The Indian pharmaceuticals market has become the largest exporter of medicines by volume. India is the largest provider of generic drugs globally with the Indian generics accounting for 20 per cent of global exports in terms of volume. In terms of market size, the Indian pharma industry, which is expected to grow over 15 per cent per annum between 2015 and 2020, will outperform the global pharma industry, which is set to grow at an annual rate of 5 per cent between the same period. The market is expected to grow to US$55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by its size.
While talking about the beginning of Indian pharmaceutical industry, it begun in the late 50s and early 60s, out of the need to meet local shortages and bring down the cost. At that time, most medicines were imported into India and market was dominated by MNCs. Once domestic market was conquered by local companies, there was a need to spread their wings in international market in late 80s and early 90s. By late 2000, over 50 per cent revenue for major Indian manufacturers was from International markets.
Looking at the early years, the Indian pharmaceutical industry in 1950s had limited resource and opportunities, with few technological capabilities to manufacture modern drugs, locally. In order to tackle this situation and overcome the challenges, Indian entrepreneurs received an enormous support from the government to fill this void in the pharmaceutical industry. As a result, pharmaceutical industry in India turned to a mass production of generics of every imaginable nature.
The pharma industry in India emerged as the most dynamic technological content segment in the Indian manufacturing in the 1990s. In the span of three decades from the 1950s through the 1970s, the Indian pharmaceutical industry has grown from its formerly meager existence, with a low production base, heavy dependence on imports, domination by foreign firms and high prices of drugs, to being one of the largest pharmaceutical industries in the world.
Indian pharmaceutical industry at present
Over the years in this journey from 1950s to 2010 Indian pharmaceutical industry has added several feathers to its growth crown (see figure 1).
In this period, the Indian pharmaceuticals market has become the largest exporter of medicines by volume. India is the largest provider of generic drugs globally with the Indian generics accounting for 20 per cent of global exports in terms of volume. In terms of market size, the Indian pharma industry, which is expected to grow over 15 per cent per annum between 2015 and 2020, will outperform the global pharma industry, which is set to grow at an annual rate of 5 per cent between the same period. The market is expected to grow to US$55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by its size.
Also, the world’s largest number of US Food and Drug Administration (USFDA) approved factories outside the USA are located in India. Overall drug approvals given by the USFDA to Indian companies have nearly doubled to 201 in FY 2015-16 from 109 in FY 2014-15 (see figure 2).
With any success also come challenges and setbacks, as today, Indian pharma industry is well established and present in all global markets.
Current Challenges Regulations
Keeping in mind the sheer number of SRA (Stringent Regulatory Authority) approved facilities in India, the pharma industry is bound to become the centre of attention by many authorities. Currently, there is a fierce increase in the number of companies receiving a notice or warning letters (see figure 3).
There’s no simple solution to this, but following are some points that can bring these incidents down:
a. Training local regulatory inspectors to perform inspections of international levels. This way many deficiencies can be identified and addressed locally, without it becoming a Global News ‘Item’.
b. The Local Regulatory body i.e. CDSCO and State FDA needs to get Accredited by WHO and India should join PICs, this will automatically raise the bar of local regulators. We cannot expect our companies and facilities to be world class while our regulators are way behind.
c. Proactive quality approach - while many pharma companies in India are already working in this direction, the challenge is to get the industry thinking on these lines, as well. International requirements of ADR, Pharmacovigilance etc. should be made mandatory for domestic markets, too. At present, 80 per cent pharma companies maintain this infrastructure for international markets. Making it mandatory for domestic market as well will increase the quality perception of Indian market in International arena.
Today, one of the biggest concerns of International clients, regulators and agencies is quality of Indian medicines. Internationally, India’s generic medicine industry has been questioned for compromising on product quality. The Indian pharmaceutical industry is the largest supplier of cost-effective generic medicines to the developed world. With the widest range of medicines available for exports and with the availability of the largest number of approved pharmaceutical manufacturing facilities, India is all set to become the leader of pharmaceutical exports to the world.
Until product quality control is not introduced in the domestic market, India’s international image will not improve. The country’s medicine industry has to put its house in order and the government should monitor it stringently.
A considerable amount of domestically available (medicines meant for Indian market) get exported to other countries from India. According to IBEF, the domestic Indian pharmaceutical industry is estimated to be US$26 billion in 2014 growing at nearly 20 percent and is expected to reach nearly US$50 billion in 2020.
As compared to international markets, quality requirements for domestic markets are pretty lax, but when the similar medicine stock is exported, Indian image takes a beating. In short, the quality parameters for international markets and domestic market should be bought on par. Once, the effective quality check and control system is set for domestic market, it can automatically reflect internationally.
Biosimilars were envisaged as the ‘Next Frontier’ the next ‘Engine of Growth’ but sadly almost all biosimilars approved in India are facing a challenge in court by innovators.
Our domestic home grown pharma companies are in a race to be the ‘First’ in the market, disregarding the basic principle of biosimilar i.e. similars are not exact copy like a synthetic generic molecule, and further push our regulators to approve these formulations without adequate supporting documents.
The right way for Bio Similar development should be followed i.e. it should be similar in therapeutic effect but not exact copy of the molecular structure, and demonstrable QSE profile and adequate multi-centric trials. If we get the biosimilar equation right, it will be the next growth engine for the industry.
Quality lapses and human resource in pharma industry:
With the Indian pharma industry’s personnel turnover at 33 per cent, every three years, there is a completely new staff in a company. The attrition rate in the pharma industry is extremely high.
Pharma is one of the world’s most paperwork-intensive industries. It is also one of the world’s most scrutinised industries. It is a very people-sensitive industry, wherein a well-being and health of a human being matters a lot.
So how does a company maintain quality in the absence of skilled staff? In my experience of having worked in the industry for 15 years, I have noticed a general lack of responsibility amongst people. They don’t want to take responsibility for their actions.
To train a single person on good manufacturing practices for pharmaceutical products - GMP principles takes one year and cost over Rupees 5,00,000 in training costs. This trained person can only start contributing positively by the 2nd year and by this point he is already looking for another job in the market. If we intent to pay attention to quality, this is impossible until the brain drain in the industry is not addressed.
In the pharma industry, quality work cannot be automated, it needs manual intervention and until the employees start sticking around for a min of 8 to 10 years, it is impossible to achieve lasting success in this field.
Inflexion point and role of government
In early 2000, the Indian pharma industry was climbing the growth ladder with increasing USFDA approval, and rising stocks of pharma companies. And now it’s time for USFDA to conduct follow up inspections.
Today, in the given situation, the future of the industry depends on how we react and address today’s challenges. In order to strengthen the ties of the pharma industry, we need a national policy on pharmaceuticals and government’s intervention is the areas needed. In this case, on the other hand, distracting pharma companies with DPCP, NDPO etc… are not the solution. The government should become the facilitator in the industry, get our local regulators accredited and lay the foundation for industry to prosper.
With these changes, we are certain that the international inspections will reduce by over 90 per cent if our national regular is WHO accredited and we are members of Pharmaceutical Inspection Co-operation Scheme (PICS).