growth in this sector. Top quality personnel including decision makers for procurement of bulk drugs, machinery, packaging materials, ancillary equipment and services will visit the exhibition.
Besides, the event is expected to prove a venue for building upon the pharmaceutical businesses in North India, which houses major companies like Ranbaxy and Panacea Biotech. Delhi is a transit point for drugs manufactured in the states of Haryana, Uttar Pradesh, Himachal Pradesh, Jammu & Kashmir and Punjab. The show is expected to give boost to the business in the region, both in pharma and allied sectors. It will cover areas like lab equipment, machinery manufacturers, pharma ingredients, excipients, packaging material, water treatment, waste management, and pharma software companies.