The
two-day ICHQ7A Symposium organized by ISPE India at ITC
Hotel Kakatiya Sheraton & Towers, Hyderabad during April
28 and 29, 2006, focused on ICHQ7A with 3 concurrent
sessions on Chemical, Biotech and Steriles. The response
from the participants was indicative of the fact that
ISPE India, in its endeavour to provide guidance for
industry on Q7A Good Manufacturing Practice Guidance for
Active Pharmaceutical Ingredients, has achieved its
objective.
Mr. Satish Reddy, COO & MD, Dr. Reddy's Laboratories
Limited, delivered the keynote address. He said the
future years are more challenging for the Indian
Pharmaceutical industry. He highlighted ISPE's
contribution in broadening the knowledge base in
engineering pharmaceutical innovation. While terming it
as a privilege to deliver the keynote address, Mr.
Satish Reddy lauded ISPE efforts in filling the gaps
between the pharmaceutical manufacturers and regulatory
authorities. About the vision of Dr. Reddy's, he said
that while the formative years have been tough, Dr.
Reddy's aims to position itself as one of the world's
best GMP compliant company in the years to come.
Mr. Ajit Singh, Chairman ISPE India, in his welcome
address, exhorted the Indian Pharma industry to strive
towards meeting international regulatory standards. Mr.
Singh, as chairman of the India affiliate, led the
effort to organize the new affiliate and befittingly
ISPE India was named Affiliate of the year for 2004. Mr.
Singh, chairman of Associated Capsules Group of
Companies, Mumbai, was named the ISPE member of the year
2004.
Mr. Gopal K Nair, Vice
Chairman, ISPE India, explained ISPE India's
contribution towards knowledge sharing. ISPE India has
been successfully organizing conferences with the first
being in April of 2003. He said all the ISPE conferences
have been well attended by the industry. While thanking
the Charter Sponsors for their financial support to ISPE
India, Mr. Nair, the former technical director of
GlaxoSmithKline Pharma-ceuticals Ltd, said ISPE India is
keen on bridging the gap between the Indian Pharma
industry and the academia.
Dr. M. Venkateshwarlu, ISPE India Director and Deputy Drugs Controller General
of India, West Zone, focused on regulatory approach. He termed the ICHQ7A
as one of the excellent documents generated out of conscious-driven efforts
from three countries. He said adopting the GMPs for APIs and Biotechnology
products are very vital for the Indian Pharma industry. He said Indian drug
legislation does not differentiate between drug substance and drug products.
Dr. Sabine Kopp, Scientist, Quality Assurance and Safety Medicines, WHO,
detailed the WHO philosophy on Quality Assurance of Medicines. She focused
on WHO's role and function, WHO international guidelines, standards and norms
in the area of quality assurance, new global tools to improve quality of pharmaceuticals
and efforts of WHO to assist member states in building regulatory capacity.
She said about WHO's mission that people everywhere should have access to
the essential medicines they need; that the medicines are safe, effective,
and of good quality; and that medicines are prescribed and used rationally.
The International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH) is a unique project
that brings together the regulatory authorities of Europe, Japan and the
United States and experts from the pharmaceutical industry in the three regions
to discuss scientific and technical aspects of product registration. GMP regulations
require a quality approach to manufacturing, enabling companies to minimize
or eliminate instances of contamination, mix-ups, and errors. Most GMP requirements
are very general and open-ended, allowing each manufacturer to decide individually
how to best implement the necessary controls. This provides much flexibility,
but also requires that the manufacturer interpret the requirements in a manner
which makes sense for each individual business.
The symposium discussed in detail about the GMPs in Chemical, Biotech and
Sterile in three concurrent tracks. All the sessions were highly interactive
in nature. All the speakers and the directors of ISPE accommodated the queries
from the 200 participants at the concluding ceremony.
The track one session on Chemical chaired by Mr. J.J. Sipahimalani, CMA
Laboratories and the speakers were Mr. Tom Cupps, Associate Director Chemical
Dev. Procter & Gamble Pharmaceuticals and Mr. Nada Kuganathan, Associate
Director, Technical Projects, Corporate Quality Assurance, Watson Pharmaceuticals
Inc. Mr. Nada Kuganathan interacted through video conference from California,
US.
