With drugs going off patent over the next three years valued at around a whopping Rs 3,20,000 crore (US$ 80 billion) and also increased penetration of generics in the global market, Indian pharmaceutical industry sees a great opportunity and various stakeholders are gearing up to obtain a share in the pie that appears to be lucrative. Further, the industry fully realizes that the opportunity that arises could be exploited fully provided critical knowledge gaps could be bridged across the domain.

Going by this, the  need of the hour is introduction of value-added courses at the  post graduate  level and upgradation of undergraduate curriculum by introducing topics like pharmaceutical project management  and supply chain management that would help students to acquire skills in documentation, comprehensive understanding of engineering drawings, internal audits, project execution, regulatory aspects and Intellectual Property Rights among others.

According to Kaushik Desai, chairman,  Industrial Pharmacy Division,  Indian Pharmaceutical Association, there is a need to revise syllabus. This should be done to ensure that ICH Guidelines with new regulatory additions like risk assessment, Q8, Q9 and Q10 are covered.

Likewise, Desai stated that  industrial pharmacy graduates need to be armed with know-how on the principles of Quality by Design (QbD), Validation and Calibration processes, in addition to Regulatory Affairs  on  Guidance documents, Technology Transfer & Pilot Plant Scale-up studies.

There is also need for industrial training for teachers, participation of industry experts in curriculum development, utilization  of retired Industry personnel in colleges, and  Industry – Institute partnership, he added.

Key strengths of the Indian pharma are the strong manufacturing base, cost competitiveness,  R&D infrastructure, highly trained pool of scientists and professionals,  solid process development skills, highest quality approvals from regulatory authorities  including  US FDA, EDQM and  MHRA. The country is also an important centre for clinical trials.

The major growth segments  are contract research , export of both bulk drugs and formulations, clinical research, pharmacoeconomics , information technology and Intellectual Property Rights.

According to the  IMS Health Market Prognosis, March 2010, the global pharma market in 2002 was US $515 billion and in 2009 was $ 837 billion. The Indian pharma industry in 2009, recorded an annual turnover of  Rs 48,000 crore (US$ 12 billion) with a  growth rate of 12 per cent. The exports was Rs 38,000 crore (US$ 9.5 billion) with a growth of  20 per cent  among  200 countries. In terms of global ranking for volumes India is ranked third and is in the 14th slot in terms of value. 

The country has the largest number of US FDA approved facilities outside USA  with  over 140 plants and more than 1,000 WHO GMP approved facilities. The total number of units are 4,500 with 400 companies in the large and medium sector. There are 60,000 formulations in 60 categories produced in India. The OTC Market is valued at Rs 12,000 crore (US$ 3.0 billion) registering a growth of  31 per cent annually. The fastest growing segments are diabetic, cardiovascular, central nervous system,  anti ulcerants, oncology and  lipid regulators.

Indian pharma industry turnover is likely to touch Rs 200,000 crore (US $50 billion) by 2015, with  domestic formulations  expected to account for around  Rs 88,000 crore (US $ 22 billion).