Indian pharmaceutical companies and their subsidiaries have successfully spread their presence in the global generic markets and have entrenched themselves in all the three types of markets, viz., matured generic markets (eg. USA, UK, Germany), early generics markets (Eg. Italy, Spain, France, Japan) & emerging generics markets (eg. Brazil, China, Turkey, Hungary). The Indian companies have received 178 Abbreviated New Drug Applications (ANDAs) approvals from US Food & Drug Administration (FDA) as compared to 144 in the previous year despite stringent approval norms. The US FDA granted a total of 476 ANDAs approvals during the year 2012 as against 431 approvals in the previous year. Of these total US FDA approvals, Indian companies grabbed 37.4 per cent approvals in 2012 as against 33.4 per cent in the last year.

The generic opportunity is not without its own share of challenges. High competition from local companies, competition from the innovator brand, low pricing, quality issues, shrinking profit margins and at times regulatory hassles are some of the main challenges faced by the generics industry.

To overcome these challenges, many generic manufacturers have adopted different strategies. Companies have used new technology platforms, new components and new configurations to provide better patient compliance and increase patient’s quality of life. Super generics, biosimilars, bio-superiors, NDDS and value added formulations are some of the new product alternatives that have emerged. Thus, competition is being tackled with enhanced value proposition and product differentiation.

The pulse of Indian companies in this dynamic generics scenario was explored by Interlink Knowledge Cell which conducted a brief survey of five leading pharma experts for their opinion on the above. Findings of this exclusive survey are discussed below.

Markets catered to Indian companies are mainly catering to the generic markets in the regulated markets such as USA, UK and emerging markets such as Brazil, South Africa, China, Turkey etc. Our experts opined that while registration in non-regulated markets is relatively simpler, that in regulated markets is very challenging. Each ANDA application does involve a lot of time, effort and expense for the applicant organisation to bear. So, in regulated markets the number of players is comparatively lesser than in un-regulated markets. The easier the registration process, the stronger is the level of generic competition.

The decision on which markets to enter ultimately rests with the organisation, based on resources available. Typically, the top 50 companies focus on regulated markets while the rest find it easier to enter the non-regulated markets.

Type of products offered
Unanimously all the five experts concurred that India specialises mainly in offering the identical generic version of the original product, particularly of antibiotics, cardio-vascular drugs, etc.

Developing a NDDS version of the original product is not ‘everybody’s cup of tea’ as it involves a high degree of scientific competence of the R&D team. Offering generics that are difficult to develop (eg. Patches, Pulmonary devices, special topical forms, etc) are also not common from Indian companies. A few top Indian companies are working on biosimilars.

Challenges faced in generic marketing
The most important challenges in generic marketing were the tough competition from the innovator brand followed by the low pricing and low margins. Competition from other brands was not rated as a major challenge. As regards regulations, experts cited that, ‘getting approvals from the regulatory bodies’ is also a difficult issue that they face, particularly in the regulated markets and in China. Other challenges faced include patent battles with the innovator brand with its long drawn legal proceedings and at times, rejection due to quality issues.

Steps to take for meeting these challenges
Indian companies are taking multiple steps towards tackling these challenges. These steps are on the following fronts; management mindset from average volume, high margin to above average volume and meagre volume where quantum of margin would be higher. Upgrading Manufacturing plants to standards of US FDA, upgrading the registration department and documentation processes, hiring / training competency of people in these areas, implementing strict QA / QC norms are some of the important steps that organizations can take. Conduct BE / BA studies for all exported generics.

One of our experts also felt that the industry must take onus of ensuring quality checks periodically of exported generics from the country, by creating a new independent monitoring mechanism.

Difficulties faced when implementing these solutions
It was expressed that, while the top companies have adequate financial resources to implement the above mentioned steps, the smaller Indian companies face this constraint and do get caught up in a difficult situation. The entire industry gets a bad image if the quality of even a few Indian-made generics is poor. Monitoring the quality is a major issue. In developing countries, the government is often the major purchaser due to shrinking availability of funds for healthcare and due to ageing population. Getting orders from these governments is getting very difficult.

In conclusion, Indian companies do have a challenging time in choosing the path ahead for their generic business, particularly with regards to the markets they choose and the resources they can make available to enter the more mature western markets.