Dr. D.B. Patankar, Intas Pharmaceuticals, chaired the track two session
on Biotech. Dr. Holy Haughney, Vice President, Pall Biopharmaceuticals Marketing
Asia, Dr. Dominic Arnold, Biotechnology Engineer & Director, R&D,
Pall Life Sciences Singapore, Dr. Pankaj Tahiliani, SLS Manager, Pall India,
and Dr. S C Singhai, VP Projects, Dr. Reddy's Laboratories Ltd were the speakers.
The track three session on Steriles was chaired by Dr. P.G.Shrotriya, Elite
Consultancy Services, and the speaker was Gordon Farquharson, Principal Consultant
Technology, Bovis Lend Lease Limited.
GMP is also sometimes referred to as "cGMP". The "c" stands for "current,"
reminding manufacturers that they must employ technologies and systems which
are up-to-date in order to comply with the regulation. ISPE offers education
and training, as well as on-site training to help professionals and organizations
comply with all aspects of GMP.
The symposium highlighted the emerging need for GMP compliance. In the Indian
Pharma industry, companies who reach Rs. 70 to 80 crore turnover with excellent
manufacturing facilities prefer to enter European markets. As a matter-of-fact,
these companies lack support from top management to bring change in attitude
and perception. Having created something excellent by itself is not the end
of it. Maintaining those standards becomes more paramount. The point of concern
here is a company cannot have one set of standards for the Indian market and
another for the European or US markets. It will be very difficult for any
management to manage this. It will become critical when an international regulatory
agency inspects them.
Expressing concern, Dr. P.G. Shrotriya, said: "The shift from 'manage mode'
to 'compliance mode' has to be complete and sincere. The documentation prepared
in compliance with the international regulatory agency requirement has to
be practiced. If it is not practiced, the company is thoroughly exposed as
the experiences of many regulatory authorities suggest."
The response seems to be forthcoming as the interactive sessions stretched
beyond the schedule. S.K. Thillai Chidambaram, Manager, QA, Shasun Chemicals
and Drugs Ltd, Chennai, a participant said: "The interpretation of the various
norms from the regulatory authorities' perspective was highly educative. Experts
from not only India but also from abroad put forth their views convincingly.
For youngsters like us this was a great opportunity to update our knowledge
base. We request ISPE to organize this type of symposiums on a regular basis.
We want ISPE to facilitate more regular interaction through internet. We would
like to see Q&A session on ISPE website."
Gopal K Nair, CEO, Grasp Enterprise, responded positively. "This is a very
good idea. The only problem is we are in Mumbai alone. All our volunteers
are working from here only. As we grow, we would certainly like to implement
this. It is worth doing."
Balwant Grewal, Vice President of Asia Pacific Operations, ISPE, Singapore,
elaborated further. "This is in sync with the Communities of Practice, an
ISPE initiative. The queries related to a specific segment in Pharma manufacturing
would be posted and the same would be discussed and clarified by experts.
"
"The CoPs has been launched by our other affiliates. We have CoPs on Active
Pharmaceutical Ingredients (API), Biotechnology, Clinical Materials (CM),
Commissioning and Qualification (C&Q), Containment, Critical Utilities
(CU), Good Automated Manufacturing Practice (GAMP), Investigational
Medicinal Products (IMP), Process Analytical Technology (PAT), Process/Product
Development (PPD), Project Management (PM) and Sterile Products Processing
(SPP)," adds Gopal K Nair.
"ISPE has signed an MoU with Bombay College of Pharmacy to start a post
graduate course which will be a diploma course in Pharmaceutical Engineering
and later on may be a degree course. The course will cover all aspects of
industry like manufacturing operations, designs, validation and all those
relevant to the industry. A fresh pharmacy graduate or postgraduate, who
is not fit to work in the real time environment, will be benefited," elaborated
Gopal K Nair.
In the Indian context, there exist a big gap between the academia and industry.
The academia has to update the curriculum to meet the contemporary requirements
of the industry. "This is a major concern and the academia should accept the
need for change management. My interactions with the undergraduates, graduates
and middle level executives over the years have made me understand the existing
gulf," concurs Dr. P.G. Shrotriya, ISPE Director.
