The Indian pharma industry’s thrust on strengthening compliance during international regulatory audits, along with the Union government’s move to device a legislation making it mandatory for the doctors to prescribe generic drugs , is expected to accelerate the growth momentum of this sector.
The country is already the pharmacy of the world. Every third drug prescribed globally is from India. Now under the US President Trump administration, there will be more demand for generics.
The US healthcare is already driven by medical insurance and this will generate the need for high quality, cost effective generic drugs.
There is a renewed focus by the Indian pharma industry on strengthening regulatory affairs, embed quality management system and enforce the intellectual property rights (IPR) regime. All this will provide the much needed confidence to foreign investors. This is also in sync with the Union government’s FDI policy to attract 100 per cent via automatic route. The drugs and pharmaceuticals sector attracted cumulative FDI inflows worth US$ 13.32 billion between April 2000 and September 2015, according to the data released by the Department of Industrial Policy and Promotion (DIPP).
The US $20 billion Indian pharmaceutical industry which is expected to touch US$ 55 billion in 2020, is likely to witness a slew of changes soon. These include consolidation, decrease in imports of bulk drugs and setting up dedicated pharma parks and clusters.
The Union government had unveiled 'Pharma Vision 2020' aimed at making India a global leader in end-to-end drug manufacture. Approval time for new facilities has been reduced to boost investments. Further, the government introduced mechanisms such as the Drug Price Control Order and the National Pharmaceutical Pricing Authority to deal with the issue of affordability and availability of medicines.
India with 30,000 brands and 14,000 medical devices is the third largest in terms of volume and 13th largest in terms of value. The country has proved its capability in drug production and also as an enabler for healthcare.
Need for stable regulatory environ
There is need for a stable regulatory environment to facilitate ease of approvals. The industry looks forward to harmonize regulatory frame work. It has also recommended higher level of transparency from the NPPA. The need of the hour is a better clarity on the pricing norms. “We need to strengthen the quality standards, sustain our cost advantage and build next generation capabilities across the industry. Therefore there is a need for speedy decisions from the government to fast forward and plan our future strategy,”said Pankaj Patel, president, Federation of Indian Chambers of Commerce & Industry(Ficci).
The industry will now need to narrow the skill gap and embark on regular training. India is already known for its excellence in information technology and pharmaceuticals. The two sectors need to collaborate and propel compliance of regulations, embark on minimal human interface for manufacture and exhibit high level of technology adoption, said Kaushik Desai, Hon. Secretary, Indian Pharmaceutical Association and pharma consultant.
The industry needs to focus on collaboration to drive innovation, network to strengthen its position in the international market and create an eco system with government support.
According to the Ficci president, the industry recommends a stable and predictable price regime which is in line with pharmaceutical policy 2012. “This will help the industry to plan their business in future. The next is on retrospective pricing issue and the DPCO amendment. Industry fully supports the government to ensure that notified prices are implemented as per the DPCO 2013. But various challenges exist in implementing the revised ceiling prices on pre-manufactured stocks. We have submitted a representation to the government with certain practical options. Its outcome is keenly awaited by the industry”, he said.
In order to encourage the API industry, the government should explore setting up of clusters for API and intermediates to enable manufacture of next generation drug ingredients. This will help the sector to remain at the forefront of technology and differentiate itself from the other players. Ficci has been working with the govt departments closely, he added.
The cost advantage and availability of quality technical talent will boost Indian pharma industry’s growth prospects in the regulated markets of US and EU, said Dilip Surana, Chairman & Managing Director, Micro Labs Limited.
Though in the wake of US President Donald Trump’s policies and the Brexit in the EU, speculations are rife that Indian pharma industry would be affected, the Micro Labs chief does not see these issues impacting expansions.
“All said and done, the cost advantage is a big plus for India. Next is the availability of technical manpower and the Indian pharma industry is well developed. So it is obvious that products have to be manufactured in India. Now in the case of developments like President Trump and Brexit everybody wants to make products from within their country, said Surana.
Shifting of DOP & NPPA, a game changer
Union government’s plan to shift the department of pharmaceuticals and NPPA under the Ministry of health could turn out to be a major administrative step in the Indian healthcare landscape, noted Industry experts. They view it as a game changer for the sector provided its happens in a time bound manner.
According to Dr B R Jagashetty, former National Adviser (Drugs Control) to MoHFW & CDSCO and former Karnataka drugs controller, all issues related to medicines be it biotech, Ayush and veterinary should come under the umbrella of the Ministry of Health and Family Welfare(MoHFW).
