Quality in Pharma & Bio-technology

Driven by increasing affordability, shifting disease pattern and modest healthcare and services in the country growing at a compounded annual rate of 14% from 2000-2005, the Pharmaceutical industry accounts for 15-20% of the total healthcare spent, growing at a compound rate of 9%.

Analysis shows that if the Indian economy continues on its high current growth path, the Indian Pharmaceutical market will undergo a major transformation in the next decade. The market will triple to USD 20 billion by 2015 and move into the world’s ten top Pharmaceutical market compounding to an annual growth rate of 12.3 %. India along with Japan, Canada and UK will move to the next level with USA and Chine with a growth expectation of USD 20-23 billion by 2015.

Looking at the above scenario, Indian Pharmaceutical industry will require a large group of highly trained professionals to bring about a change required for achieving such high goal. Hence it is imperative that to attain the projected business volumes, India needs to invest heavily in two segments i.e.,

·          Infrastructure in high end manufacturing and testing facility

·          Focused training as per international standards for effective global presence.

CII’s vision for 2020 is not only to position India in the first 5 countries in the global Pharma and Biotech sector contributing 20% of the economic growth, but also to showcase its national Pharma/Biotech industry for enhancement of knowledge and skills at the international level. Consequently, CII_IQ has drawn up an ambitious road map to transcend business driven research-to-research driven business. The immediate milestone to be crossed is that of focused and tailor made training programmes for the Pharma/Biotech industry within India for enhancement of knowledge and skills to international level.

Deliverable

 

Consequently, CII_IQ has entered into a MOU with Mandava Associates of USA to provide consultancy and organize high-end training in different areas if Pharma and Biotechnology. Mandava Associates has over 100 years combined experience in product development, product approval and regulatory services and has in-depth knowledge in the areas of Pharmaceutical, Biotechnology, Biologics and medical devices. The organization has a successful track record of handling applications and submissions for marketing and authorization to regulatory authorities worldwide.

Future Plans

 

CII_IQ is also planning to work closely with Confederation of Indian Pharma Industry (CIPI) to promote basic training programmes for SME sectors in different Pharma/Biotech clusters in India. To begin with, CII_IQ has conducted in-house training programmes in the area of cGMP, international cGMP, computer validation, Pharmaco vigilance and Epidemology  and advances in Clinical Trials with Jubilant Organosys, Shashun, Lotus, Dabur, Reddy’s Labaoratories and Lamda Therapeutics.

CII-IQ has already chalked plans to conduct 8 in-house training programmes in Good Pharma Practices (GPP), 6 programmes on Quality Assurance and Audit (QAA) and 4 inhouse programmes on Pharma Resource Building (PRB) during 2008-2009 for high end Pharma and Biotech Industry. It is also planning to conduct 12 open house programmes for the SME clusters in association with CIPI out of which 6 programmes will be supported by Quality Council of India.