Pradnya C. Deshmukh, Deputy General Manager Quality, IPCA Laboratories
Ltd, Mumbai, said that ISPE has to offer more opportunities for the active
members to express their views. Highlighting the significance of harmonization,
Dr. P.G. Shrotriya, said: "harmonisation is extremely critical for a country
like us. We are at a takeoff stage. Indian Pharma industry has a tremendous
opportunity to enter into the regulatory market like Europe or US or Australia
or Canada. However it is very important for us to accept the international
regulatory authority guidelines. Unless we accept that and we have compliance
too to the regulatory requirements of these countries, it would be pretty
difficult to enter these markets. That is why harmonization becomes very critical.
We are not lagging behind too."
Around 70 to 80 Indian companies are approved by FDA and a similar number
by EMEA. But this is confined to a very small segment of the Pharma industry.
Another opportunity which is there at door step of Indian Pharma industry
is outsourcing. The industry has to gear up itself to outsourcing too. "If
some manufacturer in US or Europe wants us to manufacture a product and export
the same to their countries on their licenses we have to have that level of
quality and concept. We must be prepared to change. Bring in the change by
being contemporary and meet the international regulatory requirements," sums
up Dr. Shrotriya.
The Indian affiliate of ISPE has made its presence felt in a very short
span of time. A. Siva Prasad, Asst. Manager - Sales, Pam Pac Machines Pvt
Ltd, ACG Worldwide, said that the symposium has brought a perceptive change
in his approach towards Pharma engineering. P.M. Naik, Project Director,
Cadila Healthcare Limited, Mumbai has this to say. "This symposium on ICHQ7A
guidelines focuses on the upgradation of the regulatory requirements for
harmonization. The symposium is highly informative. As the Biotech industry
is in the evolution stage, I hope, in future, more knowledge sharing will
be made possible in Biotech sector."
L.K. Pradhan, Associate Vice President, Manufacturing, Wockhardt Limited
said: "This symposium is a very good platform for knowledge sharing. ISPE
has brought qualitative knowledge about GMPs to our doorstep which otherwise
would cost us a lot if we go to Europe and America. The symposiums being organized
by ISPE during the last two years are of high quality. These are very useful
for industry, academia and research institutions."
D. Ravichandran, Assistant Manager, OA Corporate, Shasun Research
Centre, Chennai, said: "The interactive sessions at this symposium were great.
It was a learning experience as experts came forward to share their expertise
and experience."
Dr. A.K. Singal, ISPE Director & Managing Director, Pharmaplan, is buoyant.
"The message I have for the Indian pharmaceutical industry is good times are
here again and for the rest of the world it is India calling. If you want
cheaper outsourcing and if you want equal quality product at an affordable
price and you want to make profits, come to India and start manufacturing."
He added: "ISPE is purely an academic not-for-profit organisation. We advocate
and practice in knowledge transmission in the best possible way. That is our
motto."
R. Gopinath, Assistant Manager, Quality Control, Dr. Reddy's Laboratories
Ltd, echoes the feelings of middle level management and the generation next.
He said, "the experience and the expertise are shared here. I attended the
Biotech session. It was highly interactive and helped us a great deal in refreshing
ourselves about key issues on validation. Understanding and exposure to the
global standards helps people who are fresh from the universities."
S. Kuppuswamy, Senior Scientist, APL Research Centre, A division of Aurobindo
Pharma Ltd, Hyderabad, summed up the response to the symposium with the saying:
"The wisest man on earth is yet to learn something." He said that this symposium
helped a lot in filling the gaps in interpreting the available information
and broadening the knowledge base. Dr. Niraj Bansal, Deputy General Manager-QA,
Macleods Pharmaceuticals Ltd, Daman, appreciated the efforts of ISPE. He said,
"symposium of this kind provide one stop solutions for the Pharma industry.
It provides current insights into Pharma engineering. The interactive sessions
were good."
The ISPE India's ICHQ7A symposium clearly highlighted the growing needs
of the Indian Pharma industry. As Dr. Reddy's COO & MD rightly said in
his keynote address, the Indian Pharma industry is all set to conquer globally.
All it needs to do is become GMP compliant and ISPE India has to play a major
role in that direction.
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