“Though there is nothing wrong in having a separate full-fledged Ministry combining the issues of both drugs and food like that of Maharashtra, the present decision to bring DoP and the NPPA under the MoHFW instead of having a separate ministry of pharmaceuticals, is relevant and a welcome move. However, its implementation needs to be fast-tracked,” said Dr. Jagashetty.
Currently, biotech is under the information technology department. Now this sector deals with fermentation technology for the development of monoclonal antibodies which needs drug approvals. Therefore it should also come under MoHFW, he added.
Kaushik Desai, Gen. Secretary, Indian Pharmaceutical Association and pharma consultant noted the if the move materialises, it is laudable. There will be only one ministry accountable for making quality medicines affordable and accessible. It will result in better interdepartmental co-ordination between NPPA, CDSCO and DoP. If done effectively, it will help in ease of doing business in the true sense and support industrial growth.
Viewing the proposed move by PMO to bring NPPA & DOP along with CDSCO as a step in the right direction, Harish Jain, secretary, Karnataka Drugs and Pharmaceutical Manufacturers Association pointed out that it would lead to better co-ordination and avoid duplication of efforts.
“However, whether all these departments should come under Health Ministry is open to debate. Instead, PMO should look at total revamp rather than adopt a partial approach. There should be a mega ministry of life sciences comprising pharmaceuticals, Ayush, vaccines & sera, biopharmaceuticals, medical devices and nutraceuticals, headed by a minister of cabinet rank. It can oversee licensing, testing enforcement, NIPER, export promotion councils, Jan Aushadhi, besides create appellate tribunals for speedy settlement of disputes", said Jain.
Skill upgrade initiatives
Indian pharmaceutical industry should commence its skill upgrade initiatives . This is as per the August 2016 guidance by the Drug Controller General of India which had issued a circular stipulating the deadline at January 1, 2018. The industry should now upgrade skills sets of persons employed in their units, according to Life Sciences Sector Skill Development Council (LSSSDC) set up under auspices of Ministry of Skill Development.
“India workforce stands at 3.7per cent in terms of the National Occupation Standards laid down while it is 97 per cent in South Korea and 50 per cent in China.
The developed countries also have a very high rate as the low rate out- weighs the other factors in the economy ,we cannot compromise on the same,” said Ranjit Madan, chief executive officer of Life Sciences Sector Skill Development Council, while speaking at the launch of skill development project in Maharashtra.
Scouting for digital marketing personnel
Indian pharma companies are currently facing a dual challenge of hiring and creating a digital marketing sales team. On the one hand the companies are under huge pressure for promoting their products & services , on the other to access the right tech and marketing savvy teams to approach customer engagement.
With changing times, the ideology of customers is no longer to interact and connect with sales representatives. Their reduction in sales call rates is increasingly expensive and has lost its core value of interaction. Also with increasing inquisitiveness of consumers to fetch direct information indicates that they are more interested in obtaining medical information and engaging with clinicians than meeting with promotional representatives.
More promising in the area of specialist medicine, is digital interaction which are proven to be far more effective at a fraction of cost. Even partial adoption of digital can reduce promotional costs by between 20 and 50 per cent. So companies need to divert and spread their channels, said Munira Loliwala, Business Head – EMPI (Engineering, Manufacturing, Process/Pharmaceuticals & Infrastructure), TeamLease.
According to Uma Nandan Misra, dean, Pharmacy Training Institute, Bengaluru, India has moved well in digitisation . Top 250 pharma companies are fairly well entrenched in this space. This industry exports to 220 countries and with change in regulations and demand for transparency. Being tech savvy can help this sector to thrive. Moreover, digitization in global pharma companies is mostly led by those of Indian origin.
Majority of today’s Healthcare Professionals (HCP) are digital natives, which means that there is already sufficient access to tech platforms and online tools. More than 86 per cent of the HCP carry smartphones and almost 50 per cent carry tablets to work. The need for pharma companies is to bridge this gap between them and the HCPs to reach the target audience. Companies would need to re-examine their approach and strategy to engage with such talent, noted Loliwala.
The need of the hour is drug product specific training and this includes digital technology. Currently in pharma companies, it is a mix of veterans in sales along with a young agile tech savvy brigade who are way ahead in digital technology. However, qualifications in pharma and biotechnology are much desired to succeed, noted Misra.