Irrational price control, inadequate regulatory standards along with lack of resources to compete with MNCs for new drug discovery research are key issues impacting the growth of the Indian pharma industry, according to industry experts.

The sector, which has registered revenues to the tune of Rs.84,000 crore or US$ 21 billion with an annual growth of 13 per cent, has a formidable task of anticipating where it is heading.

As a pre-cursor to the 63rd Indian Pharmaceutical Congress (IPC) being held in Bangalore from December 16-18, 2011 industry experts told Pharmabiz that dealing with the Drug Price Control Order (DPCO) was a major challenge.

Irrational price control is continuing to plague the pharma Industry, stated Madhusudan V, Global Operations, Banner Pharmacaps, US.

The industry has to deal with the DPCO and is yet to understand the impact of the new proposed pricing policy. In order to counter the negative impact, the pharma industry would need to develop a global mindset for quality and adopting the Quality Management System-based and Risk-based approaches for implementation of Good Manufacturing Practices, stated SM Mudda, chairman, scientific services Local Organizing Committee and executive director- Technical & Operations, Micro Labs Limited.

Going hand- in-hand with the DPCO issues are low investments in innovative R&D which has always taken the back seat amongst Indian pharmaceutical companies. In order to stay competitive in the future, Indian companies will have to refocus and invest heavily in R&D. Another issue is the paucity of resources to compete with multinational companies for new drug discovery research and to commercialize molecules on a global basis, added Mudda.

According to Suresh Khanna, Honorary Joint Secretary, Local Organizing Committee of 63rd IPC and chairman, Stabicon Lifesciences Pvt Ltd., drugs need to be manufactured at economies-of- scale. There is need for proactive support from government in policies and speedy execution at all levels to bring in the desired competitive edge. This would support the cost advantage to domestic market as well as at the international market.

Airing views on a negative sentiment was Dr Premnath Shenoy, Hon. Secretary, Karnataka Drugs & Pharmaceutical Manufacturers Association (KDPMA) who said that frequent changes in the guidelines from regulators lead to a lack of clarity, inconsistency in implementation of Drugs & Cosmetic Rules in different states. Other hindrances are lack of good infrastructure including clean power and water as well as industry employable graduates.

However, now the Industry has the option of getting out of the price control by focusing on exports. For this the industry would need to lay emphasis on meeting the ‘soft requirements’ of developed markets which cover adherence to timelines, transparency, confidentiality and build value system at all levels to ensure that India is able to be recognized as the pharma powerhouse, pointed out Madhusudhan.